Houston, TX (January 21th, 2019) – RadioMedix Inc. is pleased to announce that the company has been awarded a two-year, $2.0 M Phase II SBIR contract award by the NIH NCI (HHSN261201800048C; UPIID:75N91018C00048) for the clinical development of Targeted Alpha-emitter Therapy (TAT) of neuroendocrine tumors. This Phase II Contract award is a continuation of the successfully completed Phase I SBIR contract (HHSN261201600015C). This award will support the Phase I, non-randomized, open-label, dose escalation study to determine the safety, bio-distribution, and preliminary effectiveness of 212Pb-octreotate analog (AlphaMedix™) in adult subjects with Somatostatin Receptor (SSTR) expressing neuroendocrine tumors (NCT03466216). Dr. Izabela Tworowska (RadioMedix) serves as a Principal Investigator of the SBIR Phase II contract and is working together with Dr. Julien Torgue (co-I, Orano Med). The clinical studies are currently on-going at the Excel Diagnostics and Nuclear Oncology Center (Houston, TX).
“Patients with advanced Neuroendocrine Tumors (NETs) have limited treatment options available to them. Our goal is to address this unmet clinical need by using targeted alpha-emitter therapy”, said Izabela Tworowska, PhD, CSO of RadioMedix. “We are grateful to NCI for acknowledging the importance of alpha-emitter therapy and supporting our clinical studies of 212Pb-octreotate analog. This SBIR Phase II Contract is the second award highlighting RadioMedix – Orano Med collaboration.”
“TAT is believed to be the next generation of radiopharmaceuticals in the field of Radioligand Therapy (RLT) in oncology. Our proprietary 212Pb labeled agent has potential to advance the effectiveness of Peptide Receptor Radionuclide therapy (PRRT) as compared to currently approved PRRT agents for neuroendocrine cancers”, said Dr. Ebrahim S. Delpassand, CEO of RadioMedix. “Unique properties of 212Pb can induce targeted and irreversible damage to the cancer cells, which can result in significant clinical benefits to NET patients”, added Dr. Delpassand.
This project has been funded in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261201800048C.
More about RadioMedix
RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and therapeutic (alpha and beta-labeled) radiopharmaceuticals. RadioMedix has also established contract service facilities for academic and industrial partners: cGMP manufacturing and analytical suites for human clinical trials, and commercial phase manufacturing of the radiopharmaceuticals, and drug discovery facility with small animal Molecular Imaging Center for the pre-clinical evaluation of radiopharmaceuticals in vitro and in vivo .
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About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as cervix, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs).
AlphaMedixTM is a radiolabeled SSTR-targeting therapeutic investigational drug for the treatment of NETs patients. The product consists of SSTR-targeting peptide complex radiolabeled with 212Pb and serve as an in vivo generator of alpha-emitting particles. 212Pb isotope is particularly suitable for SSTR therapy applications based upon its half-life, high energy, the short path length of decay and irreversible damage of double stranded DNA.
Izabela Tworowska, PhD,