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Formatech To Provide Product for Phase I Trials

Cellceutix Corp. has concluded an agreement with Formatech, Inc. to formulate Kevetrin for a Phase I study.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Cellceutix Corp. has concluded an agreement with Formatech, Inc. to formulate Kevetrin for a Phase I study. The terms of the agreement were not disclosed. Kevetrin will be presented as a lyophilized powder for reconstitution in saline solution at the time of use. The drug is being developed to treat drug resistant cancers.

“This agreement allows us to stay on track for our IND filing,” said George Evans, chief executive officer of Cellceutix. “Formatech is a quality formulator and has been very flexible and responsive in meeting our needs.”

“We are very pleased to have been selected by Cellceutix to participate in this exciting research effort,” said Indu Isaacs, Ph.D., chief executive officer of Formatech. “We look forward to helping Cellceutix achieve its goal of reaching Phase I with Kevetrin as soon as possible.”

Additionally, Formatech has selected Tracon Pharmaceuticals’ TRC102 clinical product as the next candidate for its Fillanthropy Program. Under this program, Formatech donates the services to aseptically fill and finish one lot of the drug candidate to support Tracon’s upcoming trials.

“TRC102 is a small molecule inhibitor of DNA base excision repair that shows very promising results in animal models and cancer patients when administered in conjunction with chemotherapeutic agents such as Temodar and Alimta,” said Jeffrey Bernard, Formatech’s director of business development. “This compound appears to potentiate chemotherapeutic efficacy as well as prevent drug resistance. We’re excited to play a role in the development of this beneficial compound.”

“We are pleased to be able to work with Formatech, one of the leaders in the field of drug product formulation and manufacture,” said Charles Theuer, Tracon’s president and chief executive officer. “We are deeply appreciative that their Fillanthropy Program will allow us to continue our Phase I study of TRC102 in combination with Temodar for advanced cancer patients, and to initiate a Phase II study of TRC102 in combination with Alimta for patients with lung cancer.”

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