Showing posts with label photorefractive keratectomy. Show all posts
Showing posts with label photorefractive keratectomy. Show all posts

Thursday, January 29, 2009

International Stem Cell Corporation Begins Pre-Clinical Trials on Human Corneal Epithelial Cells

Trials Designed to Improve Laser Eye Surgery Outcomes

International Stem Cell Corporation (OTCBB:ISCO), the first company to perfect a method of creating human "parthenogenetic" stem cells from unfertilized eggs, is planning pre-clinical trials aimed at applying its laboratory-grown human corneal epithelial cells to improve photorefractive keratectomy (PRK), a form of corrective laser eye surgery.

These trials are the first step toward Food and Drug Administration (FDA) clinical trials to test the efficacy of using ISCO cells to improve healing after corneal surgery, and are part of the company's efforts to increase the clinical utility of its discoveries in culturing corneal cells and tissues.

This work is being done in collaboration with Dr. Paul H. Chen, M.D., who has developed the cell transfer technology. Dr. Chen is an eye surgeon at North County Laser Eye Associates, and he is on staff at Scripps Memorial La Jolla and Scripps Encinitas Hospitals.

"This collaboration is an excellent opportunity for ISCO to use its cell culture and manufacturing expertise to create therapeutic human cells that can enter the market relatively quickly and improve patient's quality of life," said Jeffrey Janus, ISCO's president. "We are fortunate to be working with Dr. Chen on this exciting project."

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB): International Stem Cell Corporation is a California biotechnology company focused on developing therapeutic and research products. ISCO's technology, Parthenogenesis, results in the creation of pluripotent human stem cell lines from unfertilized human eggs. ISCO scientists have created the first Parthenogenetic homozygous stem cell line (phSC-Hhom-4) that can be a source of therapeutic cells that will minimize immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. These advancements offer the potential to create the first true "Stem Cell Bank" and address ethical issues by eliminating the need to use or destroy fertilized embryos. ISCO also produces and markets specialized cells and growth media worldwide for therapeutic research through its subsidiary Lifeline Cell Technology. For more information, visit the ISCO website at: 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 future financial and/or operating results, future growth in research, technology, clinical development and potential joint venture 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 International Stem Cell Corporation

Kenneth C. Aldrich, Chairman, CEO
kaldrich@intlstemcell.com
760-940-6383
or
Jeffrey Janus, President
jjanus@intlstemcell.com
760-940-6383
or
The Investor Relations Group
212-825-3210
Investor Relations:
Adam S. Holdsworth
aholdsworth@investorrelationsgroup.com
or
Media Relations:
Laura Colontrelle
lcolontrelle@investorrelationsgroup.com

Wednesday, January 16, 2008

San Diego North Coast Times Publishes ISCO Eye Surgery Trial Article


International Stem Cell Corp. Joins Eye Surgery Trial

OCEANSIDE -- Shares of International Stem Cell Corp. rose nearly 19 percent Monday after the company said it will supply corneal cells for human trials in an effort to improve vision correction surgery.

The Oceanside-based company's stock closed at 95 cents per share, up 15 cents for the day.

It is producing the corneal cells from unfertilized, or parthenogenic human egg cells, said Jeff Krstich, chief executive of the company, on Monday. These cells act like surface -- or epithelial -- cells for the cornea, the clear tissue in front of the eye.

Dr. Paul H. Chen is conducting the trial with the UCSD Shiley Eye Center, the Burnham Institute in La Jolla, the University of Michigan and other centers.

The trial will test whether adding the corneal cells after a laser surgery called photorefractive keratectomy, or PRK, can speed healing and reduce pain. Chen is also testing parthenogenically produced keratinocytes, a type of skin cell, Krstich said.

PRK is one popular kind of operation to correct vision. During the surgery the surface cells are removed. The procedure can cause pain and healing takes longer than another popular corrective surgery, LASIK, which preserves the surface cells, Krstich said.

(Click on the link below to read the article in full.)

