OTTAWA, Oct. 31, 2018 (GLOBE NEWSWIRE) -- Orion Biotechnology Canada Ltd., a developer of novel medical treatments, announced today the completion of a scientific advice meeting with the Medicines and Healthcare products Regulatory Agency (MHRA), UK, regarding the company’s innovative microbicide candidate OB-002H. This follows on from a previous Pre-IND interaction with the United States Food and Drug Administration.
Despite the increased uptake of Pre-Exposure Prophylaxis (PrEP) with oral Truvada, we are still seeing unacceptable levels of new HIV infections and it is clear that the HIV prevention field needs additional options including topical products. Designed to prevent the transmission of HIV, OB-002H gel has the potential to address an urgent and growing need for an HIV prevention product that is affordable, appealing to use, and easily integrates into the lifestyles of people at risk for HIV infection regardless of age, sex or gender.
Dr. Ian McGowan, Chief Scientific Officer of Orion Biotechnology, said, “We were very pleased to have had this dialogue with the MHRA. It confirmed that our pre-clinical program includes all the studies and data needed to complete our clinical trial application (CTA), and that our clinical study design was appropriate and met MHRA requirements. This is an important step in completing preparations for our CTA submission and bringing our novel microbicide to the clinical phase of testing which will take place in Poland. We look forward to receiving feedback from the Polish National Regulatory authority about our Phase 1 study.”
“The meeting with the MHRA was a very important step for the Company as it provided us with a clear endorsement that our preclinical and clinical programs were in line with MHRA expectations for the conduct of microbicide development. It also gives us confidence that the CTA we submit in Poland should be acceptable to the Polish National Regulatory Authority and allow us to enter the clinic with minimal delay,” commented Mark Groper, President and CEO of Orion. “Following this informative meeting with the MHRA, we can confirm that we are on track to evaluate OB-002H in a clinical trial for both men and women that should begin in Q2 2019.”
About Orion Biotechnology Canada, Ltd.
Orion Biotechnology Canada Ltd, is a privately held pharmaceutical company founded on the vision of radically improving the health of the global population through successful treatment and prevention of the most serious chronic illnesses and life-threatening diseases. Since 2011, Orion has been developing a robust pipeline of potential products based on novel formulations discovered in different parts of the world. Our close ties to diverse institutions and experts around the globe continue to stimulate the rapid discovery of promising new treatments. With operations in North America, Europe and Asia, Orion brings together innovative technologies from some of the world’s leading research institutions such as the Mintaka Research Foundation and the Center for Public Health Research at Nanjing University. Learn more at www.orionbiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking information, which reflects Orion’s current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Orion’s control, that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, Orion assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
| Contact: Ross MacLeod Orion Biotechnology Canada Ltd Phone: +1.343.291.1032 info@orionbiotechnology.com | 343 Preston Street 11th Floor, Ottawa, Ontario www.orionbiotechnology.com |