CytoDyn obtains IRB approval for leronlimab for patients with TNBC
Category: #health  | By Mateen Dalal  | Date: 2019-11-13 |
  • shareshare_icon
  • 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

  • shareshare_icon
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal     twitter

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

Apollo plans to expand looking at average occupancy surge

Apollo plans to expand looking at average occupancy surge

By Mateen Dalal

Apollo Hospitals Enterprises Ltd., one of India's leading healthcare providers, is reportedly targeting to increase the average occupancy rate in its hospitals to 68-70% for the fiscal year 2024. The company recently announced impressive finan...

ChatGPT’s creator OpenAI proposes regulation of AI by humans

ChatGPT’s creator OpenAI proposes regulation of AI by humans

By Mateen Dalal

OpenAI, the creator of ChatGPT, has reportedly put forward a proposal for the establishment of an international organization to regulate artificial intelligence (AI). Led by CEO Sam Altman, the company believes that AI systems developed within the ne...

Medtronic pledges USD 350 Mn to expand R&D operations in India

Medtronic pledges USD 350 Mn to expand R&D operations in India

By Mateen Dalal

Medtronic, a leading healthcare technology company, has announced plans to expand its R&D center in Hyderabad, India, with a whopping investment of USD 350 million. The existing facility is already the largest center for the company outside the U...