Showing posts with label corneal repair. Show all posts
Showing posts with label corneal repair. Show all posts

Tuesday, October 5, 2010

International Stem Cell Corporation and Insight Bioventures India Structure Indian Affiliate to Develop Stem Cell-Based Eye Care Therapeutics...

International Stem Cell Corporation and Insight Bioventures India Structure Indian Affiliate to Develop Stem Cell-Based Eye Care Therapeutics for India and Produce Research Products for Asia

International Stem Cell Corporation (OTCBB: ISCO), www.internationalstemcell.com, and Insight Bioventures India Private Limited (IBVI), (www.insightbioventures.in) today announced that they have agreed on financial and structural terms for establishment of an Indian affiliate of ISCO (ISCO India). This is an important milestone in ISCO and IBVI's goal to facilitate development and commercialization of ISCO's stem-cell derived corneal tissue, CytoCor™, and retinal cells, CytoRet™, for treatment of blindness and severe vision impairment as well as cell systems for drug screening in India and establish a manufacturing base for ISCO's Lifeline Cell Technology® (Lifeline) brand of cell culture media for commercialization throughout Asia.

IBVI is an experienced biomedical business developer that facilitated the earliest cell therapy guidelines with the regulatory agencies in India and is well connected with Indian research and clinical centers, corporations and government. IBVI has now partnered with MARG Group (www.marggroup.com), one of India's fastest-growing infrastructure developers with interest in ports, airports, power plants, commercial spaces, special export zones and other integrated infrastructures, to form 'Insight-MARG Biofund' (Biofund). The MARG Group is the lead facilitator of Biofund, the largest of its nature in India so far and with great possibility for being complemented by Indian government grants.

ISCO is a public US biopharmaceutical company that has pioneered the creation of a new class of stem cells, 'human parthenogenetic stem cells', with broad therapeutic application potential and ability to form non-rejected, immune matched therapeutic cells for millions of people. Two ISCO therapeutic programs from this platform are CytoCor and CytoRet that offer first-in-class opportunities to treat diseases in the front and the back of the eye where surgery and traditional small molecule and protein therapeutics are not options. ISCO also markets and sells cell culture research products through its Lifeline affiliate and international distributors, including in Asia. Lifeline is interested in leveraging its expertise to develop live human cell systems for drug screening in India.

G.R.K. Reddy, MARG Group's founder and chairman, says, 'MARG Group and IBVI have formed Biofund to leverage our resources and network of cutting-edge research and clinical institutes, corporate entities and government agencies in India. We believe ISCO India's unique combination of novel therapeutics to address large unmet medical needs and current and near-term research product businesses will be a first successful Biofund investment and set the stage for subsequent ventures.'

The agreed financial and structural terms will enable formation of ISCO India as a majority-owned Indian affiliate of ISCO, initially with laboratories in India's first clinical research facility (CRF) for stem cells and regenerative medicine in Hyderabad with the intent to relocate to India's first platinum-rated research center, MARG Science Park (www.margsciencepark.com), in Chennai. The park is a member of International Association of Sciences Parks (IASP) and has established networking and alliances with renowned institutes and organizations. The affiliate will be managed jointly by a team of experienced managers in India and ISCO executives.

ISCO expects that manufacturing of Lifeline media products and shipping of cell products from this central Indian base will be established to supply the growing network of Lifeline's Asian distributors with high-quality products in a cost-efficient fashion. In parallel, ISCO India intends to explore development of Lifeline cell systems for drug screening in India. On the therapeutic side, ISCO India will leverage the access to leading eye care researchers, patients and regulatory agencies in India and advance the CytoCor and CytoRet cellular ophthalmology programs towards the clinic and through safety-efficacy trials.

Central to the operation will be continued collaboration with the ophthalmology scientists and clinicians at Sankara Nethralaya (www.sankaranethralaya.org) in Chennai established last spring. ISCO India will also collaborate with the Centre for Cellular and Molecular Biology (CCMB, www.ccmb.res.in) in Hyderabad that was instrumental in the establishment of the CRF and will be a joint CRF tenant with ISCO India. Both institutions are respected worldwide for their research in cellular science and therapy.

According to Dr. Jayaraman Packirisamy, Executive Director of IBVI, 'As we launch Biofund, ISCO India will provide an opportunity to address large unmet medical needs while establishing an ecosystem for the well-educated work force, world-class research and development facilities and investors in India. By combining manufacturing of existing and development of new research products with well-defined therapeutic development, we create an attractive risk-reward profile that is rarely seen in our industry.'

Brian Lundstrom, ISCO's President, adds 'ISCO wishes to collaborate with leading research and clinical groups like CCMB and Sankara Nethralaya for our cellular ophthalmology programs. Moreover, we have to manufacture our Lifeline media in Asia and ship those with our primary human cells from an Asian location in order to supply that fast-growing market with the highest possible quality products in a cost-efficient manner. The combination of well-proven Indian research and clinical institutes, world-class facilities, and funding from the Insight-MARG Biofund provides ISCO with a unique way to advance our programs and businesses without additional US capital investment or issuance of equity shares.'

