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International Stem Cell Corporation Reports Significant Progress Towards Creation of the First Bank of Immune-Matched Human Parthenogenetic Stem Cells

§ October 11th, 2010 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation Reports Significant Progress Towards Creation of the First Bank of Immune-Matched Human Parthenogenetic Stem Cells

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, announced today that its oocyte collection and activation protocol has received the approval of an Institutional Review Board (IRB). IRB review and approval is a Federal requirement for all studies enrolling human subjects, and ensures appropriate subject safety and monitoring to protect subjects from unnecessary medical risks. ‘Obtaining IRB approval for our oocyte collection and activation protocol is a major step forward towards the goal of building a viable bank of human parthenogenetic stem cells,’ said Dr. Simon Craw, Vice President of ISCO.

ISCO’s breakthrough discoveries have resulted in unique stem cells carrying distinct advantages over other human pluripotent stem cells. ISCO uses unfertilized eggs (oocytes) to create human ‘parthenogenetic’ stem cells (hpSCs). Like human embryonic stem cells (hESCs), hpSCs are pluripotent, i.e. they have the capacity to become almost any cell type in the body, yet avoid ethical issues associated with use or destruction of viable human embryos. Unlike hESCs, hpSCs can be created in a form such that they can be immunologically matched to millions of individuals. This makes possible, for the first time, the establishment of a bank containing a manageable number of stem cell lines immune matched to a large patient population.

ISCO also announced that Prof. M. Kalichman of the University of California San Diego and Director of the San Diego Research Ethics Consortium has been engaged to provide help in creating an effective system for the ethical review of ISCO’s donor recruitment processes including facilitating Stem Cell Research Oversight (SCRO) committee review and approval. SCRO committee review involves the analysis and approval of the scientific rationale, including any ethical considerations associated with stem cell research. The SCRO committee membership is mandated to include an ethicist, an assisted reproductive technology expert, appropriate scientific expertise, a patient advocate and a non-scientific member of the public.

Prof. Kalichman said, ‘I look forward to working with International Stem Cell Corporation to help with both identifying and recommending solutions to the challenges of conducting ethically responsible research with human stem cells.’

These achievements mark major milestones along ISCO’s strategic path of leveraging its discoveries and intellectual property to create a bank of immune matched pluripotent human stem cells and their therapeutic derivatives that can be used for clinical research and ultimately as a valuable medical resource to the growing field of regenerative medicine.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available at ISCO’s website, http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated technological developments and therapeutic applications, the potential benefits of collaborations, affiliations, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “should,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Simon Craw, PhD, Vice President
760-940-6383
sc@intlstemcell.com

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Kenneth Aldrich, Chairman and Co-Founder of International Stem Cell Corporation will be making two public appearances this week on behalf of ISCO.

§ October 11th, 2010 § Filed under Nano Medicine Comments Off on Kenneth Aldrich, Chairman and Co-Founder of International Stem Cell Corporation will be making two public appearances this week on behalf of ISCO.

On Monday, September 13, 2010, Mr. Aldrich will be speaking as part of a panel at the Stem Cells USA & Regenerative Medicine Congress in Philadelphia, discussing the topic, “Autologous vs. Allogeneic Business Models”.
On Wednesday, September 15, 2010 at 9:35AM EDT, Mr. Aldrich will present at the Rodman and Renshaw Annual Global Investment Conference in New York. The webcast can be viewed live at: http://www.wsw.com/webcast/rrshq18/isco.ob. The presentation will be archived and viewable at the same link for 90 days. After the Rodman and Renshaw Conference, a link to the presentation will also be posted to the ISCO website, http://www.internationalstemcell.com.
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A Primer on the Use of Stem Cells in Ophthalmology by Irving J. Arons

§ October 11th, 2010 § Filed under Nano Medicine Comments Off on A Primer on the Use of Stem Cells in Ophthalmology by Irving J. Arons

An extremely comprehensive article about stem cell programs in opthalmology by Irving J. Arons

A Primer on the Use of Stem Cells in Ophthalmology
by Irving J. Arons

I recently came across an interesting news release from International Stem Cell Corporation (ISCO) announcing that it had formed a new business unit, Cytovis, to focus on stem cell programs in ophthalmology, including CytoCor for the cornea and CytoRet for the retina.

That got me thinking about how little I knew about what was going on in stem cell research in ophthalmology, despite having written about two developments in the field, the London Project to Cure Blindness and the University of California Irvine (UCI) program to develop an artificial retina based on stem cell research.

I decided to become better informed by taking a closer look at what was happening in this field, and presenting that story.

Introduction
Commenting on a EuroRetina Meeting held earlier in 2008, John Morrow of Newport Biotech Consultants noted, as reported by Ophthalmology Times Europe in September 2008, “Stem Cells are looked upon as either an ethical train wreck or the gateway to the alleviation of human illness, depending on which side of the political spectrum one resides. This unfortunate notoriety has resulted in unprecedented coverage in the media, but this has not done much to advance the cause of this technology. Yet recent ophthalmologic research suggests that the medical applications of stem cells hold notable promise for the treatment of ocular degenerative conditions and that realization of this potential may come about in the near future.”

I think Dr. Morrow’s thoughts eloquently sum up the subject. Stem cell research is politically charged but holds tremendous promise for the future, especially in ophthalmology.

