Procyon follows its products into late-stage development
Montreal-based Procyon Biopharma has implemented a dramatic corporate restructuring plan, which aims at shifting its focus from an early-stage research company to a late-stage drug development company.
Montreal-based Procyon Biopharma has implemented a dramatic corporate restructuring plan, which aims at shifting its focus from an early-stage research company to a late-stage drug development company.
This will allow Procyon to maximise shareholder value in the short to medium term. Following recent developments at Procyon, the company has undertaken to substantially reduce its anticipated burn-rate while maintaining its development activities for its three main drug candidates, namely: PCK3145, for advanced metastatic prostate cancer; PPL-100, a new formulation of its protease inhibitor for drug-resistant HIV/AIDS; and Fibrostat, for the prevention of hypertrophic scars.
The restructuring has resulted in the closing down of three of its five basic research laboratories as well as the immediate termination of 14 of its 42 employees, mainly in the basic research and administrative support functions. Henceforth the company's major focus will be on the conduct of clinical trials with its lead drug candidates.
Procyon's therapeutic peptide for advanced metastatic prostate cancer, PCK3145, recently received clearance from the FDA to initiate a dosing study of once versus twice weekly administration of the drug at the Memorial Sloan-Kettering Cancer Center in New York. The Company expects to complete this study by mid-year and plans to initiate a complete Phase IIb trial across the United States and Canada thereafter. The preclinical work on PPL-100, the Company's protease inhibitor for drug-resistant HIV/AIDS, is nearing completion and Procyon expects to bring the candidate to the clinic in the second half of 2005. Finally, the Company is currently assessing the option to apply for a Phase IIb protocol amendment to study the clinical utility of Fibrostat in the prevention of hypertrophic scars.
'Although unfortunate, these measures are necessary in order to manage our financial position and burn rate to allow our continuing operations to function for the next 18 months without impacting on our three main development programs,' said Hans J. Mader, president and chief executive officer of Procyon Biopharma. 'This will allow us to deliver our anticipated milestones for 2005 which include the elucidation of PCK3145's complete mechanism of action and receptor and the confirmation of its dosing regimen, followed shortly by the main Phase IIb trial; the disclosure of PPL-100 pharmacokinetic and resistance profiles in Q1 2005 and the initiation of its Phase I trial by Q3 2005; and the completion of a proof-of-concept study with Fibrostat for the prevention of scarring by Q4 2005,' he added.
The Company forecasts a burn rate of approximately $850,000 per month for the fiscal year 2005. It anticipates its burn rate will be slightly higher during the first quarter, but lower during the remainder of the year.