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news.CytRx, a biopharmaceutical company specialising in oncology, said that it has made progress with its clinical program assessing the efficacy and safety of its drug candidate Bafetinib in three oncology indications.
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CytRx has recruited its first patient in a Phase 2 proof-of-concept trial in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL), which is advancing towards the initiation of a Phase 2 proof-of-concept trial in advanced prostate cancer, and is set to begin clinical evaluation later this year in glioblastoma multiforme.
CytRx said that in the Phase 2 proof-of-concept ENABLE clinical trial, high-risk B-CLL patients who have failed treatment with first-line agents will self-administer oral doses of Bafetinib twice daily.
CytRx has recruited first patient for its ENABLE Phase 2 proof-of-concept clinical trial with Bafetinib in patients with B-CLL, at MD Anderson Cancer Center in Houston.
CytRx is expected to launch additional clinical sites for the ENABLE trial, including a site in the US and several sites in India. Additionally, the activities are underway to gain approval from the Indian regulatory agency (DCGI) and respective site ethics committees.
CytRx is preparing to initiate its Phase 2 trial with Bafetinib in patients with metastatic hormone-refractory prostate cancer, which is now called the PROACT trial (PROstate Advanced Cancer Treatment). The PROACT trial is expected to be initiated in a clinical site in the US, as well as multiple clinical sites in India.
CytRx has submitted the investigational new drug (IND) application for Bafetinib and the PROACT clinical trial protocol to the DCGI and the proposed clinical sites are working with their respective ethics committees to obtain site approvals.
Steven Kriegsman, president and CEO of CytRx, said: “Patient enrollment is underway in the B-CLL trial, which we are now calling ENABLE (Effectiveness iNAdvanced B-Cell Lymphocytic Leukemia).
“Our oncology drug development team also is focused on gaining approvals for additional clinical sites for this trial as well as for our planned advanced prostate cancer trial to increase the enrollment rate and shorten the time required for trial completion.
“We plan to keep investors apprised of our progress with the Bafetinib clinical program, as well as our clinical programs with oncology drug candidates INNO-206 and tamibarotene.”
Daniel Levitt, chief medical officer of CytRx, said: “We are pleased with our progress with the Bafetinib clinical program, which is expected to allow us to further evaluate its potential in the treatment of advanced-stage cancers.
“Our optimism for this drug candidate is based on a key design differentiator, its pairing of Bcr-Abl inhibitor with a potent inhibitor of Lyn kinase, which is over expressed in many cancers.”