US firm Innovate Oncology, a subsidiary of BioAccelerate Holdings, has entered an exclusive agreement with Prostagenics to acquire the development and commercialization rights to capridine-beta for the treatment of prostate cancer.
The agent is a novel nitroacridine derivative which has shown activity against prostate cancer. It works by stimulating expression of p16, the tumor-suppressor gene, and inhibits cyclic dependent kinases CDK-2, CDK-4 and CDK-6. As it renders aggressive hormone-independent prostate cells hormone-sensitive, the firm hopes it may be effective in treating both hormone-sensitive and hormone-insensitive tumors in combination with anti-androgen therapy. In addition, there is proven preclinical activity against a range of cancers, and toxicology studies indicate that capridine-beta may be less myelosuppressive than commonly-used cytotoxics.
An Investigational New Drug application is being prepared for submission to the US Food and Drug Administration for a Phase I clinical trial in prostate cancer, intended to determine the maximum tolerated monotherapy dose against advanced solid tumors. Secondary objectives will be to evaluate toxicities, obtain preliminary data on efficacy and investigate the pharmacokinetics of intravenous administration.
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