What are Stem Cells?
Every organ and tissue in our bodies is made up of specialized cells that originally come from a pool of stem cells in the very early embryo (“embryonic stem cells”). Throughout our lives we rely to a much more limited degree on rare deposits of stem cells in certain areas of the body (“adult stem cells”) to regenerate organs and tissues that are injured or lost, such as our skin, our hair, our blood and the lining of our gut.

Stem cells are like a blank microchip that can be programmed to perform particular tasks. Under proper conditions, stem cells develop or “differentiate” into specialized cells that carry out a specific function, such as in the skin, muscle, liver, or in the eye. Additionally, stem cells can grow extensively without differentiating and give rise to more stem cells…

To read the full article, please visit – http://irvaronsjournal.blogspot.com/2010/09/primer-on-use-of-stem-cells-in.html

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International Stem Cell Corporation Not Adversely Affected by Stem Cell Research Funding Ban

§ October 11th, 2010 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation Not Adversely Affected by Stem Cell Research Funding Ban

OCEANSIDE, CA – August 26, 2010 – International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, announced today that the recent action of a federal district judge blocking federal funding of embryonic stem cell research is not expected to have negative effects on ISCO’s therapeutic programs using its human parthenogenetic stem cells.

According to ISCO’s Chairman Ken Aldrich, “Because we have never depended on federal or state money to fund our research, the new ruling is simply not applicable to any of our programs in the US or any of our international efforts. Although we believe anything that restricts legitimate scientific research is detrimental to science and our Country and hope the ruling is quickly reversed, the ruling could in a strange way benefit ISCO by creating additional incentives for researchers to use our parthenogenetic stem cell lines.”

Because ISCO’s technology, parthenogenesis, does not destroy or damage a viable human embryo, its parthenogenetic stem cell lines (“hpSC”) offer an alternative way to continue research previously done with embryonic cell lines without raising ethical issues about the destruction of life. Published peer-reviewed papers have shown hpSC to be “pluripotent”, a characteristic shared with embryonic stem cells that allows them to become tissues leading to all the cells found in the human body. Therefore, ISCO’s hpSC lines offer an alternative to the ethical issues that continue to be problematic for embryonic stem cells.

When enacted, legislation prohibiting the creation of a human embryo for research purposes prohibited both successful methods, such as fertilization, as well as less understood methods such as parthenogenesis. Parthenogenetic methods since developed by ISCO do not create human embryos that could become viable human beings, yet can result in pluripotent hpSC lines with potential therapeutic value. “The recent court ruling may cause Congress to revisit its legislation. If so, then ISCO’s research showing its hpSC lines present an alternative to embryonic stem cells, without raising the ethical concerns about the creation or destruction of viable human life, may lead to Congress allowing federal funding of hpSC in future legislation. ISCO would then be free to provide hpSC lines to federally-funded researchers and move more of our work back into the US from foreign jurisdictions”, said Jeffrey Janus, Senior Vice President of ISCO and one of its founders.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike all other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals across racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, develops a line of cosmeceutical products via its subsidiary Lifeline Skin Care and advances novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics do not. More information is available at ISCO’s website, http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and therapeutic applications, the potential benefits of collaborations, affiliations, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “should,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Jeffrey Janus
Sr. Vice President, Operations
760-640-6383
jjanus@intlstemcell.com

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International Stem cell Corporation Chairman Discusses Recent Stem Cell Research Funding Decision

§ October 11th, 2010 § Filed under Nano Medicine Comments Off on International Stem cell Corporation Chairman Discusses Recent Stem Cell Research Funding Decision

This is Ken Aldrich and I am Chairman of International Stem Cell Corporation and I thought I should comment briefly on the recent decision of the federal district court of the District of Columbia concerning stem cell research.

What the court did was to announce that it was prohibiting the use of federal funding by the NIH for embryonic stem cell research which is a major blow if the decision is upheld for the stem cell industry. It’s interesting because it actually does not affect International Stem Cell Corporation in any direct negative manner.

The truth of the matter is we have not been able to use federal funding since the very beginning of the company because of a particular provision in the Dickey Wicker amendment that specifically calls out parthenogenic stem cells as a form of embryo, in spite of the fact that they genuinely are not an embryo in fact cannot ever become any living human being and don’t involve the destruction of anything that could become human being. Nevertheless, we have always been caught up in the Dickey Wicker amendment. So we haven’t been hurt by this decision, if anything it has perhaps leveled the playing field for us a bit with the embryonic stem cell group.

But the bottom line is we don’t really think it is good for the country and we hope there will be a change. But we do hope is that perhaps this will open the political debate and as people begin to look at the broader spectrum and realize that parthenogenic stem cell, which is our stock and trade, do not involve the destruction of any embryos, it may be that the specific language of the Dickey Wicker amendment can ultimately be removed and we would then become eligible along with everyone else for federal funding through the NIH and other government programs. If so, it would be a wonderful result. In the meantime, it is a difficult time for everyone in the industry. We’ll keep you informed. Thank you

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International Stem Cell Corporation Formalizes Stem Cell Based Eye Care Programs into Cytovis™

§ October 11th, 2010 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation Formalizes Stem Cell Based Eye Care Programs into Cytovis™

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, today announced that its stem cell therapeutic programs focused on protective, transparent corneas (CytoCor™) in the front of the eye and the light-sensitive retinal tissue (CytoRet™) in the back of the eye will be formalized into a new business unit, Cytovis™. Together these programs will leverage external and internal development, regulatory and commercial expertise in cellular ophthalmology to form a focused portfolio of complementary product candidates designed to address high unmet medical needs with apparent pharmacoeconomic and quality of life benefits.


