International Stem Cell Corporation (OTCBB:ISCO), www.intlstemcell.com, today announced significant progress on its international development strategy for stem cell-derived human corneal tissue. Such tissue can potentially be used to replace cadaver-derived corneas in treatment of severe corneal vision impairment and to eliminate the need to use live animals in safety testing of drugs, chemicals and consumer products.
During a recent trip to Asia and Europe, an ISCO senior management team identified and interacted with a group of integrated eye hospitals and ophthalmology research institutions with world-class laboratory facilities, along with potential sources of research funding. One of these is Sankara Nethralaya (www.sankaranethralaya.org), one of India's leading not-for-profit clinical and research organizations dedicated to treatment of eye diseases.
Research during the past ten to fifteen years has demonstrated stem cell differentiation into a variety of human cell types. Rarely has it been possible to produce such integrated, functional human tissue, in this case, tissue that has characteristics compatible with human cornea in structure and function. This tissue technology may offer a first-in-class opportunity for high-quality, cost-efficient transplantation tissue for the 10 million people world-wide suffering from corneal vision impairment, particularly in Asia and Europe. It may also provide a much needed alternative to the use of live and extracted animal eyes in the $500+M market for safety testing of drugs, chemicals and consumer products.
During the coming months, ISCO expects to formalize relationships with a number of entities such as Sankara Nethralaya to provide ISCO's cornea development program with the scientific, facility and financial resources needed to advance the technology as rapidly as possible to clinical application. The ultimate goal is not only to address the clear unmet medical and safety testing needs, but also to be among the first pluripotent stem cell applications to achieve widespread commercialization.
Dr. Sengamedu Srinivasa Badrinath, President and Chairman Emeritus of Sankara Nethralaya says: 'At Sankara Nethralaya, we see 1,600 eye patients and do over 100 eye surgeries a day. We employ sixty scientists and clinicians dedicated to the development and application of new state-of-the-art ophthalmic technologies. My senior team at Sankara Nethralaya and I look forward to helping ISCO advance its cornea technology that has potential to significantly reduce the severe quantitative and qualitative limitations in corneal donor tissue across the world today.'
Brian Lundstrom, ISCO's President, continues: 'The addition of Sankara Nethralaya to our international collaborative network will contribute substantial scientific and clinical ophthalmology expertise and resources and complement the instrumentation alliance with The Automation Partnership and the safety testing collaboration with Absorptions Systems. The next step is to organize an experienced therapeutic development team to establish the optimal development path with relevant regulatory authorities and create data needed to advance ISCO's stem cell-derived corneal tissue into clinical trials.'
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 parthenogenetic stem cells (hpSCs) from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO's website, 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, and other opportunities for the company and its subsidiary, 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
Tuesday, May 25, 2010
International Stem Cell Corporation Moves International Cornea Development Program Forward
Tuesday, May 18, 2010
International Stem Cell Corporation and The Automation Partnership Enter into Strategic Alliance to Automate Cornea Tissue Production
OCEANSIDE, CA – May 18, 2010 – International Stem Cell Corporation (ISCO.OB), www.intlstemcell.com, announced today that it had entered into a strategic alliance with The Automation Partnership (TAP), www.automationpartnership.com, to automate and scale up the production of stem cell-derived human corneal tissue. The alliance has been formed to create instrumentation for ISCO and its partners and affiliates to produce development and commercial volumes of donor tissue for cornea transplantation and to reduce the use of animals and animal eyes in safety testing of drugs, chemicals and consumer products.
Cornea-related loss or reduction of vision can be caused by physical injury, infections and degenerative diseases. In cases where cornea replacement is indicated, current medical practice typically involves a one-two hour outpatient procedure under local anesthesia using full or partial corneas from healthy human cadavers. 10 million people worldwide are candidates for such treatment, primarily in Asia and Europe where there is significant quantitative and qualitative shortage of human cornea donation.
