Pacific Therapeutics Ltd (PT:CNX)

Pacific Therapeutics Ltd. is a publicly traded company listed on the Canadian National Stock Exchange (CNSX) under the symbol PT.



Pacific Therapeutics a Specialty Pharmaceutical Company is focused on the identification, development and sales of drug candidates to treat diseases of the liver and lungs caused by excessive and progressive tissue scarring, called fibrosis.








The company's strategy includes the reformulation and repurposing of FDA approved drugs to treat excessive scarring in liver and lung disease. Pacific Therapeutics will complete clinical testing, manufacturing and other regulatory requirements sufficient to seek marketing and sales authorizations of its drug candidates in the US, Europe, Canada and other countries.



Pacific Therapeutics' lead drug candidate; PTL-202 is set for Phase 1 clinical trials in 2012. PTL-202 is a combination of drugs that have been approved by the FDA to treat diseases other than fibrosis. PTL-202 is being developed by Pacific Therapeutics to treat a progressive lung scarring disease, named Idiopathic Pulmonary Fibrosis (IPF). More people die of annually IPF than either prostate or breast cancer. IPF is estimated to be a $2 billion market opportunity.



On July 12, 2011 Pacific Therapeutics engaged CRBIO (Clinical Research and Biosciences of Hyderabad), India to conduct a clinical trialwith PTL-202 in a drug to drug interaction study in humans. CRBIO is the clinical trials a division of RA Chem Pharma Limited, India.



Pacific Therapeutics' second drug candidate, PTL-303, is also a combination of drugs, one of which has been approved for human use in Japan. PTL-303 has been shown to be effective in the reduction of molecules that contribute to the development of diseases including, liver cirrhosis in humans. PTL-303 may be developed as a treatment to reduce the severity of progressive diseases like chronic liver disease.



Chronic liver disease which may lead to cirrhosis of the liver is responsible for over 1.4m deaths annually (WHO, World Health Report 2004) In the US chronic liver disease is among the top ten disease related causes of death (CDC, National Center for Health Statistics, 2004). This market is estimated to be $3.0 billion.



A provisional patent covering PTL-202 titled: "Composition and Method for Treating Fibrosis" was filed by the company with the United States patent office on October 29, 2008. A PCT application covering the technology of PTL-303 was filed October, 2009.



Pacific Therapeutics' business and drug development strategy reduces risk, time and the capital costs of developing new drug therapies for liver and lung diseases caused by fibrosis. By combining existing approved drugs that have already known safety and toxicity profiles, the company eliminates the inherent risks involved with basic pre clinical research and animal testing.



Future Plans - 2012

• Approval for Phase 1 Clinical Trials PTL-202 for drug-drug interaction as required for regulatory approval
• Initiate Phase 1 drug-drug interaction Clinical Trials PTL-202
• Results from 1 drug-drug interaction Clinical Trials PTL-202
• Manufacturing and Bioavailability studies
• Prepare for 2013 Health Canada Regulatory Approval for PTL-202

Our lead drug PTL-202

Our lead drug PTL-202

The lead product candidate PTL-202 is a combination of drugs that have been approved by the FDA in other indications. PTL-202 is being developed for the treatment of progressive scarring of the lung, Idiopathic pulmonary fibrosis (IPF), a $2 billion market opportunity. IPF has a prevalence in the US and Europe totalling 200,000 patients. The death rate in IPF is higher than either prostate or breast cancer.



In animal trials the combination was more effective than either of its components at reducing indicators of fibrosis. Pacific is planning to formulate the fixed dose combination and initiate a clinical trial of PTL-202 consisting of a drug/drug interaction and pilot bio-equivalency study in 2012. These studies will be followed by final formulation and bioequivalence studies prior to initiation of a Phase 2 proof of principle study.



A provisional patent was filed in the United States by the Issuer in October 2007 to cover the composition of matter and method of use of this combination. In October 2008, the Issuer filed a PCT application based on the above provisional application. The Issuer received a positive preliminary examination of the PCT application in the spring of 2009 and is now ready to formulate PTL-202 and take it into a drug/drug interaction study in humans in 2012.



Click here for more information