ABOUT INSIGHT BIOVENTURES INDIA

Insight Bioventures Private Limited (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: www.insightbioventures.in.

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, parthenogenesis, cornea, retina, research products, biotechnology, India

International Stem Cell Corporation
Brian Lundstrom, President
+1-510-220-5599
bl@intlstemcell.com
or
Insight Bioventures India Private Limited
Dr. Jayaraman Packirisamy, Executive Director
+91-98489-12260
jayaram@insightbioventures.in

Wednesday, July 28, 2010

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), www.internationalstemcell.com, via its wholly-owned subsidiary, Lifeline Cell Technology® (Lifeline) www.lifelinecelltech.com, and Sristi Biosciences, 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

Wednesday, June 30, 2010

International Stem Cell Corporation - Excerpt from Agora Financial's Breakthrough Technology Alert by Patrick Cox


The following is an excerpt from the June 29, 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 www.agorafinancial.com


Q&A with ISCO

International Stem Cell Corp. (OTCBB: ISCO) has also been the target of rumor campaigns. ISCO, incidentally, recently announced further positive IP news. Specifically, Advanced Cell Technology, Inc. (ACT) was just issued U.S. Patent Number 7736896 covering a method for producing retinal pigment epithelial cells. ISCO, however, had previously acquired rights to this technology from ACT, so the award solidifies their position in stem cell eye therapies.

ISCO's corneal research also got an unexpected boost last week, though it's not clear how many people know it yet. A stem cell breakthrough from Italy made quite a few headlines. The article that provoked the coverage was in the June 23 online version of The New England Journal of Medicine (NEJM). Specifically, it featured clinical research from professor Graziella Pellegrini et al. titled "Limbal Stem-Cell Therapy and Long-Term Corneal Regeneration." A helpful video by ABC News can be viewed here.

The coverage of the journal article is, however, incomplete. So let me put it in perspective.
The procedure made use of the well-established practice of extracting and cultivating limbal stem cells. Each of the patients, in effect, had stem cells removed from at least one eye. Once the adult stem cells were multiplied in the lab, they were applied to the cornea. There, they regenerated the corneal epithelium (the outermost thin layer of the cornea), restoring sight.

This is wonderful proof of the power of stem cells, but it doesn't represent a breakthrough in terms of basic science or investment possibilities. This is because the cost of extracting these surviving stem cells is very high. So is multiplying and reattaching them. The only reason the experiments were even allowed to proceed is that all the cell materials come from the subjects of the procedures. They would not have been allowed if, for example, scientists wanted to use the stem cells from one patient to treat another patient. Nor is it clear to what extent, if any, a company can patent these procedures.

On the other hand, the Italian procedures were most successful when they were combined with the implantation of replacement corneal structures. Those replacement corneas cannot be regenerated from limbal stem cells. In fact, they came from cadavers.

ISCO, however, is now able to grow them in the lab to produce cheaper, safer corneas. ISCO is involved in discussions with various companies to commercialize those parthenogenic corneal structures.

For most patients, who have enough of their own stem cells to regenerate the corneal epithelium, ISCO's corneas are all that are required to recover sight. Eventually, in fact, I suspect that ISCO will also have off-the-shelf limbal stem cells that will regenerate the corneal epithelial too. These cells would be from each of ISCO's cell bank lines. Now being established, it will include 50-100 cell lines that immune match most of the world's population. No other company has this ability to provide inexpensive stem cells for the masses.

Now allow me to debunk some of the rumors currently being spread about ISCO. Normally, as you know, I don't like to dignify these attacks, but I do make exceptions when it's important. I'm doing this, by the way, in a question-and-answer format that board chairman Ken Aldrich was kind enough to answer. The questions deal with some of the unfounded rumors circulating. If these don't concern you, feel free to skip them. Q1. Did ISCO close its financing?

A1. Yes, they did a $10 million financing, and then used $2.5 million as part of a balance sheet cleanup that removed approximately $15 million of 10% preferred stock and still left them with an additional $7.5 million in cash on the balance sheet, in addition to whatever cash was already there.

Q2. Doesn't Socius hold a lot of preferred stock that will be a future burden to ISCO?

A2. No, all of that has been retired as part of the capital restructuring announced in an 8-K filed June 11, 2010. As a result, Socius and its predecessor company, Optimus, hold no preferred shares of ISCO at all.

Q3. Is the company running out of money?

A3. Based on the monthly "burn" rate of about $550,000 for the last 15 months ($562,000 for the last quarter), the proceeds of the company's most recent financing of $7.5 million after the repayment of the outstanding preferred stock of Socius and Optimus would give the company at least 12 months of "runway," even without any additional revenues from operations, licensing or partnerships.

I could go on, but this is pretty long. Next week, I'll have more updates.

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.