ITM: FDA Acceptance of IND to Advance Phase III Clinical Trial COMPETE with Solucin® for Treatment of GEP-NET in the U.S.

Recruitment in the U.S. for the COMPETE trial to begin shortly

Solucin^® studied as a first-line therapy

Exclusively-produced nephroprotective amino acid solution administered

GARCHING, Germany--(BUSINESS WIRE)--Isotopen Technologien München AG (ITM), a specialized radiopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug Application (IND) to advance its innovative radiopharmaceutical Solucin^® (n.c.a. ¹⁷⁷Lu-Edotreotide), into a phase III clinical trial in the U.S..

The COMPETE trial is led as an international, pivotal, multi-center, phase III clinical trial, evaluating the efficacy and safety of Targeted Radionuclide Therapy with Solucin^® compared to Everolimus¹ in patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The primary objective of the trial is to prolong progression-free survival (PFS) compared to Everolimus. COMPETE will be conducted in Europe, North America, South Africa and Australia. The company plans to start recruitment immediately at five designated sites in the U.S.: Excel Diagnostics & Nuclear Oncology Center, Mayo Clinic, Moffitt Cancer Center & Research Institute, University of Michigan Comprehensive Cancer Center, and Virginia Mason Medical Center.

The study protocol of COMPETE was designed together with members of the European Neuroendocrine Tumor Society (ENETS). Accordingly, a broad indication was chosen with non-functional GE-NET / functional or nonfunctional P-NET. Everolimus, the current standard of care therapy, was chosen as the comparator for Targeted Radionuclide Therapy with Solucin^®. The COMPETE trial will also be the first to test Targeted Radionuclide Therapy as a first-line therapy against NET. The results of the trial could influence the future treatment algorithm of NETs.

In order to both maximize the therapeutic properties of Targeted Radionuclide Therapy and ensure that patients in the COMPETE study are exposed to as few side effects as possible, an amino acid solution consisting of arginine and lysine will be administered shortly before treatment. This amino acid solution has nephroprotective properties but is not yet commercially available. The Mayo Clinic, the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the Washington University School of Medicine in St. Louis, and the Memorial Sloan Kettering Cancer Center have jointly filed comments with the FDA recommending that regulatory changes be made to make arginine and lysine more easily available as bulk drug for patients who undergo Targeted Radionuclide Therapy.²

“We are pleased to have received FDA acceptance for our clinical trial protocol and look forward to beginning recruitment for COMPETE in the U.S.”, said Steffen Schuster, CEO of ITM. “We are delighted to be able to collaborate with distinguished American experts in the fields of Targeted Radionuclide Therapy, Oncology, and Endocrinology to provide the best possible treatment for NET patients."

References

1) Afinitor [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2018.

2) http://www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=29116