>>CARLSBAD, CA--(MARKET WIRE)--Apr 6, 2005 -- CancerVax Corporation (NasdaqNM:CNVX - News) announced today plans to discontinue the Phase 3 clinical trial of Canvaxin(TM) in patients with Stage IV melanoma based upon the recommendation of the independent Data and Safety Monitoring Board (DSMB), which recently completed its planned, second, interim analysis of the data from this study. The DSMB found that the data are unlikely to provide significant evidence of a survival benefit for Canvaxin-treated patients with Stage IV melanoma versus those receiving placebo.
Based on a limited review of data from the Phase 3 clinical trial of Canvaxin(TM) in Stage III melanoma, the DSMB recommended that this clinical trial continue as planned. CancerVax and Serono, CancerVax's worldwide development partner for Canvaxin(TM), intend to continue the Phase 3 clinical trial in Stage III melanoma, and expect that the DSMB will review the third interim analysis of data from this clinical trial in the third quarter of 2005. It is anticipated that the final analysis of data from this clinical trial will take place after the required number of clinical events have occurred, which is currently estimated to occur in mid-2006. There were no safety issues identified with either of the Phase 3 clinical trials of Canvaxin, and the recommendation to close the Stage IV study was not made because of any potential safety concern.
In 2004, enrollment of 1,160 patients in the Phase 3 clinical trial in Stage III melanoma was completed. As of the date of this announcement, a total of 496 patients out of a planned total enrollment of 670 patients were enrolled in the Phase 3 clinical trial in Stage IV melanoma, and further enrollment has been discontinued.
"This news is disappointing. Treatment of patients with Stage IV melanoma has proven to be very difficult and, as yet, no therapeutic agent has been shown to impact overall survival in these patients," said David F. Hale, President and CEO of CancerVax Corporation. "We would like to sincerely thank the patients and their families, and the clinicians and other healthcare professionals who participated in this clinical trial, for their strong support over the past several years.
"We remain committed to completing our Phase 3 clinical trial in patients with Stage III melanoma. The data from the Phase 3 clinical trial in Stage IV melanoma will be fully analyzed, and will be presented in an appropriate scientific forum. In addition to the ongoing study in patients with Stage III melanoma, we expect to begin enrollment soon in a Phase 2 study to evaluate the clinical response to Canvaxin(TM) of patients with in-transit melanoma, an uncommon form of melanoma in which multiple subcutaneous or intradermal metastases are visible."
About the DSMB
The DSMB consists of independent experts in medical and surgical oncology, statistics and medical ethics who are not participating in the clinical trials, whose primary responsibility is to monitor, on a periodic basis, the data emerging from a clinical trial and to provide recommendations to the sponsor on whether a study should be modified or discontinued.
Conference Call and Webcast Today at 9:00 am Eastern Time
CancerVax management will host a conference call today to discuss the DSMB recommendation to discontinue the Canvaxin Phase 3 clinical trial for stage IV melanoma at 9:00 a.m. Eastern Time. A live audio webcast of management's presentation will be available at ir.cancervax.com. Alternatively, callers may participate in the conference call by dialing (888) 396-2386 (domestic) or (617) 847-8712 (international). The passcode is 33640768. A replay of the conference call can be accessed by dialing (888) 286-8010 (domestic) or (617) 801-6888 (international). The passcode for the replay is 59816558. The webcast will also be archived on CancerVax's website.
About CancerVax Corporation (www.cancervax.com)
CancerVax Corporation is a biotechnology company focused on the research, development and commercialization of novel biological products for the treatment and control of cancer. The Company's lead product candidate, Canvaxin(TM), is one of a new class of products being developed in the area of specific active immunotherapy, also known as therapeutic cancer vaccines. In December 2004, CancerVax announced an exclusive worldwide collaboration with Serono Technologies, S.A., a Swiss corporation, for the development and commercialization of Canvaxin.
In addition to Canvaxin(TM), CancerVax has licensed three specific active immunotherapeutic product candidates targeting the EGFR signaling pathway, including one product candidate in Phase 2 clinical trials. The Company also plans to identify and develop new product candidates based on its proprietary specific active immunotherapy, anti-angiogenesis and telomere signaling T-oligonucleotide technology. CancerVax's corporate headquarters and research and development facility is located in Carlsbad, California, and its biologics manufacturing facility is located in the Los Angeles area.<<
Never thought much of this company, but didn't check it out much, either. Hale just isn't the biggest achiever in biotech, IMO. Suspect the stock will tank on this news. The trial for Stage III patients probably has lower odds of success, too, though outright discontinuation was not recommended.
Cheers, Tuck |
