ContraVir Pharmaceuticals Initiates Pharmacokinetic Study of Lead Antiviral FV-100 for Treating Shingles

EDISON, N.J., Dec. 9, 2014 /PRNewswire/ -- ContraVir Pharmaceuticals, Inc. (OTCBB: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has initiated a pharmacokinetic (PK) study of FV-100, the Company's clinical-stage antiviral for treating shingles. The PK study, to be conducted at Duke University in early 2015, is designed to further understand the effect of a potent inhibitor of Cytochrome P450 3A4 on the pharmacokinetics of FV-100, allowing ContraVir to better understand the potential for clinically important drug-drug interactions and to further optimize treatment for Phase 3 development.

FV-100 is a fast acting, low dose, once-daily oral antiviral agent being developed for the treatment of herpes zoster, or shingles, which is an infection caused by the reactivation of varicella zoster virus.  In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain, known as post-herpetic neuralgia, or PHN.

James Sapirstein, Chief Executive Officer of ContraVir, commented, "Initiation of this PK study strongly aligns with our goal of optimizing the treatment regimen for FV-100.  We look forward to reporting the results of this study in 2015, and to accelerating our plans to begin dosing shingles patients in the next clinical efficacy trial."

In addition to the current PK trial, ContraVir has completed planning a larger clinical study of FV-100 to confirm the previous favorable efficacy and safety results.  The study is designed to measure the efficacy of FV-100 for treating Shingles and associated PHN, as measured by the incidence of clinically meaningful pain at the end of the follow-up period, as well as determine the best dose and regimen of treatment.

About ContraVir Pharmaceuticals

ContraVir is a biopharmaceutical company focused on the discovery and development of targeted antiviral therapies. ContraVir's lead candidate, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is an infection caused by the reactivation of varicella zoster virus (VZV).  Published preclinical studies demonstrate that FV-100 is significantly more potent against VZV than acyclovir, famcyclovir, and valacyclovir, the FDA approved drug for treating shingles. Moreover, FV-100 has been shown to have a more rapid onset of antiviral activity in preclinical models, and may fully inhibit the replication of VZV more rapidly than these drugs at significantly lower concentration levels and with a better dosing regimen. Phase I trials of FV-100 in volunteers were successfully completed, as well as a Phase IIa clinical trial in shingles patients. ContraVir plans to conduct a large trial in patients with shingles to further explore FV-100's potential to treat the long-lasting nerve pain typically associated with shingles. ContraVir was formed in May 2013 by Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) and spun off as an independent public company in January 2014. For more information, please 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 December 31, 2013 and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:

Tiberend Strategic Advisors, Inc.

Joshua Drumm, Ph.D. (investors)
[email protected]; (212) 375-2664

Claire Sojda (media)
[email protected]; (212) 375-2686

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/contravir-pharmaceuticals-initiates-pharmacokinetic-study-of-lead-antiviral-fv-100-for-treating-shingles-300006647.html

SOURCE ContraVir Pharmaceuticals, Inc.

Related Links

http://www.contravir.com