Biotron up after phase II HIV/HCV trial kicks off

By Dylan Bushell-Embling
Monday, 12 November, 2012

Shares in Biotron (ASX:BIT) grew 8% on Friday, after the company commenced a key trial of antiviral drug candidate BIT225 in patients with both HIV and hepatitis C (HCV).

The 12 patients to be enrolled in the Thai phase II study will receive 28 days of treatment with BIT225, in combination with the standard approved HCV treatment – interferon and ribavarin (IFN/RBV). Patients will then continue to receive IFN/RBV for up to 48 more weeks.

Subjects will be treatment naïve to IFN/RBV, but will be on antiretroviral drugs at time of enrolment, with HIV levels below the detection threshold.

The aim of the trial is to generate safety and pharmacokinetic data of BIT225 in the presence of other anti-HIV drugs, and in co-infected patients. The open label trial will include patients with all three genotypes of HCV.

Biotron managing director Michelle Miller said that while BIT225 has shown potential at treating both HIV and HCV, “in this particular study we are focusing on the HCV aspect of the disease in the dual-infected patients.”

A concurrent phase 1b/2a trial is assessing the candidate's ability to target HIV.

There are significant numbers of co-infected HIV and hepatitis C patients, with an estimated 25-40% of HIV sufferers in the US also having HCV.

“The pharmaceuticals industry and international regulatory authorities are focused on new treatments for this difficult-to-treat population,” Miller said, noting that co-infected patients currently have a significantly worse prognosis than patients with either virus alone.

Biotron (ASX:BIT) shares climbed 8% to13.5c on Friday, after the commencement of the trial was announced, and were trading unchanged from this price as of nearly 3pm on Monday.

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