Plus Therapeutics Announces Commercial Manufacturing Supply Agreement for Its Lead Investigational Drug

September 2nd, 2021

RadioMedix, Inc. is a key manufacturer and supplier of cGMP radiotherapeutics for late-stage clinical trials and commercial production.

RadioMedix will produce cGMP drug product for Rhenium-186 NanoLiposome (186RNL) and may extend to future products under the RNL platform.

AUSTIN, Texas, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that it has entered into an agreement with RadioMedix, Inc. (RadioMedix) for the commercial production of the Company’s radiopharmaceuticals.

 

Izabela Tworowska, RadioMedix CSO, selected as Semi-Finalists of 2021 Women’s Venture Competition!

The AIM-HI Accelerator Fund just announced 10 semi-finalists for the 2021 Women’s Venture Competition! These oncology companies have been selected from among an exceptional pool of applications submitted globally by women scientist-entrepreneurs. Decision making was led by a selection committee comprised of world-class key opinion leaders, life sciences industry experts, investors, and entrepreneurs.

Excel Diagnostics and Nuclear Oncology Center Announces FDA Authorization of IND for 225Ac-PSMA I&T Targeted Alpha Therapy for Castration Resistant Prostate Cancer.

Houston-Texas August 2nd, 2021

Excel Diagnostics and Nuclear Oncology Center (EDNOC), a premier Diagnostic Imaging and Radioligand Therapy   center in Houston, Texas announces approval of its physicians sponsored Investigational New Drug (IND) application for providing Targeted Alpha Therapy (TAT) with 225Ac-PSMA I&T for metastatic Castration Resistant Prostate Cancer (mCRPC). “We are glad to be able to make this game changing drug available to our patients suffering from mCRPC. Excel Diagnostics and Nuclear Oncology Center has been a pioneer in bringing new targeted Radioligand Therapies such as Lu-177 DOTATATE, and Lu-177 PSMA to serve our patients in the United States. The addition of 225Ac-PSMA I&T is in continuation of our mission to address unmet needs in the field of Nuclear Oncology” said Dr. Ebrahim Delpassand, Chairman and Medical Director of EDNOC and co-Principle Investigator of the trial. “PSMA is an established prostate cancer target. Highly encouraging results have been reported by using Targeted Alpha Therapy (TAT) Radiopharmaceuticals in conditions such as neuroendocrine, prostate, or hematological malignancies. These breakthroughs have brought significant amount of hope to our patients suffering from different types of advanced cancers.” Said Dr. Rodolfo Nuñez, Director of Nuclear medicine Department at EDNOC and Co-Principle Investigator of the trial.

 

Vect-Horus and RadioMedix Announce FDA Approval of Exploratory IND of Diagnostic 68 Ga-RMX-VH in Glioblastoma Multiforme

MARSEILLE, France & HOUSTON--(BUSINESS WIRE)--Vect-Horus and RadioMedix are pleased to announce the FDA clearance of exploratory Investigational New Drug (eIND) application to evaluate 68Ga-RMX-VH for the detection and mapping of Low Density Lipoprotein Receptor (LDLR) overexpressed in Glioblastoma Multiforme (GBM). The Phase 1 exploratory study sponsored by RadioMedix will start enrollment upon IRB « Internal Review Board » approval. The study will investigate safety, dosimetry and distribution of 68Ga-RMX-VH in patients with primary or recurrent GBM. The eIND clinical study will proceed in Excel Diagnostic and Nuclear Oncology Center (Houston, TX).

 

National Foundation for Cancer Research announces 2021 Salisbury Award Competition Winners

ROCKVILLE, MD - The National Foundation for Cancer Research (NFCR) announced winners of the 2021 Salisbury Award Competition for Entrepreneurial Translational Research, selected from among eight semi-finalists after pitch presentations in front of a judging committee consisting of prominent cancer research scientists, clinicians, early-stage investors and business leaders.

The semi-finalists were determined earlier in the spring based upon applications from among academic laboratories or early-stage companies advancing promising experimental cancer therapeutic, diagnostic, detection and vaccine innovations.

 

Detectnet (copper Cu 64 dotatate injection) Now Included in NCCN Guidelines® for Neuroendocrine Tumors

The newest FDA-approved PET imaging agent for neuroendocrine tumors — DetectnetTM (copper Cu 64 Dotate injection) — is now included in the National Comprehensive Cancer Network ® (NCCN) Clinical Practice Guidelines in Oncology – Neuroendocrine and Adrenal Tumors, version 1.2021. The announcement was made by RadioMedix Inc. and its commercial partner, Curium, on May 5. Detectnet is a positron emission tomography (PET) agent indicated for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adults.

 

RadioMedix wins 2020 TechConnect Innovation Award and pitched at Virtual TechConnect Business Summit

Houston (TX), Jan. 04, 2021 (GLOBE NEWSWIRE) -- RadioMedix Inc. Houston-based clinical-stage radiopharmaceutical company is proud to announce that the company was selected for the 2020 TechConnect Innovation Award. The annual TechConnect Business Innovation Awards program recognizes the top 15% of submitted technologies as ranked by the selection committee in multiple categories from the Energy, Nanomaterials, Health and Medicine, AI, Robotics, and others. The Summit is co-organized by SBIR/STTR Innovation Program and co-located with Defense Innovation Summit.