Global efforts are underway to transition from the use of live animals and excised animal eyes to test drugs, chemicals and consumer products. For example, Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) estimates a need to spend €270M and use 160,000 animals for eye safety testing alone to catch up with the back-log of insufficiently tested agents. In the US, the National Institutes of Health (NIH) and the Environmental Protection Agency (EPA) have launched a five-year program dedicated to finding new, non-animal technologies for toxicity testing of chemical compounds.
ISCO has discovered and filed for patents on a cell culture process for the synthesis of standardized, human, corneal tissue using stem cells. Histology, permeability and optical testing has demonstrated compatibility with natural corneas. Efforts are ongoing to further characterize this tissue and standardize and scale up its synthesis. Automation is necessary to produce sufficient, reproducible tissue for development and commercialization of the therapeutic and toxicity testing applications.
Brian Lundstrom, ISCO’s President, says: “Given the substantial unmet therapeutic and toxicology testing needs for human corneal tissue, ISCO has embarked on a focused effort to advance this technology with international investors, eye clinics, and development and commercialization partners. After reviewing a range of potential cell culture automation companies, we are very pleased that TAP has agreed to contribute their over twenty years of experience towards this goal.”
David Newble, TAP’s CEO says: “TAP has successfully installed and supported over 160 automated cell culture systems worldwide and continues to design new and customize existing equipment for cell culture and other emerging life science applications. The opportunity to join forces with ISCO in the cornea tissue area will enable us to contribute solutions for clear biomedical needs while also creating new technology and knowhow that will be useful in other applications downstream.”
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 (hpSCs) from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO’s website, 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.
About The Automation Partnership
The Automation Partnership (TAP) provides advanced automation systems and services to improve productivity in life science research, development and production.
For over 20 years TAP has been the leader in the design and development of automated cell culture and processing systems with applications in regenerative medicine, discovery research, bioprocess development and biologics production. Systems include SelecT, CompacT SelecT and Cellmate.
In addition, TAP has a strong track record in providing a range of custom automation solutions for biobanking, biological sample management, compound management and advanced high throughput screening applications.
TAP is a privately-owned company with headquarters near Cambridge, UK and a sales and support facility near Wilmington, Delaware, USA.
FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, 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
Brian Lundstrom, President
760-940-6383
bl@intlstemcell.com
Or
The Automation Partnership
Matthew Walker
Head of Communications
+44 1763 227 200
Matthew.walker@automationpartnership.com
Posted by PSEO at 11:24 AM
Labels: biotechnology, corneal replacement, human cornea, International Stem Cell Corporation, live animal testing alternative, stem cell, The Automation Partnership
Tuesday, May 11, 2010
International Stem Cell and Absorption Systems Confirm Results Showing Stem Cell Derived Corneal Tissue as an Alternative to Animals for Drug Testing
Other Tests Show Tissue's Ability to Focus Light, Pointing to Potential Therapeutic Applications
OCEANSIDE, Calif. – May 10, 2010 – International Stem Cell Corporation (OTCBB: ISCO), http://www.internationalstemcell.com/, the first company to perfect a method of creating human "parthenogenetic" stem cells from unfertilized eggs, announces the results of a second set of experiments confirming that its lab-grown corneal tissue closely mimics the drug absorption and drug metabolism characteristics found in normal corneal tissue. Other tests show that the stem cell derived corneal tissue refracts light, thus providing a further indication of its potential therapeutic value in treating corneal injury and disease.
Two sets of collaborative experiments between ISCO and Absorption Systems have now shown that corneal tissue cultured by ISCO exhibits topical drug absorption barrier properties and tissue-appropriate enzymatic activity, making it a promising model for studying human ocular drug absorption as an alternative to live animal testing. ISCO's human corneal tissue is created in the laboratories of its wholly owned subsidiary, Lifeline Cell Technology (Walkersville, MD).
