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CytoDyn Announces Stunning Results from Clinical Trials Evaluating mTNBC and MBC with Leronlimab and will Request an Emergency Type C Meeting with FDA to Enroll 50 Awaiting Patients with a Serious Solid Tumor Cancer Condition
GlobeNewswire GlobeNewswire•January 31, 2020
Third patient data supports leronlimab (PRO 140) as a potential treatment option for metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC). Patient CTC dropped to zero after 2 weeks of leronlimab treatment, same as the first patient on leronlimab
VANCOUVER, Washington, Jan. 31, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (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 very strong data from patients in its clinical trials with metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC).
New data from the first patient enrolled in the Company’s mTNBC Phase 1b/2 trial showed no detectable levels of circulating tumor cells (CTC) with leronlimab in combination with carboplatin at 16 weeks of treatment. In addition, this patient experienced significant reductions in epithelial-mesenchymal transition (EMT) cells dropping to zero after five weeks with treatment and currently reports zero EMT. New data from the second patient enrolled in the Company’s mTNBC Phase 1b/2 trial showed no detectable levels of CTC with leronlimab in combination with carboplatin after two weeks of treatment. This patient also showed a 70% reduction in EMT cells after just two weeks of treatment. Initial data from the third patient in the mTNBC trial indicated the CTC dropped to zero after two weeks of treatment with leronlimab.
“Remarkably, the new patient enrolled in the clinical trial showed a significant drop in CTC and a reduction of EMT cells, the putative metastatic cells from 7 per 4mL of blood to two cells in just two weeks of treatment with leronlimab in combination with carboplatin,” said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “The rapid response to the treatment in a pattern that is identical to previous patients is equally as remarkable and supports a predictable method of action for this drug. Additionally, no adverse effects were observed in the clinical trials, further supporting leronlimab’s potential safety profile.”
New findings from the patient enrolled through an emergency investigational new drug (IND) with stage 4 HER2+ MBC that has metastasized to the liver, lung and brain, demonstrate no new metastasis in the brain after treatment with leronlimab as the only product for the metastasis to her brain. Prior to enrolling in the trial, the patient had 18 identifiable tumor spots in the brain. Today, following two months of weekly 700 mg doses of leronlimab, there are only three identifiable lesions, as seen in an MRI. This patient’s radiologist cancelled the suggested new round of radiation due to results that he believes is due only to leronlimab.
“We are excited to see this continuous spectacular data that further supports leronlimab as a potential game-changing treatment for patients living with cancer,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “As a company, our hope is to bring suffering patients safe and effective treatment options. Today, we have heard from over 50 individuals who are waiting to be treated with leronlimab and our regulatory team is reaching out to the FDA to organize an emergency Type C meeting to discuss the data evidenced in our clinical trials. This is an extremely exciting time for CytoDyn, as we continue to demonstrate our commitment to patients through the development of leronlimab. All patients’ oncologists and CytoDyn’s thought leaders will convene an urgent meeting to discuss strategy in order to bring immediate awareness of leronlimab’s potential for all patients with solid tumors, which could represent approximately 22 different forms of cancer.”
About Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growth–estrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene.1 TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur.2,3 Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective.4 Currently, there are no targeted therapies approved to treat triple-negative breast cancer.5
CytoDyn Announces Stunning Results from Clinical Trials Evaluating mTNBC and MBC with Leronlimab and will Request an Emergency Type C Meeting with FDA to Enroll 50 Awaiting Patients with a Serious Solid Tumor Cancer Condition
GlobeNewswire GlobeNewswire•January 31, 2020
Third patient data supports leronlimab (PRO 140) as a potential treatment option for metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC). Patient CTC dropped to zero after 2 weeks of leronlimab treatment, same as the first patient on leronlimab
VANCOUVER, Washington, Jan. 31, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (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 very strong data from patients in its clinical trials with metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC). New data from the first patient enrolled in the Company’s mTNBC Phase 1b/2 trial showed no detectable levels of circulating tumor cells (CTC) with leronlimab in combination with carboplatin at 16 weeks of treatment. In addition, this patient experienced significant reductions in epithelial-mesenchymal transition (EMT) cells dropping to zero after five weeks with treatment and currently reports zero EMT. New data from the second patient enrolled in the Company’s mTNBC Phase 1b/2 trial showed no detectable levels of CTC with leronlimab in combination with carboplatin after two weeks of treatment. This patient also showed a 70% reduction in EMT cells after just two weeks of treatment. Initial data from the third patient in the mTNBC trial indicated the CTC dropped to zero after two weeks of treatment with leronlimab.
“Remarkably, the new patient enrolled in the clinical trial showed a significant drop in CTC and a reduction of EMT cells, the putative metastatic cells from 7 per 4mL of blood to two cells in just two weeks of treatment with leronlimab in combination with carboplatin,” said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “The rapid response to the treatment in a pattern that is identical to previous patients is equally as remarkable and supports a predictable method of action for this drug. Additionally, no adverse effects were observed in the clinical trials, further supporting leronlimab’s potential safety profile.”
New findings from the patient enrolled through an emergency investigational new drug (IND) with stage 4 HER2+ MBC that has metastasized to the liver, lung and brain, demonstrate no new metastasis in the brain after treatment with leronlimab as the only product for the metastasis to her brain. Prior to enrolling in the trial, the patient had 18 identifiable tumor spots in the brain. Today, following two months of weekly 700 mg doses of leronlimab, there are only three identifiable lesions, as seen in an MRI. This patient’s radiologist cancelled the suggested new round of radiation due to results that he believes is due only to leronlimab.
“We are excited to see this continuous spectacular data that further supports leronlimab as a potential game-changing treatment for patients living with cancer,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “As a company, our hope is to bring suffering patients safe and effective treatment options. Today, we have heard from over 50 individuals who are waiting to be treated with leronlimab and our regulatory team is reaching out to the FDA to organize an emergency Type C meeting to discuss the data evidenced in our clinical trials. This is an extremely exciting time for CytoDyn, as we continue to demonstrate our commitment to patients through the development of leronlimab. All patients’ oncologists and CytoDyn’s thought leaders will convene an urgent meeting to discuss strategy in order to bring immediate awareness of leronlimab’s potential for all patients with solid tumors, which could represent approximately 22 different forms of cancer.”
About Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growth–estrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene.1 TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur.2,3 Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective.4 Currently, there are no targeted therapies approved to treat triple-negative breast cancer.5
5
