Under the terms of the deal Althea will manufacture Bio-Path’s liposomal Grb-2, which is being developed for the treatment of chronic myelogenous leukemia (CML) and acute myeloid leukemia (AML).
An investigational new drug application (IND) has been filed with the US Food and Drug Administration (FDA), with Phase I trials due to be conducted at the University of Texas MD Anderson Cancer Center.
Peter Nielsen, Bio-Path Holdings president and CEO, said: “Althea is an outstanding company with significant experience in the contract manufacture of lyophilized therapeutics. We are confident in their ability to produce the quality of drug we need for our upcoming clinical trials.”
Grb-2 has been granted Orphan Drug status by the FDA, with Bio-Path also seeking a grant of up $600,000 dollars from the agency for development of the therapeutic.
This would help quicken the development of Grb-2, which Bio-Path believes would offer significant advantages over the current treatment administered to the 40,000 people in the US with CML.
If commercialised Grb-2 would enter a market that Bio-Path believes to be worth $1bn a year. To supplement revenues generated by Grb-2, Bio-Path is also hoping to out-license the drug delivery technology that underpins its lead candidate.
Bio-Path claims that its technology is the only one capable of systemic delivery of nucleic acid drugs to diseased cells, making it very suitable for the treatment of cancer.
The technology can deliver double stranded (siRNA) and single stranded (antisense) nucleic acid drugs, which are formulated into liposomes capable of entering into tumours.
Commenting on the technology Nielsen said: “If Bio-Path’s delivery technology performs as we expect it to based on our preclinical studies in animals, a significant hurdle to commercialising antisense and siRNA therapeutic drug products will have been overcome.”