The developmental plan will be comprised of preclinical testing in cell lines to determine the inhibitory effects of Liposomal Grb-2 on cell growth and invasion. From there, preclinical studies in TNBC and IBC animal models would study Liposomal Grb-2 suppressive effects on tumor growth and tumor metastasis in these cancers. If the preclinical studies confirm benefit, Bio-Path anticipates that it would then proceed to a Phase I clinical trial. The Phase I trial could progress relatively quickly since the toxicity profile of Liposomal Grb-2 is already being established in the Company’s current Phase I trial in blood cancers. The preclinical programs are expected to start in 2013 and last one year, after which time the Phase I clinical trial could begin after FDA approval to proceed.The plan is for Dr. Naoto T. Ueno, M.D., Ph.D., to be the lead researcher for the preclinical studies, which will be conducted at the MD Anderson Cancer Center. Dr. Ueno is a Professor at the MD Anderson Cancer Center, Executive Director of the Morgan Welch Inflammatory Breast Cancer Program and Chief, Section of Translational Breast Cancer Research.
Bio-Path Holdings To Expand Development Of Liposomal Grb-2 Into Two Additional Indications: Triple Negative And Inflammatory Breast Cancers
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