CytoCor is the brand name for ISCO’s corneal tissue that can be derived from the company’s proprietary parthenogenetic stem cells or commonly used embryonic stem cells. Research and development with partners Absorption Systems in the US,Sankara Nethralaya in India and Automation Partnership in the UK continues for the purpose of optimizing the tissue for transplantation in the 10 million people worldwide suffering from corneal vision impairment and as an alternative to the use of live animals and animal eyes in the $500+M market for safety testing of drugs, chemicals and consumer products. ISCO’s goal in the coming months is to establish funding and infrastructure in India for accelerated development of CytoCor for the therapeutic application and to advance and implement the chemical testing application with partners in the US and Europe.


CytoRet is the brand name for ISCO’s stem cell-derived retinal tissue. ISCO is using its parthenogenetic stem cells to develop individual retinal pigmented epithelial (‘RPE’) cells and layered retinal structures internally and in collaboration with the laboratory of Dr. Hans Keirstead, Professor of Anatomy and Neurobiology at the University of California, Irvine. ISCO recently commenced a new research collaboration with UC Irvine to launch the next phase of its retinal studies with that institution, including preclinical trials. Potential therapeutic applications include retinitis pigmentosa, an untreatable inherited disease affecting about 100,000 Americans, and the dry form of age-related macular degeneration, a major cause of blindness in the elderly of the Western world. ISCO’s goal is to establish functional proof of concept for RPE cellular therapy in models of human disease in the next twelve-eighteen months.


Jointly referred to as Cytovis (‘cyto’ for cellular, ‘vis’ for vision), these two cellular ophthalmology programs share a number of features and benefits. First, with the aging of the population worldwide and the growing number of work-related eye injuriesin India, China and other major countries, the market opportunity is growing steadily. Second, there are strong pharmacoeconomic and quality-of-life rationales for full or partial vision restoration or delay of vision impairment diseases. Third, delivery of cells and tissues to the confined anatomy of the eye inherently provides for better safety and efficacy than, for example, the systemic circulation or the central nervous system. This will likely result in lower regulatory barriers and shorter and less costly development paths compared to that of anatomically deeper and more widespread diseases. Fourth, a number of eye diseases cannot be treated with surgery or traditional small molecule or protein therapeutics, yet cell and tissue therapy is proven to work but currently limited by availability of safe and sufficient cells and tissue from human donors. Finally, eye care development programs like CytoCor and CytoRet share a number of regulatory, development and commercial aspects that make it feasible for a relatively small team to produce substantial clinical outcomes and achieve competitive presence in the marketplace alone or in collaboration with dedicated partners.


Brian Lundstrom, ISCO’s President, says: ‘ISCO’s proprietary parthenogenetic stem cell technology continues to form the foundation for the company’s long term regenerative medicine therapy programs. In the nearer term, CytoCor and CytoRet’s unique benefits in the field of cellular ophthalmology offer the potential for partnering and funding at a relatively early stage. Combined with the current and future revenue of Lifeline Cell Technology and the revenue potential of Lifeline Skin Care, scheduled for launch in the 4th quarter, Cytovis adds significantly to ISCO’s diversity and value creation potential for its investor base in a cost-efficient fashion.’


ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike all other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals across racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, develops a line of cosmeceutical products via its subsidiary Lifeline Skin Care and advances novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics do not. More information is available at ISCO’s website, http://www.internationalstemcell.com.


To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.


FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated technological developments and therapeutic applications, the potential benefits of collaborations, affiliations, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “should,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.


Key Words: Stem Cells, Biotechnology, Parthenogenesis


International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com

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Video: Summary of Recent Developments in Stem Cell and Regenerative Medicine from Kenneth Aldrich, Chairman of International Stem Cell Corporation

§ August 18th, 2010 § Filed under Nano Medicine Comments Off on Video: Summary of Recent Developments in Stem Cell and Regenerative Medicine from Kenneth Aldrich, Chairman of International Stem Cell Corporation

Greetings. This is Ken Aldrich, I am Chairman of International Stem Cell Corporation and thought I would share with you briefly some of the thoughts that I’ve had recently about developments in the stem cell and regenerative medicine area. One of the things that I have noticed from a lot of emails that we get, there is a fair amount of confusion out there about the significance of some of the new events that have taken place.

Specifically, I have gotten a lot of requests to explain what the impact of the recent announcement by Geron Corporation that they had entered FDA human trials might be. Well frankly, it is a very, very important step and one that benefits, I think, everyone in our industry and I wanted to comment on it a little bit. What that means is that one of the companies in our field has finally found the mechanism and found the procedures to begin the process of bringing cells to the clinic through human trials. So Geron, which is one of the largest companies, and has spent an enormous amount of money developing this, is now leading the path for all of us. I think we will learn from their experiences and it will make the path getting through to the FDA a lot more productive for all of us that follow.

