EDISON, N.J., Sept. 11, 2017 (GLOBE NEWSWIRE) -- ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical
company focused on the development and commercialization of targeted antiviral therapies, announced today that the U.S. Food and
Drug Administration (FDA) has approved an Investigational New Drug (IND) Application in the U.S. for its lead HBV compound, TXL™
for the treatment of chronic hepatitis B.
Earlier this year, ContraVir announced that it had completed a Phase 1, multiple dose study in healthy subjects and
a Phase 2a, 28 day study in HBV-infected patients. These studies were conducted in Thailand, a country with a high prevalence of
chronic HBV infection. Having successfully achieved proof-of-concept, ContraVir intends to expand the TXL™ clinical program and
initiate its first US-based clinical trial for TXL™ in the fourth quarter of 2017, pending approval by the Institutional Review
Board. The study will enroll patients with severe renal impairment, and thus will generate data which we believe will further
support the favorable safety profile of TXL™.
“While we already have an existing open IND for TXL™ in HIV, the approval of the IND for TXL™ in HBV, is a
significant step to further drive the expansion of our development program,” said James Sapirstein, Chief Executive Officer of
ContraVir. “We are particularly excited about this news, as it broadens the reach of our clinical program and allows us to conduct
co-development programs in the U.S. for patients with both HIV and HBV infection.”
About TXL™
Tenofovir exalidex (TXL™) is a highly potent prodrug of the antiviral tenofovir. Tenofovir is the active component of both
Vemlidy (tenofovir alafenamide) and Viread® (tenofovir disoproxil fumarate).TXL’s novel liver-targeting prodrug structure results
in decreased systemic circulating levels of tenofovir, thereby reducing the potential for renal and bone side effects. ContraVir
has completed a Phase 2 trial of TXL™, in which HBV-infected subjects were administered doses up to 100 mg for 28 days and is now
optimizing its formulation to further enhance drug delivery. To date, TXL™ has achieved clinical proof of concept for antiviral
activity and displayed an excellent safety, tolerability, and pharmacokinetic profile. Based on the agent’s best-in-class
potential, ContraVir believes TXL™ can become the cornerstone of a curative combination therapy for hepatitis B.
About ContraVir Pharmaceuticals
ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with a
specific focus on developing a potentially curative therapy for hepatitis B virus (HBV). The Company is developing two novel
anti-HBV compounds with complementary mechanisms of action. TXL™ currently in Phase 2, is designed to deliver high intrahepatic
concentrations of TFV, while minimizing off-target effects caused by high levels of circulating TFV. CRV431, the other anti-HBV
compound, is a next-generation cyclophilin inhibitor with a unique structure that increases its potency and selective index against
HBV. ContraVir is also developing Valnivudine™, an orally available nucleoside analogue prodrug; Valnivudine™ is currently in Phase
3 for the treatment of herpes zoster. In addition to direct antiviral activity, Phase 2 data suggest that Valnivudine™ has the
potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN). For more
information visit www.contravir.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate,"
"believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on ContraVir's current
expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial
competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and
litigation; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not
be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing
efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory
approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press
release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be
commercially successful. ContraVir does not undertake an obligation to update or revise any forward-looking statement. Investors
should read the risk factors set forth in ContraVir's Form 10-K for the year ended June 30, 2016 and other periodic reports filed
with the Securities and Exchange Commission.
For further information, please contact: Sharen Pyatetskaya Director of Investor Relations sp@contravir.com; (732) 902-4028
