CytoDyn Announces FDA Clearance of Its Phase II Oncology Trial
CytoDyn (OTCQB: CYDY) has received FDA clearance to begin its Phase II oncology trial evaluating leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (CRC). The clearance follows productive feedback sessions with the FDA and submission of the final study protocol in September 2024. The trial will be conducted in partnership with Syneos Health, with a kickoff meeting scheduled for late November 2024 and patient enrollment beginning in early 2025. The company's CCR5 antagonist, leronlimab, shows potential for multiple therapeutic indications.
CytoDyn (OTCQB: CYDY) ha ricevuto l'
CytoDyn (OTCQB: CYDY) ha recibido la autorización de la FDA para iniciar su ensayo oncológico de Fase II evaluando el leronlimab en pacientes con cáncer colorrectal (CRC) estable de microsatélites en recaída/refractario. La autorización sigue a sesiones de retroalimentación productivas con la FDA y la presentación del protocolo final del estudio en septiembre de 2024. El ensayo se llevará a cabo en asociación con Syneos Health, con una reunión de inicio programada para finales de noviembre de 2024 y el reclutamiento de pacientes comenzando a principios de 2025. El antagonista CCR5 de la empresa, leronlimab, muestra potencial para múltiples indicaciones terapéuticas.
CytoDyn (OTCQB: CYDY)는 재발성/내성 미세위성 안정 대장암(CRC) 환자에서 leronlimab을 평가하는 2상 종양학 시험을 시작하기 위한 FDA 승인을 받았습니다. 이 승인은 FDA와의 생산적인 피드백 세션과 2024년 9월 연구 최종 프로토콜 제출 후에 이루어졌습니다. 이 시험은 Syneos Health와 협력하여 진행되며, 2024년 11월 말에 킥오프 미팅이 예정되어 있고 2025년 초에 환자 등록이 시작됩니다. 회사의 CCR5 길항제인 leronlimab은 여러 치료 적응증에 대한 잠재력을 보여줍니다.
CytoDyn (OTCQB: CYDY) a reçu l'
CytoDyn (OTCQB: CYDY) hat die FDA-Zulassung erhalten, um seine Phase-II-Onkologie-Studie zur Bewertung von leronlimab bei Patienten mit rezidivierenden/refraktären Mikrosatelliten-stabilem kolorektalem Krebs (CRC) zu beginnen. Die Zulassung folgt auf produktive Feedback-Sitzungen mit der FDA und die Einreichung des endgültigen Studienprotokolls im September 2024. Die Studie wird in Partnerschaft mit Syneos Health durchgeführt, mit einem Kick-off-Meeting, das für Ende November 2024 geplant ist, und der Patientenrekrutierung, die Anfang 2025 beginnt. Der CCR5-Antagonist des Unternehmens, leronlimab, zeigt Potenzial für mehrere therapeutische Indikationen.
- FDA clearance received for Phase II oncology trial
- Partnership established with Syneos Health for trial execution
- Clear timeline set with patient enrollment starting early 2025
- None.
VANCOUVER, Washington, Nov. 04, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it has received clearance from the FDA to commence its Phase II oncology trial. The study will evaluate the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (“CRC”).
This milestone reflects the continued positive development of the Company’s improved relationship with the FDA. Clearance for the Phase II oncology trial was achieved following productive feedback sessions with the FDA over the past few months and the submission of a final study protocol to the FDA in September 2024. As previously announced, the trial will be conducted in partnership with Syneos Health. A trial kickoff meeting has been set for late November 2024 and patient enrollment will begin in early 2025.
“We have appreciated the opportunity to work constructively with the FDA on the review and finalization of our CRC protocol,” said Dr. Jacob Lalezari CEO. “With the agency’s input and our partnership with Syneos Health, we are well positioned to advance our clinical evaluation of leronlimab for oncology and make real strides towards developing the treatment paths of tomorrow.”
About CytoDyn
CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. Leronlimab is being studied for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH.
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Syneos Health translates unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Syneos Health brings a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together, Syneos Health shares insights, uses the latest technologies and applies advanced business practices to speed its customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. To learn more about how Syneos Health is shortening the distance from lab to life®, visit syneoshealth.com.
Note Regarding Forward-Looking Statements
This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Media Contacts
CytoDyn
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Gagnier Communications
CytoDyn@gagnierfc.com
FAQ
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