ContraVir Doses First Subject in Phase 1b Clinical Study of CMX157 for Treating Chronic Hepatitis B Infection
EDISON, N.J., April 19, 2016 /PRNewswire/ -- ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has dosed the first healthy volunteer in the Phase 1b portion of the Company's Phase 1b/2a multiple ascending dose clinical study of CMX157, ContraVir's novel, highly potent lipid conjugate of tenofovir for treating hepatitis B virus (HBV) infection.
James Sapirstein, CEO of ContraVir, stated, "Dosing the first healthy volunteer in the CMX157 Phase 1b/2a clinical study is a significant milestone. We're confident this trial will build upon the safety database that was already established in a completed Phase 1 study. Concurrently we are preparing to launch the Phase 2a portion of our study, which will evaluate the antiviral activity and safety of CMX157 in patients diagnosed with HBV, in the second quarter of 2016."
The Phase 1b portion of the study will enroll 50 healthy volunteers assigned to one of five sequential, ascending CMX157 dosing cohorts. Participants will receive two weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157 or placebo; eight per cohort receiving CMX157 and two per cohort receiving placebo. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of CMX157. Initiation of each higher dose cohort will proceed following review of the data from the previous cohort. An independent review will be conducted by a Data Safety Monitoring Board (DSMB) between the 25 mg and 50 mg cohorts (the midpoint of the Phase 1 portion of the study).
Following this DSMB review, ContraVir plans to initiate the Phase 2a portion of the study in parallel with the continuing Phase 1b portion. The Phase 2a will enroll 60 treatment-naïve patients with chronic HBV infection to compare CMX157 to tenofovir DF (TDF, marketed by Gilead Sciences as Viread®). This portion of the study will also consist of a sequential dose escalation, with 10 patients per cohort receiving four weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157, and two patients per cohort receiving 300 mg of TDF, the standard dose of Viread®. As in the Phase 1b portion of the study, initiation of each higher dose cohort will follow review of the data from the previous cohort and there will be a DSMB review between the 25 mg and 50 mg CMX157 cohorts.
About ContraVir PharmaceuticalsContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with two candidates in mid-to-late stage clinical development. ContraVir's lead clinical drug, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is currently in Phase 3 clinical development. 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 (PHN) in a Phase 2 clinical study. ContraVir is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir for the Hepatitis B virus. CMX157's novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal and bone side effects.
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, 2015, and other periodic reports filed with the Securities and Exchange Commission.
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SOURCE ContraVir Pharmaceuticals, Inc.