AlphaRx has completed the lyophilization process for Zysolin, allowing the company to proceed to clinical batch material manufacturing for human trials.
The company said that the process has been solely developed by AlphaRx’s scientists and the resulting formulations have been successfully tested in animal studies conducted by the US Army under a Material Transfer Agreement.
Joseph Schwarz, chief scientist, at AlphaRx, said: This is a technological milestone for AlphaRx and the entire nanomedicine industry. It is well known that many FDA approved ingredients used in nanomedicine formulations can not be readily lyophilized, representing the major obstacle to their therapeutic development, a critical step which we have overcome.
Zysolin is protected by 3 US patents pending and the company plans to file a new patent application to protect the new process.