FASgen has announced that it has been awarded an SBIR grant from National Cancer Institute for refinement of its serum FAS (fatty acid synthase) ELISA cancer diagnostic test, FAS- Detect ELISA.
The test is an excellent signal for identifying FAS that is over-expressed by most cancers and circulates in the blood of cancer patients. FASgen's therapeutic solution is a series of novel small molecule FAS inhibitors that display robust efficacy against many types of human cancers in animal models. This affords a new and remarkable opportunity for cancer detection and the identification of patients that will be responsive to the Company's anti-cancer therapy. FAS-Detect is a proprietary product of FASgen Diagnostics LLC, an affiliated FASgen company. FASgen is a recognized world leader in the research of the fatty acid biosynthesis pathway and the over-expression of FAS in cancer. This research is the result of more than 15 years of efforts at The Johns Hopkins University School of Medicine and the Company, which was founded seven years ago based upon discoveries made at Hopkins.
The latest grant award from NCI supports ongoing work in the refinement of the current ELISA research test to differentiate FAS derived from cancer from FAS elaborated from normal tissues that occur in some diseases unrelated to cancer. The Company's current ELISA format already identifies the over expression of FAS in the blood of cancer patients and is sensitive to 1.6 ng./ml. FAS-Detect is available for research purposes through the Company's website. "The refinement of the serum FAS assay will significantly aid oncologists with earlier and better diagnostic information to assist in the treatment of patients. With the arrival of the FASgen therapeutic product, there will then be another highly specific tool in the oncologists' arsenal for treatment of the disease," said Eric F. Stoer, FASgen's Chairman and Chief Executive.
The FAS research has led to a very exciting anticancer clinical development program for FASgen's lead compounds, FAS31 and FAS93. Phase I clinical trials are anticipated to start at The Johns Hopkins Oncology Center later this year. This program is supported by grant funding to the Company from NCI for the Orphan Drug indication of recurrent ovarian cancer, and further supported at Hopkins by NCI with a SPORE grant for the indication of lung cancer. Extensive testing has demonstrated efficacy against five different types of human cancer in xenograft models in mice, with the substantial reduction in size of the tumors and, in many instances, the complete elimination of the tumor. In vivo studies of cancer prevention in mouse models have also shown evidence of prevention or significant delay in the onset of tumor development with no adverse effects on the animals. "It is our belief that the FAS31 and FAS93 lead compounds represent a significant step forward for the treatment of solid tumors, with an oral dosing formulation that has thus far proven to be essentially non-toxic providing a high therapeutic index," said Mr. Stoer.