ContraVir Pharmaceuticals Selects Pharmaceutical Product Development to Manage Phase 2b Study of Lead Antiviral FV-100 for Treating Shingles
EDISON, N.J., Oct. 16, 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 entered into an agreement with Pharmaceutical Product Development, LLC (PPD), a leading contract research organization (CRO), to conduct a Phase 2b clinical trial of ContraVir's lead clinical asset, FV-100, in shingles patients. The planned Phase 2b study is designed to measure the efficacy of FV-100 for treating the severe, lingering nerve pain commonly associated with shingles known as post-herpetic neuralgia (PHN), as well as to optimize the dose and regimen to be used for registration studies.
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 the potential to reduce the incidence, severity, and duration of shingles-associated PHN, based on data from a completed Phase 2a clinical study.
James Sapirstein, chief executive officer of ContraVir, commented, "Given the positive results FV-100 has shown in early clinical studies, we look forward to initiating the Phase 2b trial and working with PPD to advance our differentiated product. It was important for ContraVir to select a CRO with the skills and experience to complete our Phase 2b study efficiently, while enabling us to further explore FV-100's potential to address this significant medical need."
The Phase 2b study will build upon prior clinical research of FV-100, including a successful Phase 1 trial of FV-100, as well as a Phase 2a clinical trial in shingles patients, which demonstrated excellent safety and tolerability for FV-100. Furthermore, the 400 mg FV-100 arm of the Phase 2a trial showed a dose dependent antiviral clinical response as well as clinically meaningful reduction in PHN and duration of pain observed compared to valacyclovir. The company recently completed a $9.0 million private financing to fund the upcoming Phase 2b study.
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 1 trials of FV-100 in volunteers were successfully completed, as well as a Phase 2a clinical trial in shingles patients. ContraVir plans to conduct a Phase 2b 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 fiscal year ended June 30, 2014, 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
SOURCE ContraVir Pharmaceuticals, Inc.
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