Enzalutamide

FDA Confirms Single Study with Primary Endpoint of Progression-Free Survival Sufficient for NDA; company expects to begin pivotal Phase 3 trial in mid-2027 Our productive discussions with the FDA have established a clearly defined and achievable clinical development pathway for Enolen” — Cam Gallagher SAN CARLOS, CA, UNITED STATES, July 1, 2026 / EINPresswire.com / -- Alessa Therapeutics (“Alessa”), a clinical-stage biopharmaceutical company advancing novel localized drug delivery technology for the treatment of early-stage prostate cancer, today announced that it received positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA) for its planned pivotal Phase 3 trial for Enolen ® , the Company’s lead product candidate for the treatment of low to intermediate risk, localized prostate cancer. The FDA confirmed that a single trial comparing Enolen to active surveillance is sufficient to support a New Drug Application (NDA) filing toward the front-line treatment of localized prostate cancer. In addition, the FDA confirmed that no additional clinical trials beyond the ongoing Phase 1 trial will be required before proceeding to this pivotal trial, nor would any additional non-clinical work be needed. “Our productive discussions with the FDA have established a clearly defined and achievable clinical development pathway for Enolen,” said Cam Gallagher, President and Chief Executive Officer of Alessa Therapeutics. “Pre-clinical and clinical results to date clearly demonstrate the important role Enolen could play as an alternative to both active surveillance and to aggressive treatment options which bring with them significant negative side effects. As we continued to progress our Phase 1 trial of Enolen in two additional cohorts, we expect to begin this pivotal Phase 3 trial in mid-2027.” Enolen utilizes novel anti-androgen eluting implants containing the FDA-approved prostate cancer compound enzalutamide. It is currently being studied in a Phase 1 trial evaluating its safety, tolerability, and preliminary efficacy for localized sustained delivery of enzalutamide into the tumors of men with prostate cancer. The study first launched at the National Cancer Institute (NCI), and is now actively enrolling patients at eight sites across the U.S. The positive feedback received by the FDA following the Type C meeting builds upon the recent momentum achieved by Alessa in the development and advancement of Enolen. Earlier this year, Alessa announced that Enolen received Fast Track designation by the FDA, which is granted to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The designation is intended to facilitate development and expedite review of qualifying drugs. “We believe that this novel pathology-based primary endpoint provides the ideal foundation for demonstrating the efficacy of Enolen clinically and provides a rapid path to potentially deliver an urgently needed new treatment option to patients with early-stage prostate cancer,” said Pamela Munster, M.D., Chief Scientific Advisor and founder of Alessa. “We are pleased to be in alignment with the FDA on our development strategy for Enolen and look forward to continuing our advancement of this much needed therapy.” About Enolen ® Enolen leverages Alessa’s proprietary local delivery technology which can deliver anti-androgens directly to diseased tissue in the prostate. This localized delivery can help eliminate the side effects of systemic anti-androgen and testosterone-lowering drugs, including fatigue, sexual dysfunction, muscle mass loss, cognitive issues, metabolic syndrome and cardiovascular events. Preclinical and clinical studies to date demonstrate that Alessa’s implant technology can deliver durable and continuous release of effective anti-cancer agents, achieving high local drug concentrations while minimizing the negative side effects which can result from systemic exposure. Preliminary findings from the Phase 1 trial presented by NCI researchers earlier this year demonstrated that all 20 patients enrolled in the initial cohort were successfully implanted. These implantations achieved very high intraprostatic enzalutamide levels with minimal systemic drug exposure and resulted in no delay to surgery. Furthermore, pre-radical prostatectomy MRI’s conducted for 20 patients showed a reduction in tumor volume in 86% of the lesions over an average duration of 36 days. There were no reported effects on testosterone levels or negative effects on sexual function. Reported side effects were consistent with a biopsy-like procedure, and without impact on future surgery or imaging. About Alessa Therapeutics Alessa Therapeutics is a clinical-stage biopharmaceutical company pioneering a proprietary drug-delivery technology platform for the sustained and localized release of clinically proven prostate cancer therapies. Developed by Dr. Pamela Munster and her team at the University of California, San Francisco, Alessa’s patented drug-eluting implants, each about the size of a grain of rice, can provide two or more years of continuous drug elution directly to diseased tissue, thus eliminating the side effects that can result from systemic exposure to certain prostate cancer drugs. Founded in 2018, Alessa is backed by leading healthcare investors including Cure Ventures and Mission BioCapital. Learn more at alessatherapeutics.com. Rachel Ford Hutman Ford Hutnam Media +1 301-801-5540 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

