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License Agreement of “Genetically Engineered Proaerolysin” for the Treatment of
Benign Prostatic Hyperplasia
Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano,
Japan; President and CEO: Mutsuo Kanzawa (“Kissei”)] 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. (“Protox”)] to obtain an exclusive right
in Japan for the development and commercialization of “Genetically Engineered
Proaerolysin” (the “Agent”) which is being developed by Protox, for
the treatment of benign prostatic hyperplasia (“BPH”).
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, “Urief® tablet” (generic name: silodosin) for the treatment of dysuria associated
with BPH has been developed. Also, a phase III program for “KUC-7483”
(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 “Genetically Engineered
Proaerolysin”
<<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 “Genetically Engineered Proaerolysin”. URL: http://www.protoxtherapeutics.com
- About “Genetically Engineered Proaerolysin”-
“Genetically Engineered Proaerolysin” is an inactive fusion protein,
which was generated using “Proaerolysin” 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. | close
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