Cotinga Looks to Expand COTI-2 Trial to Include Other Therapy Combos

Cotinga Looks to Expand COTI-2 Trial to Include Other Therapy Combos
Cotinga Pharmaceuticals is seeking approval from the U.S. Food and Drug Administration (FDA) to expand its ongoing Phase 1 trial of COTI-2 to include combination therapies and a broader spectrum of cancer types. The clinical trial (NCT02433626) is currently assessing the safety and tolerability of COTI-2 in patients with head and neck squamous cell carcinoma (HNSCC) and gynecological cancers. The company now plans to explore the experimental therapy alone or in combination with standard of care chemotherapeutics in multiple solid tumors. Specifically, Cotinga hopes to expand the gynecological cancers part of the study to evaluate COTI-2 in combination with Avastin (bevacizumab) and Taxol (paclitaxel) or doxorubicin. In addition, COTI-2 will be tested in combination with Platinol (cisplatin) in HNSCC and other solid tumors. Pending FDA approval, Cotinga anticipates the trial's protocol could be changed by May. The decision to change the protocol was supported by positive preliminary trial data and preclinical results demonstrating COTI-2's positive interaction with chemotherapeutic drugs. “After close consultation with our academic collaborators and investigators, we submitted a substantially updated regulatory package to the FDA seeking approval to evaluate COTI-2 as a combination therapy in our ongoing trial,” Alison Silva, president and CEO of Cotinga Pharmaceuticals, said in a press release. “W
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