FDA and Telix align on advancement into Part 2 of the ProstACT Global Phase 3 study in the United States. FDA agrees with the clinical protocol and proposed statistical framework across three standard-of-care combination cohorts. Part 2 (randomized cohort) continues to recruit in jurisdictions where the study has regulatory approval. MELBOURNE, Australia and INDIANAPOLIS, July 02, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX, “Telix”) today announced the successful outcome of a Type B meeting with the United States (U.S.) Food and Drug Administration (FDA) to review the Part 1 safety and dosimetry data and Part 2 protocol design of the ProstACT Global Phase 3 trial of its therapeutic candidate TLX591-Tx (lutetium-177 ( 177 Lu) rosopatamab tetraxetan) in metastatic castration resistant prostate cancer. The FDA has confirmed that the safety data from Part 1 of the study is sufficient to enable progression of Part 2 of ProstACT Global into the U.S. in which TLX591-Tx is administered in two doses, 14 days apart, in combination with one of three randomized standard of care (SOC) therapies: abiraterone, enzalutamide or docetaxel. The FDA and Telix also achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan. The result is a consistent framework for study execution as enrollment continues internationally and expands into the U.S. David N. Cade, MD, Group Chief Medical Officer, Telix, said, “This is an excellent outcome that enables submission of our IND amendment for initiation of Part 2 of ProstACT Global in the U.S. Part 2 continues to enroll strongly in regions where recruitment is open.” Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, Salt Lake City, and ProstACT Global Principal Investigator and Steering Committee member, commented, “TLX591-Tx has the potential to redefine how radiopharmaceutical therapy is integrated into clinical practice. Because the complete treatment course is delivered over approximately two weeks, physicians can layer it into an existing regimen with minimal interruption, providing greater flexibility to sequence therapies while preserving future treatment options in patients with metastatic prostate cancer.” Initiation of Part 2 in the U.S. remains subject to the FDA’s review of an Investigational New Drug (IND) amendment. The IND amendment will also be aligned with a pending regulatory submission to initiate the ProstACT Global study in Europe. The trial continues to enroll patients in regions where Part 2 is approved 1 . About ProstACT Global ProstACT Global (ClinicalTrials.gov ID: NCT06520345 ) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68 Ga-PSMA-11 PET 2 imaging agent (such as Illuccix®, kit for the preparation of gallium-68 ( 68 Ga) gozetotide injection, or Gozellix®, kit for the preparation of gallium-68 ( 68 Ga) gozetotide injection) following prior treatment with one ARPI. The antibody-based approach demonstrates differentiated targeting and pharmacology to other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies 3 , collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is hepatically (liver) excreted, a comparatively radioresistant organ 4 . TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing the prevalence of xerostomia (dry mouth) and dry eye, which are typical adverse effects of existing PSMA-targeted RLTs 5 . Additional information on the Phase 3 ProstACT Global study can be found at: About Telix Pharmaceuticals Limited Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix®, Telix's next-generation PSMA-PET imaging agent approved by the U.S. FDA. The Company's late-stage therapeutic pipeline includes three assets in pivotal-stage trials - TLX591-Tx in prostate cancer, TLX101-Tx in recurrent glioblastoma, TLX250-Tx in kidney cancer, complemented by a deep pipeline of next generation assets. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit or follow Telix on LinkedIn, X and Facebook. Investor Relations Annie Kasparian annie.kasparian@telixpharma.com Charlene Jaw charlene.jaw@telixpharma.com Media Eliza Schleifstein 917.763.8106 (Mobile) Eliza@schleifsteinpr.com This announcement has been authorized for release by the Telix Pharmaceuticals Ltd. Disclosure Committee on behalf of the Board. Legal Notices Cautionary Statement Regarding Forward-Looking Statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. 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Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved. 1 Part 2 is enrolling in Australia, New Zealand, Canada, Türkiye, and the United Kingdom, and has also received regulatory approval to commence in China, Singapore and South Korea. 2 Positron emission tomography. 3 Tagawa et al. Curr Oncol Rep. 2021; Steinhelfer et al. J Nucl Med. 2024. 4 Tagawa et al. Cancer. 2019. 5 Pepin et al. Pract Radiat Oncol. 2025.