There is another aspect to this however, that is unique to our company, International Stem Cell Corporation, in that we have also realized that the United States in only one part of the global market. And as a result, we’ve spent a lot of energy over the last year or so exploring foreign collaborations in those areas where perhaps the US is not the most attractive market. For example, we are working in India with replacing human corneas with corneas developed from our parthenogenic stem cells. The U.S. is probably not a major market for this because our systems here in this country allow for cornea transplants rather well. But in countries like India, as well as China and Korea and other places, the infrastructure doesn’t exist to harvest corneas from cadavers and deliver them and as a result, we have a wide open market there with enormous interest. I think that is one example of how the international market will impact the development of regenerative medicine.

We’re looking at that and we are looking at a variety of other areas and I’m sure other companies are doing the same. Eventually, we are all in this boat together to try to cure major diseases. We’re delighted with the progress with the FDA from companies here. We’ll be following in those footsteps when we can and we also be hopefully be leading the way in some of the international collaborations that may make all of us better off in the world of regenerative medicine.

Thank you.

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Partnership Pays Off

§ August 17th, 2010 § Filed under Nano Medicine Comments Off on Partnership Pays Off

Northern Exposure by Emmet Pierce, San Diego Business Journal, August 16, 2010. Excerpt:

An example of San Diegans collaborating with Canadians is the work that has taken place at the UC San Diego Moores Cancer Center in cooperation with research at the University of Toronto. The partnership has enabled San Diego researchers to acquire a $20 million grant to develop drugs to be used against leukemia stem cells, Barr says.Dr. Catriona Jamieson, director of the stem cell research program at the Moores center, said scientists from Toronto and San Diego share “a deep and abiding interest in cancer stem cell biology.” The Canadian consulate in San Diego was instrumental in helping to create a relationship in which both institutions would benefit, sharing information and applying for funds to support their research.

“The idea was to establish a Canada-California cancer stem cell initiative and obtain connections with Canadian funding agencies, particularly Genome Canada and the Ministry of Health,” she said.

Jamieson added, “The most important thing is it allows people with disparate abilities and backgrounds to work together on the same problem.”

Barr said the University of Toronto also was able to secure a $20 million research grant because of the collaboration, “so the team is greater than the sum of its parts.”

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FDA files injunction again Regenerative Sciences citing Regenexx violates regulations

§ August 12th, 2010 § Filed under Nano Medicine Comments Off on FDA files injunction again Regenerative Sciences citing Regenexx violates regulations

For those of you who follow this blog, you’ll imagine my surprise to wake up the morning to the following announcement from the FDA:
_____________________________________________________________
FDA NEWS RELEASE
For Immediate Release: August 6, 2010
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
Violations of current good manufacturing practice and labeling requirements cited
The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.
The company’s cultured cell product is derived from a patient’s bone marrow or fluid surrounding the patient’s joints (synovial fluid). The cells are grown, processed, and mixed with drug products outside the body before being injected back into the patient.
Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication.
“FDA recognizes the importance of the development of novel and promising new therapies,” said Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research. “However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”
The complaint for the injunction was filed Aug. 6, 2010, by the Justice Department on behalf of the FDA in the U.S. District Court for the District of Columbia, against Regenerative Sciences and three of its employees, Christopher J. Centeno, M.D., John R. Schultz, M.D., and Michelle R. Cheever. The injunction would permanently prevent the company and cited individuals from adulterating and misbranding the cultured cell product while the product, or one or more of its components, is held for sale after shipment in interstate commerce.
Regenerative Sciences has agreed to cease production of the cultured cell product while the case is pending.
The FDA warned Regenerative Sciences about its cGMP violations as recently as June 2010. The company failed to make sufficient corrections, and the conduct of the individuals cited in the complaint demonstrates refusal to comply with the law.
http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com
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Oxygen, hypoxia and the stem cell niche

§ August 7th, 2010 § Filed under Nano Medicine Comments Off on Oxygen, hypoxia and the stem cell niche

Oxygen in Stem Cell Biology: A Critical Component of the Stem Cell Niche by Ahmed Mohyeldin, Tomás Garzón-Muvdi and Alfredo Quiñones-Hinojosa, Cell Stem Cell 2010(Aug 6); 7(2): 150-61. Review. [PubMed citation][FriendFeed entry]. Via Twitter @CellStemCell: Access [to the full text] is free in August worldwide so readers can try out new enhanced online format.

Abstract:

The defining hallmark of stem cells is their ability to self-renew and maintain multipotency. This capacity depends on the balance of complex signals in their microenvironment. Low oxygen tensions (hypoxia) maintain undifferentiated states of embryonic, hematopoietic, mesenchymal, and neural stem cell phenotypes and also influence proliferation and cell-fate commitment. Recent evidence has identified a broader spectrum of stem cells influenced by hypoxia that includes cancer stem cells and induced pluripotent stem cells. These findings have important implications on our understanding of development, disease, and tissue-engineering practices and furthermore elucidate an added dimension of stem cell control within the niche.

