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Biotech / Medical : Sugen (SUGN) -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (128)	1/13/1998 9:13:00 AM
From: Larry L	Read Replies (1) \| Respond to of 550

To all: Exciting news: REDWOOD CITY, Calif.--(BW HealthWire)--Jan. 13, 1998-- Stephen Carter, MD, Appointed Senior Vice President, Clinical & Regulatory Affairs SUGEN, Inc. (NASDAQ:SUGN) announced today that, following approval from the Food and Drug Administration to proceed into Phase III, the Company has initiated a pivotal study with the objective of establishing SU101's efficacy in first relapse Glioblastoma Multiforme patients. The Company anticipates that this will be the first of several pivotal studies that it will undertake with SU101 in different patient populations over the next two years. The protocol for this multi-center study, which has now received its first IRB approvals, calls for the enrollment of an estimated 380 patients in over twenty sites in the United States and Canada. Patients will be randomized between two arms, in order to compare the efficacy of single-agent SU101 against that of single-agent Procarbazine, the most commonly used chemotherapeutic drug in BCNU-refractory brain tumor patients. The study's primary end-point is Survival, with secondary end-points of Time to Disease Progression, Objective Response Rates and Quality of Life. The Company's objective is to complete accrual in approximately 18 months, with a six month follow-up. The protocol includes an interim analysis which is expected to take place during 1999. SU101 is a small molecule signal transduction inhibitor that blocks the signalling of the PDGF receptor, which SUGEN scientists have established to be the driving oncogene in subsets of brain, prostate, lung and ovarian tumors. The Company announced recently that it has received two U.S. patents for the use of SU101 in the treatment of PDGF receptor driven tumors. SU101 is currently in Phase II studies in first line brain tumor patients, in combination with BCNU, and as single agent therapy in hormone refractory prostate cancer; additional Phase II's are in planning, including studies in ovarian and lung tumor patients. "SUGEN and its clinical advisors believe at this point that SU101 is an active compound in PDGF receptor driven tumors, so the challenge for us now is to demonstrate that we can achieve statistically significant improvements in outcome for specifically defined patient populations," commented Stephen Evans-Freke, Chairman & Chief Executive Officer of SUGEN, Inc. "We are excited about SU101 passing this significant milestone of the start of its first pivotal study, but we do not intend to put all our SU101 eggs into this one basket. We are committed to pursing multiple registrational pathways with this promising drug candidate, in order to maximize its chances of reaching the market as the first signal transduction inhibitor for the treatment of cancer." Separately, SUGEN announced the appointment of Dr. Stephen Carter as Senior Vice President, Clinical and Regulatory Affairs. Dr. Carter had been serving previously as a consultant to SUGEN, but will now assume responsibility for all SUGEN's rapidly expanding clinical development activities with Dr. Peter Langecker, SUGEN's current Vice President, Clinical & Regulatory and SUGEN's internal clinical development team reporting to him. Formerly a practicing oncologist and a Deputy Director of the National Cancer Institute, Dr. Carter served in various senior drug development positions at Bristol Myers-Squibb from 1982 to 1995, most recently as Senior Vice President, Worldwide Clinical Research and Development. SUGEN, Inc. is a biopharmaceutical company focused on the discovery and development of small molecule drugs which target specific cellular signal transduction pathways. These signalling pathways are regulated by cell surface receptors or intracellular signalling molecules known as tyrosine kinases (TKs), serine-threonine kinases (STKs) and tyrosine phosphatases (TPs). TKs, STKs and TPs are three of the largest known families of receptors in the body and are key regulators of critical cellular functions. Aberrant signalling of TKs, STKs and TPs has been shown to result in a variety of chronic and acute pathological diseases, including cancer and diabetes as well as dermatologic, ophthalmic, neurologic and immune disorders. In addition to SU101, SUGEN currently has two other products in clinical trials: SU5416 (a Flk-1/KDR angiogenesis inhibitor) in Phase I for the treatment of solid tumor cancers; and SU5271 (an EGF receptor inhibitor) in Phase I for the treatment of psoriasis. The Company has research and development collaborations with Zeneca, ASTA Medica and Allergan.