Biotechnology company CytoDyn Inc. (OTCQB: CYDY) this morning provided an update on its PRO 140 (leronlimab) as a single agent for maintenance of HIV viral load suppression. Per the update, approximately 92 percent of newly enrolled patients administered PRO 140 in a 700 mg dosage as part of the CD03 Phase 3 investigative monotherapy trial have achieved viral load suppression. Patients enrolled in the Phase 3 monotherapy trial were prescreened for CCR5-tropic HIV-1 infection and treated for up to 12 weeks.
“Our analysis of data indicate that patients treated with PRO 140 700 mg dose who achieve suppressed viral load at the six-week mark are highly likely to continue to maintain suppressed viral load,” CytoDyn president and CEO Nader Pourhassan, Ph.D., stated in the news release. “Given these promising data (92% responder rate), we plan to submit a pivotal monotherapy trial protocol for PRO 140 as a single-agent maintenance therapy before the end of 2018 with the intention of filing for a label expansion subject to combination therapy’s first approval.”
To view the full press release, visit http://nnw.fm/10Xzt
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
More from NetworkNewsBreaks
NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
To receive instant SMS alerts, text STOCKS to 77948
For more information please visit https://www.NetworkNewsWire.com