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GLGS, which suffered an ignominious demise under its former name, SafeScience, is rising from the dead as as oncology company and a leader in glycobiology. I just listened to GLGS presentation at the 10-21-03 Rodman & Renshaw Conference. The presenters were John Burns (CFO) and Fred Pierce (VP Bus. Dev.). These notes combine material from the presentation with material from the press release that accompanied it. An important 1/03 article mentioned Glycobiology as one of the top 10 most promising fields in biotechnology and identified GLGs as one of 7 companies that will make a difference in Glycobiology. GLGS has an extraordinary SAB. GLGS’s lead drug, GCS-100, is unique in having the triple threat of targets in anti-angiogenesis (VEGF), anti-metastatics (through interference with a process called “cellular adhesion”), and mitochondria disruption (apoptosis) modes of action. The targets of the most successful chemotherapy drugs target disruption of the mitochondria. So does GCS-100, to its mechanism of action is one that practicing oncologists will readily understand, and they will appreciate its lower toxicity. GLGS’s platform is based on pectin. They snip out branched regions of sugar chains and come up with structures that allow you to bind to proteins or glycoproteins present on cancer cells. GCS-100 is focused on oncology but it may have implications for immunology, endometriosis, and advanced macular degeneration due to its three properties described above. The drug was originally designed as an anti-metastatic back in 1992, looking at galectin-3 as a target. They then found in work at Childrens Hospital that GCS-100 was also a very potent antiangiogenesis compound. At the time, anti-angiogenesis was not considered that exciting, so they focused upon what they view at the most important characteristic of the drug, which is its apoptotic characteristics. The drug’s apoptotic effect comes from depolarizing the mitochondria and changing the exchange of energy across the mitochondrial membrane. In doing so they can selectively induce cell death in cancer cells without affecting healthy cells. In May 2003 they presented data showing that the GCS-100 compound is active in both solid tumors and blood-borne tumors. It works both in BCL2-overexpressing cancer cells as well as in non-expressing-BCL2 cells. The drug has been very well tolerated in two Phase IIA trials and one Phase I trial. No grade 3 or 4 adverse effects. They need to go to 150 mg/m2 to see complete responses (they are as high as 80 mg/m2 thus far). In the 12 patient Phase I dose escalation trial conducted in 7 different cancer types, GCS-100 was well tolerated and no dose-limiting toxicity was observed in any patient. A maximally tolerated dose of GCS-100 was not reached at dose levels up to 80 mg/m2, four times greater than previous clinical trials. Five (41.7%) of the twelve patients enrolled in the trial achieved stable disease. All five patients had stable disease for at least three months. Three of these five patients had stable disease for at least five months. Three (25%) of the twelve patients enrolled in the trial remained on GCS-100 and completed the six-month clinical trial protocol. One of the three patients (a renal cell carcinoma patient) who completed the six-month clinical trial protocol still remains on GCS-100 after 18 months of treatment in a special extension protocol and has achieved a partial response. The clinical trial evaluated patients with unresectable, relapsed, or refractory advanced solid tumors for which there is no curative therapy. Cancer tumor types treated in the trial included breast, lung, colorectal, kidney, stomach, ovarian and pancreatic cancer. GCS-100 was administered intravenously, twice weekly, at doses of 30, 42.5, 60 or 80 mg/m2 (three patients per dose group) for up to six, four-week treatment cycles, or six months. As is customary in such clinical trials, patients were taken off GCS-100 if their disease progressed as determined by tumor lesion measurements. The life expectancy of these patients was 3-4 months at enrollment. The Company plans to conduct three Phase I dose escalation trials in 2004. The first trial will use GCS- 100 as a monotherapy enrolling up to 30 patients and is planned to begin in early 2004. The other two trials will enroll an additional 30 patients, 15 patients per trial, each evaluating the safety of GCS-100 in combination with a different standard chemotherapeutic agent. Following the Phase I monotherapy trial, two Phase II trials are planned in late 2004 in an unmet clinical indication of cancer (probably multiple myloma or pancreatic cancer) evaluating GCS-100's safety and efficacy as a monotherapy. Two additional Phase II trials are planned to evaluate GCS-100 in combination with different approved chemotherapeutic agents. The Phase II program could enroll over 300 patients. If they can repeat the earlier results that they received in pancreatic cancer in the 300-patient study, they may be able to get FDA approval. They will be applying for fast track and orphan drug status for pancreatic cancer. Marc | ||||||||||||||
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