Data and Safety Monitoring Board Recommends Discontinuation of Canvaxin™ Phase 3 Clinical Trial for Patients with Stage III Melanoma

Business Wire,  Oct 3, 2005  

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CARLSBAD, Calif. & GENEVA -- CancerVax Corporation (NASDAQ:CNVX) and Serono (Virt-X:SEO) (NYSE:SRA) announced today their decision to discontinue the Phase 3 clinical trial of Canvaxin(TM) in patients with Stage III melanoma based upon the recommendation of the independent Data and Safety Monitoring Board (DSMB), which recently completed its planned, third, interim analysis of the data from this study. The DSMB found that the data are unlikely to provide significant evidence of an overall survival benefit for patients with Stage III melanoma who were treated with Canvaxin(TM) versus those who received placebo.

"This news is particularly disappointing because we understand the devastating impact of this disease on patients with advanced-stage melanoma, as well as their families and friends. We are extremely grateful for the strong support we have received for this clinical trial from the clinicians, nurses, study coordinators and, especially, the patients who participated in this clinical trial," said David F. Hale, President and CEO of CancerVax Corporation. "We will discontinue all further development and manufacturing operations for Canvaxin(TM), but we currently plan to continue to further the development of the other product candidates in our product pipeline, which we believe hold promise for the treatment of patients with cancer."

"The Phase 2 results were promising, and we were thus hopeful that this highly innovative product would be successful in a Phase 3 clinical trial in patients with Stage III melanoma," said Franck Latrille, Senior Executive Vice President, Corporate Global Product Development of Serono. "We continue to have a strong pipeline with five Phase 3 programs and significant newsflow expected in the next year. Serono remains committed to oncology with Humax-CD4, adecatumumab and TACI-Ig, with study results from all three programs expected in 2006."

There were no significant safety issues identified with either the Phase 3 clinical trial of Canvaxin(TM) in patients with Stage III melanoma, or with the Phase 3 clinical trial of Canvaxin(TM) in patients with Stage IV melanoma, which was discontinued earlier this year. The recommendations to close both of these clinical trials were not made because of any potential safety concerns. Once the data from these clinical trials are fully analyzed, they will be presented at appropriate scientific meetings.

About the DSMB and Interim Analyses

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.

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. CancerVax has been evaluating Canvaxin(TM) in a Phase 3 clinical trial for the treatment of patients with Stage III melanoma in collaboration with Serono. CancerVax also has a pipeline of product candidates and technologies that are being developed for the potential treatment of cancer. These include SAI-EGF, a product candidate that targets the epidermal growth factor (EGF) receptor signaling pathway; and D93, CancerVax's lead anti-angiogenic humanized monoclonal antibody. CancerVax plans to file an Investigational New Drug (IND) application for clinical trials of D93 in early 2006, and to initiate a clinical trial with SAI-EGF in patients with advanced non-small-cell lung cancer in 2006.

About Serono

Serono is a global biotechnology leader. The Company has eight biotechnology products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth and has recently entered the psoriasis area. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas, including oncology. Currently, there are approximately 30 ongoing development projects.

In 2004, Serono achieved worldwide revenues of US $2,458.1 million, and a net income of US $494.2 million, making it the third largest biotech company in the world. Its products are sold in over 90 countries. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).

CANCERVAX CORPORATION

CONFERENCE CALL AND WEBCAST TUESDAY, OCT. 4, AT 9:00 AM EASTERN TIME

CancerVax management will host a conference call on Tuesday, Oct. 4, at 9:00 a.m. Eastern Time, to discuss the DSMB recommendation to discontinue the Canvaxin(TM) Phase 3 clinical trial for patients with Stage III melanoma. A live audio webcast of management's presentation will be available at http://ir.cancervax.com. Alternatively, callers may participate in the conference call by dialing (866) 831-6270 (domestic) or (617) 213-8858 (international). The passcode is 70660579. 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 42654318. The webcast will also be archived on CancerVax's website.