Cellect Biotechnology, WU finalize accelerated clinical trial agreement
As the two organizations move closer to the commencement of the clinical trial to determine the safety and tolerability of the Apograft technology for bone marrow transplantations, Cellect Biotechnology and Washington University announced the signing of an Accelerated Clinical Trial Agreement. Cellect has successfully completed the technology transfer to WU's facility, and results of the in-vivo portion of the toxicology study have shown no signs or symptoms of toxicity. "We are continuing to advance our lead development program, ApoGraft, and pleased to achieve this milestone with Washington University," commented Dr. Shai Yarkoni, CEO "We have had ongoing and positive discussions with the U.S. Food and Drug Administration, and based on its feedback we can bypass further pre-Investigation New Drug interactions and proceed directly to IND filing. Therefore, our immediate next step is to complete our IND application and submit it to the FDA during the third quarter, and our objective remains to commence treatment of U.S. patients during the first half of 2020."