Antev Announces FDA Approved Plan for Revolutionary Drug Teverelix®: Prostate Cancer Treatment for High-Risk Patients Now Closer Than Ever!

Antev Ltd., a pioneering late clinical-stage biotech company, is thrilled to announce that the US Food & Drug Administration (FDA) has granted written guidance on their proposed Phase 3 pivotal trial design. This marks a significant milestone for the company’s novel gonadotrophin-releasing hormone (GnRH) antagonist, Teverelix trifluoroacetate (Teverelix), as it is set to be the first Phase 3 trial for a specific label to treat prostate cancer in patients with increased cardiovascular risk. The trial provides a much-needed solution, offering a prostate cancer drug with a better cardiac toxicity profile.

Prostate cancer is one of the deadliest forms of cancer amongst men, with around 5 million cases in the US and Europe. But now, there is hope. Teverelix, a decapeptide, is the first hormone therapy that has been specifically approved to treat advanced prostate cancer patients with a history of cardiovascular disease. This is especially important as up to 30% of men with prostate cancer also suffer from CVD. Prior treatments using GnRH agonists have been linked to an increased risk of cardiovascular events, a conclusion that is supported by the American Heart Association in a 2021 scientific statement. With Teverelix, advanced prostate cancer patients with CVD can finally have a safe and effective treatment option.

Antev is thrilled to have achieved this pivotal milestone in its journey to secure regulatory guidance for Teverelix, its innovative treatment for advanced prostate cancer patients with increased cardiovascular risk. The written acceptance of the proposed Phase 3 trial design by the US FDA provides a clear path forward and highlights the company’s commitment to developing treatments with profound castration, improved tolerability, and significantly reduced cardiovascular risk compared to GnRH agonists, which generate billions of dollars in annual sales. Cardio-oncology is a burgeoning new therapeutic area, and Antev is leading the charge to deliver better patient and payor outcomes.

Antev’s Chief Medical Officer, Dr Steve van Os, is thrilled with the progress the company is making in developing a novel GnRH antagonist to help earlier-stage prostate cancer patients with an increased cardiovascular risk. With cardiovascular diseases now the leading cause of death in men with prostate cancer, and up to 30% of prostate cancer patients having a history of CVD, there is an urgent need for safer therapies that can treat prostate cancer without increasing cardiovascular risk. Dr van Os is confident that Antev’s work on this novel therapy will help meet this need. Having worked on the global development and registration of Xtandi® for late-stage prostate cancer patients, he is very optimistic about the potential impact of this new therapy.

Dr Neal Shore MD FACS, CMO of Surgery and Oncology at GenesisCare USA and Antev’s Scientific Adviser, has identified an unmet medical need for a new specific ‘cardio-oncology’ indication for androgen deprivation therapy. This proposed Phase 3 trial aims to provide the evidence that this GnRH antagonist could be the treatment of choice for prostate cancer patients with cardiovascular risks, effectively treating their cancer without worsening safety.

GnRH agonists and antagonists have both been approved for the treatment of prostate cancer, but they work in markedly different ways. The agonist stimulates the GnRH receptor, resulting in an initial spike in testosterone, which is quickly suppressed as a result of the negative feedback loop. The antagonist, on the other hand, acts by directly blocking the GnRH receptors at the pituitary gland, thereby preventing testosterone production without the surge. Both methods are valuable tools in the battle against prostate cancer.

Antev’s proposed ANT-1111-04 is an ambitious global Phase 3 clinical trial that seeks to revolutionize the standard of care for advanced prostate cancer patients with increased cardiovascular risk. Up to 1,500 participants will be randomized on a 1:1 basis and the trial is expected to culminate in 2027. It is a monumental undertaking with the potential to have a profound impact on the lives of many.

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