Bafetinib oral pill will soon be evaluated for its potential to treat advanced prostate cancer.
CytRx Corporation will soon initiate a phase 2 proof-of-concept clinical trial in the second half of 2010 to evaluate the effectiveness and safety of its oncology drug candidate bafetinib (formerly known as INNO-406) in patients with an advanced form of prostate cancer known as metastatic hormone-refractory prostate cancer, the company announced.
Bafetinib is an orally available, rationally designed, dual Bcr-Abl and Lyn kinase inhibitor, which is currently being planned as a third-line treatment for patients with chronic myeloid leukemia (CML) or 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 Phase I 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.
Bafetinib has been granted Orphan Drug Status for the treatment of Philadelphia chromosome-positive (Ph+) CML by the FDA.
“We see an opportunity for bafetinib in the treatment of this advanced-stage cancer due to its ability to inhibit Lyn kinase. Lyn kinase is over-expressed in hormone-refractory prostate tumor specimens compared to tumor samples from the same individuals taken before hormone therapy,” CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D., stated.
The inhibition of Lyn kinase has been shown to prevent prostate tumor growth and lymph node metastases in mouse models. By inhibiting Lyn kinase, bafetinib could have a role in the treatment of these advanced-stage cancer patients by blocking the growth and progression of metastatic hormone-refractory prostate tumors.
Currently chemotherapy increases the survival time of advanced-stage prostate cancer patients, these agents are quite toxic.
Potent, orally available bafetinib could improve survival and provide these patients with a better quality of life by reducing drug-related side effects, according to CytRx president and CEO Steven A. Kriegsman.
CytRx is planning to commence the clinical programme in the second half of 2010. This will be in addition to two previously announced Phase 2 clinical trials with bafetinib in patients with advanced-stage cancers.
These multiple, cost-efficient trials are geared to provide us with indications of efficacy in relatively short timeframes.
CytRx expects to enroll up to 50 patients with metastatic hormone-refractory prostate cancer who have failed first-line therapy with either the chemotherapy agent docetaxel or mitoxantrone in this planned Phase 2 proof-of-concept clinical trial.
The trial endpoints will be reduction in prostate-specific antibodies and increase in progression-free survival compared to baseline and historical data. The study will be conducted in several cancer treatment centers worldwide.
Prostate cancer is the second most common malignancy and second-leading cause of cancer death among American men, according to the American Cancer Society. Of those diagnosed, one in 35 men will die of prostate cancer.
Treatment of prostate cancer include surgery, radiation or both, followed by hormonal treatment.
Hormonal treatment can shrink the cancer, delay its growth and reduce symptoms; however, patients with metastatic prostate cancer usually stop responding to this therapy within two years.
The disease at this stage, called metastatic hormone-refractory prostate cancer, is typically treated with chemotherapeutic agents, and patients have a median survival period of less than two years, according to the National Cancer Institute.
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics.
The CytRx oncology pipeline includes three programs in clinical development for cancer indications, including INNO-206, bafetinib and tamibarotene.
CytRx recently announced plans to initiate Phase 2 clinical trials with its oncology candidate INNO-206 as a treatment for pancreatic cancer, gastric cancer and soft tissue sarcomas. The Company also has announced plans to initiate two Phase 2 clinical trials with bafetinib as a treatment for high-risk B-cell chronic lymphocytic leukemia (B-CLL) and glioblastoma multiforme, a common and aggressive type of primary brain tumor.
CytRx is also developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease.
CytRx also maintains a 28% equity interest in publicly traded RXi Pharmaceuticals, Inc.