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International Stem Cell Corporation – Breakthrough Technology Alert

§ August 6th, 2010 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation – Breakthrough Technology Alert


The following is an excerpt from the August 3, 2010 Breakthrough Technology Alert, published by Agora Financial. Agora Financial is a fully independent publisher and has no financial connections to companies listed below. Breakthrough Technology Alert’s editor is industry expert Patrick Cox. Patrick is renowned for his innovative forecasts and keeping readers “ahead of the story”.

For more information about Patrick Cox and Breakthrough Technology Alert please visit http://www.agorafinancial.com

ISCO Collaborations Accelerate

Last week, I told you about International Stem Cell Corp.’s (OTCBB: ISCO) new European subsidiary, ISCO Europe. That announcement closely followed an announced alliance with a leading Indian provider of corneal transplants. Now ISCO has announced that it has entered into a distribution agreement for its Lifeline brand of human cell culture products in India.

Jeffrey Janus, senior vice president of operations of ISCO and CEO of its subsidiary Lifeline, said in a press release, Sristi Biosciences is part of one of the most experienced biotechnology companies in India and the first to advance cell therapy into human trials in that country. Their network among academic and corporate researchers and experience and capacity to import and handle primary cell cultures, media and growth factors in India will be highly valuable for Lifeline to continue the international commercial expansion of its brand.

For transformational profits,

Patrick Cox

To learn more about Patrick Cox and Breakthrough Technology Alert please click here. © 2010 by Agora Financial, LLC. 808 St. Paul Street, Baltimore, MD 21202. All rights reserved. No part of this report may be reproduced by any means or for any reason without the consent of the publisher. The information contained herein is obtained from sources believed to be reliable; however, its accuracy cannot be guaranteed.

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Cell of origin for human prostate cancer

§ August 1st, 2010 § Filed under Nano Medicine Comments Off on Cell of origin for human prostate cancer

Scientists at UCLA find cell of origin for human prostate cancer by Kim Irwin, UCLA Newsroom, July 29, 2010. Excerpts:

“Certainly, the dominant thought is that human prostate cancer arose from the luminal cells because the cancers had more features resembling luminal cells,” said Witte, senior author of the study and a Howard Hughes Medical Institute Investigator. “But we were able to start with a basal cell and induce human prostate cancer, and now, as we go forward, this gives us a place to look in understanding the sequence of genetic events that initiates prostate cancer and defining the cell-signaling pathways that may be at work fueling the malignancy, helping us to potentially uncover new targets for therapy.”

…..

The new human-in-mouse model system developed in the study was created by taking healthy human prostate tissue that will induce cancer once it is placed in mice, instead of taking malignant tissue that is already cancerous and implanting it. This model can now be used to evaluate the effectiveness of new types of therapeutics. By using defined genetic events to activate specific signaling pathways, researchers can more easily compare therapeutic efficacy. The new model, by deconstructing tissue and then reconstructing it, also will aid in analyzing how the cells change during cancer progression.

This news release is based on the publication: Identification of a Cell of Origin for Human Prostate Cancer by Andrew S Goldstein and 5 co-authors, including Owen N Witte, Science 2010(Jul 30); 329(5991): 568-71. [PubMed citation][FriendFeed entry][Twitter trackbacks via Topsy].

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Disagreement about melanoma CSCs

§ July 29th, 2010 § Filed under Nano Medicine Comments Off on Disagreement about melanoma CSCs

The Evolving Science of Cancer Stem Cells by Carmen Phillips, NCI Cancer Bulletin 2010(Jul 27); 7(15). Excerpt:

Researchers from Stanford University earlier this month reported in Nature that they had found a marker, CD271, that identified a somewhat unique population of cells that could produce melanoma in highly immunocompromised mice; anywhere from 2.5 percent to 41 percent of cells in their human tumor samples expressed the marker. In additional experiments using similar mice on which human skin was engrafted, only tumor cells with the marker could produce tumors and metastases in the mice. (In his lab, Dr. Morrison noted, the same marker did not differentiate tumor-forming from nontumor-forming cells.)

The publication about CD271 is: Human melanoma-initiating cells express neural crest nerve growth factor receptor CD271 by Alexander D Boiko and 11 colleagues, Nature 2010(Jul 1); 466(7302): 133-7. [PubMed citation].

Comments: The sentence: “In his lab, Dr. Morrison noted, the same marker did not differentiate tumor-forming from nontumor-forming cells” is noteworthy. Why the difference in results for CD271?

The publication by Boiko and co-authors was cited in a previous post to this blog, “Melanoma-initiating cells identified“, dated July 1, 2010.

See also an earlier post to this blog, “Tumorigenic cells not rare in human melanoma“, dated December 3, 2008.

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International Stem Cell Corporation and Sristi Biosciences Enter Distribution Agreement for Lifeline Cell Technology’s Brand of Human Cell Culture…

§ July 29th, 2010 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation and Sristi Biosciences Enter Distribution Agreement for Lifeline Cell Technology’s Brand of Human Cell Culture…

International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, via its wholly-owned subsidiary, Lifeline Cell Technology® (Lifeline) http://www.lifelinecelltech.com, and Sristi Biosciences, http://www.sristibio.com, have entered into a distribution agreement for the Lifeline® brand of human cell culture products in India.

Lifeline specializes in development, manufacture and distribution of primary human cells and media and growth factors for optimized culturing of cells, including stem cells. These products are being requested by customers internationally, including in India, which represents one of the fastest growing markets for products of this kind.

