Kosan Biosciences Incorporated has initiated a company-sponsored multi-centre Phase I clinical trial of KOS-1022 (DMAG) in patients with advanced haematologic malignancies.
"The rationale for testing KOS-1022 in these haematologic cancers is particularly compelling. Preclinical data have demonstrated that KOS-1022 reduces the levels of several client proteins, such as Flt3, Akt, and Bcr-Abl, which may be important targets in leukaemias," stated Daniel V. Santi, Kosan Chairman and Chief Executive Officer. "This Kosan-sponsored trial expands the clinical development program for KOS-1022, which is currently in Phase I testing through our collaboration with the National Cancer Institute. We are also pleased by the grant of this patent, which will accord us important intellectual property protections as we continue our work in this area," he added.
The Phase I clinical trial will assess the safety, pharmacokinetics and pharmacodynamics of escalating doses of KOS-1022 in patients with acute myelogenous leukemia, acute lymphocytic leukemia, or chronic myelogenous leukaemia.
In addition to the Phase I study announced, KOS-1022 is being evaluated in Phase I clinical trials in advanced solid tumours sponsored by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) between Kosan and the NCI Cancer Therapy Evaluation Programme (CTEP). 17-AAG, a first-generation Hsp90 inhibitor, as well as KOS-953, Kosan's proprietary formulation of 17-AAG, are also currently being investigated in multiple Phase II single-agent and Phase Ib combination clinical trials in a variety of tumour types. In 2004, Kosan obtained orphan drug designation for 17-AAG from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for the treatment of multiple myeloma and chronic myelogenous leukaemia.
Meanwhile, the company has been granted by US Patent & Trademark Office patent No. 6,890,917 B2, entitled "Geldanamycin Derivative and Method of Treating Cancer Using Same," covering the KOS-1022 composition of matter and its use for treating a range of cancers. The Company is the exclusive licensee of the patent in these fields and others. KOS-1022 is a second-generation Hsp90 inhibitor that is highly potent and water soluble, with good bioavailability.