Glioblastoma(GBM), recurrent (rGBM) and newly diagnosed (nGBM) Glioblastoma, the brain tumor that killed Senator Ted Kennedy, Beau Biden and Senator John McCain, was still mostly untreatable not until Tactical’s Carboxyamidotriazole Orotate (CTO).
Recent reports suggest veterans of the Vietnam, Iraq and Afghanistan wars who have been victims of exposure to Burn Pits, later developed GBM. GBM exhibits debilitating neurological symptoms and higher suicide rates never seen in other cancers.
Since 2005, GBM, an Orphan Disease (approximately 18,000/yr), has a median overall survival (OS) of between 12 to 20 months in newly diagnosed GBM, with surgery, radiotherapy (with temozolomide) and adjuvant temozolomide, plus tumor-treating fields. rGBM recurs frequently within a year, and the median OS is 10 months.
Tactical’s Oral, Safe and Brain-penetrating drug, Carboxyamidotriazole Orotate (CTO) showed efficacy with significantly improved Overall Survival from 10 months to 28 months+ in nGBM. Two patients are recurrence-free at 5 years.
The drug, Carboxyamidotriazole Orotate (CTO) & Intellectual Property (IP): CTO is a patented first-in-class inhibitor of genes of non-voltage dependent calcium signaling associated with multiple oncolytic pathways and calcium channels. At clinically relevant CTO levels, differential expression of some mRNA showed inhibition of transcriptional signatures of several oncogenes, and in contrast, activation of tumor suppressors. The IP portfolio includes 8 US and 75 International patents lasting until 2033.
Rashida Karmali, Ph. D, CEO at Tactical Therapeutics, is very excited that high-profile organizations and healthcare partners are recognizing her company after the results of their phase 1 trial for its drug called Carboxyamidotriazole Orotate, or CTO. The drug has been tested on patients with different types of advanced solid cancers as well as on patients of Glioblastoma, recurrent (rGBM) and newly diagnosed (nGBM).
Speaking on the success of CTO and its potential for more impact if funded for future trials, Dr. Antonio Omuro, Fellow of the American Academy of Neurology, had this to say:
“We are excited about CTO because it has shown highly promising results in patients with glioblastoma and other malignant gliomas, which are devastating diseases. I have no question in my mind that this drug deserves further studies to confirm efficacy, which hopefully will lead to FDA approval. Additional funds are crucial to funding the next studies, starting with a Phase 2 trial that will be launched soon.”
Dr. Antonio Omuro, who also oversaw the Phase 1 trials, further described the results of this trial, saying, “In 15 Newly diagnosed GBM (13/15), excellent overall survival was observed, with median Overall survival not reached after 28 months; 2-year survival 62%; 1-year survival 93% Two patients remain recurrence-free at 5 years. The safety profile was excellent, and we were also able to demonstrate that CTO crosses the blood-brain barrier and can achieve high concentrations in brain tumors”.
As a result of this ground-breaking result, Tactical Therapeutics, Inc., a clinical-stage biopharma has been selected to present at the MedInvest Oncology Investor Conference taking place December 14-15, 2022, in New York, NY.
CEO at Tactical Therapeutics, Rashida Karmali, Ph. D, commented on this, saying, “We are honored to be selected to present at this unique event. We welcome the chance to interact with many of the world’s most accomplished leaders and investors who are all dedicated to improving the health and lives of patients with glioblastoma and difficult-to-treat solid cancers.” Karmali stated.
Tactical Therapeutics, Inc., is a privately funded company that has developed a patented lead therapeutic, CTO, for glioblastoma and other solid cancers. Three Phase I trials have been completed. Two Phase II trials are planned for rGBM and nGBM. The company is pursuing partnering and licensing strategies.
