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RadioMedix received $2 M SBIR Phase II Contract award from NCI NIH for the targeted alpha-emitter therapy of neuroendocrine cancers
Posted by RadioMedix . on
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...
RadioMedix and Curium Announce FDA Fast Track Designation For 64Cu-Dotatate
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Houston, TX and St. Louis, MO, Jan. 09, 2019 (GLOBE NEWSWIRE) — RadioMedix Inc. and its commercial partner Curium announced today that their investigational diagnostic radiopharmaceutical, 64Cu-Dotatate, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). 64Cu-Dotatate is a PET diagnostic agent being studied for somatostatin receptor expressing neuroendocrine tumors (NETs). RadioMedix Inc. has completed the Phase III clinical trial of the agent and expects to file a New Drug Application with the FDA in 2019. “If approved, 64Cu-Dotatate will be an exciting new diagnostic agent for the detection of neuroendocrine tumors,” said Ebrahim Delpassand, MD, CEO of RadioMedix. ...
RadioMedix presented at the 2018 BIO Investor Forum in San Francisco
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(Houston, December 14, 2018). RadioMedix Inc has been selected by the National Cancer Institute (NCI) Small Business Innovation Research Development Center (SBIR) to participate in 2018 BIO Investor Forum. The company received federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services (HHSN261201600015C, HHS261201800048C/75N91018C00048) for the development of radiotherapeutic alpha-emitter labeled agents. Dr. Izabela Tworowska, Chief Science Officer of RadioMedix, presented an overview of the company pipeline, the financial growth of RadioMedix, and status of the clinical development of radiotheranostic drugs. The presentation was sponsored by NCI SBIR Development Center’s Investor Initiatives program....
RadioMedix and Orano Med receive FDA Orphan Drug Designation for AlphaMedix(TM) for the treatment of neuroendocrine tumors
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Houston (TX U.S.), Courbevoie (France), November 13th, 2018. RadioMedix Inc. (a Texas-based clinical stage biotechnology company) and Orano Med (a nuclear biotechnology company) announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AlphaMedixTM for the treatment of neuroendocrine tumors (NETs). AlphaMedixTM is a 212Pb-labeled somatostatin analogue used for the targeted alpha therapy (TAT) of neuroendocrine tumors (NETs). “TAT has brought new hope to our patients with cancer, and the range of available therapies in this area will only increase in the near future. We are pleased to conduct the first TAT clinical trial in the...
RadioMedix and ITM announce agreement for manufacturing of Ge-68/Ga-68 generators in U.S.
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Houston (TX, USA) and Garching (Germany), July 25, 2018 – RadioMedix Inc. and ITM Isotopen Technologien München (ITM), a specialized radiopharmaceutical group of companies announced today that ITM’s subsidiary, Isotope Technologies Garching GmbH (ITG), and RadioMedix signed a manufacturing and supply agreement for the production of the next generation of Ge-68/Ga-68 (Germanium-68/Gallium-68) generators at the new RadioMedix Spica Center (RSC) in Houston, Texas. RSC is a 21 CFR 211 compliant, radiopharmaceutical manufacturing facility dedicated to late-stage investigational and commercial stage radiopharmaceuticals. The medical radionuclide Gallium-68, which is produced in Ge-68/Ga-68 generators, is used in the field of Targeted Radionuclide Therapy to...