WOODBRIDGE, ON, April 7, 2015 /CNW/ - Pivotal Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the "Company"), a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease ("CVD") and overall health and the University Hospital of Strasbourg, are pleased to announce today that POMEGA trial chief investigator Dr. Yannick Georg has been designated laureate of the EUR 30,000 young researcher French Interregional Clinical Research and Innovation (GIRCI Est) Award.
Dr. Yannick Georg, surgeon in the Department of Vascular Surgery and Kidney Transplantation of the Cardiology Competence Centre of the University Hospital of Strasbourg (Director: Prof. Nabil Chakfé), is conducting the POMEGA clinical trial jointly with Prof. Oliver Morel (Department of Cardiology), Prof. Bernard Gény (Department of Physiology and Functional Explorations of the Thoracic Pathology Competence Centre) and Professors Valérie Schini-Kerth and Florence Toti (Faculty of Pharmacy).
The POMEGA Trial
The POMEGA trial is a prospective, randomized double blinded clinical trial comparing the therapeutic impact of a novel omega-3 formulation (VASCAZEN®) vs. placebo in patients diagnosed with asymptomatic stenosis scheduled for carotid endarterectomy. Biochemical composition of atheromatous plaques and changes in blood composition will be investigated. The POMEGA trial will start in the second quarter of 2015. It was approved by the national French regulatory authority, l'Agence Nationale de la Sécurité du Médicament (ANSM) on January 13, 2015.
The expected benefit of VASCAZEN® is twofold: reduce the intraplaque concentration of procoagulant and proathérosclérotic microparticles and obtain a rationale for broadening the therapeutics options to stabilize these atheromatous plaques.
Recognition of Clinical Excellence of the Department of Vascular Surgery and Kidney Transplantation
Prof. Nabil Chakfé and Dr. Yannick Georg are particularly proud and pleased that their Department was selected as a reference site. "This award underscores the recognition of our Department's participating in multidisciplinary research and our strong commitment towards innovation," Prof. Chakfé and Dr. Georg said.
"We are very pleased that the French authorities have recognized the innovative character of the clinical research performed by Dr. Georg and his colleagues at the University Hospital of Strasbourg and we are enthusiastic about starting our future clinical collaboration in France with the Department of Vascular Surgery and Kidney Transplantation of Prof. Nabil Chakfé in Strasbourg," Dr. George Jackowski, founder and CSO of Pivotal Therapeutics Inc., said.
About University Hospital of Strasbourg
Ranking among the first-in-class university hospital centres (CHU) in France, the University Hospital of Strasbourg (HUS) is recognized for the quality of medical treatment given to its patients, its excellence in clinical research and innovation and its position as a leader in initial and permanent training and teaching for health professionals in the Eastern French region of Alsace.
Its strong collaboration with the University of Strasbourg as recognized internationally by the Shanghai classification serves as an example and a reference within the French hospital-university environment.
Research is at the very heart of the Strasbourg University Hospital as evidenced by its Hospital-University Institute (IHU) specialized in minimally invasive surgery guided by imaging techniques, its 21 certified groups (CNRS, INSERM, University of Strasbourg) and its partnership with four LabEx (Laboratories of Excellence). The University Hospital of Strasbourg contributes to medical progress allowing it to participate in cutting edge and highly innovative projects to the benefit of the patients.
As a partner with the Centre Against Cancer Paul Strauss, the University Hospital of Strasbourg created the Regional Cancer Institute, a vehicle for the cooperation of the public efforts in oncology research and education in Strasbourg and the region. Many projects like the medical technology platform, the Regional Cancer Institute, international and European collaborative projects demonstrate the ambitious policy of the University Hospital of Strasbourg not only in favor of the Alsatian population and beyond but also with regard to novel health initiatives and projects at national, European and international levels.
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded Canadian (OTCQX:PVTTF; CSE:PVO) specialty pharmaceutical company with a focus on cardiovascular disease and overall health. Pivotal Therapeutics' lead product VASCAZEN® is a prescription only medical food (a category regulated by the US FDA), commercially available throughout the United States, formulated to meet the dietary Omega-3 deficient needs of patients with cardiovascular disease through elevating Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) to levels associated with reduced risk of cardiovascular complications.
OMAZEN® is currently commercialized in Canada as a high purity (>90 %) patented Omega-3 formulation.
BENEFISHIAL™ is the first in a series of non-prescription nutraceutical products with compositions and formulations specific to the needs of people likely to benefit from a nutritional supplement containing highly pure Omega-3.
The information contained in this document is as of April 7, 2015. This press release contains forward-looking statements. Such forward-looking statements are subject to a number of risks, assumptions and uncertainties that could cause Pivotal's actual results to differ materially from those projected in such forward-looking statements. These statements can be identified by the use of words such as "will", "anticipate", "estimate", "expect", "project", "forecast", "intend", "plan", "believe", "project", "potential", and similar expressions with any discussion of future operating or financial performance or events. In particular, factors that could cause actual results to differ materially from those in forward looking statements include the following: Pivotal's inability to obtain additional financing on acceptable terms; growth in costs and expenses; inability to compete with others who provide comparable products; risk that the Company's products will not gain widespread market acceptance; risks relating to the Company's ability to maintain its CSE listing. Forward-looking statements speak only as of the date made and are not guarantees of future performance. The Company undertakes no obligation to publicly update or revise any forward-looking statements contained in this document as a result of new information or future events or developments. The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this information.
SOURCE Pivotal Therapeutics Inc.
For further information: University Hospital of Strasbourg Contacts: Dr. Yannick Georg, Phone: +33 3 69 55 15 05, E-Mail: [email protected]; Prof. Nabil Chakfé, Head of Department, Phone: +33 3 69 55 08 88, E-Mail: [email protected]; Mrs. Fatiha Ait Rais, Press Officer (Attaché de presse), Phone: +33 3 88 11 61 66, E-Mail: [email protected]; Company Contacts: Kristine DiMatteo, Communications and Public Relations Manager, Phone: 905-856-9797 ext. 231, E-Mail: [email protected]