Boston Life Sciences Inc has informed that the US FDA had send a written response to the Company's Axosine (Inosine) IND filing, in which the FDA placed the Company's phase I study on "Clinical Hold" pending the submission of additional pharmacology/toxicology data by the Company.
In some cases, this data has already been compiled and can be submitted imminently, while in other cases, reprocessing of brain tissue samples and specialized histologic staining has been requested by the Agency, which the Company estimates will take at least four weeks to complete, BLSI says in a release.
While the Company does not expect additional tissue analyses to yield untoward toxicologic findings, there can be no assurance that such will be the case. The Company has submitted a letter to the FDA stating its intention to perform this additional work and requesting confirmation that the submission of this data will be sufficient to remove the clinical hold and to initiate the phase I study. The Company cautions that there is no assurance that such a "positive" response will be forthcoming from the Agency, or that the Agency will not request additional studies to be performed either in response to the Company's request for clarification or during further review of the IND by the Agency, the release added.
Boston Life Sciences, Inc (BLSI) is a development stage biotechnology company engaged in the research and development of novel therapeutic and diagnostic solutions for central nervous system diseases (CNS) and cancer.