Date: 2014-04-28
Type of information: Initiation of preclinical development
phase: 2
Announcement: treatment of the first patient
Company: Bavarian Nordic (Denmark)
Product: CV301
Action
mechanism: CV301 is an immunotherapy product candidate for the treatment of multiple cancers. It originates from the same poxvirus technology platform as PROSTVAC®. Both products are prime-boost vaccines sequentially combining two different poxviruses (vaccinia and fowlpox). While PROSTVAC incorporates a single antigen over-expressed in prostate cancer (PSA), CV-301 incorporates two antigens (CEA and MUC-1) that are over-expressed in other major cancers, including breast, colon, bladder and other cancers, which makes CV-301 potentially applicable in various cancers.
Disease: bladder cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This randomized, prospective, phase II study aims to determine the efficacy of Bacillus Calmette-Guerin (BCG) given in Combination With PANVAC (CV-301) versus BCG given alone in adults with high grade non-muscle invasive bladder cancer (NMIBC) who failed at least 1 induction course of BCG (NCT02015104).
Latest
news: * On April 28, 2014, Bavarian Nordic has announced that the first patient has now been treated in a randomized, prospective Phase 2 study of its active immunotherapy candidate CV301 in bladder cancer. In the study, sponsored by the National Cancer Institute, 54 patients with high grade non-muscle invasive bladder cancer whose cancer has progressed after initial BCG (Bacillus Calmette-Guerin) treatment will be treated with BCG alone or in combination with CV301. BCG has been approved in many countries to prevent the recurrence of superficial bladder tumors. The study's primary endpoint is to determine if there is an improvement in disease-free survival for patients receiving BCG treatment and CV-301 immunotherapy compared to those receiving BCG treatment alone. It is the hypothesis that the combined administration of BCG and CV-301 may augment the BCG-induced cytotoxic T lymphocyte response against bladder cancer cells expressing MUC-1 and/or CEA and potentially reverse BCG failure in patients that progressed following a prior induction course of the therapy. Lead investigator for the study is Piyush K. Agarwal, M.D., Head, Bladder Cancer Section, National Cancer Institute, NIH. An abstract on this study, entitled "A Randomized, Prospective, Phase II Study to Determine the Efficacy of Bacillus Calmette-Guerin (BCG) given in combination with PANVAC versus BCG given alone in Adults with High Grade Non-Muscle Invasive Bladder Cancer (NMIBC) who failed at least 1 Induction Course of BCG," has been accepted for presentation in the Trials in Progress section at the 2014 ASCO Annual Meeting in Chicago, IL from May 30 to June 3. Abstract #TPS4590. Poster Board: #157B. Presenter: Sam Joseph Brancato, M.D.
