PROGRESS OF CLINICAL DEVELOPMENT VANCOUVER, BRITISH COLUMBIA – April 16, 2012 (Investorideas.com Newswire) Pacific Therapeutics Ltd. (PT.CNSX) (the “Company”) is pleased to provide an update on the progress of the clinical development of PTL-202. As previously announced the Company has engaged CRBIO of India to conduct a drug drug interaction study of PTL-202 and its components. CRBio has submitted the PTL-202 drug-drug interaction clinical trial protocol to the Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, New Delhi, India.
The clinical study protocol is currently being reviewed by the Central Drugs Standard Control Organization ( India 's pharmaceutical regulatory authority). The study will be conducted once this regulatory approval is received, which is expected this quarter. The study protocol calls for dosing of 12 normal healthy adult males. This an open label, non randomized, three treatment, three period single dose study. Once enrolment is completed the study should only take 1 month to complete.
The lack of any drug drug interaction will be a positive result and signal the continued clinical development of PTL-202. CRBio is 'full service' contract research organization. It is set up in a centrally located area in Hyderabad India . The facility is spread over 20,000 sq.ft. in well laid out areas with operations such as Clinical, Bioanalytical, Pharmacokinetic & Statistical, QA & RA , QC . With 4 full time doctors plus paramedical staff, clinics consist of 72 beds and CRBio has a 3,000 volunteer database and a state of the art bioanalytical laboratory. CRBio as an independent contractor has completed over 150 BA/BE (Bioavailability Bioequivalence) projects similar to the PTL-202 drug drug interaction study.
ABOUT PACIFIC THERAPEUTICS LTD. (http://www.pacifictherapeutics.com/)
Pacific Therapeutics Ltd is a clinical stage specialty pharmaceutical company focused on the identification and development of drug candidates to treat diseases of excessive scarring (fibrosis). The company's lead drug candidate PTL-202 is a combination of Pentoxifylline (a FDA approved drug used for treating intermittent claudication) and N-Acetyl-Cysteine (NAC) an amino acid and an extremely potent and important antioxidant. PTL-202 is currently being reviewed for initial trials in humans which are expected to commence in 2012. PTL-202 a combination of approved drugs focused on treating fibrosis such as Idiopathic Pulmonary Fibrosis and Liver Cirrhosis.
The Company's strategy includes reformulating approved drugs to increase efficacy and patient compliance, completing the further clinical testing, manufacturing and other regulatory requirements sufficient to seek marketing authorizations. This strategy may reduce the risk, time and cost of developing therapies for fibrosis by avoiding the risks associated with basic research and using compounds with unknown safety and toxicity profiles.
FORWARD LOOKING STATEMENTS Certain statements included in this press release constitute forward-looking information or statements (collectively, “forward-looking statements”), including those identified by the expressions “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “may”, “should” and similar expressions to the extent they relate to the Company or its management. The forward-looking statements are not historical facts but reflect current expectations regarding future results or events.
This press release contains forward looking statements. These forward-looking statements are based on current expectations and various estimates, factors and assumptions and involve known and unknown risks, uncertainties and other factors. Readers should not place undue reliance on the Company's forward-looking statements, as the Company's actual results, performance or achievements may differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements if known or unknown risks, uncertainties or other factors affect the Company's business, or if the Company's estimates or assumptions prove inaccurate. Therefore, the Company cannot provide any assurance that such forward-looking statements will materialize. The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws.
On Behalf of the Board of Directors /s/ Doug Unwin Douglas H. Unwin, CEO & President