CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced that bafetinib (formerly known as INNO-406) has received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product for the treatment of chronic myeloid leukemia (CML). The positive opinion of the COMP has now been forwarded to the EU commission for final approval and publication in the community register. Bafetinib also has been granted Orphan Drug Status for the treatment of Philadelphia chromosome-positive (Ph+) CML by the U.S. Food and Drug Administration (FDA).
“We are delighted that the COMP has provided a positive opinion regarding bafetinib's orphan medicinal product status for the treatment of CML”
CytRx recently announced plans to begin three Phase 2 proof-of-concept open-label clinical trials with bafetinib. The clinical trial in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL) is expected to commence in the first half of 2010, and clinical trials in patients with advanced prostate cancer and glioblastoma multiforme (a common and aggressive type of primary brain tumor) are expected to commence in the second half of 2010.
"We are delighted that the COMP has provided a positive opinion regarding bafetinib's orphan medicinal product status for the treatment of CML," said Steven A. Kriegsman, CytRx President and CEO. "Bafetinib is based on a known mechanism of action, which we believe reduces its development risk, and has demonstrated the ability to inhibit the Bcr-Abl enzyme, which is prevalent in CML. Bafetinib's key differentiator over currently marketed kinase inhibitors is its ability to inhibit a specific enzyme called Lyn kinase, which is overly expressed in certain malignancies. We believe that its function as a dual kinase inhibitor makes bafetinib potentially viable in the treatment of multiple blood-borne and other cancers, and we are firmly focused on advancing its clinical development in three Phase 2 proof-of-concept clinical trials this year."
The European Commission grants orphan medicinal product status to promote the innovation of drugs that are developed to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the EU. With this designation, CytRx will have market exclusivity in the EU for 10 years in the event that bafetinib receives marketing approval as a treatment for CML. The designation also provides for special benefits, including research support, eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development, or at the time of application for marketing approval.
Bafetinib is a potent, orally available, rationally designed, dual Bcr-Abl and Lyn kinase inhibitor, which was developed as a third-line treatment for patients with CML and certain forms of acute myeloid leukemia (AML) that are refractory or intolerant of other approved treatments. In November 2008, CytRx announced that bafetinib demonstrated clinical responses in patients with CML in an international, open-label Phase 1 dose-ranging clinical trial conducted in patients with CML and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to Gleevec and, in some cases, second-line tyrosine kinase inhibitors such as dasatinib and nilotinib.
SOURCE CytRx Corporation