Cesca Therapeutics Awarded Patent, Preps for Clinical Study

Cesca Therapeutics Inc. has been awarded a U.S. patent for its regenerative cell therapy, and it is about to begin a clinical study using that therapy. The patent covers stem and progenitor cell compositions recovered from bone marrow or cord blood and for the device and methods to achieve those compositions.

Cesca recently announced it received approval from the U.S. Food and Drug Administration for its clinical trial to evaluate its regenerative therapy for patients with critical limb ischemia, a debilitating circulatory disease that often results in amputation. The double-blinded, placebo-controlled trial will monitor 204 patients at up to 60 hospitals. If successful, Cesca’s therapy is supposed to salvage the affected limb with regenerative growth. A successful trial already has been conducted in India, the company reported.

“We are pleased to have received this very significant patent expansion, which strengthens the company’s Surgwerks and Cellwerksproduct patent portfolio,” said Kenneth L. Harris, president of Cesca Therapeutics. “Specifically, this patent allowance further protects our CLIRST III and AMIRST II trials as well as our bone marrow transplant program and their  future U.S. commercial coverage.”

“This patent also underscores the medical, scientific and technical progress our company continues to make as evidenced by our June 16, 2015 announcement of the FDA IDE approval for a U.S. Pivotal Clinical Trial in critical limb ischemia (CLIRST III) and our IEC/IRB approval in India for our AMIRST II trial announced on May 20, 2015 for an ST-Evaluated Myocardial Infarction (STEMI),” said CEO Robin C. Stracey.

This announcement was made concurrently with the release of the company’s third quarter financial results which showed increased losses.

Cesca develops medical equipment to harvest, store and preserve marrow and blood products, which can then be used for therapies. The company in recent years has been focused on using its equipment to develop regenerative therapies using those marrow and blood products. Cesca lost $4.8 million in its fiscal third quarter, compared to a loss of $1.9 million during the same quarter ended March 31 the previous year.

The Rancho-Cordova, Calif.-based company is struggling to keep its footing; it’s financial reports were late and its stock has been trading below the $1 minimum to continue trading on the Nasdaq Stock Market.