Revive Therapeutics Ltd.
TSX VENTURE : RVV
OTCQB : RVVTF

Revive Therapeutics Ltd.

December 06, 2016 07:00 ET

Revive Therapeutics Ltd. Announces Positive Study Results in Rett Syndrome

TORONTO, ONTARIO--(Marketwired - Dec. 6, 2016) - Revive Therapeutics Ltd. ("Revive" or the "Company") (TSX VENTURE:RVV) (OTCQB:RVVTF), a company focused on commercializing treatments for rare diseases such as Cystinuria, Wilson's disease and Rett syndrome, today announced positive final study results of REV-003 (Tianeptine) from its research collaboration with Rettsyndrome.org for the potential treatment of Rett syndrome.

"I am very encouraged by the results of these studies, which undoubtedly suggests the potential of REV-003 as a treatment of Rett syndrome," commented Steven Kaminsky, PhD, Chief Science Officer of Rettsyndrome.org. "The success of REV-003 in both tiers of the Rettsyndrome.org Scout program lays the foundation for future clinical studies. I look forward to continuing our relationship with Revive as they plan the next steps for REV-003 as a therapeutic solution for Rett syndrome."

The purpose of the study was to test the efficacy of REV-003 on optokinetic responses using the female Mecp2 (Bird) mouse model of Rett Syndrome. This study was conducted under the Rettsyndrome.org Scout Program. This test can be used to study visual function in Rett Syndrome. In the study, REV-003 was well-tolerated and had no effects on body weight. Vehicle-treated Mecp2 Heterozygous mice exhibited fewer optokinetic responses compared to vehicle-treated wild type mice . Treatment with REV-003 significantly reversed these deficits in the Mecp2 Heterozygous mice (p < 0.05). Optokinetic responses in REV-003-treated mice were similar to those seen in the wild type mice.

The study results from the study follows the positive results from the initial set of studies announced in April 2015. The initial study results assessed body weight, grip strength, gait analysis, and neurologic and behavioral parameters. In the studies, REV-003 was well-tolerated and had no effects on body weight, improved motor coordination in the rotarod test, reduced clasping to almost normal levels, normalized prepulse inhibition of startle at the higher dose, and significantly improved gait features, in particular the positioning of the paws.

As part of the research collaboration, Revive supplied the drug to conduct the study, and all raw data, samples and specimens arising from the performance of this study remain properties of Revive. The study was performed by PsychoGenics Inc., funded and managed by Rettsyndrome.org.

"We are very impressed with the outcome from the research program offered by Rettsyndrome.org as it confirms the potential of REV-003 to treat multiple symptoms that are affected in patients with Rett syndrome," said Fabio Chianelli, President of Revive. "We are committed to developing therapeutic solutions for rare diseases, such as Rett syndrome, and we look forward for the potential to advancing our Rett syndrome program in collaboration with Rettsyndrome.org and the pharmaceutical community."

About Rettsyndrome.org

Rettsyndrome.org is the most comprehensive nonprofit organization dedicated to accelerating research of treatments and a cure for Rett syndrome and related disorders while providing information and family empowerment. As the world's leading private funder of Rett syndrome research, Rettsyndrome.org has funded over $35M in high-quality, peer-reviewed research grants and programs to date. The organization hosts the largest global gathering of Rett researchers and clinicians to establish research direction for the future. Rettsyndrome.org, a 501(c)3 organization, has earned Charity Navigator's most prestigious 4 star rating year after year. To learn more about our work and Rett syndrome, visit www.rettsyndrome.org or call (800) 818-7388 (RETT).

About Revive Therapeutics Ltd.

Revive Therapeutics Ltd. (TSX VENTURE:RVV) (OTCQB:RVVTF) is focused on commercializing treatments for rare diseases such as Cystinuria, Wilson's disease and Rett syndrome. Additional information on Revive is available at www.ReviveThera.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This news release includes certain information and statements about management's view of future events, expectations, plans and prospects that constitute "forward-looking statements", which are not comprised of historical facts. Forward-looking statements may be identified by such terms as "believes", "anticipates", "intends", "expects", "estimates", "may", "could", "would", "will", or "plan", and similar expressions. Specifically, forward-looking statements in this news release include, without limitation, statements regarding: the granting of a patent for Bucillamine for the treatment of gout; the potential efficacy and commercial viability of Bucillamine for treatment of gout and Bucillamine for the treatment of Cystinuria; expansion of the Bucillamine clinical testing program; the Company's drug research and development plans; the timing of operations; and estimates of market conditions. These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results or events, performance, or achievements of Revive to differ materially from those anticipated or implied in such forward-looking statements. The Company believes that the expectations reflected in these forward-looking statements are reasonable, but there can be no assurance that actual results will meet management's expectations. In formulating the forward-looking statements contained herein, management has assumed: that business and economic conditions affecting Revive will continue substantially in the ordinary course and will be favourable to Revive; that clinical testing results will justify commercialization of the Company's drug candidates; that Revive will be able to obtain all requisite regulatory approvals to commercialize its drug candidates; that such approvals will be received on a timely basis; and, that Revive will be able to find suitable partners for development and commercialization of its drug repurposing candidates on favourable terms. Although these assumptions were considered reasonable by management at the time of preparation, they may prove to be incorrect.

Factors that may cause actual results to differ materially from those anticipated by these forward-looking statements include: uncertainties associated with obtaining regulatory approval to perform clinical trials and market products; the need to establish additional corporate collaborations, distribution or licensing arrangements; the Company's ability to raise additional capital if and when necessary; intellectual property disputes; increased competition from pharmaceutical and biotechnology companies; changes in equity markets, inflation, and changes in exchange rates; and other factors as described in detail in Revive's Annual Information Form for the period ended June 30, 2014 and Revive's other public filings, all of which may be viewed on SEDAR (www.sedar.com). 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. 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.

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