This US Phase IIb Betas trial is similar to the previously announced Canadian-based Regenesis trial. The recruitment target for this US study is to enroll 20-30 patients at three to four enrolling sites. This will accompany the currently enrolling Canadian Phase IIb Regenesis stroke trial, projected to enroll 134 patients at approximately 18 sites. The US and Canadian Phase IIb clinical stroke studies share similar protocols, safety and efficacy endpoints.
Alan Moore, president and CEO of Stem Cell Therapeutics (SCT), said: “We are very excited by the FDA’s acceptance of the investigational new drug application (IND) for our US Phase IIb acute ischemic stroke trial. This acceptance demonstrates that SCT has met an important clinical development milestone especially for a non-US biotech company. This US companion study of the Canadian Phase IIb study is a key component of the pre-pivotal Phase III program as we aspire to meet worldwide regulatory acceptance and because the FDA sets a critical regulatory standard.”