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How a clinical-stage biotech company could become the first to commercialize cell therapy for critical limb ischemia

Jocelyn Aspa Jocelyn Aspa, The Market Online
4 Comments| October 25, 2021

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Chest pains can be terrifying and certainly anxiety-inducing but imagine chest pains that feel like the most painful kind of heartburn you’ve ever had. This is one of the symptoms of ischemia, which is a condition where blood flow is restricted or reduces the heart muscle’s ability to pump blood.

Over the next seven years, the ischemic heart disease market is projected to grow at a compound annual growth rate of 4.67 percent to reach US$4.74 billion by 2028.

Enter Hemostemix Inc. (HEM) (TSX-V:HEM, OTC:HMTXF, Forum), which is a clinical-stage biotechnology company that is focused on commercializing a proprietary stem cell therapy to treat these conditions. Impressively, the company is on pace to become the first company to commercialize an autologous cell therapy for critical limb ischemia.

The company’s technology is based on over 10 years of clinical data that has proven the ability of its autologous cell product to regenerate diseased and damaged tissue. The company’s efficient, scalable and cost-effective platform has exponential potential to create therapies for a wide range of ischemic diseases.

The basis of the company’s technology is a novel cell population within the blood called the synergetic cell population (SCP), which can be collected from a simple blood draw and consists of progenitors and other supporting cells. In line with this, Hemostemix’ proprietary technology includes methods for collecting SCP and developing a personalized regenerative therapy that can be given to a patient within seven days of the initial cell collection.

Case in point, the company’s lead clinical-stage candidate, ACP-01, is an autologous — which means taken from the same person — cell therapy to treat limb ischemia and is currently in a Phase 2 clinical trial in both Canada and the United States.

Patients report no chest pain after stem cell treatment

In early October, the Calgary-based company announced a second video in a series of interviews with ACP-01 patients that was taped in August of this year. Over 300 patients were treated for ischemic cardiomyopathy, dilated cardiomyopathy, vascular dementia, COPD and pulmonary hypertension.

In the video, the patient discussed that his chest pain was vastly reduced one week following his stem cell treatment and that his life returned to normal levels after six weeks. Late Dr. Kit Arom, who co-founded the Minnesota Heart Institute, published results from this study of the efficacy and safety of thoracoscopic direct injection of ACP in patients with end-stage dilated cardiomyopathy.

At least 41 patients with cardiomyopathy aged between 14 and 59 underwent ACP stem cell injection, including 21 with dilated cardiomyopathy and 20 with ischemic cardiomyopathy. Arom said all participating patients tolerated the cardiac rehabilitation “very well” while the six-minute walk tests showed an improvement of 36 percent — an increase of 126 metres in walking capacity at 90 days.

Hemostemix in the news

In September, the company announced the first video of the series of interviews with ACP-01 patients. The first video discussed how one patient’s ejection fraction improved nearly 100 percent, increasing from the low 20s to 40.

The company’s ACP-01 treatment is being tested in a randomized, placebo-controlled double-blind trial evaluating the safety and efficacy in patients with advanced critical limb ischemia who have tried all other methods of treatment to save their limb from amputation.

Two years ago, on October 21, 2019, the company also announced results from its Phase II CLI trial, which noted ulcers healed and ischemic chest pain had been resolved in 83 percent of its patients with outcomes lasting at least 4.5 years.

Overall, Hemostemix owns 91 patents across five patent families called Regulating Stem Cells, In Vitro Techniques for use with Stem Cells, Production from Blood Cells of Neural Lineage and Automated Cell Therapy.

The investment corner


As the company continues to advance its lead candidate — and with the impressive results it is already yielding — investors will only continue paying attention.

In line with this, because the company is already in a Phase 2 trial, this already means half the battle is won in terms of advancing into a Phase 3 — which is undoubtedly the most difficult part of the process. However, with these strong and promising results, the reward opportunity for investing in this clinical-stage company is certainly a risk worth taking.


FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.



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