BCRX was in my hot watch list (potential investments in nearest future). However, today I added BCRX to portfolio. Briefly about this small-cap biotech company. “BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds that are in late-stage pivotal trials; peramivir, a neuraminidase inhibitor for the treatment of influenza, and forodesine, an orally-available purine nucleoside phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL). Additionally, BioCryst has a third product candidate, BCX4208—a next generation PNP inhibitor—in mid-stage trials for the treatment of gout. www.biocryst.com
Thus, the company pipeline included 3 experimental drugs for 3 different diseases: influenza, T-cell lymphoma and gout. The company has very strong science basis for each drug program. Peramivir is already in two Phase III trials. In one trial researchers plan to test the efficacy of the drug used in combination with the current standard of care. That trial, which gets underway in November, will enroll 400 patients and BioCryst plans to finish in May, 2011. Another trial will further explore efficacy, safety and tolerability in patients who have the flu. That trial will wrap in June, 2011. This Phase III study will provide an important opportunity to evaluate peramivir in an area of unmet medical need for seriously ill patients in the hospital setting. http://www.fiercevaccines.com/story/biocryst-outlines-phase-iii-plans-peramivir/2009-10-01
So, biotech investors are awaiting 3 very important events for BCRX in nearest future: Q IV 2010 and Q II 2011.
pivotal Phase 2 study for forodesine in the treatment of cutaneous
T-cell lymphoma (CTCL) achieved its protocol-specified objective of
enrolling 100 late-stage patients (Stage IIB to IVA) in January, and BioCryst expects to report data from the study in the second half of 2010. Skin lymphomas are covered under the U.S. Orphan Drug Act. And even if Cutaneous T-cell lymphomas (CTCLs) are the largest group of cutaneous lymphomas, representing 65% of all cutaneous lymphomas in the United States, there are about 1,500 new cases per year in US, as compared to 58,870 new cases per year for all types of non-Hodgkin lymphoma (Source, NHL data: The National Cancer Institute Surveillance, Epidemiology and End Results [SEER] Program, 2006). Thus, even very positive phase II trial data for CTCL will not produce potential blockbuster drug for BCRX. Any way if results are strong
Experimental gout drug BCX4208 is also in 2 phase II trials. Primary Completion Date: September 2010 (Final data collection date for primary outcome measure). One study was started in September 2009 with estimated enrollment 120 patients. Primary Outcome Measures: • To determine the effect of different doses of orally administered BCX4208 on serum uric acid (sUA)levels in subjects with gout. [ Time Frame: Day 22 ] http://clinicaltrials.gov/ct2/show/NCT00985127