Flamingo Therapeutics has initiated a new Investigator-initiated Trial aimed at assessing the safety and effectiveness of danvatirsen in patients with acute myeloid leukemia and myelodysplastic syndrome (MDS) who have either relapsed or failed frontline therapy. This trial, conducted in collaboration with Montifore Einstein Comprehensive Cancer Center (MECCC) in New York, USA, and MD Anderson Cancer Center (MDACC) in Houston, USA, marks a significant step forward in combating these challenging blood diseases that predominantly affect older individuals.

The Phase 1 trial will evaluate danvatirsen, a STAT3 inhibiting oligonucleotide developed by Ionis, both as a standalone therapy and in combination with venetoclax, a frontline treatment for relapsed/refractory MDS and AML. These diseases, notorious for their high relapse rates and limited treatment options, have seen some improvements in survival with new therapies, yet there remains a dire need for more effective treatments, especially for those who experience relapse.

Dr. Aditi Shastri, Principal Investigator of the IIT and a leading researcher at MECCC, expressed enthusiasm for the study, highlighting its potential to pioneer a new therapeutic approach for AML and MDS patients. The collaboration between academic medical centers and industry underscores a concerted effort to translate research findings into tangible clinical benefits.

Funding for the IIT comes from a multi-year grant awarded by the US FDA Office of Orphan Products Development (OOPD) to MECCC, indicating recognition of the trial's importance in addressing unmet medical needs. Dr. Shastri, along with Dr. Naval Daver at MDACC, leads the trial at their respective sites, leveraging their expertise in AML and MDS research.

Flamingo, expressed confidence in the collaboration with esteemed experts like Drs. Shastri and Daver, emphasizing the significance of expanding danvatirsen's clinical development program. With ongoing trials in head and neck cancer and AML/MDS, Flamingo aims to advance novel treatments for patients in need.

The Phase I study (NCT05986240) will evaluate danvatirsen's safety, efficacy, pharmacokinetics, and pharmacodynamics as a monotherapy and in combination with venetoclax, with the ultimate goal of determining a recommended phase 2 dose and guiding further investigations.

 

Source: prnewswire.com

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