CytRx Corporation, a biopharmaceutical company specializing in oncology, announced initiation of a pharmacokinetic clinical trial with its oncology drug candidate bafetinib in patients with recurrent brain tumours. Results from this trial are expected in the second quarter of 2011 and will be used in evaluating potential further clinical development of bafetinib in patients with brain cancer.
Six to eight patients with recurrent primary brain cancer or recurrent brain metastases who have undergone brain surgery will be evaluated in the trial, which is being conducted at City of Hope Cancer Centre in the US. The trials primary objective is to provide neuropharmacokinetic information, such as the ability of bafetinib to cross the blood brain barrier and the percentage that enters the brain compared to the amount in systemic blood.
In addition to the announced clinical trial in patients with brain cancer, the Company has already initiated enrollment of patients in both its PROACT Phase 2 proof of concept prostate cancer clinical trial evaluating the efficacy and safety of bafetinib in patients with advanced cancers, and its enable clinical trial in patients with a late-stage form of leukaemia known as high-risk B-cell chronic lymphocytic leukaemia, or B-CLL.
“This rapid clinical trial is designed to provide proof of bafetinib's ability to cross the blood brain barrier, verifying results from prior animal studies. It is essential that bafetinib cross this natural protective barrier in pursuing brain cancer," said Daniel Levitt chief medical officer, MD, PhD CytRx “This trial also will allow us to gain initial experience in terms of bafetinib's tolerability at the dose under consideration for possible future testing in patients with brain cancer”.
“Lyn kinase is overexpressed in biopsy samples of glioblastoma multiforme, the most common adult brain tumor, which suggests that it may be required for tumour cell growth and progression. As a result, we believe that the administration of bafetinib, which inhibits Lyn kinase, may stop the growth of brain cancer,” Dr Levitt added.
Steven A. Kriegsman, president and CEO, CytRx said, “This is another important step in our strategy to advance clinical development of bafetinib in brain cancer either with internal resources or through a strategic alliance. New treatments for the management of primary and metastatic brain malignancies are urgently needed. The approval of targeted anti-cancer therapies in recent years has resulted in improved survival rates for many patients with solid tumours outside the brain; however, it is becoming more common for those cancer patients to suffer from metastatic disease to their brains.
Brain tumours can be benign, with no cancer cells, or malignant, with cancer cells that grow quickly. There are two main types of brain cancer. Primary brain cancer, or glioma, starts in the brain and metastatic brain cancer starts somewhere else in the body and moves to the brain.
CytRx holds rights to bafetinib (formerly known as INNO-406) in all territories except Japan. 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 Leukaemia (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 leukaemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to Gleevec(R) and, in some cases, second-line tyrosine kinase inhibitors such as dasatinib and nilotinib. In April 2010, the Company announced that bafetinib had 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 status for the treatment of chronic myeloid leukaemia (CML). Bafetinib also has been granted Orphan Drug Status for the treatment of Philadelphia chromosome-positive (Ph+) CML by the US Food and Drug Administration (FDA).
CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programnes in clinical development for cancer indications: bafetinib, tamibarotene and INNO-206.