Here’s some stuff from when we engaged Syneos fo
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Posted On: 07/01/2025 9:38:50 PM
Here’s some stuff from when we engaged Syneos for our mss-CRC ph.II trial. From Sep 24. To your question, still no mention of adding checkpoint inhibitors to the protocol. I don’t argue that it’d be a great idea. But these trial designs take awhile to get approved and I find exception to you continuing to bring of some apparent labeling of Cytodyn’s insufficiency to include ICI’s. At this point with patients being included and dosed, it’s beyond the pale to suggest that CYDY is somehow deficient in a previously approved and currently enrolling ph.II trial in mss-CRC because you somehow feel that we should alter the protocol (which would take months) to add an additional arm of 350 up to 700mg, and added ICIs. NO. ITS NOT HAPPENING…
“ As previously announced, the Company’s final study protocol was submitted to the FDA for approval in September 2024, and CytoDyn expects to start screening patients in early 2025.”
https://www.cytodyn.com/investors/news-events...s-phase-ii
“ CytoDyn Engages Syneos Health as CRO For Its Phase II Oncology Trial
Download as PDFOctober 04, 2024 8:30am EDT
VANCOUVER, Washington, Oct. 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 engaged Syneos Health as the contract research organization (“CRO”) for its upcoming Phase II oncology trial. The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (“CRC”).
Syneos Health is a leading fully integrated biopharmaceutical solutions organization that supports customers in accelerating the delivery of life-saving therapies to market. Syneos Health leverages advanced data analytics and AI/ML capabilities to improve outcomes at every stage of the asset lifecycle, from clinical development to commercialization. Syneos Health has helped to develop or commercialize 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.
“Investigating leronlimab in the field of oncology remains our top priority, and we are excited to further invest in our promising relationship with Syneos Health. With this expanded mandate, we expect to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab,” said Dr. Jacob Lalezari, CEO.
As previously announced, the Company’s final study protocol was submitted to the FDA for approval in September 2024, and CytoDyn expects to start screening patients in early 2025.”
“ As previously announced, the Company’s final study protocol was submitted to the FDA for approval in September 2024, and CytoDyn expects to start screening patients in early 2025.”
https://www.cytodyn.com/investors/news-events...s-phase-ii
“ CytoDyn Engages Syneos Health as CRO For Its Phase II Oncology Trial
Download as PDFOctober 04, 2024 8:30am EDT
VANCOUVER, Washington, Oct. 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 engaged Syneos Health as the contract research organization (“CRO”) for its upcoming Phase II oncology trial. The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (“CRC”). Syneos Health is a leading fully integrated biopharmaceutical solutions organization that supports customers in accelerating the delivery of life-saving therapies to market. Syneos Health leverages advanced data analytics and AI/ML capabilities to improve outcomes at every stage of the asset lifecycle, from clinical development to commercialization. Syneos Health has helped to develop or commercialize 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.
“Investigating leronlimab in the field of oncology remains our top priority, and we are excited to further invest in our promising relationship with Syneos Health. With this expanded mandate, we expect to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab,” said Dr. Jacob Lalezari, CEO.
As previously announced, the Company’s final study protocol was submitted to the FDA for approval in September 2024, and CytoDyn expects to start screening patients in early 2025.”
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