FDA Clinical Trial Approval Spikes Hemostemix’s Share Price

Genetics companies can have the most innovative ideas for clinical trials while boosting an equally innovative pipeline, but without regulatory approvals companies can’t do much to work towards a profit.

One cell-therapy company, Hemostemix (TSXV:HEM), is that much closer to starting clinical trials with the its US Food and Drug Administration (FDA) clinical trial approval announced on Thursday (April 18).

This will allow the company to expand its Phase 2 clinical trial for critical limb ischemia (CLI) with ACP-01 to enroll patients at clinics across the US and Canada, where the company has already received Health Canada approval.

This milestone achievement for breaking through into further trials in the US means the company can further investigate the safety and efficacy of ACP-01, Hemostemix’s lead product candidate for CLI.

“To be expanding the trial across the United States is a significant milestone that will secure the future of ACP-01, as it will expedite the patient intake to meet our trial goals and lay the groundwork for future trials for other indications,” Kyle Makofka, president and CEO of Hemostemix said in the press release. Makofka went on to say Health Canada and the FDA have the highest standards of all the regulatory agencies in the world.

CLI is a severe form of peripheral artery disease (PAD), which is caused by reduced blood flow to the legs. The result is an array of complications including nerve and tissue damage, which often results in death or amputation of the affected limb.

Approximately 20 million people in the US in 2015 were affected by PAD—with 8 million later suffering from CLI—with that amount expected to reach 30 million by 2030. The medical costs alone in the US attributed to CLI reach over $25 billion annually.

Hemostemix develops and commercializes blood-derived cell therapies for inadequately addressed medical conditions by current therapies. It’s also the first company to test stem-cell therapy in an international multicenter.

It secured a manufacturing agreement with an FDA current good manufacturing practices certified laboratory in Florida, Aspire Health Sciences, which will be used to manufacture ACP-01 for the Phase 2 trial. In short, this means the company should be ready to start the trial, other than securing trial sites and patient enrollment.

Investor takeaway

Shares of Hemostemix have increased handsomely since Thursday’s announcement rising by 90.91 percent to close at $0.10.

Although the company’s share price has seen a big dip since its high of $1.24 in December 2014, with notice of this clinical trial moving forward in the US, investors may gain more confidence in the company.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.