PETACH TIKVA, Israel, March 18, 2015 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, announced today it has completed the development of a commercial predictive biomarker blood test kit for the A3 adenosine receptor (A3AR). The biomarker test can be used at any molecular biology lab, where a small blood sample from a prospective patient would be tested and within just a few hours, results indicate if the patient would benefit from treatment with Can-Fite's drugs, which are currently in clinical trials for rheumatoid arthritis, psoriasis, and liver cancer.
A3AR is present in high concentrations in inflammatory cells and cancer cells. Can-Fite's proprietary drugs target and bind to A3AR, causing cancer and inflammatory cell apoptosis (programmed cell death). This creates a targeted anti-cancer and anti-inflammatory effect, while leaving normal cells unharmed. Identifying patients with elevated A3AR levels would indicate which patients would benefit most from Can-Fite's drugs, thereby offering personalized medicine.
"The completion of the development of our commercial A3AR biomarker test kit comes at a very important time since we plan to use the test kit in our upcoming advanced clinical studies. We believe the test kit will create efficiencies in our trials in patient enrollment and monitoring. As we progress into late-stage clinical trials for CF101 in auto-immune diseases, our A3AR biomarker test kit is ready for wide-scale use to help doctors and their patients identify who will be most responsive to Can-Fite's drugs. We believe these patients can significantly benefit from personalized medicine due to the high degree of clinical heterogeneity," stated Can-Fite CEO Dr. Pnina Fishman.
Not to mention Dr. Frost is taking a few thousand shares off the street. What do you think is going on here? Buyout? Gota love this guy and all that he has done in this space.
They just did....ACADIA plans to submit its NUPLAZID NDA for the treatment of Parkinson’s disease psychosis in the second half of 2015. The company had previously planned to submit the NDA in the first quarter of 2015. The decision to move back the planned submission is based on additional time required to complete the preparation of systems to support commercial manufacturing and supply and, in turn, to support the U.S. Food and Drug Administration’s (FDA) review of NUPLAZID. The change in submission timing is not a result of any change to NUPLAZID’s clinical or safety profile, nor is it a result of any interaction with or request for information from the FDA.
“We have concluded that additional time is needed to complete the readiness of our commercial manufacturing systems,” said Steve Davis, Interim Chief Executive Officer of ACADIA. “While we are very disappointed with the change in timing, we believe that this is the prudent course of action to take. We are working expeditiously to ensure that our systems are robust and ready for FDA review and commercial launch. Importantly, we remain confident in the safety and efficacy package supporting the NDA of NUPLAZID, which received Breakthrough Therapy designation from the FDA last year.”
Zogenix Announces Agreement of Sale of Zohydro(R) ER Business to Pernix for $100 Million at Closing Plus Potential Milestones of $283.5 Million
Nice call. Who next? I think ZGNX will pop soon on a partnership deal. PGNX and NVIV might be primed too. I also own ELTP MNKD and SYN and many others. Cashed in yesterday on OREX