IND to Phase II
A sponsor needed help with their strategy and implementation with a US IND for an androgen receptor antagonist for treatment of prostate cancer. Pharm-Olam’s Regulatory department provided daily consulting and preparation of the IND which was later accepted by the FDA. The sponsor was impressed with our performance and hired Pharm-Olam to run their Phase I first-in-man study where we provided Regulatory, Pharmacovigilance, Data Management, Protocol Development, Biostatistics, Monitoring and Project Management.
The FIM study was split into several cohorts and required patients who had failed previous androgen therapy and were naïve to chemotherapy and other types of treatment. The study is currently ongoing with 8 sites in the USA and has completed enrollment of the Phase II portion with LPI 2 weeks early.
The sponsor is very pleased with Pharm-Olam’s performance and awarded 3 additional full service studies in healthy volunteers.