The National Cancer Institute, part of the National Institutes of Health, has granted RadioMedix a two-year, $2 million Phase II SBIR contract for the clinical development of its Targeted Alpha-emitter Therapy (TAT) for neuroendocrine tumors.

The award follows and is a continuation of the success of its Phase I SBIR contract around the use of 212Pb-octreotate analog (AlphaMedix) for patients with advanced neuroendocrine tumors (NETS) who have limited treatment options available to them.

"Current approaches to cancer treatment are largely ineffective once the tumor has metastasized. Neuroendocrine tumors are rare, accounting for only 0.5% of all malignancies and their symptoms are usually vague and nonspecific," Izabela Tworowska, CSO of RadioMedix and the principal investigator of the SBIR Phase II contract, told HCB News. "Surgery is the principal therapy for localized disease however its success in advanced disease is limited. The combination chemotherapy used for management of NETs is associated with high toxicity and limited efficacy."

A heterogeneous group of rare neoplasms, neuroendocrine tumors stem from neuroendocrine cells and appear primarily in the gastrointestinal tract and pancreas, expressing somatostatin receptors. They can also occur in the thymus, lung and uncommon sites such as the cervix, heart and prostate.

AlphaMedix is a radiolabeled SSTR-targeting therapeutic investigation drug designed to treat NETs patients. Its composition consists of SSTR-targeting peptide complex radiolabeled with 212Pb, enabling it to act as a vivo generator of alpha-emitting particles. Its half-life, high energy, short path length of decay and irreversible damage to the double stranded DNA make it a well suited-source for SSTR therapy applications.

The Phase I clinical study was designed based on the results of the pre-clinical toxicity and efficacy studies performed with the scope of the NCI NIH Phase I Contract. The award builds on the progress made in this non-randomized, open-label, dose escalation study, with the NIH NCI Phase II Contract focused on determining the safety and pharmacokinetics of Pb212-octreotate (AlphaMedix) and selecting the effective doses for therapy of patients with somatostatin receptor positive neuroendocrine tumors.

"The recent FDA approval of 177Lu-DOTATATE (Lutathera, Advanced Accelerated Applications, currently Novartis) highlights the growth of the radiotherapeutic market. Despite this great success, there is a significant potential for improvement in safety, efficacy and lengthening progression free survival of patients by using targeted alpha emitter-therapy," said Tworowska. "Our hypothesis is that alpha emitters such as 212Pb with higher linear energy transfer (LET) and shorter path-length in tissue can deliver lethal dose to the tumor cells, causing permanent double strand DNA damage and less damage to the normal tissue. These characteristics should translate into the higher efficacy and safety of the treatment."

RadioMedix recently scored another award in the form of a fast-track designation by the FDA for 64-Cu-Dotatate, an investigational diagnostic radiopharmaceutical that it’s developing and commercializing alongside Curium.

The project is funded with federal funds from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services.

Clinical studies around the use of AlphaMedix are currently underway at the Excel Diagnostics and Nuclear Oncology Center in Houston.

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