Source: http://www.nctimes.com/articles/2008/01/15/business/news/7_10_411_14_08.prt

Tuesday, January 15, 2008

ISCO to Provide Corneal Epithelial Cells Differentiated from Its Parthenogenetic Stem Cells for Use in Photorefractive Keratectomy FDA Clinical Trial

International Stem Cell (OTCBB:ISCO) announced today that it will be providing corneal epithelial cells, derived from its Parthenogenetic stem cells and human keratinocytes (a type of skin cell), for use in Federal Drug Administration (FDA) clinical trials aimed at creating a tissue transplant technology to improve photorefractive keratectomy (PRK).

ISCO entered into a research agreement with Dr. Paul H. Chen, M.D. who has developed the cell transfer technology. He has a separate collaboration with the University of Michigan and is expanding his research team to include the University of California San Diego Shiley Eye Center, and Burnham Research Institute, both located in La Jolla, CA, and The State University New York (SUNY) Albany. Dr. Chen is on staff at Scripps Memorial, La Jolla and Scripps Encinitas Hospitals.

Today's announcement is part of ISCO's efforts to increase the clinical utility of its discoveries in culturing corneal-like tissues from its Parthenogenetic stem cells and to provide human stem cells for the study and cure of disease. Parthenogenetic cells come from unfertilized human eggs and can be immune-matched to millions of people therefore reducing ethical and immune rejection issues. "Our goal, in addition to conducting our own clinical trials in our targeted areas of ocular, liver and pancreatic diseases, is to do collaborations with other prominent researchers and provide our Parthenogenetic stem cells for their human trials," said Jeff Krstich, CEO, International Stem Cell Corporation.

"It is exciting to have our cells involved in studies that could lead to a safer and more effective treatment that hopefully will provide improved visual recovery, less pain, and an improved refractive correction outcome," noted Krstich. "If successful, such technology might also provide broader applications for the treatment of a variety of conditions, including non-healing epithelial defects, such as diabetic epithelial defects, neuropathic epithelial defects, and alkali burn epithelial defects."

PRK was the first clinical laser procedure to be developed for refractive vision correction, but lost favor to LASIK because the PRK procedure calls for laser ablation of the surface of the cornea which is relatively more painful and requires a longer healing time. PRK's advantages, however, include better vision improvement and fewer side effects associated with complications of the surgical "flap" that is created in the LASIK process. The PRK procedure does not require the creation of a flap and is associated with less risk of corneal ectasia, dry eyes, flap striae and epithelial ingrowth.

ABOUT INTERNATIONAL STEM CELL CORPORATION:

International Stem Cell Corporation (ISCO) is a California biotechnology company focused on developing therapeutic and research products. ISCO's technology, Parthenogenesis, results in the creation of pluripotent human stem cell lines from unfertilized human eggs that can be transplanted without immune-rejection. One of these lines called phSC-Hhom-4 can be a source of therapeutic cells that will not be immune rejected after transplantation into millions of individuals of differing sexes, ages and racial groups. These advancements offer the potential to create the first true "Stem Cell Bank" and addresses critical ethical issues by eliminating the need to use or destroy fertilized embryos. ISCO also produces and sells specialized cells and growth media worldwide for therapeutic research through its subsidiary Lifeline Cell Technology. For more information, visit the ISCO website at: www.internationalstemcell.com.

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

About Dr. Paul H. Chen, M.D.

Dr. Paul H. Chen is a Board Certified ophthalmologist who provides comprehensive eye care with an interest in cataracts, glaucoma, eyelid enhancements, and laser vision correction.

Dr. Chen graduated summa cum laude in Molecular Biology from Princeton University and received his MD degree from Harvard Medical School. He completed his specialty training in Ophthalmology at the UCSF Medical Center in San Francisco.

His laboratory investigations have resulted in several scientific publications. Furthermore, he is the inventor of two U.S. patents used for the rapid diagnosis of infections. Dr. Chen has been involved in FDA clinical research on new eye drop treatments for corneal erosions, and he performed the first AlphaCor artificial corneal implants in San Diego County.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential 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, 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.

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
kaldrich@intlstemcell.com
or
Jeff Krstich, CEO
jkrstich@intlstemcell.com
760-940-6383
or
Media Relations:
The Orbach Company, Inc.
Nevena Orbach, 818-904-0500
nevena@orbachco.com