Geron is getting the publicity of late as a result of the FDA's approval of a trial to determine the safety of its spinal cord embryonic stem cell application. However, three much smaller (in terms of their market caps) firms in our stem cell sector may have research results in the embryonic arena equally as interesting. Two of these firms, BioTime, Inc. and Advanced Cell Technology, have Dr. Michael West in common. West was CEO of Advanced Cell Technology from 1998 to 2007 before becoming CEO of Biotime, Inc. These two companies and International Stem Cell Corp. are associated by license and product development agreements.
Lifeline Cell Technology, the predecessor of ISCO and still an operating subsidiary, was formed in 2001 as a limited liability corporation with Dr. Elena Revazova as Director of Research. International Stem Cell Corporation (ISCO) was created in its current manifestation as the result of a reverse merger in December 2006 at which time it began trading under the symbol ISCO.OB. Lifeline Cell Technology LLC had previously been restructured into International Stem Cell Corporation of California which was the entity involved in the reverse merger with ISCO.
Elena Revazova, Ph.D., M.D., Director of Research and Development, is an expert in creating stem cell lines without the introduction of cancer causing factors. Dr. Revazova was a cell biologist in the Soviet Union before coming to the U.S. eight years ago and is now a US citizen. We'll have more to say about ISCO's Russian connection when post about ISCO's finanaces.
In December 2008, Dr. Revazova and Jeffrey Janus, CEO of Lifeline Cell Technology (wholly owned operating entity of publicly traded International Stem Cell Corp.) were granted the following patent:
What's interesting is that this patent follows, and implicitly builds, as apparently has other research at ISCO, on the trail of technology licensed from Advanced Cell Technology (ACT) in 2005. Here is ACT's 'comments on our technology platform' press release of mid November 2008, about three weeks before the above patent was granted.
"Advanced Cell Technology, Inc. (ACTC) commented today on its technology platform. The Company noted that it believes it has the only technology that can produce stem cell lines of all types without the destruction of the embryo, which should increase the likelihood of receiving federal funding for clinical development. In addition, one of the Company’s licensees, International Stem Cell Corporation (ISCO.ob), is using Advanced Cell’s parthenogenesis technology, which has the capability of developing some types of stem cells using genetic engineering.
The 2005 licenses Lifeline Cell Technology entered into with ACT involved three exclusive license agreements for the production of therapeutic products in the fields of diabetes, liver disease, retinal disease, and the creation of research products in all fields. The license agreements give ISCO access to all aspects of Advanced Cell Technology’s human cell patent portfolio as it existed at May 2005, plus a combination of exclusive and non-exclusive rights to future developments. Of note, Biotime, Inc. licensed this technology for all uses other than diabetes, liver disease and retinal disease in August 2008.
In exchange for worldwide therapeutic rights to Advanced Cell Technology’s portfolio of patents and patent applications in the fields of diabetes, liver disease and retinal disease, ISCO paid $75,000 in May 2007, $112,500 in May 2008. Following these payments, annual payments of $150,000 are required plus milestone payments linked to the launch of therapeutic products (not research products) ranging from $250,000 at first launch to $1 million upon reaching sales of $10 million, with a maximum of $1.75 million in the aggregate. The agreements also require Lifeline to pay royalties on sales in the amount of 3% to 12% (not part of the $1.75 million cap), depending on particular license, and to meet minimum research and development requirements. The agreements continue until expiration of the last valid claim within the licensed patent rights. Advanced Cell Technology is required to defend any patent infringement claims.
Representative of the relationship ISCO and ACT have, the license agreement also calls any technology either party currently owns, develops or licenses in the future to be licensed to the other party for use in their specific therapeutic field. This arrangement gives Advanced Cell Technology and ISCO continuing access to future discoveries made or licensed by either party. One has to wonder what the license agreement says about the transferability of such technology; for example, would ACT be able to transfer any technology developed by ISCO to the new ACT/CHA Biotech joint venture, Stem Cell & Regenerative Medicine International?
Agreements that have the effect of tying all three companies together are explained in a Biotime Inc. SEC document:
"Biotime, and our wholly-owned subsidiary Embryome Sciences, Inc., have signed a letter of intent with International Stem Cell Corporation and its wholly-owned subsidiary Lifeline Cell Technology (“Lifeline”) to jointly produce and distribute a wide array of research products from human embryonic stem cell technology. Embryome Sciences and Lifeline intend to jointly manufacture products serving the complex needs of this industry, including cells and related products that will allow researchers to identify and study the thousands of cell types that can be made from hES cells. Among these planned products are ESpy cell lines (complex derivatives of hES cells that send beacons of light in response to the activation of particular genes). The ESpy™ cell lines will be developed in conjunction with Lifeline (ISCO) using ACTCellerate™ technology licensed from ACT and other technology sub-licensed from Lifeline."
In addition, ISCO has expanded the parthenogenesis technology to a level that includes preclinical trials (recently announced) on retinal disease and the application of 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.
As the company points out, "ISCO’s human parthenogenetic stem cells have the potential to treat human disease yet possess key medical and ethical advantages over other kinds of stem cell products. They can be matched to common immune types and thus reduce the chance of transplant rejection among large segments of the population. Because they are created from unfertilized human eggs, they do not require the destruction of human embryos."
ISCO also own the worldwide rights to use in its chosen therapeutic fields, a technology known as Somatic Cell Nuclear Transfer to create human stem cells.
Interesting. I am hopeful the corneal stem cell work will be ready for clinical application soon.
David D. Richardson, M.D.
Medical Director
San Gabriel Valley Eye Associates, Inc.
207 S. Santa Anita Street, Suite P-25
San Gabriel, CA 91776
626.289.7856
http://www.sgveye.com/
Posted by: David D. Richardson, M.D | February 20, 2009 at 06:22 AM
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