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Friday June 4, 7:32 am Eastern Time
Company Press Release
Food and Drug Administration Signs Off on SUGEN's Clinical Strategy to Move Directly Into Phase III Trials With SU5416, Lead Angiogenesis Inhibitor
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--June 4, 1999-- SUGEN, Inc. (Nasdaq:SUGN - news) today announced that the Food and Drug Administration (FDA) has agreed with the Company's proposed clinical trial design for Phase III trials of SU5416, its lead angiogenesis inhibitor, in colorectal and non-small cell lung cancer.
''The success of this meeting with the FDA helps validate SUGEN's development strategy for SU5416 to move rapidly forward into Phase III trials,'' said Stephen Carter, MD, Senior Vice President, Clinical and Regulatory Affairs.
The trials, which are expected to begin this summer in the U.S. and Europe, will compare SU5416 against standard chemotherapy regimens in patients who have not yet received any chemotherapy. Both trials will provide for scheduled interim analyses. The primary endpoint is survival, with secondary endpoints of time-to-disease progression and objective response rate. The studies will analyze tumor samples, using SUGEN's proprietary gene expression array technology.
SUGEN is also working with the AIDS Malignancy Consortium on a registrational Phase II trial in AIDS-related Kaposi's sarcoma, expected to begin this summer.
To date, more than 135 patients with end-stage disease have been administered SU5416 in seven Phase I and Phase I/II clinical trials. Results from the Phase I studies of SU5416 showed that the drug was well tolerated with mild side effects. There were also observations of lesion shrinkage in Kaposi's sarcoma, colorectal and basal cell cancer patients, and of disease stabilization in a considerable number of patients, including non-small cell lung patients. Ten patients have been treated with SU5416 for greater than six months and individual patients have remained on study for greater than one year, with no evidence of cumulative toxicities.
SU5416 is a proprietary small molecule angiogenesis inhibitor that prevents the formation of new blood vessels required for tumor growth by blocking the signaling pathway of the vascular endothelial growth factor (VEGF) receptor.
SUGEN, Inc. is a biopharmaceutical company focused on the discovery and development of small molecule drugs, which target specific cellular signal transduction pathways. In addition to SU5416, SUGEN currently has two other anti-cancer drugs in development: SU101 (a PDGF receptor inhibitor) is in Phase III trials in refractory brain cancer, will be entering Phase III in refractory prostate cancer this year, and is in Phase II in ovarian and non-small cell lung cancers; and SU6668 (a multi-mechanism inhibitor of angiogenesis and tumor growth) is in Phase I for the treatment of solid tumors. The Company has major research and development collaborations with Zeneca, ASTA Medica, Allergan and Taiho.
This press release contains, in addition to historical information, forward-looking statements that involve risks and uncertainties, including the commencement of clinical trials, the outcome of such trials and the FDA approval process. The Company's actual results 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 fully discussed in the Company's 1998 Form 10K. 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.
Additional written materials and press releases regarding SUGEN are available through the SUGEN Fax-On-Demand Information Service by dialing 1-888-329-4699 or at www.sugen.com.
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Contact:
SUGEN, Inc.
Susan Kinkead, 650/553-8300
irdept@sugen.com
or
Burns McClellan, Inc.
Stephanie Diaz, 415/352-6262 (Investors)
Michelle Corral, 415/352-6262 (Media)
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