Celgene advances Actimid into Phase II

Celgene has advanced the development of one of its leading clinical candidates, Actimid (CC-4047).

Actimid, a proprietary immunomodulatory drug (IMiD), is being evaluated as a potential therapy for prostate cancer. This recently initiated multi-centre Phase II; two-stage, open-label trial will investigate the safety and efficacy of Actimid, as a single agent, in hormone-refractory prostate cancer (HRPC) patients.

'The initiation of this phase II trial demonstrates our commitment and long-term strategy for our IMiDs, such as Actimid, with the objective of improving the therapeutic outcome, potency and side effects for potential new treatments across a broad range of solid tumor and hematologic cancers,' said Dr Sol J Barer, president and coo of Celgene Corporation. 'We are encouraged by the emerging data on CC-4047 and its potential to address unmet medical needs in the fight against prostate cancer.'

Phase II Clinical Trial

This is a multi-center, two-stage, open-label study of the efficacy and safety of CC-4047 administered orally to adult male subjects with HRPC. Up to 36 patients are expected to enroll in the study. The initial group of 19 patients will be evaluated for 16 weeks. An additional 17 subjects may be enrolled if at least 4 subjects have a prostate-specific antigen (PSA) response of greater than or equal to 50 percent. The primary endpoint is a PSA response defined as a decline in PSA of greater than or equal to 50 percent on two consecutive measurements obtained at least 28 days apart.

About Actimid (CC-4047)

Actimid is representative of a class of orally administered IMiDs offering meaningful potential as a next generation therapy addressing unmet medical needs. Interim data from an ongoing Phase I/II trial in relapsed and refractory multiple myeloma patients indicate that Actimid demonstrated anti-tumor activity. Actimid (CC-4047) is not approved by the FDA and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.

About Prostate Cancer:

Prostate cancer is the most diagnosed cancer in American men and the second leading cause of cancer death. Prostate cancer is twice as common and has more than twice the mortality rate in African-American men than in Caucasian men. The 5-year survival rate for patients whose cancer is caught while still confined to the prostate is 99% while the 5-year survival rate for those diagnosed with distant (metastatic) disease is 30.9%. In the U.S. alone, nearly 200,000 men will be diagnosed with prostate cancer this year equaling one man diagnosed every three minutes. It is estimated that more than 30,000 to 40,000 men in the U.S. will die of prostate cancer. Prostate cancer affects one in eight American men.