Formatech to make Kevetrin for Ph I trials
The drug, which is designed to treat resistant-cancers, is entering Phase I studies after showing last year that it brought about a greater reduction in tumor size than standard therapies in preclinical animal models.
Under the new production deal, US contract manufacturing organisation (CMO) Formatech will manufacture Kevetrin as a lyophilised powder for reconstitution in saline solution when the study begins.
Cellceutix CEO George Evans explained that Formatech’s flexibility had been key in winning it the contract and added the “agreement allows us to stay on track for our IND filing.”
In March last year, Formatech significantly increased lyophilisation capacity at its manufacturing facility in Andover, Massachusetts with the installation of second good manufacturing practices (GMP) quality unit.
At the time, business director Jeffrey Bernard said that: “By doubling our capacity for processing lyophilized products, we have reduced the bottleneck, can better meet our clients scheduling needs and most importantly get them to the clinic on time.”
Clinical Faze Fillanthropy
Other Formatech news this week focused on the production of candidate cancer drugs for Phase I trials, with the firm agreeing to produce a batch of Tracon Pharmaceutical’s anticancer compound TRC102.
However, unlike the Cellceutix contract which is a commercial agreement, Formatech will donate its services to Tracon as part of its “Fillanthropy” manufacturing programme.
The initiative, launched in October last year with the production of GeoVax’ HIV vaccine, sees Formatech select one company a month to which it donates fill and finish services for one batch of a candidate drug.
Tracon CEO Charles Theuer said that Formatech’s offer “[Allows] us to continue our Phase I study of TRC102 in combination with Temodar for advanced cancer patients, and to initiate a Phase 2 study…in combination with Alimta in patients with lung cancer.”
Under the terms of the Fillanthropy programme Tracon is required to donate a proportion of the cost saving it achieves through Formatech’s efforts to a charitable organisation of their choice.