According to Lifeline’s CEO and SVP of Operations at ISCO, Jeffrey Janus, ‘Sristi Biosciences is part of one of the most experienced biotechnology companies in India and the first to advance cell therapy into human trials in that country. Their network among academic and corporate researchers and experience and capacity to import and handle primary cell cultures, media and growth factors in India will be highly valuable for Lifeline to continue the international commercial expansion of its brand.’

Lifeline’s scientists have over 20 years of experience developing products for the culture of human cells. The company has made significant contributions to the creation and standardization of human cell systems used today for clinical applications and in academic, government and pharmaceutical research laboratories. The group sells over 75 standardized products directly and via its distributors in the US and abroad. It also engages in customized product development for its largest customers.

Dr. Sudhir Reddy, Sristi Biosciences’ CEO adds, ‘We are pleased to be the first company to introduce the Lifeline products to the growing Indian research market. Our cell culture experience and broad market reach in India will benefit the brand and help Sristi Biosciences further accelerate its commercialization and corporate growth in the biomedical field.’

ISCO recently announced the beginning of a collaboration on its human corneal tissue, CytoCor™, with leading Indian eye hospital and research center, Sankara Nethralaya, and Letter of Intent with Insight Bioventures India (IBVI) to seek funding and establishment of development and manufacturing operations for ISCO’s research and pharmaceutical products in India (ISCO India), including the Lifeline products and CytoCor.

‘The Lifeline distribution agreement with Sristi Biosciences is central to ISCO’s international expansion. Besides facilitating commercialization of the Lifeline products in India, Sristi Biosciences’ cell therapy development, regulatory and manufacturing expertise will be important as ISCO and IBVI seek to establish ISCO India with cost-efficient development and manufacturing of research and pharmaceutical products for the Indian and broader Asian markets,’ says Brian Lundstrom, ISCO’s President.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO’s website.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

ABOUT SRISTI BIOSCIENCES

Sristi Biosciences Private Limited is a result of twelve years of research and corporate development in the therapeutic space and is the healthcare component of leading biotechnology group, SRI Biotech, in India. Sristi Biosciences’ two main divisions include Tissue Engineering and Cell Therapy that has pioneered chondrocytes-based cell therapy in India and Drug Discoverythat covers the Indian research product market with natural compound libraries, molecular diagnostics and markers, informatics and cell-based products. Sristi’s integrated research and development facility in Hyderabad is state-of-the-art and the company has wide collaborative and commercial presence across the research market in India, including 23 leading biotech institutes and major corporate bodies.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated developments and therapeutic applications, the potential benefits of collaborations, affiliations, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com

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Researchers Study CSCs as Therapeutic Targets for Mesothelioma

§ July 28th, 2010 § Filed under Nano Medicine Comments Off on Researchers Study CSCs as Therapeutic Targets for Mesothelioma

Researchers Study Cancer Stem Cells as Therapeutic Targets for Mesothelioma, Asbestos.com, July 26, 2010. Excerpt:

In a study published in the International Journal of Oncology, Cortes-Dericks and colleagues tested whether cancer stem cells in malignant pleural mesothelioma express resistance to cisplatin and pemetrexed, two chemotherapy drugs commonly used to treat mesothelioma cancer.

This news item is based on the OA publication entitled: Putative cancer stem cells in malignant pleural mesothelioma show resistance to cisplatin and pemetrexed by Lourdes Cortes-Dericks, Giovanni L Carboni, Ralph A Schmid and Golnaz Karoubi, Int J Oncol 2010(Aug); 37(2): 437-44. [PubMed citation].

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Prostate CSCs sensitive to gamma-tocotrienol?

§ July 27th, 2010 § Filed under Nano Medicine Comments Off on Prostate CSCs sensitive to gamma-tocotrienol?

Gamma-Tocotrienol Kills Prostate Cancer Stem Cells, PRNewswire, July 25, 2010. Excerpt:

The scientists found that low doses of gamma-tocotrienol cause apoptosis in the prostate cancer stem cells and suppress their colony formation capability. This results in a lower prostate cancer stem cell population (as defined by the protein markers CD133 and CD44). Further tests in mice models were conducted, where mice implanted with hormonal refractory prostate cancer cells were given gamma-tocotrienol orally. The results showed that gamma- tocotrienol not only reduced tumour size formed, but also decreased the incidence rate of tumour formation by 75%, as compared to the control group of mice, which had 100% tumour formation. These results strongly suggest that gamma-tocotrienol could be developed for prostate cancer prevention and treatment.

The news release by Davos Life Science is based on the publication:

Gamma-tocotrienol as an effective agent in targeting prostate cancer stem cell-like population by Sze Ue Luk and 11 co-authors, including Ming-Tat Ling, Int J Cancer 2010(Jul 8) [Epub ahead of print][PubMed citation].

Comment:

See also a relevant patent application: (WO/2010/047663) Use of Tocotrienol Composition for the Prevention of Cancer.
Publication Date: 29.04.2010
Applicants: DAVOS LIFE SCIENCE PTE. LTD. [SG/SG]; 16 Tuas South Street 5 Singapore 637795 (SG) (All Except US).
LING, Ming Tat [CN/AU]; (AU) (US Only).
YAP, Wei Ney [MY/SG]; (SG) (US Only).
WONG, Yong Chuan [MY/CN]; (CN) (US Only).
YAP, Yee Leng, Daniel [MY/SG]; (SG) (US Only).

