|By Marketwired .||
|June 27, 2014 07:00 AM EDT||
TORONTO, ONTARIO -- (Marketwired) -- 06/27/14 -- Revive Therapeutics Ltd. (TSX VENTURE: RVV) ("Revive") announced today positive results from the second-half of its Phase 2a proof-of-concept study (the "Study") of REV-001 targeted for the treatment and/or prevention of opioid-induced respiratory depression for patients with sleep apnea in a post-operative setting.
The purpose of the Study is to determine the effect of an oral dose of REV-001 on alfentanil-induced respiratory depression and analgesia. The results of the Study indicate that a single dose of REV-001 may treat and/or prevent opioid induced respiratory depression in a post-operative setting, without affecting analgesia. The 16-patient, placebo-controlled, double-blind, randomized two-way crossover trial was performed by one of the leading experts in the field, Professor Dr. Albert Dahan, M.D., Ph.D., at the Leiden University Medical Center in The Netherlands. Full results of the Study to be published.
The data from the second-half of the Study in the eight patients yielded the following key findings:
-- Treatments with REV-001 was safe and well tolerated at the 50 mg dose, was not associated with serious adverse events, and there was no treatment-related discontinuations; -- A significant increase on respiratory drive as measured by inspired minute ventilation at an elevated expired PCO2 (VE55) of 36% (p = 0.039) by REV-001 as compared to placebo during high-dose alfentanil infusion induced respiratory depression; -- Treatments with REV-001 did not affect the opioids analgesic properties; and -- Treatments with REV-001 did not affect sedation.
"Overall, this is a successful study showing the respiratory stimulatory effects of REV-001, that now seems to have a novel target, that is reversal of opioid-induced respiratory depression and a unique solution in a post-operative setting," said Prof. Dr. Albert Dahan M.D., Ph.D., Principal Study Investigator and Professor of Anesthesiology at the Leiden University Medical Center, The Netherlands.
"I am very pleased with the successful completion of our first human clinical trial and that we met our milestone for REV-001 on time and on budget. The positive results of the REV-001 human clinical trial now positions the drug for partnering discussions," said Fabio Chianelli, Revive's Chief Executive Officer. "This achievement not only validates our ability to successfully repurpose drugs for new indications, but also provides us with the opportunity to advance our business development activities via licensing and acquisitions."
About Post-Operative Pain and Sleep Apnea
According to the National Center for Health Statistics, there are over 100 million surgeries performed annually in the United States with approximately 50% of those requiring post-operative pain medication such as opioids. However, opioids are known to raise serious concerns such as respiratory depression, oxygen desaturation and other side effects such as constipation, nausea and vomiting. Patients who have obstructive sleep apnea (OSA) are at a particular risk of experiencing such negative side-effects from opioids. There are 18 million Americans with sleep apnea and the condition is exacerbated with age, obesity, smoking and alcohol. According to an article titled "A Rude Awakening - The Perioperative Sleep Apnea Epidemic" published in the New England Journal of Medicine in June 2013, the risk of perioperative complications increase substantially with those who have OSA. Hospitals must take into consideration the financial implications that may become prevalent for patients who have OSA in order to reduce the risk of adverse events, such as opioid-induced respiratory depression. It has been estimated that between 29% and 41% are at high risk of opioid-induced respiratory depression. (Source: Hanna MH et al. Anesthesiology. 2005;102(4): 815-821 and Overdyk FK et al. Anesth Analg. 2007;105(2): 412-418). Currently, there are no approved drugs for OSA and the only drug treatments to counter opioid-induced respiratory depression is to administer opiate receptor antagonists such as naloxone (Narcan®). However, those antagonists eliminate the analgesic activity of the opioid drug and thus are rarely used by hospitals and healthcare facilities to prevent or treat opioid-induced respiratory depression. According to the article "A Rude Awakening - The Perioperative Sleep Apnea Epidemic", perioperative sleep apnea in the United States has been considered as an 'Epidemic'.
REV-001 is the repurposing of the drug tianeptine, an old but unique anti-depressant drug, which is marketed in Asia, parts of Europe and South America. Despite its narrow geographic scope, the decades-long clinical experience of tianeptine suggests much about its safety. In fact, tianeptine has been shown to have substantial cardiovascular and other safety at both normal doses and in overdose. (Source: Wilde, M. I. & Benfield, P. Drugs 49, 411-439 (1995)). More recently, in animal studies conducted by Revive, tianeptine was shown for the first time to prevent opioid(morphine)-induced respiratory depression in an animal model. The novel findings in Revive's animal studies enabled Revive to apply for intellectual property protection covering the use of tianeptine to treat respiratory depression.
About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. is a Canadian public company (TSX VENTURE: RVV) focused on acquiring, developing and commercializing treatments for major market opportunities such as gout, post-operative pain, and rare diseases. Revive aims to bring drugs to market by finding new uses for old drugs, also known as drug repurposing, and improving the therapeutic performance of existing drugs for underserved medical needs. Additional information on Revive is available at www.revivethera.com.
The information in this news release includes certain information and statements about management's view of future events, expectations, plans and prospects that constitute forward looking statements that may not be based on historical fact, including without limitation statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions. These statements are based upon assumptions that are subject to significant risks and uncertainties. Because of these risks and uncertainties and as a result of a variety of factors, the actual results, expectations, achievements or performance may differ materially from those anticipated and indicated by these forward looking statements. Such factors include, among others, Revive's stage of development, lack of any product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market products, the ability to protect intellectual property, dependence on business partners and the prospects for negotiating joint ventures, distribution and licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to; the risks and uncertainties that Revive may not be able to successfully develop and obtain regulatory approval for its products; intellectual property disputes; future operating results are uncertain and likely to fluctuate; ability to raise additional capital; successfully establishing additional corporate collaborations, distribution or licensing arrangements; establishing marketing and the costs of launching products may be restricting; Revive's lack of experience in commercial manufacturing; increased competition from pharmaceutical and biotechnology companies; and other factors as described in detail in Revive's filings on SEDAR (www.sedar.com), including, without limitation, Revive's Filing Statement dated November 26, 2013 filed on SEDAR on November 27, 2013.
Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. Although Revive believes that the expectations reflected in forward looking statements are reasonable, it can give no assurances that the expectations of any forward looking statements will prove to be correct. Except as required by law, Revive disclaims any intention and assumes no obligation to update or revise any forward looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward looking statements or otherwise.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.