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news.Biotechnology firm Bio-Path Holdings has completed enrollment of patients in Cohort 7 of its Phase Ib clinical trial, which is assessing the toxicity of the firm’s compound, Liposomal Grb-2 in acute myeloid leukemia (AML).
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The study is assessing Liposomal Grb-2, combined with low-dose cytarabine (LDAC) chemotherapy in patients with advanced AML.
The company has started enrollment into Cohort eight, which will complete the Phase Ib study of Liposomal Grb-2.
Three patients have been assessed in cohort seven, which was the first cohort of the firm’s Phase Ib trial to to evaluate the toxicity of Liposomal Grb-2 as a combination therapy.
Patients have been treated twice a week for four weeks with 60 mg/m2 of Liposomal Grb-2, for a total of eight doses in combination with the standard regimen of LDAC.
According to the firm, results were consistent with previous cohorts, demonstrating Liposomal Grb-2 to be safe and well tolerated.
Bio-Path president and CEO Peter Nielsen said: "I am highly encouraged to see that a patient suffering from advanced AML who was treated with Liposomal Grb-2 has achieved complete remission, and that another patient is continuing to improve.
"Complete remission in a patient with refractory and treatment-resistant AML is an exciting milestone for Bio-Path and blood cancer patients, suggesting that Liposomal Grb-2 might have the potential to improve survival rates in combination with frontline chemotherapy."
The cohort 8 includes patients, which will be treated with 90 mg/m2 of Liposomal Grb-2, in combination with frontline LDAC.
The firm will finalize the Phase Ib clinical study, upon successfully completing the evaluation of three patients in Cohort eight.