Protox Therapeutics (OTC: PTXRF.PK) applies genetic engineering techniques to create innovative, targeted protein-based therapeutics which are focused on prostate conditions and cancer. The Company's clinical-stage pipeline is based on the PORxin and INxin technology platforms. Lead drugs in clinical development include PRX302 for the treatment of benign prostatic hyperplasia (BPH or enlarged prostate) and localized prostate cancer as well as PRX321 for primary brain cancer (glioblastoma multiforme / GBM and astrocytoma).
Protox announced positive top-line results this morning from its double-blinded placebo controlled Phase 2b TRIUMPH study of PRX302 in patients with moderate to severe benign prostatic hyperplasia (BPH). The study achieved its primary clinical endpoint of a statistically significant improvement in International Prostate Symptom Score (IPSS) at 90-days post-treatment for patients treated with PRX302 versus subjects receiving placebo. IPSS is a validated primary clinical endpoint used to assess the treatment benefit in BPH trials, and the index is measured on a 0-35 scale (with 0 = no problems, 35 = severe symptoms).
Of the 73 per protocol efficacy evaluable subjects, 52 received PRX302 and 21 received placebo, and the PRX302 arm showed an average IPSS improvement at 90 days of 9.1 points versus an average IPSS improvement of 5.8 points for the placebo arm, a statistically significant improvement of 3.3 points. A sub-group analysis was performed for subjects with severe BPH and demonstrated an average IPSS improvement at 90 days from baseline of 10.8 versus 5.8 points for placebo group. No significant safety issues were identified in this study.
Protox will discuss the results with potential development / commercialization partners and detailed results from this study will be presented at the Annual Meeting of the American Urological Association in San Francisco from May 29 to June 3. PRX302 is the lead drug in the company's PORxin technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from BPH and prostate cancer. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.
PRX302 represents a potentially new treatment option for BPH and other prostate conditions with blockbuster potential based on $3 billion in annual sales for BPH drugs (e.g. Flomax, Avodart, Proscar) and the 575,000 surgical procedures that are performed each year in the top seven markets worldwide. Click here for a market analysis article on Protox / BPH that was written by Terika Ray and originally posted at BioMedReports.com last month.
The positive results announced today should add to the significant percentage increases in both share price and trading volume since I first wrote about the Company in early October while the stock was trading around 50 cents.