(Toronto, Ontario June 25, 2014) Hemostemix, a clinical-stage Canadian-Israeli company developing innovative blood-derived cell therapies for severe medical conditions, announced today the kick-off of a services collaboration with Criterium Inc. as its clinical research organization (CRO) for the company’s phase 2 clinical trial in critical limb ischemia.
“We are pleased with the progress of our clinical trial in Canada,” stated Hemostemix President, Dr. Valentin Fulga. “Under the guidance of the company’s clinical trial steering committee, the trial is expected to be treating patients shortly at three Canadian hospitals and expand rapidly to additional clinical sites.”
“After a thorough selection process, we are pleased to have retained Criterium, Inc. as the company’s CRO for the phase two trial of our lead product, ACP-01, for patients with critical limb ischemia,” stated Hemostemix Chairman and CEO, Bill Baker. “The project teams have been put in place and the collaboration has already commenced under the leadership of Dr. Fulga and Daniel Tan. At this time, the focus of the company is to complete the corporate reverse-takeover process and to expedite our treatment of the first patients.”
As the newest member of the Centre for Commercialization of Regenerative Medicine’s (CCRM) industry consortium, Hemostemix is quickly emerging as one of Canada’s most advanced cell therapy companies. The company anticipates that before third Quarter of 2014, it will treat patients in its phase 2 trial and complete its reverse merger into a publicly trading company on the TSX Venture Exchange (see the company’s most recent update (6 June) for further details).
“Our collaboration with Hemostemix represents an exciting opportunity for Criterium to take advantage of our Canadian operation and experience with cardiovascular disease in a way that we believe will add true value to the execution of this clinical trial,” stated Criterium’s President John Hudak.
Hemostemix is a clinical-stage Canadian-Israeli company developing and commercializing innovative, autologous (patient’s own), blood-derived cell therapies to treat a variety of medical disorders not adequately addressed by current treatments. The Company is launching a phase 2 clinical trial of its lead product (ACP-01) in critical limb ischemia.
Hemostemix is a company incorporated in Israel with an operating research, development and manufacturing facility in Kiryat Weizmann Science Park, Ness Ziona. Hemostemix and Kwalata are wholly-owned subsidiaries of Canadian-based parent company, TVI (together the “Hemostemix Group”). Kwalata holds the intellectual property on behalf of the Hemostemix Group. TVI has an agreement with Technical Ventures RX Corp (TSX-V:TIK.P) regarding a Qualifying Transaction in which TIK.P would acquire TVI in a share transaction. The two companies are working together to expedite this transaction and the directors of TIK have approved this press release. For more information, visit www.hemostemix.com.
Criterium, Inc. is a full-service CRO (contract research organization) that offers a unique mix of high-quality clinical research services and communication processes for the biopharmaceutical, pharmaceutical, and medical device industries to manage trials from initial planning to approval. Founded in 1991, Criterium’s services are customized to fit each client’s specific needs, providing a seamless flow of data and information from the investigative site through Criterium and back to the sponsor — 24/7, in real-time. Criterium’s experienced team manages and implements clinical trials using technology-based solutions. Dedicated clinical professionals are committed to providing personal service and to forming strong and productive relationships with clients. Criterium’s well-established staff are trained according to ICH GCP guidelines.
The Oncology Consortia of Criterium are a collaboration of outstanding Cancer Research Consortia that deliver innovative research and unparalleled expertise: The Academic GI Cancer Consortium (AGICC) and the Academic Myeloma Consortium (AMyC). The Consortia Model utilizes translational science methodologies to streamline cancer research and development. The Consortia is presently represented by Key Opinion Leaders (KOLs) and Top Investigators at 11 of the most prestigious institutions in the USA.
Corporate headquarters are located in Saratoga Springs, New York with offices in Florida and California, and representatives in-country in the European Union, Israel, and Russia. This multi-national approach enables Criterium to provide time- and cost-efficient study management and monitoring to all our clients. To learn more about Criterium, visit the website www.criteriuminc.com.
Contact: Claire R. Wynters, Public Relations