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Irradiating brain’s stem cell niche

§ July 26th, 2010 § Filed under Nano Medicine Comments Off on Irradiating brain’s stem cell niche

Irradiating brain’s stem cell niche doubles survival time for patients with brain cancers by Kim Irwin, News Release, UCLA Newsroom, July 23, 2010. Excerpt:

Patients with deadly glioblastomas who received high doses of radiation that hit a portion of the brain which harbors neural stem cells had double the progression-free survival time as patients who had lower doses or no radiation targeting the area, a study from the radiation oncology department at UCLA’s Jonsson Comprehensive Cancer Center has found.

The news release is based on this OA publication: Irradiation of the Potential Cancer Stem Cell Niches in the Adult Brain Improves Progression-free Survival of Patients with Malignant Glioma by Patrick Evers and 6 co-authors, including Frank Pajonk, BMC Cancer 2010(Jul 21); 10(1):384. [Epub ahead of print][FriendFeed entry].

Comment: On the brain as a model system to study the impact of radiation dose given to stem cell niches. Provides clinical evidence, based on an improvement in progression-free survival, to support the hypothesis that higher radiation doses to neural stem cell (NSC) niches improves patient survival by eradicating CSCs.

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International Stem Cell Corporation Plans $10 Million Financing Through European Subsidiary

§ July 23rd, 2010 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation Plans $10 Million Financing Through European Subsidiary

International Stem Cell Corporation (OTCBB:ISCO), http://www.intlstemcell.com, announced today that it had entered into a Memorandum of Understanding with ARG Vermogensverwaltung AG (‘ARG’), a German Investment Fund, to create a new European subsidiary (‘ISCO Europe‘) to be funded with up to $10 million of capital derived from ARG and other independent sources in Europe. Shares of ISCO Europe are expected to trade on the Deutsche Bourse independently of the company’s shares in the US. ISCO Europe’s shares will not be convertible into ISCO shares on any US exchange.


ISCO Europe will be licensed by ISCO to develop and market therapeutic products derived from ISCO’s technology throughout the Euro Currency Countries and Switzerland. New technologies developed by either ISCO or ISCO Europe will be made mutually available, thus expanding the total funding available to ISCO worldwide without issuing new ISCO shares and enhancing the potential market and scientific development capacity of both companies.


It is expected that the new subsidiary will be funded initially by a private equity investment by ARG and that ARG will then assist in forming an investment group to invest up to $10 million concurrently with the listing of ISCO Europe on the Deutsche Bourse, the largest Securities Exchange in Europe. Following the financing of ISCO Europe, ISCO is expected to retain ownership of 80% or more of this new subsidiary.

‘Although negotiations are still at the non-binding memorandum of understanding stage, this transaction, when completed, will expand ISCO’s access to capital for worldwide expansion and ISCO’s access to new scientific development without requiring equity dilution of ISCO’s current shareholders. We are creating an investment, research and development, marketing and distribution entity by adding capital and human resources from Europe to help fulfill ISCO’s goal of supplying its proprietary cells and cell therapies to the world,’ said Kenneth Aldrich, Chairman and co-founder of ISCO.


ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)


International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO’s website. To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.


FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated developments and therapeutic applications, the potential benefits of collaborations, affiliations, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.


Key Words: Stem Cells, Biotechnology, Parthenogenesis


International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Andrey Semechkin, Ph.D., CEO
aes@intlstemcell.com

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International Stem Cell Corporation and Insight Bioventures Seek to Establish Indian Operations

§ July 21st, 2010 § Filed under Nano Medicine Comments Off on International Stem Cell Corporation and Insight Bioventures Seek to Establish Indian Operations

International Stem Cell Corporation (OTCBB: ISCO), http://www.internationalstemcell.com, and Insight Bioventures India Private Limited (IBVI), (http://www.insightbioventures.in) announced today that they have signed a letter of intent concerning funding and establishment of an Indian affiliate of ISCO (ISCO India). The goal is to establish world-class development and manufacturing operations for ISCO’s research and pharmaceutical products in India, including its Lifeline Cell Technology® research products and human corneal tissue, CytoCor™, for treatment of corneal vision impairment and testing of chemicals.

IBVI is an experienced biomedical business facilitator with a solid network among Indian corporations, academia and government. In collaboration with Sristi Biosciences (http://www.sristibio.com), a full-fledged developer, manufacturer and commercial operation and the therapeutic arm of Indian bio industry leader Sri Bio (http://www.sribio.com), IBVI facilitated the earliest submissions and approvals of the stem cell therapy guidelines of India. Some of IBVI’s major collaborators include ophthalmology research center and hospital, Sankara Nethralaya (http://www.sankaranethralaya.org), The Centre for Cellular and Molecular Biology (a federally funded institute run by the Indian government, http://www.ccmb.res.in), the All-India Institute for Medical Sciences (http://www.aiims.edu), and the Indian Council for Medical Research (http://www.icmr.nic.in). IBVI has established a dedicated Biofund to finance novel businesses in India.

