|Phase I trial of novel HER2/neu Antigens will Start at Mayo; Isis Initiates Phase 2 Study of ISIS-APOCIIIRx|
|By Staff and Wire Reports|
|Friday, 04 May 2012 18:39|
TapImmune Inc. (OTCBB: TPIV) has announced that following recent IRB approval a Phase I Clinical Trial on a novel set of HER2/neu Class II antigens will start at Mayo Clinic, Rochester MN. Mayo Clinic received IND allowance from the FDA for this trial in 2011. TapImmune is sponsoring the Phase I study and has an Exclusive Option to License the antigen technology at the end of Phase I. Following an overwhelming response from breast cancer patients wishing to be part of this trial, Mayo anticipates the initial patient recruitment to be fully subscribed. The study will have an interim safety analysis that will examine safety after 5 patients have been enrolled and received a single cycle of treatments.
These proprietary antigens were discovered by Keith Knutson Ph.D. and colleagues using a series of computer based predictions followed by testing of breast cancer patient responses to the predicted target peptides. Importantly this immune response data indicates that these antigens are naturally processed and that tolerance to these self-antigens is not a limiting factor. The peptides show high affinity binding to human MHC proteins for 84% of the population, making this potentially applicable to a wider spectrum of patients when compared to other HER-2/neu vaccine compositions.
The Phase I trial will be carried out in breast cancer patients who finished standard Herceptin(r)- based therapy and are at a high risk of disease recurrence.
The primary endpoints of the study will be safety and immunogenicity. This study represents the first step in the clinical development of TapImmune's HER-2/neu vaccine program, with follow on studies adding TAP expression and additional class I target peptides in a 'prime and boost' approach being the ultimate goal. It is, therefore, a major milestone for
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 2 study evaluating ISIS-APOCIIIRx in patients with hypertriglyceridemia. Hypertriglyceridemia, a condition characterized by high levels of triglycerides, is often associated with premature coronary artery disease and pancreatitis. Patients with severe hypertriglyceridemia often cannot control their triglyceride levels with existing medicines. ISIS-APOCIIIRx lowers triglycerides by reducing the protein, apoC-III. Both triglycerides and apoC-III are independent risk factors for cardiovascular disease.
Isis is pursuing a staged development plan for ISIS-APOCIIIRx designed to shorten the time to bring this medicine to patients at high-risk of cardiovascular disease and pancreatitis. ISIS-APOCIIIRx is the third drug to advance into Phase 2 clinical studies from Isis' cardiovascular franchise. In this franchise, Isis is creating a suite of drugs targeting each of the atherogenic lipid components of cardiovascular disease to allow lipidologists to tailor treatment for the particular combination of lipid disorders that affect each individual patient.
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