PR just out. https://www.cytodyn.com/media/pres
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Posted On: 05/08/2019 9:24:52 AM
PR just out.
https://www.cytodyn.com/media/press-releases/...ta-showing
CytoDyn Provides Updated Pre-Clinical Data Showing Leronlimab (PRO 140) Continues to Suppress Breast Cancer Metastatic Burden >98% Compared with Untreated Animals
VANCOUVER, Washington, May 08, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announces that in a murine xenograft human breast cancer metastatic model, after 9 weeks, compared with untreated mice at 8 weeks, the leronlimab treated mice continued to have a >98% reduction in metastatic burden. Moreover, to test the ability of leronlimab to fight high tumor burden models, four of the mice in the control group with advanced metastatic disease, were treated with leronlimab. Two of these four mice were still alive at week 16.
Based on these results, CytoDyn will expand pre-clinical animal studies in eight different cancer indications and plans to file for Orphan Drug Designation with the U.S. Food and Drug Administration (“FDA”) for leronlimab in metastatic triple-negative breast cancer (mTNBC) following the FDA’s recent granting of Fast Track Designation. Importantly, the latest data provide continued validation of prior research conducted by Richard G. Pestell, M.D., Ph.D., CytoDyn’s Chief Medical Officer, about CCR5 inhibition and, specifically leronlimab’s ability to disrupt cell motility and to inhibit tumor metastasis in a highly targeted way.
“We anticipate presenting the findings at an appropriate medical conference and publish the results,” said Dr. Pestell. “Should our mouse xenograft breast cancer metastasis studies using leronlimab correlate in humans, leronlimab may offer paradigm-shifting treatment options for metastatic cancer patients,” continued Dr. Pestell. “We look forward to interim data from our first human trial in mTNBC this year that will inform our future development and regulatory strategy,” concluded Dr. Pestell.
https://www.cytodyn.com/media/press-releases/...ta-showing
CytoDyn Provides Updated Pre-Clinical Data Showing Leronlimab (PRO 140) Continues to Suppress Breast Cancer Metastatic Burden >98% Compared with Untreated Animals
Quote:
With recently granted Fast Track Designation for mTNBC, Section 561A(f)(2) of the FD&C Act, now requires leronlimab to be available within 15 days under expanded access policy for patients with serious or life-threatening illnesses
VANCOUVER, Washington, May 08, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announces that in a murine xenograft human breast cancer metastatic model, after 9 weeks, compared with untreated mice at 8 weeks, the leronlimab treated mice continued to have a >98% reduction in metastatic burden. Moreover, to test the ability of leronlimab to fight high tumor burden models, four of the mice in the control group with advanced metastatic disease, were treated with leronlimab. Two of these four mice were still alive at week 16.
Based on these results, CytoDyn will expand pre-clinical animal studies in eight different cancer indications and plans to file for Orphan Drug Designation with the U.S. Food and Drug Administration (“FDA”) for leronlimab in metastatic triple-negative breast cancer (mTNBC) following the FDA’s recent granting of Fast Track Designation. Importantly, the latest data provide continued validation of prior research conducted by Richard G. Pestell, M.D., Ph.D., CytoDyn’s Chief Medical Officer, about CCR5 inhibition and, specifically leronlimab’s ability to disrupt cell motility and to inhibit tumor metastasis in a highly targeted way.
“We anticipate presenting the findings at an appropriate medical conference and publish the results,” said Dr. Pestell. “Should our mouse xenograft breast cancer metastasis studies using leronlimab correlate in humans, leronlimab may offer paradigm-shifting treatment options for metastatic cancer patients,” continued Dr. Pestell. “We look forward to interim data from our first human trial in mTNBC this year that will inform our future development and regulatory strategy,” concluded Dr. Pestell.
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