Biotechnology company CytoDyn Inc. (OTCQB: CYDY) this morning announced its November 23, 2018, receipt of FDA approval for its IND submission, allowing the company to initiate a phase 1b/2 clinical trial for metastatic triple-negative breast cancer (“TNBC”) patients. CytoDyn has identified sites for five clinical trials, and it intends to dose its first several patients with expected initial readout during the first quarter of 2019.
“Metastatic triple-negative breast cancer (TNBC) is a deadly disease with poor prognosis due to the spread of the cancer in the blood stream.” CytoDyn Chief Medical Officer Dr. Richard Pestell, M.D., Ph.D., F.A.C.P., M.B.A., stated in the news release. “Current therapies are directed to the primary tumor, rather than the movement or spread of the cancer in the blood stream… In order to really impact cancer survival, we need to control the metastasis. We recently discovered that the receptor CCR5, which is required for the entry of HIV into immune cells, is also expressed on cancer cells. CCR5 on cancer cells promotes the cancer cell spread in the blood stream. CCR5 controls homing of metastasis to the bones, brain, lung and other sites. PRO 140 binds CCR5 in cancer cells, so we believe we can now directly target the metastatic process. Our previously published studies of 2,200 breast cancer patients showed that CCR5 is overexpressed on over 95% of TNBC patient tumors, making CCR5 an ideal target for this disease.”
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CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on PRO 140 (leronlimab), a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a key role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor is also implicated in tumor metastasis and in immune-mediated illnesses such as graft-vs-host disease (GvHD) and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with PRO 140 in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. The Company plans to seek FDA approval for PRO 140 in combination therapy and plans to complete the filing of a Biological License Application (BLA) in the first quarter of 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with PRO 140 as a once-weekly monotherapy for HIV-infected patients, and plans to initiate a registration-directed study of PRO 140 monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that PRO 140 monotherapy can prevent viral escape in HIV-infected patients, with some patients on PRO 140 monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate PRO 140 for the prevention of GvHD and expects to initiate clinical trials with PRO 140 in metastatic triple-negative breast cancer in 2018. For more information, visit the company’s website at www.CytoDyn.com
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