Ergomed Significantly Increases Contribution in CEL-SCI’s Phase III Trial


CEL-SCI Corporation and its Clinical Research Organization (CRO) Ergomed plc recently announced they have expanded their co-development agreement with increased activities to be undertaken by Ergomed. Pursuant to the expanded co-development agreement, Ergomed’s contribution to the Phase III study will increase from $10 million to $12million. The companies are undertaking the Phase III trial of CEL-SCI’s investigational immunotherapy Multikine (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer.

Under the extended agreement, Ergomed will contribute up to $12 million toward the cost of performing clinical services for the Phase III study in exchange for a single-digit percentage of milestone and royalty payments, up to a specified maximum amount. Well over 500 patients have been enrolled in the world’s largest Phase III trial for head and neck cancer.

“At this point in the clinical trial, we have decided to increase our investment in the development of Multikine, as we believe that it holds the potential to treat head and neck cancer in a new way. Our potential returns from this agreement will increase in line with our investment,” said Ergomed CEO Miroslav Reljanovic.

“Working with a skilled CRO, our Phase III trial is making significant progress toward completing study enrollment goals. We are pleased to enter into this expanded co-development agreement with Ergomed. It further aligns Ergomed’s goals with CEL-SCI’s as Ergomed will be rewarded for its $12-million co-development investment from the commercialization of the drug,” added CEL-SCI CEO Geert Kersten.

The Multikine Phase III study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care (SOC) versus subjects who are treated with SOC only.

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase I study under a Cooperative Research and Development Agreement (CRADA) with the US Naval Medical Center, San Diego, and at the University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world- renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy, Multikine (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase III clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current SOC as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the US Naval Medical Center, San Diego, under a CRADA, and at UCSF.

CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. For more information, visit www.cel-sci.com.

Founded in 1997, Ergomed plc is a profitable UK-based company, providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. Ergomed provides clinical development, trial management, and pharmacovigilance services to over 60 clients ranging from top 10 pharmaceutical and generics companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes. Ergomed has wide therapeutic expertise, with a particular focus in oncology, neurology and immunology and the development of orphan drugs. Ergomed’s approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.

As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies. Here Ergomed shares the risks and rewards of drug development, leveraging its expertise and services in return for carried interest in the drugs under development. – a low risk investment model for potential high returns. For further information, visit www.ergomed.com. .

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