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Hemostemix Announces Important Manufacturing Process Refinements
CALGARY, Alberta, Nov. 08, 2018 (GLOBE NEWSWIRE) -- Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: HEM; OTCQB: HMTXF) is pleased to announce that is has completed refinements to its manufacturing process, which will result in an approximate 40% reduction in manufacturing time for its lead product ACP-01.
As disclosed on February 22, 2018, the Company entered into a Manufacturing Agreement with Aspire Health Science, LLP (“Aspire”), where in addition to manufacturing ACP-01 for the Company’s current Phase II clinical trial for critical limb ischemia (“CLI”), Hemostemix has access to Aspire’s laboratory and personnel for research and development (“R&D”) purposes. Over the past several months, the Company has run multiple R&D batches. A total of thirty-nine (39) research batch runs have been completed with a focus on optimizing the manufacturing process of ACP-01, with an underlying focus on continuing to expand the potential of the Company’s technology platform.
As a result of its research and development activities, the Company has succeeded in refining its method of manufacturing protocols resulting in an approximate 40% reduction in manufacturing time for ACP-01. Currently, manufacturing time takes five (5) days, however, the Company’s R&D has proven it can be reduced to three (3) days. The Company intends to obtain approval from the US FDA to be able to use the refined manufacturing process. The Company believes this is of significant importance, as once approved for use, it will not only reduce future manufacturing costs for all of its products, but will result in an approximate 67% increase in the amount of product treatments that can be manufactured with its existing manufacturing facility infrastructure.
The Company is also pleased to announce that Mr. Kyle Makofka, CEO and President of the Company will be attending the 7th Global Family Office Investment Summit (the “Summit”) sponsored by the Ritossa Family Office to be held at the Four Seasons Resort Jumeirah Beach in Dubai, United Arab Emirates (“UAE”) from November 10-12, 2018.
The Summit is billed as of the world’s largest and most exclusive gatherings of family wealth. The Summit is a private forum exclusively organised by family offices for family offices, ultra-elite private investors, prominent business owners, Sheikhs, royal family members, financial families and their private offices from around the world. Facilitated by family offices, the Summit will provide two days of private peer-to-peer conversation, networking and cross-border thought leadership including several interactive round tables focussed on disruptive technologies, medical advances and the future of biotech.
In addition, the Company confirms that the announcement of the Company on November 7, 2018 was substantially the same as the announcement of the Company on October 9, 2018 and was not intended to update or revise the earlier announcement.
"By utilizing the R&D expertise and capacity at Aspire’s facility, we have been able to run a significant number of research and development initiatives which should provide long-term benefits to the Company. Achieving a 40% reduction in manufacturing time for our products will be particularly significant should the Company progress to a Phase III clinical trial for CLI which would involve hundreds of patients, resulting in significant cost savings for the Company. A three-day manufacturing period will also be easier to automate in the future and make our treatment therapy more commercially attractive." said Kyle Makofka, President and CEO of Hemostemix. "We feel that the recent R&D findings will also lead to furthering our already strong intellectual property portfolio.”
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 one of the first clinical-stage biotech companies 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.
Kyle Makofka, President and CEO
Suite 2150, 300– 5th Avenue S.W.
Calgary, Alberta T2P 3C4
Phone: (403) 506-3373
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.
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 trials and 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.