The Conversation (0)
Hemostemix (TSXV:HEM), a clinical-stage, autologous cell-therapy company, is pleased to announce that the United States Food and Drug Administration has raised no objections to the Company’s Investigational New Drug application. This allows the Company to expand its Phase II clinical trial for critical limb ischemia to enroll patients at clinical sites across the United States in …
Hemostemix (TSXV:HEM), a clinical-stage, autologous cell-therapy company, is pleased to announce that the United States Food and Drug Administration has raised no objections to the Company’s Investigational New Drug application. This allows the Company to expand its Phase II clinical trial for critical limb ischemia to enroll patients at clinical sites across the United States in addition to Canada, where the Company has already received Health Canada approval.
As quoted in the press release:
The ongoing Phase II clinical trial investigates the safety and efficacy of the Company’s lead product, ACP-01. The Company’s patented process results in producing specific stem cells that have the ability to support the generation of new blood vessels to combat the life-threatening complications of CLI. The stem cells are raised and expanded from the patient’s blood and then re-injected into the diseased tissue. The results of the current clinical trial will determine whether the curative effects seen in Phase I trials of ACP-01 will be equally strong in a larger and more varied patient group.
Dr. Ravi Jain, Chief Scientific Officer at Hemostemix, states, “Our Phase II clinical trial approval was previously obtained with Health Canada and now with the US FDA review completed and receiving no objections by the FDA, we can accelerate patient recruitment across Canadian and US trial sites. With the approvals in place, Hemostemix, with its CRO Topstone Research Inc., will be actively onboarding 15-20 clinical trial sites in Canada and the United States over the next 6 months.”