VANCOUVER, Washington, Jan. 13, 2020 (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, announced today that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of leronlimab as an adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC).
The BTD filing is based on data from the first patient in the Company's mTNBC Phase 1b/2 trial and an additional single-patient trial under an emergency investigational new drug (IND) protocol evaluating leronlimab for the treatment of HER2+ metastatic, stage 4, breast cancer (MBC).
Data from the first patient in the Phase 1b/2 trial showed the patient had no detectable circulating tumor cells (CTCs) or putative metastatic tumor cells in the peripheral blood and additional large reductions in CCR5 expression on cancer-associated cells at 11 weeks of treatment with leronlimab. This patient's data also demonstrated tumor shrinkage of >20% after just a few weeks of treatment. The data from the patient under the emergency IND protocol with HER2+ metastatic, stage 4, MBC showed no sign of new metastatic spots in the liver, lung and brain during the treatment with leronlimab.
“This strong data confirms the power of leronlimab as a CCR5 inhibitor for patients living with mTNBC, and is clearly replicating early animal study results that demonstrated 98% elimination of metastases,” said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner of CytoDyn, and an advisor to CytoDyn. “Our collective team of key opinion leaders believes that all patients with similar cancers in regards to CCR5 expression may also benefit from the use of leronlimab, including melanoma, brain, throat, lung, stomach, breast, ovarian, uterine, pancreatic, bladder, and thyroid cancer patients. We also believe the mechanism of action for leronlimab may have potential indications in autoimmune diseases such as multiple sclerosis, polymyolitis, Crohn's disease, inflammatory bowel syndrome and psoriasis.”
Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added: “In the early stages of these clinical trials, we are seeing remarkable improvements in patients living with metastatic breast cancer, a deadly disease that requires imminent new treatment options. We now have several different types of cancer patients reaching out to us to be treated with leronlimab under both the expanded access program, and the Right to Try Act. Currently, we have 4 patients enrolled (2 in the Phase 1b/2 mTNBC trial and 2 under the emergency IND protocol (expanded access program). Our thought leaders believe that leronlimab may have the potential to treat over 20 different cancer indications and at least 10 autoimmune diseases, including graft versus host disease (GvHD) and NASH. Based on the number of indications we intend to pursue, we believe we have one of the broadest platform technologies in biotech and are extremely excited to accelerate development of future indications. CytoDyn has been cleared by the FDA to proceed with its Phase 2 trials for both GvHD and NASH. Today's announcement ushers in a new phase in our corporate history, as we anticipate dramatically increasing the patient population we can help. We look forward to working with the FDA and continuing to provide additional data that further supports leronlimab as a potential treatment option for patients.”
About Breakthrough Therapy Designation (BTD)
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). In addition, the breakthrough therapy should have a compelling scientific rationale and promising mechanism of action (MOA), such as targeting a molecular driver of disease.
If the BTD is granted, it will fall under one of …
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