By Mike Havrx
Protox Therapeutics (TSX: PRX.TO) (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).
PRX302 Poster Presentation at SIU – Nov. 2009: Click on the preceding link for a PDF link to the Company’s poster presentation of detailed 12-month results from a Phase 2 open-label clinical trial that were presented at the 30th World Congress of the Societe Internationale d’Urologie (SIU) in early November. Below is a summary of the poster presentation at SIU 2009, 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 clinical data that has been generated to date.
1.) PRX302 is well tolerated in BPH patients at injection volumes equivalent to 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 scores improved significantly (p<0.01) out to at least 360 days following a single treatment
4.) Patients receiving the optimum dose (≥ 1mL per deposit) in the Phase II study 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 to administer in a 10-15 minute outpatient setting
On 9/8/09, Protox announced that it has completed patient enrollment in a multi-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide. TRIUMPH is the third BPH clinical trial of PRX302 conducted by Protox. In addition to being well-tolerated, the previous open-label Phase 2 study reported at the 2009 Annual Meeting of the American Urological Association, showed an 11 point improvement in the International Prostate Symptom Score at the optimal PRX302 dose used in the TRIUMPH study.
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.
The Company expects to report top-line results from the TRIUMPH study during late 2009 or early 2010. 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.
The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my 22 ProActive HavRx stock indexes. This service will allow investors to create personalized exchange-traded funds (ETFs) and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes.
Disclosure: Long PTXRF.PK
1 reply »