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Hemostemix Signs License Agreement with Aspire Health Science for ACP-01

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Calgary, Alberta, Feb. 23, 2018 — Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE:HEM) is pleased to announce it has finalized the terms of a license agreement (the “License Agreement”) with Aspire Health Science, LLC (“Aspire”) for the Company’s lead therapeutic product technology, ACP-01. ACP-01 is currently the subject of a U.S. Food and Drug Administration (FDA) and Health Canada approved Phase II clinical trial for patients with critical limb ischemia (CLI).

Aspire is an Orlando, Florida based private company focused on the field of stem cell manufacturing as well as related research and development utilizing state-of-the-art FDA cGMP (Current Good Manufacturing Practices) certified laboratory facilities in Orlando, Florida. As previously announced, the Company also recently finalized the terms of a contract manufacturing services agreement (the “Manufacturing Agreement”) with Aspire, formalizing the transition of the Company’s stem cell manufacturing operations from Company owned facilities in Israel to Aspire’s Orlando, Florida facilities.   [Read more…]

How does the U.S. FDA regulate cell therapies? (351 vs 361 Products)

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In the United States, cellular therapies are regulated by the FDA’s Office of Cellular, Tissue, and Gene Therapies (OCTGT) within the FDA Center for Biologics Evaluation and Research (CBER).

According to the FDA, the Center for Biologics Evaluation and Research (CBER) regulates:

  • Cellular therapy products
  • Human gene therapy products
  • Certain devices related to cell and gene therapy

CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.

In the U.S., human tissues intended for transplantation are regulated by the FDA as “Human cells, tissues and cellular and tissue-based products” or “HCT/Ps.” Under U.S. law, any company that engages in the collection, processing, storage, screening/testing, packaging, or distribution of HCT/Ps must register with the FDA.

[Read more…]

Cytori Completes Enrollment for Habeo™ Cell Therapy for Scleroderma and Impaired Hand Function

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  • Cytori developing cell therapies that harness the unique attributes of adipose-derived regenerative cells (ADRCs)

  • 40 patients enrolled among 5 French centers: Marseille, Montpelier, Rouen, Lyon, and Paris

SAN DIEGO, Jan. 22, 2018 — Cytori Therapeutics, Inc. (NASDAQ:CYTX) announces completion of patient enrollment in SCLERADEC II (NCT02558543), a randomized, double-blind, placebo-controlled, parallel group, multi-center clinical trial intended to study the safety and efficacy of Habeo™ Cell Therapy in up to 40 subjects with impaired hand function due to scleroderma (systemic sclerosis). [Read more…]

Veritas Genetics Launches Collaboration with Mayo Clinic to Integrate Whole Genome Sequencing into Clinical Care

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Goal is to empower physicians and patients through making whole genome sequencing broadly available

BOSTON, Jan. 8, 2018— Veritas Genetics, The Genome Company, and Mayo Clinic are entering into an agreement to make whole genome sequencing broadly available to healthy individuals.

As part of this collaboration:

  1. The team at Mayo Clinic’s Center for Individualized Medicine will provide medical and clinical expertise to the Veritas team.
  2. Veritas will integrate Mayo Clinic’s know-how into its flagship product myGenome.
  3. Patients who qualify for a Mayo Clinic research study of healthy adults will be offered Veritas myGenome screening test for whole genome sequencing.
  4. Mayo Clinic will become a shareholder of Veritas.

Veritas, Genome Company“The Center for Individualized Medicine at Mayo Clinic is the gold standard in personalized medicine and we are proud and honored to collaborate with such a professional and dedicated team. This is a great step to further realize the promise of the human genome,” expressed Mirza Cifric, Founder, CEO Veritas Genetics. [Read more…]

2017 Marks the 1st Year That Regenerative Medicine Disrupted Healthcare

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The regenerative medicine industry has been rapidly expanding over the past few years, making it a high-value, fast-growth market. Key drivers for the market include high rates of clinical trials, accelerated pathways for product approvals, new technologies to support cell and gene therapy manufacturing, and the potential for cell therapies to revolutionize healthcare.

The regenerative medicine market gained major momentum when the Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval for a CAR-T cell therapy in the U.S. in August 2017 (Kymriah). In October 2017, Kite Pharma became the second company to get FDA approval of a CAR-T cell therapy (Yescarta).

With swelling momentum to support the CAR-T technology, there are now close to 40 companies developing redirected T cells or NK cells for therapeutic use. [Read more…]

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