To all:SUGEN Inc. (Nasdaq:SUGN) today announced|
encouraging interim data from its ongoing Phase I clinical trial of its angiogenesis inhibitor, SU5416.
The data were presented at the "Biologic Principles for the Therapy of Human Colon Cancer" Conference in San Diego,
hosted by the University of Texas M.D. Anderson Cancer Center on Nov. 7, 1998.
In patients with advanced cancers, SU5416 appears to be very well-tolerated with minimal side effects. While safety is the
primary endpoint of this Phase I trial, preliminary (and at this point anecdotal) data indicates that SU5416 may have clinical
activity in cancer patients, including colorectal, lung, renal cell and AIDS-related Kaposi's sarcoma patients.
To date, 60 patients with advanced malignancies, including 11 patients with colorectal and 10 with lung cancer, have been
treated in the Phase I dose-escalation study at the University of California Los Angeles (UCLA), which began in September
1997. In this ongoing study, SU5416 has been administered twice weekly in an IV formulation, with escalating doses up to a
level of 145 mg/m2 (from an original starting dose of 4.4 mg/m2). Four patients have been on study for greater than six
months, including one patient on for nearly a year, and 10 patients have been on study for over three months, indicating
SU5416's potential to be used as chronic therapy. Most side effects observed were mild (primarily Grade 1 and 2), and
included pain at injection site, pharyngitis, phlebitis and headache. "The extended duration of many of these late-stage patients
on SU5416, one for almost a year and several for over three and six months, suggests that they may be receiving potential
clinical benefit from the drug," said Lee Rosen, MD, principal investigator, Director of the Cancer Therapy Development
Program at UCLA's Jonsson Cancer Center.
In addition to this trial, SU5416 is in a Phase I/II trial for AIDS-related Kaposi's sarcoma, and additional Phase I trials at the
Arizona Cancer Center and the Royal Marsden Hospital in London to assess different dosing regimens and potential clinical
surrogate markers. The Company is now preparing to initiate Phase II trials with SU5416 in selected indications, including
colorectal and lung, by the first quarter of 1999.
SU5416 is a small molecule inhibitor of the Flk-1/KDR signalling pathway. SU5416 prevents the formation of new blood
vessels required for tumor growth by blocking the Flk-1/KDR receptor found in the endothelial cells of these blood vessels.
The Flk-1/KDR receptor may play a role in the angiogenesis process in over 80% of all solid tumors.