CALGARY, Alberta, Aug. 16, 2018 (GLOBE NEWSWIRE) — Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM) is pleased to announce that it has received all approvals from two significant institutions to be clinical trial sites for the Company’s Phase II clinical trial for critical limb ischemia (“CLI”).
The two new sites that are now fully open to patient enrollment are both located in Texas, which is an important US state for the Company’s trial. Houston Methodist Hospital is located in Houston with Dr. Eric Peden, MD as principal investigator. Clinical Trials of Texas, Inc. (“CTT”) is located in San Antonio, Texas with Dr. Boulos Toursarkissian, MD as the principal investigator for the trial.
The Houston Methodist Hospital, located in Houston, Texas, has been recognized by U.S. News & World Report as one of the top 20 hospitals in the United States, placing it for the second time on the magazine’s prestigious Honor Roll. It is also designated as a Magnet hospital for excellence in nursing. Houston Methodist Hospital is one of the 21 hospitals that are part of the Texas Medical Center (the “TMC”), which is the largest life sciences destination in the world. The TMC also encompasses eight different academic and research institutions. With 106,000 employees, 54 institutions, and thousands of volunteers and patient visits, over 160,000 people visit Texas Medical Center each day. More heart surgeries are performed in the Texas Medical Center than anywhere else in the world.
As previously announced, Dr. Alan Lumsden, MD, a member of the Company’s Scientific Advisory Board is the Walter W. Fondren III Chair, Medical Director of the Houston Methodist DeBakey Heart & Vascular Center and chair of the Department of Cardiovascular Surgery at Houston Methodist Hospital.
Houston is an important location for the clinical trial, as with approximately 6.9 million residents in the Houston metropolitan area, it is the fifth largest metropolitan area in all of the United States, trailing only New York, Los Angeles, Chicago and Dallas-Fort Worth-Arlington. In 2017, Houston had the second highest population growth in the nation.
CTT, established in 2001, has performed over 1,000 clinical trials in over 50 indications. It has a highly-equipped and versatile 19,000 sq. ft. facility capable of conducting early phase – phase IV studies in a multitude of therapeutic areas. There are 17 board-certified physicians who practice in the San Antonio area that work with CTT to conduct studies in their respective medical specialties. This network of investigators has helped create one of the most capable research sites in the United States.
San Antonio, located in south-central Texas, is the third largest city in Texas with approximately 2.5 million people in the metropolitan area.
The Company now has six trial sites open for patient enrollment, with the majority located in the United States. In addition to the two Texas sites, the Company also has three trial sites in Florida and one in Canada that are all actively screening patients for enrollment in the study. The Company has approximately eleven additional clinical trial sites located in Canada and the United States that are in various stages of the on-boarding process including six sites that are near finalization with four of these having approved the Company’s clinical trial agreement pending final review board or budget approvals, which the Company expects will be greenlighted shortly.
In June 2017, Texas Governor Greg Abbott signed legislation into law allowing patients to access experimental stem cell treatments in Texas. House Bill 810, which came into effect on September 1, 2017, allows clinics and companies in the state to offer patients with terminal illnesses or severe chronic diseases access to treatments that have not yet been approved by the US Food and Drug Administration (“FDA”). As such, the state of Texas could be of strategic importance to the Company.
“The addition of Houston Methodist hospital, being one of the leading hospitals in the United States and part of the Texas Medical Center, will be of significant importance to Hemostemix, not only for the current Phase II CLI trial but also for future heart trials. We have made significant progress with the trial by adding these key strategic trial sites in Texas and look forward to additional sites being fully on-boarded and additional patient enrollment.” states Kyle Makofka, CEO and President of Hemostemix.
ABOUT HEMOSTEMIX INC.
Hemostemix is a publicly traded clinical-stage biotechnology company that develops and commercializes innovative blood-derived cell therapies for medical conditions not adequately addressed by current treatments. It is the first clinical-stage biotech company to test a stem-cell therapy in an international, multicenter, Phase II clinical trial for patients with critical limb ischemia (“CLI”), a severe form of peripheral artery disease (“PAD”) caused by reduced blood flow to the legs. The Phase II trial targets a participant’s diseased tissue with proprietary cells grown from his or her blood that can support the formation of new blood vessels. The Company’s intellectual property portfolio includes over 50 patents issued or pending throughout the world. Hemostemix has a manufacturing contract with Aspire Health Science, LLP (“Aspire”), for the production of ACP-01 and for research and development purposes at Aspire’s Orlando, Florida, facility. Building towards commercialization, Hemostemix has also licensed the use, sale and import of ACP-01 for certain indications to Aspire in certain jurisdictions. The Company is continuing research and development of its lead product, ACP-01 with other applications, including cardiovascular, neurological and vascular indications.
For more information, please visit www.hemostemix.com or email [email protected].
Contact:
Kyle Makofka, President and CEO
Suite 1049, 150 – 9th Avenue S.W.
Calgary, Alberta T2P 3H9
Phone: (403) 506-3373
E-Mail: [email protected]
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential,” and similar expressions, or that events or conditions “will,” “would,” “may,” “could,” or “should” occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Hemostemix management on the date such statements were made. By their nature forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Company’s stage of development, future clinical trial results, long-term capital requirements and future ability to fund operations, future developments in the Company’s markets and the markets in which it expects to compete, risks associated with its strategic alliances and the impact of entering new markets on the Company’s operations. Each factor should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise.