Pasithea Therapeutics Kicks Off Phase 1 Trials for Advanced Cancer Treatment with PAS-004

Pasithea Therapeutics, operating under the tickers KTTA and KTTAW, has recently made a significant breakthrough in the field of cancer treatment by receiving the FDA’s nod to proceed with an Investigational New Drug (IND) application. This approval moves the company closer to commencing clinical trials for its drug candidate, PAS-004, which is renowned as the pioneering macrocyclic MEK inhibitor to be evaluated in human patients.

Introduction to PAS-004

PAS-004 stands as a remarkable scientific innovation targeting the MAPK (Mitogen-Activated Protein Kinase) pathway, which is associated with numerous types of advanced solid tumors. This pathway plays a crucial role in the growth and spread of cancer cells, and therefore, represents a promising target for emerging cancer therapies.

Phase 1 Clinical Trial Ambitions

In a groundbreaking initiative set for the first quarter of 2024, Pasithea Therapeutics plans to launch a Phase 1 dose escalation study. This study will enroll patients with MAPK pathway-driven advanced solid tumors. Researchers anticipate that this initial phase will provide valuable insights into the drug’s safety profile and efficacy, paving the way for further development.

Projected Timelines and Outcomes

With the clinical trial’s commencement in early 2024, stakeholders are keenly awaiting the initial results. By the third quarter of the same year, preliminary data on PAS-004 is expected to be available. This swift progression underscores the urgency and dedication with which Pasithea Therapeutics is addressing the dire need for novel cancer treatments.

Pasithea, FDA, IND, PAS-004, cancer, trials