is a somatostatin receptor targeting peptide radiolabeled with 212Pb
. Somatostatin receptors are overexpressed in most neuroendocrine tumors
, 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 ovaries, heart, and prostate.
AlphaMedixTM obtained particularly promising results in the phase 1 trial launched in 2018. The treatment was well-tolerated and a response rate (ORR: objective response rate according to the RECIST 1.1 method) of 67% was observed. In addition, a supplementary cohort of patients already having received a radioligand therapy and in whom the disease had progressed was recruited. A response rate of 60% was measured in these patients.
AlphaMedixTM entered Phase 2 clinical trials in 2021 to assess its efficacy in the treatment of neuroendocrine tumors. The last patient never previously having received radioligand therapy was included in 2023. Remarkably, based on the responses observed up till this date, the objective response rate (ORR) endpoint has already been achieved.
The United States Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to AlphaMedixTM (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who are naïve to peptide receptor radionuclide therapy (PRRT). AlphaMedixTM is the first Targeted Alpha Therapy to receive Breakthrough Therapy Designation.
In an initial efficacy study, a single 10 µCi cycle of 212Pb-DOTAMTATE allowed the median life span of mice to be extended by a factor of 2.4. The efficacy was then improved by administering 3 cycles of 212Pb-DOTAMTATE and by decreasing the timing between cycles from three weeks to two weeks. Efficacy was further enhanced by adding a chemo-sensitizing agent, 5-fluorouracil, given in combination of three cycles of 212Pb-DOTAMTATE. These conditions yielded 79% tumor-free animals at the end of the 31-week study.
Expanded access policy:
Currently, RadioMedix, Inc. and Orano Med, do not offer an expanded access program and are not accepting expanded access requests for AlphaMedix™. Our development resources are focused on conducting clinical trials that evaluate the safety and efficacy of our treatment.
If you have additional questions about RadioMedix and Orano Med’s expanded access policy, please email us at firstname.lastname@example.org and email@example.com.
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