ReN001, which is derived from a neural stem cell line, is in a Phase I stroke trial.
Angel Biotechnology signed a contract with ReNeuron to perform development and GMP manufacturing services to support the advancement of ReN001, a Phase I stem cell therapy for stroke. The program is expected to continue through mid-2012.
ReN001 consists of a neural cell line, designated CTX, which was generated on ReNeuron’s cell-expansion and cell-selection technologies and then taken through a full manufacturing scale-up and quality-testing process. ReN001 has been shown to reverse the functional deficits associated with stroke disability when administered several weeks after the stroke event in preclinical models.
The deal with Angel Biotechnology strengthens the companies’ working relationship and covers GMP manufacture and related work for future cohorts of patients in ReNeuron’s ongoing PISCES clinical trial.
“We are pleased to be extending our contract manufacturing arrangements with Angel by way of this new contract,” states Michael Hunt, CEO of ReNeuron. “Critically, the new contract provides ReNeuron with guaranteed GMP manufacturing and non-GMP development slots over an extended period, allowing for more efficient and flexible planning and thereby further derisking our outsourced manufacturing model for our ReN001 stem cell product for stroke.”