 

RadioMedix appointed Dr.Ferey Faridian as new member of the Board of Director

 

Houston, TX, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Radiomedix a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer, announced the appointment of Dr. Ferey Faridian as a member of its Board of Directors.

“It is an honor to join the world-class team at Radiomedix to guide in the areas of strategy and finance at a time when the company is at the brink of creating new treatment modalities in neuroendocrine cancers, said Faridian.”

 

 

 

FDA has issued Drug Master File for ITM’s Gallium Generator GeGant®
GeGant® for the U.S. market will be produced and distributed by ITM’s long-term partner RadioMedix.

Garching/Munich, Germany, and Houston, Texas, U.S., December 08, 2020: ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has issued the Drug Master File (DMF no. 34938) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, distributed under the brand name GeGant®.The DMF will allow parties interested in developing new drugs for the U.S. market to refer to the DMF and use GeGant® in clinical tests for radiopharmaceuticals and in other settings.

 

RadioMedix & Curium Announce CMS Transitional Pass-Through Status for Detectnet™
(copper Cu 64 dotatate injection)

 

ST. LOUIS, Dec. 09, 2020 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that the Centers for Medicare & Medicaid Services (CMS) has granted Detectnet Transitional Pass-Through Status (code C9068) effective January 1, 2021. The descriptor for Detectnet will be: Copper Cu-64, dotatate, diagnostic, 1 millicurie. C9068 will be used to bill Detectnet for Medicare patients seen in the hospital outpatient department.

 

 

 

 

RadioMedix appointed Dr.Ferey Faridian as new member of the Board of Director

 

Houston, TX, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Radiomedix a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer, announced the appointment of Dr. Ferey Faridian as a member of its Board of Directors.

“It is an honor to join the world-class team at Radiomedix to guide in the areas of strategy and finance at a time when the company is at the brink of creating new treatment modalities in neuroendocrine cancers, said Faridian.”

 

 

 

RadioMedix and Curium Announce FDA Approval of Detectnet (copper Cu 64 dotatate injection) in the U.S.

Houston, TX and St. Louis, MO, Sept. 07, 2020 (GLOBE NEWSWIRE) -RadioMedix Inc. and its commercial partner Curium announced today that DetectnetTM (copper Cu 64 dotatate injection) was approved by the U.S. Food and Drug Administration (FDA). Detectnet is a positron emission tomography (PET) agent indicated for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. Curium expects to launch Detectnet immediately with doses available through various nuclear pharmacies or directly from Curium.  

 

ITM and RadioMedix announce Drug Master File Submission for ITM’s 68Ge/68Ga Generator GeGant® for the U.S. Market

ITM’s long-term partner RadioMedix is producing and distributing GeGant® for the U.S. market

GARCHING, Germany & MUNICH & HOUSTON--(BUSINESS WIRE)--ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, announced today that ITM has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, which is manufactured at the RadioMedix Spica Center in Houston, Texas, U.S. and distributed under the brand name GeGant®.

RadioMedix and OncoBeta announce exclusive distribution agreement for W/Re-188 generators
in U.S. and Canada

Houston, TX, USA and Garching, Germany. RadioMedix, and OncoBeta today announced the execution of an exclusive distribution agreement for the next generation of W/Re-188 generators in the U.S. and Canada.   The OncoBeta® Tungsten (Wolfram)-188/Rhenium-188

 

RadioMedix selected for 2019-2020 NIH SBIR/STTR Commercialization Accelerator Program (CAP)

Houston, Jan. 02, 2020 (GLOBE NEWSWIRE) -- RadioMedix Inc. is pleased to announce that the company has been selected for the 2019-2020 Commercialization Accelerator Program (CAP) by the National Institute of Health (NIH) SBIR/STTR

 

RadioMedix and Curium Announce FDA Filing of copper Cu 64 dotatate injection New Drug Application

Houston and St Louis, Jan. 07, 2020 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S.

 

 

 

 

Novigenix and RadioMedix to Develop Neuroendocrine Cancer Precision Diagnostic Test

LAUSANNE, Switzerland--(BUSINESS WIRE)--Novigenix SA, a leading Immuno-Transcriptomics company that develops and commercializes solutions for early cancer detection and precision medicine, today announced a collaboration agreement with RadioMedix Inc., a radiopharmaceutical company, to develop a precision

 

RadioMedix and Vect-Horus Announce Signing of a Letter of Intent to Co-Develop a Radio-Theranostic Agent for Glioblastoma

MARSEILLE, France & HOUSTON--(BUSINESS WIRE)--Vect-Horus and RadioMedix announced today the signing of a Letter of Intent (LOI) to establish an agreement for the co-development of a Vect-Horus theranostic agent for the diagnostic and radiotherapy of

 

RadioMedix and Curium Announce FDA Fast Track Designation For 64Cu-Dotatate.

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

 

 

 

 

RadioMedix received $2 M SBIR Phase II Contract award from NCI NIH for the targeted alpha-emitter therapy of neuroendocrine cancers

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

 

RadioMedix presented at the 2018 BIO Investor Forum in San Francisco

(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

 

RadioMedix and Orano Med receive FDA Orphan Drug Designation for AlphaMedix(TM) for the treatment of neuroendocrine tumors

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

 

 

 

 

RadioMedix and ITM announce agreement for manufacturing of Ge-68/Ga-68 generators in U.S.

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