CTI BioPharma Corp (NASDAQ: CTIC) strengthened on Friday stock markets, after the Seattle-based drug maker disclosed that pacritinib has been validated by the European Medicines Agency.
EMA has validated the Marketing Authorization Application (MAA) for pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia (platelet counts less than 100,000 per microliter). Validation confirms that the submission is complete and initiates the centralized review process by the EMA's Committee for Medicinal Products for Human Use (CHMP). The CHMP review period is 210 days, or about seven months.
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses.
A release issued by the company Friday said mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma.
Myelofibrosis is one of three main types of myeloproliferative neoplasms, which are a closely-related group of progressive blood cancers.
CTI BioPharma is focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis.
Shortly before the final closing bell of the week, CTI stock had gained 11 cents, or 3.2%, to $3.50.
