MTD not reached, but no responses, either (maybe some will be reported when study is done?). I guess there was some disease stabilization, but we get no numbers here:
>>RRYTOWN, N.Y.--(BUSINESS WIRE)--June 6, 2004-- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN - News) announced positive preliminary results from the phase 1 trial for the Company's vascular endothelial growth factor (VEGF) Trap in patients with advanced solid tumors. Jakob Dupont, M.D., a medical oncologist at Memorial Sloan-Kettering Cancer Center, summarized clinical data from this phase 1 trial in an oral presentation today at the annual meeting of the American Society of Clinical Oncology (ASCO). The slides from Dr. Dupont's presentation will be available on Regeneron's web site (www.regn.com on the Events page under the Investor heading) until July 5, 2004.
These results are part of a clinical development collaboration agreement with Aventis to jointly develop and commercialize the VEGF Trap with Regeneron. The joint development program includes both cancer and eye diseases and, as has been previously disclosed, budgets approximately $100 million for 2004.
"Blocking VEGF has emerged as an important and well-validated approach in the 'targeted' cancer chemotherapy field," noted George D. Yancopoulos, M.D., Ph.D., President, Regeneron Research Laboratories. "Preclinical studies have demonstrated that the VEGF Trap is a potent blocker of VEGF, and this study confirms that it can bind VEGF in patients. The VEGF Trap was well-tolerated. We can now look forward to additional studies of the VEGF Trap in patients suffering from cancer."
"The suppression of VEGF is emerging as a viable strategy in the treatment of cancer," noted Dr. Dupont. "This study lays the groundwork for future efficacy studies of VEGF trap in a variety of cancers."
The phase 1 trial was an open label, dose-escalation study conducted at three sites in the United States. The study included 38 patients with incurable, relapsed or refractory solid tumors, who received subcutaneous injections. In total, the trial enrolled patients with 15 different types of cancer. Preliminary results of this study indicated that:
the VEGF Trap was well-tolerated at the dose levels studied, suggesting that the maximum tolerated dose has not been reached,
the majority of adverse events were mild to moderate and similar to effects seen in clinical trials of anti-angiogenesis agents and consistent with previous findings with an anti-VEGF antibody. VEGF Trap may be associated with dose-dependent hypertension; however, other than hypertension, no dose-related pattern of adverse events has emerged,
the VEGF Trap achieved a long elimination half-life of approximately 25 days and there were no antibodies detected in any of the treated patients, and
circulating levels of the VEGF Trap at the highest dose (1.6 mg/kg per week) were consistent with levels observed to be effective in animal models.
Detailed results of the trial are expected to be published in a peer-reviewed journal once all patients complete the extended treatment phase available to patients who maintained stable disease after the initial 10-week treatment period and the full results of the extension phase have been analyzed.
The Role of VEGF in the Tumor Growth Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body's tissues and organs, but it has also been associated with the abnormal growth of new blood vessels surrounding tumors to support their expansion. Blocking tumor-associated angiogenesis has been shown to prevent tumor growth in a variety of preclinical models, with the most widely recognized and highly validated results achieved based on approaches that block VEGF. The VEGF Trap has been shown in preclinical studies to block the action of VEGF, thereby blocking the abnormal growth of blood vessels. Based on the understanding of how receptors work for an entire class of growth factors and cytokines in the human body (e.g., Davis et al., Science 260:1805 (1993); Stahl et al., Science 263:92 (1994)), Regeneron developed the VEGF Trap, a blocker of the growth factor VEGF. <<
snip
Anyone know when final results are expected?
Cheers, Tuck |
