Allogeneic stem cell therapy for peripheral artery disease raises hopes globally

Encouraging Phase II results were released in June 2018 for PLX-PAD, a placenta-based allogeneic stem cell therapy given intramuscularly, targeting peripheral artery disease (PAD)

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New Delhi: The recent positive Phase II clinic trial results for Pluristem’s PLX-PAD are great news for patients who suffer from peripheral artery disease (PAD), which has limited treatment options available. PLX-PAD has the potential to address a chronic disease with a slew of unmet needs, says GlobalData, a leading data and analytics company.

Encouraging Phase II results were released in June 2018 for PLX-PAD, a placenta-based allogeneic stem cell therapy given intramuscularly, targeting PAD.

The trial consisted of 172 patients with intermittent claudication (IC), an early stage of PAD. Although IC can resolve spontaneously, and has a good prognosis overall, additional treatment options are needed for patients on standard of care (consisting of palliative management through use of painkillers and anti-inflammatory drugs) with unresolved pain. It is also important to note that the need for more invasive procedures – namely, revascularization – although performed rarely in IC patients, have been on the rise. As such, PLX-PAD is on track to address the gaps in therapeutic PAD coverage while also harboring the potential to displace current treatment regimens.

Pluristem also has an ongoing Phase III trial for treating advanced PAD patients, those with critical limb ischemia (CLI) ineligible for revascularization. The FDA, EMA, and PDMA, regulatory agencies from the US, Europe, and Japan, respectively, have all granted accelerated designation pathways for PLX-PAD for these CLI-targeting studies in an effort to bring treatment faster to PAD patients most in need.

Key opinion leaders (KOLs) interviewed by GlobalData expressed excitement at the results, but cautioned that meaningful efficacy data from these trials should be backed up by PLX-PAD’s exact mechanism of action (MOA). This would lead to increased physician confidence and uptake, mostly due to reducing the amount of risk involved when adopting a nonconventional therapy, such as a regenerative therapy.

Jesus Cuaron, PhD, PPM Pharma Analyst at GlobalData, comments: “Regenerative therapies targeting cardiovascular indications aim to demonstrate that stem cells introduced into the body can induce the formation of new capillaries and/or improve function of impaired or injured tissue.

“PLX-PAD is a prime example of a regenerative product that has the potential to address a chronic disease with multiple unmet needs, an indication where the current standard of care falls short for many patients. Ideally, PLX-PAD will prove to be a truly ‘transformative’ therapy, especially when considering IC patients; however, given that this population is treated with a variety of generic medications, the anticipated high price of PLX-PAD will present a significant barrier to market entry.”