Articles from Curium

PARIS, March 28, 2025 (GLOBE NEWSWIRE) -- Curium Pharma (“Curium”), a world leader in nuclear medicine, is pleased to announce the completion of its acquisition of Eczacıbaşı-Monrol Nuclear Products Co. (Monrol), a leading nuclear medicine player, which is headquartered in Istanbul, Turkey.

ST. LOUIS, Mo., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced that it has completed enrollment of its Phase 3 SOLAR-RECUR clinical trial. The trial is a multicenter, open-label study to evaluate the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in men with suspected biochemical recurrence of prostate cancer after radical prostatectomy or radiation therapy. The additional Phase 3 trial, SOLAR-STAGE, a multicenter, open-label study to evaluate the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in staging of men with newly diagnosed unfavorable intermediate-risk, high-risk or very-high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection continues to enroll patients at sites in the U.S. and will soon open locations in Europe.

ST. LOUIS, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that its ECLIPSE trial met its primary endpoint. ECLIPSE is a pivotal Phase 3, multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T (INN: lutetium (177Lu) zadavotide guraxetan) versus hormone therapy in patients with metastatic castration-resistant prostate cancer.

PARIS, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that it has entered into a strategic partnership with PDRadiopharma Inc, a wholly-owned subsidiary of PeptiDream, for the clinical development, regulatory filing, and commercialization in Japan of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T. The two agents 177Lu-PSMA-I&T and 64Cu-PSMA-I&T target prostate specific membrane antigen (PSMA) expressed on prostate cancer cells and are being investigated for prostate cancer treatment and diagnostics. Both target tumors with high levels of PSMA expression and thus potentially forming a theranostic (therapeutic & diagnostic) pair.

PARIS, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that it has officially opened an additional and new facility in Petten, Netherlands to produce non-carrier added lutetium-177 (Lu-177) to meet the growing global demand for Lu-177 for the treatment of cancer patients.

ST. LOUIS, July 09, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that it has submitted its 505(b)(2) New Drug Application for Lutetium Lu 177 Dotatate Injection, which, if approved by the U.S. Food and Drug Administration (FDA), would be intended for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS). Curium’s submission represents a major step in its strategy to become a key player in the promising nuclear medicine therapeutic field.

PARIS, June 05, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that it has signed a long-term partnership with the Institut Laue-Langevin (ILL) for irradiation services at their high-flux nuclear reactor in Grenoble, France to produce non-carrier added lutetium-177 (Lu-177).

PARIS, May 30, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that earlier this month patients in France received the first doses of PYLCLARI® (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings:

PARIS, May 29, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that it has signed a long-term agreement to extend its current partnership with NRG I PALLAS for new irradiation services in Petten, Netherlands to produce non-carrier added lutetium-177 (Lu-177).

ST. LOUIS, April 23, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that it has successfully enrolled and scanned patients in its SOLAR clinical trials:

The proposed acquisition of Eczacıbaşı-Monrol will:

ST. LOUIS, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that beginning Friday, April 5, 2024, Ioflupane I 123 Injection will be available for Friday patient administration in the US. This additional day of production allows customers to access the product and capitalize on early morning availability on a day not previously available from Curium. Ioflupane I 123 Injection is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Customers may begin ordering for Friday patient use immediately for administration on and after April 5, 2024.

ST. LOUIS, Nov. 23, 2023 (GLOBE NEWSWIRE) -- Curium, a global leader in nuclear medicine, announced today the successful completion of patient enrollment in the pivotal Phase 3 ECLIPSE trial.

PARIS, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that in partnership with its exclusive distributor SYN Innovation Laboratories in Greece, the first patients in Greece have been injected with PYLCLARI® (INN: Piflufolastat (18F) also known as (18 F)-DCFPyL, indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings:

BERLIN, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, and PIUR IMAGING, a European medical device company at the forefront of pioneering tomographic 3D ultrasound solutions, announced today a strategic partnership to advance thyroid diagnostics in Germany.

PARIS, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the positive results of the multi-center, open-label, Phase 2 SOLAR study of Copper Cu 64 PSMA I&T in patients with histologically-proven metastatic prostate cancer. The study has met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate. The purpose of this study was to evaluate the safety, biodistribution, and image quality of Copper Cu 64 PSMA I&T to detect metastatic prostate cancer using PET/CT imaging. The SOLAR Phase 2 study was conducted in the U.S. and included a group of 26 patients with metastatic prostate cancer.

PARIS, July 28, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced that the European Commission has granted marketing authorization for PYLCLARI™ (INN: Piflufolastat (18F) formerly known as (18F)-DCFPyL) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:

PARIS, July 25, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today a ‘License and Development’ agreement with EXINI Diagnostics AB, a Lantheus company (EXINI), to customize EXINI’s artificial intelligence (AI) platform for use in Europe. The agreement builds on the existing prostate cancer PSMA-targeted PET imaging collaboration between Curium and Lantheus with an exclusive licensing and development agreement for AI-powered quantitative analysis and standardized reporting of PSMA PET/CT image assessments.

PARIS, July 21, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer. The results of the PYTHON trial were published online ahead of print in the European Journal of Nuclear Medicine and Molecular Imaging in June 2023.

PARIS, May 26, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of PYLCLARI® (INN: Piflufolastat (18F) formerly known as [18F]-DCFPyL) for primary staging of patients with high-risk PCa prior to initial curative therapy and to localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent.

PARIS, May 23, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that it has completed enrollment in its USA-led SOLAR Phase 1/2 study evaluating the safety, biodistribution, and image quality of Copper Cu64 PSMA I&T injection to detect metastatic prostate cancer in PET imaging.  

PARIS, March 14, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, confirmed today that the company has no foreseeable supply challenges of 177Lu-PSMA-I&T for the company’s ECLIPSE Phase 3 clinical trial (NCT05204927) ongoing in the USA, France, Spain, and Italy. Since patient enrollment started in March 2022, the ECLIPSE Phase 3 trial has experienced reliable and uninterrupted supply of 177Lu-PSMA-I&T.

Forecast of no further supply chain challenges for nuclear medicine industry

Additional production runs and increased processing for the benefit of patients

ST. LOUIS, Nov. 22, 2022 (GLOBE NEWSWIRE) -- Curium, the world’s leading nuclear medicine company, announced today that it intends to submit updated labeling to the U.S. Food and Drug Administration (FDA) for its generic version of DaTscan™ (Ioflupane I 123 Injection) to include a new indication and updated safety information. The additional indication will be to assist in the evaluation of adult patients for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging with suspected dementia with Lewy bodies (DLB). Curium intends to match the labeling recently approved by the FDA for GE Healthcare’s DaTscan on November 3, 2022 as generic drugs are required to have the same labeling as the reference listed drug (DaTscan). Curium will update Ioflupane I 123 Injection important risk information to include the new safety information at the time of labeling implementation. Ioflupane I 123 Injection is a SPECT brain imaging agent used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes.

A robust supply chain for the future despite near-term shortages