Protox Therapeutics Inc T.PRX

Kissei's PR - FYI

[cabbieJBJ]

https://www.kissei.co.jp/e_contents/press_e/2010/e20100430.html

April 30, 2010

@@

License Agreement of gGenetically Engineered Proaerolysinh for the Treatment of
Benign Prostatic Hyperplasia

@Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; President and CEO: Mutsuo Kanzawa (gKisseih)] announced today that Kissei has entered into a license agreement with Protox Therapeutics Inc. [Head Office: Vancouver-city, British Columbia, Canada; President and CEO: Fahar Merchant Ph.D. (gProtoxh)] to obtain an exclusive right in Japan for the development and commercialization of gGenetically Engineered Proaerolysinh (the gAgenth) which is being developed by Protox, for the treatment of benign prostatic hyperplasia (gBPHh).

BPH is a disease where men have symptoms of dysuria including urinary frequency and incomplete emptying of the bladder. BPH is caused by an enlarged prostate in men due to aging, leading to pressure on the urethra. About half of all men over the age of 50, and 80% of men over the age of 80, have the disease symptoms. Pharmacotherapy is applied for the treatment of BPH first, but surgical procedures including transurethral resection of the prostate are used for serious cases.
The Agent is an injectable drug administered into the prostate and is based on an inactive version of the protein, proaerolysin, produced by Gram-negative bacteria. When the Agent is injected into the prostate, it is activated by prostate-specific antigen (PSA) localized in the prostate, inducing a partial ablation of prostate tissue and consequently reducing the prostate volume and alleviating the symptoms.
We look forward to providing a new option for the treatment of BPH with the Agent.

At present, Protox is conducting clinical development for the Agent in Canada and USA. Protox has obtained positive results@from an interim analysis of a Phase II study in patients with BPH. Statistically significant improvement in International Prostate Symptom Score (IPSS) was achieved compared with placebo through the ablation of prostate tissue.

Kissei focuses in the area of urology diseases as one of its strategic domains. In Japan and overseas, gUrief® tableth (generic name: silodosin) for the treatment of dysuria associated with BPH has been developed. Also, a phase III program for gKUC-7483h (Kissei original product) for the treatment of overactive bladder is on-going in Japan. Kissei will have a more reinforced and enhanced R&D line-up in the area of Urology diseases by the introduction of gGenetically Engineered Proaerolysinh

<<Reference>>
- About Protox Therapeutics Inc. -
Protox has its head office in Vancouver-city, British Columbia, Canada. Protox is a biopharmaceutical company developing innovative agents based on receptor targeted fusion proteins. At present, it does not have any products on the market, but two drugs are in the clinical development stages, including gGenetically Engineered Proaerolysinh. URL: https://www.protoxtherapeutics.com

- About gGenetically Engineered Proaerolysinh-
gGenetically Engineered Proaerolysinh is an inactive fusion protein, which was generated using gProaerolysinh discovered for the first time in Gram-negative bacteria Aeromonas hydrophila as a prototype. The Agent is a prodrug generated by engineering Proaerolysin so that it is activated by prostate specific antigen (PSA), a protease localized in the prostate. Activation occurs through cleavage of a specific bond by PSA. Once activated, the drug exerts its effect by partial ablation of prostate tissue and thereby reducing the prostate volume.

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[Umpolung]

It was nice of my scan to pick this up before the news.  The partnership is a nice one--Kissei has Rapaflo (silodosin) but it's unlikely to make a large splash because of ejaculatory dysfunction and IFIS (if you recognize these two, we can take the conversation off-line).  A medical alternative to dutasteride and finasteride is just what the community is looking for.