SAN DIEGO (KUSI) Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, announced that the Investigational New Drug (IND) application submitted by its partner, Personalized Stem Cells, Inc. (PSC), has received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.

Calidi has partnered with PSC for over two yearsmost recently contributing the stem cell lines used to manufacture treatment for the upcoming first trial, CoronaStem 1, which will be conducted among 20 hospitalized COVID-19 patients in California.

We are extremely pleased to continue our partnership with PSC, securing and providing stem cells from healthy donors in strict accordance with FDA guidelines, said Allan J. Camaisa, Chairman and CEO of Calidi Biotherapeutics. Weve seen the impressive capabilities of allogeneic mesenchymal stem cells firsthand through Calidis years of work, and strongly believe that they can help provide a therapeutic solution for the global pandemic, in addition to serving as vehicles for oncolytic virus delivery and potentiation upon direct injection into cancerous tumors. The combined effect of efficient cell-based delivery, direct cancer cell killing by the oncolytic viruses and induction of anti-tumor immunity is responsible for the potent anti-tumor effects of this approach not only at the injected tumor site, but also at distant metastatic tumor sites.

The CoronaStem 1 study will proceed in the coming weeks, managed and conducted by PSC, among a limited number of COVID-19 patients, as outlined in the IND submission. PSC plans to proceed onto a larger phase 2 clinical trial and potentially into FDA compassionate use programs to reach more patients pending the success of the initial trial.

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Calidi Biotherapeutics in San Diego receives FDA Approval for COVID-19 Treatment clinical trial - - KUSI