US firm Xcellerex has inked a deal with Modigene to produce its experimental long-acting version of human growth hormone (hGH) for imminent preclinical studies, and will also make Phase I quantities of the hormone for Phase I clinical trials that are planned for next year, and then Phase II trials beyond that.
Modigene's therapy uses a technology based on a short amino acid sequence, the carboxyl terminal peptide (CTP), which occurs naturally in humans, and when attached to a therapeutic protein, extends the time that the protein is active in the body.
In children with an hGH deficiency, current treatments involve subcutaneous hGH injections on a near-daily basis, however, in preclinical models, a single injection of hGH-CTP has shown the potential to replace 7 to 10 daily injections of current commercial hGH, said Modigene.
Canada's QSV Biologics will now undertake the process development and manufacturing of Alseres Pharmaceuticals' spinal cord injury drug BA-210 (Cethrin) after a new contract was signed between the two firms.
The "first-in-field" spinal cord injury therapy is in development and the arrangement relates to the production of Phase IIb/III clinical trial material.
Cethrin is a Rho inhibitor that stimulates axon regeneration and has received Orphan Drug designation from the US Food and Drug Administration (FDA).
In other news, IntegrityBio has opened its new good manufacturing practice (GMP) fill and finish facility for the contract manufacturing of infusion- or injection-based products that are preclinical or entering Phase I and Phase II clinical trials.
The new facility located in Camarillo, California, has the capacity for up to 10,000 liquid formulation vials or 3,000 lyophilised formulation vials per lot.
Meanwhile, India's Indoco Remedies has received regulatory certification from the Brazilian food and drug agency, Anvisa, for its solid dosage manufacturing facility in Goa.
The approval will pave the way for new contract manufacturing opportunities for Indoco in Brazil, the firm said.
For the same purpose, Indoco also indicated that it is now working on obtaining certification for the plant from the medicine control council (MCC) of South Africa, as well as its other plant near by, which is a sterile manufacturing facility for ophthalmics and injectables.
