Trovagene which is a precision medicine biotechnology company developing targeted cancer therapeutics asserted that the initial patient successfully completed first cycle 1 Treatment in its Phase 1b/2 multicenter trial of PCM-075 in combination with low-dose cytarabine (LDAC) in patients with Acute Myeloid Leukemia (AML).
The patient that tolerated the combination well and correlative analyses of blood samples, taken at specified time points, also indicated activity on leukemic blood cells.The Phase 1b/2 trial is a multi-center, open-label trial exploring the safety and efficacy of PCM-075 in combination with standard-of-care chemotherapy in AML patients who are ineligible for intensive induction therapy or whose disease is relapsed or refractory.
A remarkable decrease in the percentage of blood leukemic cells was witnessed within 24 hours of administering PCM-075+ LDAC. By day 15, withing the treatment cycle, the greatest effect was witnessed with blood leukemic cells showing a decrease from greater than 40% to less than 5%.
Alex Spira, MD, PhD, FACP, Director of The Virginia Cancer Specialists Research Institute said “Our first patient on PCM-075 appears to be tolerating the drug regimen well and the observed decrease of blood leukemic cells during the treatment cycle is encouraging.”