MedCision’s new strategic partner, Athersys, Inc., recently announced the good news that their clinical program for stroke has received “fast track” designation from the FDA. The information comes as part of the company’s first quarter financial report, which gives some further details on the stroke program, as well as other ongoing clinical efforts. ‘Fast Track’ is a designation used by the FDA to facilitate development of new drugs that are undergoing clinical trial, when they feel the investigational drug will fill an unmet medical need to treat a serious or life-threatening condition.
Receiving the designation is a big deal, because drug products awarded this label are eligible for an accelerated approval and review process. Accelerated review, which is marked by more frequent communication with the FDA to address any concerns, shortens the assessment process from ten months to six months. This allows the treatment to reach patients more quickly. The designation is also prestigious, because it is only granted when an investigational drug shows significant advances in safety and efficacy over existing therapies.
Finding new treatments for ischemic stroke is an important priority at Athersys, and the financial report mentions several different clinical trials with that focus. One such study, a collaborative effort with Japanese company Healios, has just begun the process of patient enrollment. The Athersys first quarter results also include preliminary outcomes for both a preclinical and a Phase 2 clinical trial (the “MASTERS” trial) centered on the treatment of ischemic stroke patients. In addition, Athersys is seeking regulatory clearance for a Phase 3 clinical trial on stroke, known as the MASTERS-2 study. The company hopes to fulfill the necessary regulatory requirements for that study sometime this summer. Each of these trials rely on their signature product, MultiStem® cell therapy.
MultiStem® is an “off the shelf” cellular therapy manufactured from adult human stem cells. Athersys are investigating the use of this proprietary therapy for treating not only stroke, but a variety of life-threatening illnesses, ranging from inflammatory and immune disease, to neurological disease, to cardiovascular disease. The strength of the MultiStem® therapy lies in the fact that cells from one donor can be expanded to produce cell banks yielding hundreds of thousands, or even millions of doses of the product. Doses can be cryogenically stored, and thawed at need.
Athersys and MedCision recently shook hands on a deal to adopt MedCision’s ThawSTAR® AT6 Transport and Cell Thawing System into their clinical trials in order to de-risk the cell thawing process, and protect the efficacy of their cell therapy products. ThawSTAR® Systems will first be introduced in a Phase 2 clinical trial on treating heart disease, after which its use will be expanded into future clinical studies.
The full text of the press release can be read here.