According to Dr. Jayaraman Packirisamy, Executive Director of IBVI, ‘ISCO offers our investors as well as corporate and academic partners a unique combination of Lifeline marketed research products with near-term revenue potential in India, CytoCor with potential to change standard of care for the widespread corneal blindness and vision impairment in India and the rest of Asia, and an opportunity to apply our well-educated work force and industrial grade facilities to develop and manufacture these and other biomedical products cost-efficiently in India. We therefore look much forward to lead the funding and implementation of ISCO India.’

Dr. Gopal Pande, managing scientist at The Centre for Cellular and Molecular Biology adds, ‘Our institution is a leader in cell biology in India and, while we have been involved with a wide range of opportunities in this field, we believe CytoCor represents a rare opportunity to produce functional, live human tissue from individual cells. We are keen to explore the possibilities with ISCO and IBVI and hope to not only apply our scientific expertise but also to host ISCO in India’s first, state-of-the art, $60M, integrated research and clinical development facility for stem cells and regenerative medicine, CRF, established in collaboration between the CCMB and the Nizam’s Institute of Medical Sciences.’

Under the letter of intent, IBVI will lead the funding and establishment of ISCO India with facilities and staff. ISCO will train Indian scientists and commercial staff and provide rights to the company’s technologies, products and intellectual property as needed. ISCO India will be managed by a combined team of experienced development and business executives from IBVI and Sristi Biosciences in India and senior executives of ISCO in the US. ISCO India will be based in Hyderabad and continue to work closely with the leading team of ophthalmology scientists and clinicians at Sankara Nethralaya in Chennai as well as researchers and government bodies across India. Formal details of this arrangement are expected to become the subject of a definitive agreement in the near future.

‘IBVI and their corporate, academic and government network provide ISCO with an unparalleled opportunity to tap into the rapidly growing research product market in India and develop CytoCor with a team of experienced scientists and clinicians in the country with most corneal blindness and vision impairment in the world. Furthermore, IBVI’s Biofund investors enable us to do so without ISCO capital investment or issuance of equity shares. Finally, by establishing our own affiliate in India, ISCO will be able to participate in the economic benefits of our technologies and products while retaining the intellectual property control that is so important across Asia,’ says Brian Lundstrom, ISCO’s President.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO’s website.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

ABOUT INSIGHT BIOVENTURES INDIA

Insight Bioventures India Private Limited India (IBVI) is the Asian member of Insight Bioventures founded in 1997 to apply a multidimensional approach to value creation in the international life sciences community while placing client’s interests first. IBVI operates through a team of experienced associates and partners from the pharmaceutical industry, academic research and the financial sector. The company maintains long-standing relationships with opinion leaders in different therapeutic areas that assist in evaluation and advancement of innovative product concepts and medical businesses. IBVI has made tissue engineering and cell therapy a major technology focus and works with recognized leaders in these areas, e.g. Sristi Biosciences and International Stem Cell Corporation. IBVI has partnered with strong Indian corporations and high net worth individuals to establish a dedicated ‘Biofund’ to finance the best novel technologies for Indian development and with potential to address large unmet medical needs in the Asian market. More information is available on IBVI’s website: http://www.insightbioventures.in.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated developments and therapeutic applications, the potential benefits of collaborations, affiliations, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com

Read the Rest...

More about salinomycin

§ July 19th, 2010 § Filed under Nano Medicine Comments Off on More about salinomycin

New mission for salinomycin in cancer by Cord Naujokat, SciTopics, July 15, 2010. Excerpt (in the “continue reading” section):

In addition, a very recent study demonstrates that salinomycin overcomes ATP-binding cassette (ABC) transporter-mediated multidrug and apoptosis resistance in human leukemia stem cell-like cells (3).

Reference #3: Salinomycin overcomes ABC transporter-mediated multidrug and apoptosis resistance in human leukemia stem cell-like KG-1a cells, by Dominik Fuchs and 4 co-authors, including Cord Naujokat, Biochem Biophys Res Commun 2010(Apr 16);394(4): 1098-104 [Epub 2010(Mar 27)][PubMed citation].

Comments: Near the end of this article about salinomycin is the comment that “the investigation of its safety, toxicity, pharmacology and anticancer activity in humans will be a challenge.” The author then mentions a preliminary study of “a small cohort of patients with metastatic breast cancer or metastatic head and neck cancers“. The results of this preliminary study of the toxicity of salinomycin are summarized. They have not yet been published in the peer-reviewed literature, although a manuscript has been submitted [see reference #4 in the article]. The implication of these preliminary results is that there may be a “therapeutic window” for salinomycin, that is, a drug dosage that yields clinically significant benefits in the absence of excessive toxicity.

For a previous commentary on salinomycin, see: Cancer stem cell breakthrough by Kat Arney, Science Update blog, Cancer Research UK, August 14, 2009. Excerpt:

We need to stress that these were laboratory experiments, and there is no evidence yet that salinomycin can treat cancer in humans. Salinomycin is currently used as an antibiotic for chickens and cows, and it can be toxic or even fatal to humans, causing serious muscle and heart problems.

If there is a “therapeutic window” for salinomycin, it could be a small one, and is likely to vary from one tumor to another.

For a previous post to this blog about salinomycin, see: Identification of selective inhibitors of breast CSCs in mice, August 14, 2009.

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