CytoDyn obtains IRB approval for leronlimab for patients with TNBC
Category: #health  By Mateen Dalal  Date: 2019-11-13
  • share
  • Twitter
  • Facebook
  • LinkedIn

CytoDyn obtains IRB approval for leronlimab for patients with TNBC

Reports confirm that CytoDyn Inc., a late-stage biotechnology company has announced that it has recently received approval from the Institutional Review Board for leronlimab, to be directed to triple-negative breast cancer (TNBC) patients under a compassionate use, which is also called expanded access program.

Apparently, this program will enable TNBC patients who are not entitled under the current Phase 1b/2 clinical trial to get leronlimab (PRO 140). Patients with locally recurrent or metastatic TNBC who had improved within 6 months or less on advanced chemotherapy will get leronlimab combined with a physician recommended treatment.

Seemingly, the expanded access program is a potential way for patients with an instantly life-threatening condition to gain access to an investigational medical product for treatment outside of medical trials, when no other satisfactory therapy options are available. An Institutional Review Board (IRB) is a suitably constituted group that has been officially designated to review and examine biomedical research including human subjects in accordance with regulation of the U.S. Food and Drug Administration.  

According to President and Chief Executive Officer of CytoDyn, Nader Pourhassan (Ph.D.,), the IRB has given access to leronlimab for patients with triple-negative breast cancer. The company is looking to advance this treatment opportunity to various patients in the current trials.

The U.S. Food and Drug Administration has reportedly approved a “Fast Track” label to CytoDyn for two prospective indications of leronlimab for lethal diseases. The first as a combination therapy with extremely active anti-retroviral therapy for HIV-infected patients, and the second one is for metastatic triple-negative breast cancer.

If sources are to be believed, leronlimab has successfully finished nine clinical trials in more than 800 people, including meeting its key endpoints in a vital Phase 3 trial.

For the uninitiated, CytoDyn is a biotechnology company developing advanced treatments for several therapeutic indications based on leronlimab.

 

Source Credits: https://www.cytodyn.com/newsroom/press-releases/detail/360/cytodyn-receives-irb-approval-to-proceed-with-compassionate

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

A qualified electronics and telecommunication engineer, Mateen Dalal embarked on his professional journey working as a quality and test engineer. Harnessing his passion for content creation however, Mateen pens down industry-rich articles for ReportsGO.com and a few o...

Read More

More News By Mateen Dalal

Alphabet’s Google to face lawsuit from NLRB for violating labor laws
Alphabet’s Google to face lawsuit from NLRB for violating labor laws
By Mateen Dalal

In a recent turn of events, U.S. government body National Labor Relations Board (NLRB) has reportedly issued a complaint against American multinational technology company, Google LLC for unlawfully monitoring as well as questioning its workers and su...

Britain’s CMA to levy tougher competition rules on Google and Facebook
Britain’s CMA to levy tougher competition rules on Google and Facebook
By Mateen Dalal

Facebook and Google accounted for around 80% of the total 14 billion pounds spent on digital advertising in 2019. MOW has reportedly accused Google of modifying its Chromium developer tools and Chrome browser to get greater control over advertiser...

Amazon, U.S. Government team up to prevent sale of counterfeit goods
Amazon, U.S. Government team up to prevent sale of counterfeit goods
By Mateen Dalal

According to reliable sources, Washington-headquartered American multinational technology company, Amazon.com Inc has reportedly initiated a joint venture with the U.S. government’s counterfeit agency, the IPR Center (National Intellectual Prop...