GLYCOGENESYS Inc. (OTC:GLGSQ)
Industry: Healthcare
GlycoGenesys, Inc. is a biotechnology company focused on carbohydrate-based drug development. The Company's lead drug candidate is GCS-100. The Company has also developed agricultural products, some of which are also based upon carbohydrate chemistries. During the year ended December 31, 2004, GlycoGenesys has two wholly owned non-operating subsidiaries: International Gene Group, Inc. and SafeScience Products, Inc. GlycoGenesys has two wholly owned subsidiaries, International Gene Group, Inc. (IGG) and SafeScience Products, Inc. (SafeScience Products). These subsidiaries are non-operating subsidiaries. GCS-100 GCS-100 is a complex carbohydrate developed to fight bloodborne and solid tumor cancers and their metastasis, either as a monotherapy or in combination with approved chemotherapies. In addition to the intellectual property it owns relating to GCS-100, the Company has licenses from David Platt and Wayne State University and the Barbara Ann Karmanos Cancer Institute relating to GCS-100. GlycoGenesys is evaluating GCS-100 as a potential anti-cancer therapy based on a body of pre-clinical research. This research has shown that GCS-100 may interact with carbohydrate-binding receptors to modulate multiple cellular processes, such as proliferation, migration, cell-cell adhesion and programmed cell death. The results from publicly presented pre-clinical studies and published literature demonstrate several mechanisms of action associated with GCS-100 in selectively regulating the cellular functions of cancer cells. These include the ability to block the spread of cancer cells (anti-metastasis), cut off the blood supply to tumor cells (anti-angiogenesis), trigger programmed cell death (pro-apoptosis) and inhibit cancer cell proliferation (anti-proliferation). In addition, GCS-100 can cause the disruption of mitochondrial function, leading to cancer cell death. GCS-100 has also been shown to act as an anti-angiogenesis agent. VEGF, a naturally occurring protein, is known to play an important role in angiogenesis. One of the activities of GCS-100 involves interfering with the binding of VEGF with endothelial cells. By interfering with the interaction of VEGF and endothelial cells, GCS-100 may reduce the formation of new blood vessels to cancer cells, thus inhibiting angiogenesis. Phase I clinical trials of GCS-100 began in March 1997, at sites, including the M.D. Anderson Cancer Center in Houston, Texas. Phase I clinical trials are produced to determine the side effects associated with increasing doses of a drug and to evaluate the safety and actions of the drug in humans. These early clinical trials were completed in 1999. No dose limiting toxicity was identified and GCS-100 was found to be well tolerated at doses up to 20 milligrams/m2. A Phase II(a) clinical trial for colorectal cancer and a Phase II(a) clinical trial for pancreatic cancer were started in the spring of 2000. Phase II clinical trials are designed to further evaluate the safety of a drug and to begin to evaluate whether it is effective at treating a disease, such as cancer. Phase II trials may involve several sets of trials (Phase II(a), Phase II(b)). The Phase II(a) trials to evaluate GCS-100 were conducted at sites, including the Beth Israel Deaconess Medical Center in Boston, Massachusetts; University of Chicago Pritzker School of Medicine, and Sharp Memorial Hospital, Clinical Oncology Research in San Diego, California. On March 23, 2001, GCS-100 demonstrated positive clinical activity in the Phase II(a) colorectal trial. On October 30, 2002, GCS-100 demonstrated positive clinical activity in a Phase II(a) clinical trial of 20 pancreatic cancer patients at dose levels of 20 milligrams/m2. This trial was conducted at Sharp Memorial Hospital, Clinical Oncology Research, in San Diego, California and enrolled 12 patients with advanced solid tumors who had failed standard therapies. In this study, reported in October 2003, GCS-100 was well tolerated at doses ranging from 30-80 milligrams/m2 and no dose limiting toxicity was observed. I
As Of: 09/26 16:00 ET
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