PyL™ (18F-DCFPyL), Lantheus’ PSMA-Targeted Prostate Cancer Imaging Agent, to be Used in POINT Biopharma’s PSMA-Targeted Radioligand Therapeutic Phase 3 Trial in Patients with Metastatic Castration Resistant Prostate Cancer
As part of the agreement with POINT, Lantheus’ subsidiary,
“While there have been great advances in the treatment of prostate cancer, there remains an important unmet medical need for therapies that can more specifically target metastatic prostate cancer,” said
POINT will conduct a Phase 3, multicenter, open-label, randomized clinical trial to evaluate the efficacy and safety of their novel PSMA-targeted radioligand, 177Lu-PNT2002, in patients with mCRPC. PyL will be used to select patients with PSMA-avid tumors for treatment with 177Lu-PNT2002, and in a subset of patients also be used to evaluate progression.
“The combination of diagnostic imaging and radioligand therapy is a validated approach and an important development in cancer treatment,” said
PSMA is a protein that has been found to be amplified on the surface of greater than 95% of prostate cancer cells and is a validated target for the detection of primary and metastatic prostate cancer.1
About PyL™ for PET Imaging of Prostate Cancer
PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. On
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in
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This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “believe,” “can,” “estimate,” “expect,” “will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) regulatory risks related to PyL; (ii) expectations for POINT’s clinical trial and future clinical trials, the timing and potential outcomes of clinical studies and filings and other interactions with regulatory authorities; (iii) the impact of legislative, regulatory, competitive and technological changes; (iv) the safety and efficacy of PyL; (v) the intellectual property protection of PyL; and (vi) the risk and uncertainties discussed in our filings with the
1Wright, et al. Expression of Prostate-Specific Membrane Antigen in Normal, Benign, and Malignant Prostate Tissue. Urol Oncol 1995;1:18028.
2S Hammer, et. al. Preclinical Efficacy of PSMA-Targeted Thorium-227 Conjugate (PSMA-TTC), a Targeted Alpha Therapy for Prostate Cancer.
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