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

To: Master (Hijacked) who wrote (189)	5/19/1998 12:01:00 PM
From: Larry L	Read Replies (1) \| Respond to of 550

To all: News from the Oncoloy conference: REDWOOD CITY, Calif.--(BW HealthWire)--May 18, 1998--SUGEN, Inc. (Nasdaq:SUGN) today presented Phase II glioma results of its lead anticancer agent SU101 (a PDGF receptor inhibitor), currently in Phase III trials for the treatment of recurrent malignant glioma (brain cancer) and Phase II trials for prostate cancer. The Company also presented interim data from an ongoing Phase I trial with SU5416, a novel angiogenesis inhibitor. The data from these trials were presented at the 34th Annual meeting of the American Society of Clinical Oncology (ASCO) in Los Angeles. SU101 Investigator, Mark Malkin, M.D., Department of Neurology, (Memorial Sloan-Kettering Cancer Center) presented final data from a Phase II study on SUGEN's lead cancer program, SU101, a small molecule inhibitor that blocks the signaling of the PDGF receptor. The study was conducted in 15 end-stage patients with recurrent malignant glioma who had failed surgery, chemotherapy and radiation therapy. The objective of the study was to determine a dose regimen for Phase III studies, and to confirm drug activities seen in previous Phase I trials. The study showed, that a loading dose followed by weekly maintenance dosing was the optimal dose regimen for SU101. Moreover, three patients achieved minor response with duration of 18-56 weeks (with one patient still on therapy today) and three patients with stable disease with a duration of 16-26 weeks. Of the adverse events experienced, 92% of these were classified as mild or moderate. This data was presented to the F.D.A. in an end-Phase II meeting in November 1997 and provided the basis for proceeding into a 30 center Phase III registrational study in malignant glioma earlier this year. "Results of this and previous SU101 studies in recurrent malignant glioma have demonstrated that SU101 is tolerable with evidence of activity," commented Dr. Malkin. "The median time to progression in the evaluable patients in our trial was 15 weeks. If the clinical results seen can be confirmed by the current Phase III study, it would represent a 50% improvement over historical controls." In addition to Memorial Sloan-Kettering, 30 sites will be included in this multi-center study. Additional glioma trials underway include a combination study with BCNU in first line therapy. PDGF has also been shown to be the driving oncogene in subsets of prostate lung and ovarian tumors. A Phase II study in prostate cancer is underway, and SUGEN plans to initiate trials in ovarian and lung tumor patients later this year. ( Additional information on SU101, including an updated list of all study sites currently recruiting patients can be located on the SUGEN web site at www.sugen.com) SU5416 Interim Phase I data of SUGEN's angiogenesis inhibitor, SU5416 was presented by principal investigator, Lee Rosen,M.D., Director of the Jonnson Cancer Center, at the University of California at Los Angeles. To date the study has enrolled 30 patients with advanced solid tumor malignancies, and indicates that SU5416 has been well tolerated at a dose range of 4.4 to 65 mg/m2. The Phase I clinical trial, designed to assess safety of SU5416 in an escalating dose study, has demonstrated that, SU5416 can be safely administered at the doses given to date. "SU5416 is one of a number of promising angiogenesis inhibitors in early clinical testing," commented Dr. Rosen. "In our trial SU5416 appears to be well tolerated at these doses, and we expect to define a dosing regimen and plan to initiate multiple Phase II studies in different tumor types by year end." SU5416 is a small molecule inhibitor of the Flk-1/KDR receptor which has the potential to block the angiogenic process mediated by vascular endothelial growth factor ("VEGF). The Company last week announced the initiation of a first follow-up study to this trial, a Phase I/II study in Kaposi's sarcoma. 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. Inappropriate 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 and SU5416, SUGEN has 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. This press release contains, in addition to historical information, forward-looking statements that involve risks and uncertainties. The Company's actual results, including the further development of SU101 and SU5416, could differ significantly from the results discussed in the forward-looking statements. Factors that could cause or contribute to such differences include the factors more K and most recent Form 10-Q. The Company undertakes no obligation to release the results of any revision to these forward-looking statements which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.