>>ATHX-105 went down due to a preclinical rat signal??<<
Yes, but they didn't give details of the problem. From the Athersys Form 8-K March 12, 2009:
Following the FDA’s review of the IND, the proposed trial was placed on partial clinical hold pending the receipt of additional information and resolution of several issues relating to the compound’s preclinical package and the proposed phase II study design. At the suggestion of the FDA, the Company conducted two additional studies to provide further data about ATHX-105’s potential toxicological profile, one study repeating prior studies under different conditions and another study that the Company had not previously conducted and is not typically included in preclinical evaluation. While the first study confirmed the Company’s prior negative findings, the second study produced data that suggests a rat specific toxicological effect. The Company met with the FDA to discuss the issues and reached resolution regarding all of the study design issues. However, based on the results of the additional toxicological tests and discussions with the FDA, the Company believes that the toxicological finding could greatly complicate long-term toxicology testing and thereby increase substantially the development time, risks and costs associated with subsequent development of ATHX-105. Consequently, the Company has decided to suspend further development of ATHX-105 and is currently focusing on the advancement of next generation compounds that exhibit improved characteristics. |
