Biotechnology company CytoDyn (OTCQB: CYDY) this morning
announced the featured interview of its President and CEO Nader Z. Pourhassan,
Ph.D. with Stock Day’s Everett Jolly. Jolly initiated the discussion by asking
about CytoDyn’s PRO 140. The company’s flagship product is a humanized IgG4
monoclonal antibody that is designed to bind to cellular receptor CCR5, which
plays various roles with implications in HIV, tumor metastasis and immune
signaling. Pending FDA approval, which the company hopes to secure in Q4 2019,
Pourhassan indicates that PRO 140 may be available to the public in 2020.
“Most biotech companies, when they finish the biologic application, they have
an 85% chance to get approved. 9 out of 10 who don’t get approved is because of
the safety of the product. Our product has received fast track designation due
to having great safety among all of the approved drugs,” Nader Z. Pourhassan,
Ph.D., president and CEO of CytoDyn, stated in the news release.
To hear the Stock Day Podcast featuring the interview, visit http://ibn.fm/ZslPY
To view the full press release, visit http://ibn.fm/EWsf6
About CytoDyn
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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www.QualityStocks.com
480.374.1336 Office
Editor@QualityStocks.com
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