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Tactical Therapeutics Inc
Location: New York City, New York
Sector: Health .
Tactical Therapeutics, Inc is a clinical stage bio-pharma privately funded company that has developed a patented therapeutic, Carboxyamidotriazole Orotate (CTO), for treatment of glioblastomas and solid tumors.
The company has been in news world-wide since the publication of the results of CTO in Phase IB trial in forty -two glioblastoma patients. The results reported in the prestigious journal, Journal of Clinical Oncology show promising proof-of-concept and clinical effects in Glioblastomas having multiple types of genomic mutations and even in the chemo-resistant tumors. Remarkably, CTO treated glioblastoma patients demonstrated significantly longer median overall survival of twenty-eight months- the current recorded is twelve to eighteen months. Some patients remain with complete response at five years.
Four Phase I trials in one hundred patients have been completed, and two Phase II trials are planned for rGBM and nGBM. CTO has Orphan Drug Designation and the company is pursuing partnering, co-development and/or licensing strategies to ensure rapid approval of CTO to benefit GBM patients in need.
1. Strong Intellectual Property Portfolio
World-wide Intellectual Property rights lasting through 2033.
2. Safe, Effective, orally administered Drug that crosses the blood brain barrier
Competitive advantage over existing or new drugs
3. CTO has demonstrated Proof of – Concept durable partial responses in heavy treated recurrent GBM with resistant mutations, and surpassed the overall survival (05) in GBM patients with unresectable GBM – mean OS was not reached at 28 months, 2 yr OS (62%)
4. CTO has activity in multiple targets by virtue of inhibiting many types of mutations
CTO has the potential to be a block buster drug, and has competitive advantage on existing and new drugs because of properties described in #2
1. Strong Intellectual Property Protection for Drug CTO
2. Delivery of drug and safety are better than current drugs and it is unlikely that newer drugs will improve over this
3. CTO can penetrate the Blood Brian Barrier and reach the cancer cells in the brain cavity to induce its effects. The inability of most chemotherapeutic agents to cross the BBB is a major disadvantage and limitation for them to be used to treat brain tumors
4. Proof-of-Concept of efficacy demonstrated in Phase IB trial in forty-two Glioblastoma patients with pretreated and difficult to treat tumors
5. CTO when added to the standard of care treatment in recurrent GBM and in newly diagnosed GBM showed clinical effect in response in tumors with both methylated and unmethylated MGMT promotor enzyme. (This has not been seen with any other drug to date)
6. CTO has multiple targets and in GBM there are several mutations that are targets for CTO. Therefore, CTO acts comparable to a cocktail of several drugs each of which targeting one mutation only. This approach used in industry has failed
Rashida A. Karmali, JD, Ph.D., MBA, CEO and President
Dr. Karmali is Founder of TTI, Lead Scientist, Innovator, respected pioneer in cancer research. She is a registered patent and business lawyer specializing in drug discovery and development.
- After the Ph. D in Biochemistry she developed a strong Cancer Research Program and worked at Memorial Sloan-Kettering in New York. Pursuing a part-time law degree, she next became a Registered Patent lawyer.
- She worked at leading firms in New York. She started a Solo-Law practice in Technology Law & Intellectual Property in 2000 and still runs it.
- During her practice as a patent lawyer, she helped a client obtain a patent for a cancer drug (CTO), and eventually acquired its rights to develop it. Tactical Therapeutics was formed in 2005to develop this drug.
- The company’s philosophy is to develop cost effective, safe and efficacious drugs, and overcome resistance in cancers. The first target chosen to develop CTO is for glioblastoma a difficult to treat brain cancer, for which there is a critical need for drugs. The Clinical development of CTO in Glioblastoma patients has progressed with encouraging clinical results in Phase IB studies by improving the overall survival.
- Dr. Karmali is planning to start two registration trials in glioblastoma patients to get CTO approved as an Orphan Drug on the fast track to fulfill the unmet need for good drugs in GBM.