Callisto Pharmaceuticals Inc., a developer of new drug treatments in the fight against hematological cancers and related diseases, in collaboration with Dr. Waldemar Priebe, has created a method to synthesise its anti-cancer drug candidate Annamycin in a highly cost-effective process that may substantially strengthen the drug's commercial viability.
Dr. Waldemar Priebe, the discoverer of Annamycin and antibiotics, a leading Milan, Italy-based drug manufacturer that is the drug's commercial manufacturer, successfully developed the process to synthesise Annamycin, significantly streamlining the process of producing the drug. Annamycin is a member of the anthracycline family of anti-cancer drugs, which are typically difficult to synthesise cost-effectively, maintains a company release.
"We have been able to produce very high purity (greater than 98%) Annamycin, and eliminate the costly use of chromatography for purification purposes. This novel chemical route is now clearly capable of the production of 20-40 kg amounts of material, more than enough for the commercial market place,” stated Dr. Donald Picker, Callisto's executive vice president of R&D. He further added that Annamycin could provide real hope for relapsed leukaemia patients.
Callisto is developing Annamycin, a compound with a novel therapeutic profile and with the expectation of reduced cardiotoxicity, as a new treatment for patients with relapsed leukemia. Patients are designated relapsed when they fail to respond to therapies. A significant number of leukemia patients stop responding to existing drug therapies, creating a void of treatment options that Callisto is seeking to fill.
Annamycin is planned to begin a clinical trial in adult acute lymphoblastic leukaemia (ALL) patients in 4Q 2005. The FDA has designated Annamycin as an orphan drug, providing specific development and commercial advantages including 7-year marketing exclusivity at time of drug approval.