Date: 2013-12-06
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Rhizen Pharmaceuticals (Switzerland)
Product: RP6530
Action
mechanism: RP6530 is a highly selective and orally active dual PI3K delta/gamma inhibitor with efficient translation of activity through enzyme, cell, and whole blood-based studies. Besides inhibiting growth of immortalized cancerous cell lines and primary patient leukemic/lymphoma cells, RP6530 plays a significant role in modulation of the tumor microenvironment at clinically achievable concentrations. Compounded with a favorable pharmacokinetic profile and high therapeutic index, RP6530 is expected to possess clinical development potential across a wide range of hematological malignancies.
In addition to its role in alleviating progression of lymphomas, RP6530 was effective in suppressing the immune-inflammatory responses elicited in animal models of airway inflammation and arthritis thereby increasing the spectrum of diseases that can be targeted with this compound.
Disease: advanced hematological malignancies
Therapeutic area: Cancer - Oncology
Country: Italy
Trial details:
Latest
news: * On December 6, 2013, Rhizen Pharmaceuticals announced the initiation of a “first in human” Phase-1 study of RP6530, a dual Phosphoinositide-3 kinase (PI3K) delta/gamma inhibitor, for the treatment of patients with advanced hematological malignancies. The study entitled “A Phase-I, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a dual PI3K
delta/gamma inhibitor, in patients with Relapsed or Refractory Hematologic Malignancies” is designed primarily to establish the safety and tolerability of RP6530. Secondary objectives include clinical efficacy assessment and biomarker response to allow dose determination and potential patient stratification in subsequent expansion studies. The study will be conducted at San Raffaele Institute, Milan, Italy with Dr. Andrés Ferreri as the Principal Investigator.
