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news.CytRx, a biopharmaceutical company, has announced that INNO-406, the company's potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, demonstrated clinical responses in patients with chronic myeloid leukemia.
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INNO-406 is being evaluated for the treatment of patients with chronic myeloid leukemia (CML) and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to imatinib and second line tyrosine kinase inhibitors.
The clinical trial was designed to identify the optimal dose for possible future studies by escalating doses from 30mg once a day up to 480mg twice a day in a total of 56 patients with Ph+ leukemias. 31 patients had CML in chronic phase (CML-CP), nine were in accelerated phase (CML-AP), seven were in blast phase (CML-BP), and nine had Ph+ acute lymphocytic leukemia.
All patients had demonstrated intolerance or resistance to imatinib, and the majority of patients had also demonstrated intolerance or resistance to a second and in some cases a third, Bcr-Abl inhibiting tyrosine kinase inhibitor. A positive, dramatic decrease in the number of leukemia cells in the bone marrow was seen in 35% of the patients that were randomly chosen to begin their treatment with the optimal INNO-406 dose of 240mg twice per day.
The maximum tolerated dose was determined to be 240mg given twice per day based on evidence of increasing potential liver toxicity at higher doses. Only 13% of patients, across all dose groups, discontinued dosing due to unacceptable toxicity, the company said.
Steven Kriegsman, president and CEO of CytRx, said: “We are enthusiastic about our oncology drug products, and we believe that these encouraging results from the first clinical trial of INNO-406 demonstrate that our corporate oncology strategy may result in significant value added to CytRx.
“We are waiting for additional results from non-clinical studies, as well as the completion of a comprehensive corporate strategic review, to determine the most efficient and effective path to move INNO-406 forward in development.”