In a second set of tests conducted by a third party expert, a beam of diverging light was projected through the corneal tissue from different distances, becoming more or less refracted with the changing distance, showing that the corneal tissue was clear and had optical properties that allow the focusing of light. Additional experiments will be conducted to better define these optical characteristics.
According to Jeffrey Janus, Senior VP of ISCO and CEO of Lifeline, "We are very excited to confirm our initial results showing drug absorption that correlates with animal models and add to these results the observation of enzymatic activity. This not only advances our plans to manufacture a product that can be used to reduce the need for tests that use living animals, but it also is one more step toward the potential therapeutic use of this tissue as a treatment for human corneal injury or disease. This has implications, not only in the US, but also in India and Asia, where millions of people suffer from corneal blindness that now goes untreated. The experiments showing light refraction are a tempting indication that this tissue will have therapeutic application."
"There is a large commercial need for a predictive and reproducible non-animal method for testing the safety of ophthalmic drugs and consumer products," said Patrick M. Dentinger, President and CEO of Absorption Systems. "The combined knowledge and expertise of ISCO and Absorption Systems have allowed us to take a step forward toward addressing an unmet need in the field of ophthalmology by creating a unique in vitro model to study human ocular drug absorption without using animals. Our collaboration with ISCO underscores our commitment to helping bring safe drugs to market."
The collaboration between Absorption Systems and ISCO uses Absorption Systems' know-how in creating and characterizing assay systems to develop superior preclinical methods of testing drugs. Such methods can also reduce the use of laboratory animals currently necessary for other tests, including safety testing of consumer products.
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). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO's website, http://www.internationalstemcell.com/.
ABOUT ABSORPTION SYSTEMS:
Absorption Systems, founded in 1996, assists pharmaceutical, biotechnology and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies® platform, a suite of human cell-based tests systems for drug transporter characterization, exemplifies Absorption Systems' commitment to innovation. Absorption Systems has facilities near Philadelphia, PA, and in San Diego, CA, and serves customers throughout the world. For information on the company's comprehensive contract services and applied research programs, please visit http://www.absorption.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, and other opportunities for the company and its subsidiary, 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, 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
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com
Wednesday, May 5, 2010
International Stem Cell Corporation Signs Financing Agreement
OCEANSIDE, CA –May 5, 2010 – International Stem Cell Corporation (ISCO.OB), www.intlstemcell.com, today announced it has entered into a definitive agreement dated May 4, 2010 (‘the Agreement”) with Socius CG II, Ltd. (“Socius”), pursuant to which Socius has committed to purchase a single tranche of up to $10 million in non-convertible Series F Preferred Stock (the "Preferred Stock") from ISCO. The Company issued a warrant to purchase $13,500,000 worth of the Company’s Common Stock, the exercise price of the warrant being determined by the closing bid price for the Company’s Common Stock on the trading day immediately preceding the date the Company initiates the sale of the Series F Preferred.
The Company anticipates that the Closing of the Preferred Stock sale will take place 20 business days after the issuance of the Warrants. Proceeds from these sales will be used to provide general working capital and to fund additional development of the Company's proprietary Parthenogenetic Stem Cell Lines, development of commercial research products, and other research and development programs and related business activities.
Additional details on the transaction are contained in the Company's Form 8-K filed today with the Securities and Exchange Commission.
A prospectus relating to this offering is available from:
Investor Relations
International Stem Cell Corporation
2595 Jason Court
Oceanside, CA 92056
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). ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology.
FORWARD-LOOKING STATEMENTS:
Statements pertaining to anticipated future events, including the anticipated closing of the sale of Preferred Stock, 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 satisfying the conditions to closing. 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
Brian Lundstrom, President
760-940-6383
bl@intlstemcell.com
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Posted by PSEO at 7:26 AM
Labels: biotechnology, International Stem Cell Corporation, Parthenogenetic stem call lines, stem cell blog