US FDA has accepted the IND Investigational New Drug application and permitted Kitov Pharma Lt (NASDAQ:KTOV) to launch phase 1/2 clinical study of NT219 to tackle the treatment resistance in patients suffering from advanced cancer. The company will evaluate the effectiveness of NT219 in advanced solid tumors. It will also combine NT219 with cetuximab to cure metastatic or recurrent solid tumors, colorectal adenocarcinoma, or head and neck cancer.
A significant milestone for NT219 development program
Chief Medical Officer of Kitov, Bertrand Liang, said the acceptance of its IND by the US FDA to conduct clinical trial is a significant milestone for the NT219 development program. Considering the preclinical data obtained through various clinical studies using NT219, Kitov is of the view that drug candidate has an excellent potential to provide effective and safe therapy for multiple treatment resistant cancers. The company expects to generate vital clinical evidence for its NT219 with this phase 1/2 clinical trial.
Kitov will identify suitable doses in the phase 2 trial by assessing and evaluating the safety of pharmacokinetics. In the phase 1 study, the company will evaluate NT219 by increasing dosage gradually to the patients, who are suffering from refractory advanced solid tumors, weekly. On reaching a stage to oversee the third dosage, it will administer NT219 together with cetuximab, in the second batch of patients, who are suffering from colorectal adenocarcinoma or metastatic squamous cell carcinoma of the neck and head. After completing the phase 1 clinical trial and establishing phase 2 dosage for NT219, the company will commence phase 2 expansion studies. NT219 has shown compelling anti-tumor activity in the preclinical studies.
Announces commercial launch of Consensi in the US
Kitov introduced Consensi, a combination of amlodipine besylat and celecoxib, to treat osteoarthritis and hypertension simultaneously. Burke Therapeutics, a marketing partner of Coeptis Pharmaceuticals, is engaged in the sale of Consensi in the US.
Chief Executive Officer of Coeptis Pharmaceuticals, Dave Mehalick, said Consensi is a new treatment option for patients who are experiencing both osteoarthritis pain and hypertension.
Kitov has closed registered direct offering of 25 million shares at $0.40 per share for gross proceeds of $10 million.
