FDA Approves Ellipses Pharma’s EP0042 for Acute Myeloid Leukaemia Patients!

Ellipses Pharma, a pioneering drug development company committed to transforming cancer treatment, is delighted to announce that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for EP0042, a groundbreaking dual FLT-3 and Aurora kinase inhibitor. This marks a major step forward in Ellipses’ mission to accelerate the development of cancer medicines and treatments, and promises to revolutionize the future of cancer treatment.

EP0042 is an exciting new drug that has the potential to revolutionize the treatment of Acute Myeloid Leukemia (AML). Approximately one-third of AML patients have FLT3-mutations, which significantly increases their risk of relapse and worsens their clinical outcome. EP0042 is being developed to address the issue of acquired resistance to FLT3 inhibitors, offering new hope for those affected by this devastating disease.

Ellipses is set to expand its ongoing first-in-human Phase 1/2 clinical trial, which is currently in its dose-ranging phase. Upon confirmation of the recommended Phase 2 dose, Ellipses will continue to evaluate EP0042 as a monotherapy and explore its potential when used in combination with established standard treatments. This marks an exciting development in the field of clinical trials, as Ellipses takes a step towards discovering the potential of this promising therapeutic.

At the 64th American Society of Hematology Annual Meeting in December 2022, Ellipses presented exciting preliminary data from their ongoing study on EP0042. The data showed that the drug had acceptable safety and tolerability, as well as evidence of prolonged disease control in heavily pre-treated patients. This gave hope to those struggling with various blood-related diseases.

Dr Rajan Jethwa, Chief Executive Officer & Founder of Ellipses, commented:

We are thrilled to announce that the FDA has approved EP0042’s Investigational New Drug application, enabling us to open additional trial sites in the US and further our strategic goal of bringing potential new treatment options to patients in need at a rapid pace. The data we presented at the ASH conference in December showed the potential of EP0042 and we are now dedicated to turning this potential into reality.

Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses Pharma commented:

We are thrilled to have achieved another major milestone in the regulatory pathway for EP0042 with FDA IND approval. Our team is now working diligently with our clinical partners to get US sites online quickly and move forward with this positive progress. This is an exciting development for EP0042, as well as our entire portfolio.

The Institute of Cancer Research, London, has led the groundbreaking drug discovery and development work that has culminated in EP0042’s ongoing clinical-stage study. This pioneering work was funded by several organisations including The Institute of Cancer Research, Breast Cancer Now, and Cancer Research UK. Thanks to their collective efforts, the potential for life-changing treatments is closer than ever before.

About EP0042

EP0042 is an exciting new treatment for acute myeloid leukemia (AML) patients who have developed resistance to FLT3 inhibitors. Studies have revealed that dual inhibition of FLT3 and Aurora kinase is an effective way to combat acquired resistance to single FLT3 inhibitors, both in the lab and in actual patients. This innovative approach has the potential to revolutionize the treatment of AML and improve patient outcomes.

About acute myeloid leukaemia

Acute myeloid leukaemia (AML) is a devastating cancer of the bone marrow that causes the rapid production of monocytes and granulocytes. Sadly, it is one of the most common forms of leukaemia in adults, with an estimated 38,000 diagnoses every year in the US and Europe alone. Unfortunately, the 5-year survival rate for those diagnosed is just 15%. However, with early detection, proper treatment, and the support of family and friends, there is hope for a better future.

About Ellipses Pharma Limited

Ellipses Pharma, headquartered in London, is revolutionizing the way cancer treatments are developed. Our innovative drug development model provides an unbiased vetting process to reduce risk and uninterrupted funding flow to expedite the time it takes to advance lead products through clinical trials and get them to patients. We are committed to making a difference in the fight against cancer by accelerating the development of treatments worldwide.

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