A good summary of the poster presentation that occured this month.
Its hurry up and wait time - I say we see results in January.
PRX302 Poster Presentation at SIU - Nov. 2009:Click on the preceding link for a PDF link to the Company’s poster presentationof detailed 12-month results from a Phase 2 open-label clinical trial that werepresented at the 30th World Congress of the Societe Internationale d’Urologie(SIU) in early November. Below is a summary of the poster presentation at SIU2009, which concluded that PRX302 is a novel and promising, first-in-class,disease modifying agent for the treatment of BPH based on Phase I/II clinicaldata that has been generated to date.
1.) PRX302 is well tolerated in BPH patients at injection volumes equivalentto up to 30% of prostate size
2.) A volume per deposit of ≥ 1 mL was associated with improved efficacy
3.) International Prostate Symptom Score (IPSS) and Quality of Life scoresimproved significantly (p<0.01) out to at least 360 days following a singletreatment
4.) Patients receiving the optimum dose (≥ 1mL per deposit) in the Phase IIstudy had an average of 12 point improvement in IPSS at day 360 post dosing
5.) 73% of the patients receiving the optimum dose were treatment responders(>30% drop in IPSS)
6.) PRX302 does not adversely impact sexual function and is easy toadminister in a 10-15 minute outpatient setting
On 9/8/09, Protox announced that it has completed patient enrollment in amulti-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) ofPRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), acommon and bothersome urological condition that affects more than 50 millionmen worldwide. TRIUMPH is the third BPH clinical trial of PRX302 conducted byProtox. In addition to being well-tolerated, the previous open-label Phase 2study reported at the 2009 Annual Meeting of the American UrologicalAssociation, showed an 11 point improvement in the International ProstateSymptom Score at the optimal PRX302 dose used in the TRIUMPH study.