Geron Corp.

Overview
Geron Corporation is a biotechnology company founded by Dr. Michael D. West based in Menlo Park, California. The company was incorporated in 1990 and began doing business in 1992. Geron Corporation focuses on creating drugs based on telomere and stem cell research.

Geron is traded on the NASDAQ under the symbol GERN. The current chief executive officer is Dr. Thomas B. Okarma, M.D., Ph.D. It was included in the SCCC Index, a 15 stock index of companies important "to the field of stem cell, cloning, and cell transplantation research and medicine" when that index was created in 2003 and as of July 2006 comprises 18.42% of the index.

The company specializes in developing and commercialization of products in three specific areas: 1) therapeutic products for cancer that inhibit telomerase; 2) pharmaceuticals that activate telomerase in tissues impacted by cell aging, injury or degenerative diseases; and 3) cell-based therapies derived from human embryonic stem cells for treatment of various chronic diseases.

Currently, Geron Corporation has two anti-cancer products in human clinical trials. The first, called GRN163L, is a drug that targets telomerase and has been shown to be effective in treating various cancers in animals. In studies conducted at Johns Hopkins University GRN163L was active against both CD138+ and CD138neg cancer stem cells and eliminated the colony forming potential of both by 5 weeks. Similarly, GRN163L inhibited the in vitro clonogenic growth of CD138neg Multiple Myeloma Cancer Stem Cells isolated from the bone marrow aspirates of patients with Multiple Myeloma. Geron has started human clinical trials and is testing GRN163L in patients with lymphocytic leukemia. Presently Geron is recruiting patients for 3 clinical trials using GRN163L, including lung cancer, chronic lymphocytic leukemia , solid tumors .Also in trials at Duke University is GRNVAC1, a telomerase vaccine being used on patients with prostate cancer. With the vaccine, Geron plans to inject telomerase into the patient with metastatic prostate cancer to induce the body to produce a more aggressive immune response to the cancer. This vaccine has also produced significant initial results. Geron's progress with these telomerase drugs has been significant enough to have elicited a significant monetary investment in 2005 from Merck, one of the largest of the world's drug companies.

Geron plans to begin testing of GRNOPC1 in 2008. GRNOPC1 is an embryonic stem cell based drug that is designed to treat spinal cord injuries. Animal tests have shown significant restoration of mobility in animals with spinal injuries that were treated with this drug. After initiating trials for human subjects with spinal cord injuries, Geron hopes to be able to test GRNIC1, an embryonic stem cell treatment for diabetes. In tests with diabetic mice, 80% of the mice given GRNIC1 were still alive in 50 days while the entire control group, which was given no treatment, perished. Geron is also developing an embryonic stem cell treatment for heart disease, which they have named GRNCM1.

Beyond stem cells, Geron is in the early stages of developing a telomerase based treatment for HIV called TAT0002. Geron has granted a license to TAsciences.com to sell TA-65, a telomerase activator agent derived from the Chinese Astragalus plant. TA Sciences will offer this product beginning in April of 2007.

Since it was organized in 1990 Geron has been granted over 260 patents.

GERON Corporation's patents in stem cell technology
GERON Corporation had exclusive rights to three cell types derived from embryonic stem cells, as the result of paying for the research originally conducted by Dr. James Thomson at the University of Wisconsin-Madison. The patents on the other three cell types are owned by the Wisconsin Alumni Research Foundation (WARF). WARF and Geron did not charge academics to study human stem cells but did charge commercial users. In 2001 WARF came under public pressure to widen access to human stem-cell technology. WARF sued GERON Corp. to recover some of the previously sold rights. The two sides agreed that GERON Corp. would keep the rights to only three cell types.

The whole area of patents for human stem cell work is now in doubt as a legal challenge is being mounted to overturn these patents by The Foundation for Taxpayer and Consumer Rights and the non-profit patent-watchdog Public Patent Foundation. They contend that 2 of the patents granted to WARF are invalid because they cover a technique published in 1992 for which a patent had already been granted to an Australian researcher. Another part of the challenge comes from the molecular biologist Jeanne Loring who states that University of Wisconsin-Madison stem cell pioneer James Thomson's techniques (currently patents held by WARF) are rendered obvious by a 1990 paper and 2 textbooks. The outcome of this legal challenge is particularly relevant to the GERON Corporation as it can only license patents that are upheld.

WARF Stem cell patents relaxed January 2007
As an interim measure, on the 23rd of January 2007, WARF relaxed the stem cell patents, allowing industry-sponsored research at academic and non-profit institutions without a license. WARF will allow easier and simpler cost free cell transfers among researchers and would not require a license or agreement from California's taxpayer-funded stem cell research program.The patents are now being re-examined by the U.S. Patent and Trademark office.

Controversy over GERON Corp's rights to "cloning" technology
There is also uncertainty over GERON Corp.'s rights to nuclear transfer technology. A dispute between Advanced Cell Technology and GERON has been largely resolved as of September 6, 2006 when lawsuits challenging the validity of Geron's cloning technology were dismissed with prejudice by the appeals courts There is a more fundamental objection to the rights as Ian Wilmut was identified on the original patent.

Congressional Testimony
As a participant in the stem cell and cloning area, Geron Corporation has been asked to testify about its technology before the U.S. Congress. In 2001  when Congress was attempting to ban all forms of cloning, Geron Corporation C.E.O. Thomas Okarma spoke before Congress to preserve cloning for therapeutic purposes which have not yet been done six years later.

Criticism for touting human stem therapy clinical trials for 4 years in a row
Geron Corp. has come in for criticism from the Oakland based non-profit organization "Center for Genetics and Society". Geron Corp. has been criticized for promising that clinical trials based on human stem cells will occur "next year" - for the fourth year in a row, yet still have not materialized.