Phase I/II data presented at 2017 late-breaking research at American Academy of Dermatology
Short Hills, NJ, March 4, 2017– Tamir Biotechnology, a leading developer of antiviral therapies, presented data demonstrating the safety and efficacy of topical ranpirnase in the treatment of HPV associated genital warts during the 2017 American Academy of Dermatology late-breaking research session. The company’s leading asset, topical ranpirnase, was evaluated in a formal phase I/II, double blinded investigation in seventy-five (75) immunocompetent subjects with genital warts. Patients received either topical ranpirnase or vehicle (control), with twice a day application to the affected area for a period of eight (8) weeks. The dose of ranpirnase was 1mg/week.
The primary endpoint of the study, an eight (8) week mean % lesion area loss demonstrated a seventy-one (-71%) percent mean area loss for topical ranpirnase versus thirty-three (-33%) percent mean area loss for vehicle (p< 0.0025). When evaluating loss of eighty (-80%) percent of lesion area, the study’s predetermined secondary endpoint, the investigators found that sixty-one (61%) percent of ranpirnase treated subjects reached this endpoint compared to thirty-four (34%) percent for placebo treated patients (p<0.0194).
“We are very pleased to see the clear clinical effect of ranpirnase in this patient population,” said Dr. Luis Squiquera, Principal Investigator. Added Dr. Squiquera, “combined with an adverse event profile no different from vehicle, we are very confident in topical ranpirnase’s ability to treat this difficult condition.”
Armed with this data, the company expects to file request for a pre-IND meeting with the US FDA within QII 2017. Given ranpirnase has an extensive clinical and manufacturing history as a previously studied oncolytic, the company expects an accelerated timeline to receiving its IND and further progressing the development of topical ranpirnase for HPV. With an annual market size of $1.5B in 2014 according to Transparency Market Research, Tamir believes that HPV genital warts represent a large, unmet medical need.
For further information, please contact Dr. Squiquera: email@example.com