NEW YORK--(BUSINESS WIRE)--Tactical Therapeutics, Inc., a clinical stage biopharma, announced publication of “Multicenter Phase IB Trial of Carboxyamidotriazole Orotate and Temozolomide for Recurrent and Newly Diagnosed Glioblastoma and Other Anaplastic Gliomas” in the Journal of Clinical Oncology. (jco.ascopubs.org)
Phase IB studies on CTO commenced in 2013 at Memorial Sloan-Kettering Cancer Center, New York, enrolling 27 patients with recurrent GBM (rGBM) and 15 with newly diagnosed GBM (nGBM). Results show promising clinical signals of activity against multiple mutations and irrespective of the MGMT promoter status (both methylated and unmethylated) in these difficult-to-treat patients. Median overall survival (OS) was not reached in nGBM, after median follow-up of twenty-eight (28) months.
“We thank all caregivers and patients and their families for participating in the long trial. Two patients still continue,” said Dr. Rashida Karmali, president and Chief Executive Officer of Tactical Therapeutics, Inc. “The timing of publication in JCO will help raise funding for the planned Phase II trials.”
About Glioblastoma, recurrent (rGBM) and newly diagnosed (nGBM)
Glioblastoma is the most common malignant primary brain tumor in adults, with a median overall survival (OS) of between 12 to 20 months in nGBM with surgery, radiotherapy (with temozolomide) and adjuvant temozolomide, plus tumor treating fields. rGBM recurs frequently within a year. Avastin™, which is approved as a treatment option, achieves median OS of 6 to 9 months.
About Carboxyamidotriazole Orotate (Pravitinib™)
CTO is a novel oral inhibitor of non-voltage-dependent store-operated Ca2+ release-activated Ca2+ (CRAC) channels. CTO (CAI) inhibits non-voltage dependent calcium channels, resulting in disruption of multiple signal-transduction pathways that tumors use to divide and grow. CTO given orally has a safe toxicity profile, and favorable pharmacokinetics that show CTO penetrating the blood-brain barrier and accumulating in brain tumor tissue. CTO shows synergy and overcomes resistance in combination with Temozolomide.
About Tactical Therapeutics, Inc
Tactical Therapeutics, Inc., is a privately funded company, that has developed a patented lead therapeutic, CTO, for glioblastoma and other solid cancers. Four Phase I trials in one hundred patients have been completed, and two Phase II trials are planned for rGBM and nGBM. The company is pursuing partnering, co-development and/or licensing strategies to ensure rapid approval of CTO to benefit GBM patients in need.