FDA grants orphan drug tag to NuCana’s biliary tract cancer treatment
Category: #health  By Mateen Dalal  Date: 2019-06-14
  • share
  • Twitter
  • Facebook
  • LinkedIn

FDA grants orphan drug tag to NuCana’s biliary tract cancer treatment

NuCana is on its way to open a Global Phase III study of Acelarin in combination with cisplatin for patients who are suffering from the disease in 2019

NuCana plc recently announced that it has received Orphan Drug Designation for Acelarin, an investigational drug, from the U.S. Food and Drug Administration (FDA) to treat Biliary Tract Cancer. Acelarin is a ProTide transformation of gemcitabine and a new chemical entity that NuCana has produced.

Founder and Chief Executive Officer, Hugh Griffith said that there are considerable unmet requirements for patients suffering from this type of cancer.  The company performed an Phase 1b study on the combination of Acelarin and cisplatin that showed nearly double response rate, as compared with the standard of care ( gemcitabine plus cisplatin), he mentioned.

Griffith stated that many patients achieved a significant reduction in the volume of their tumor along with further shrinkage of the tumor with time. The company believes that Acelarin is a potential example of a notable advancement in biliary tract cancer and they are on their way to open their Global Phase III study with the combination of cisplatin for patients who are suffering from the disease in 2019, Griffith added.

For the record, Orphan Drug Designation is given to drugs by the FDA that are defined for prevention, diagnosis or treatment of rare diseases or conditions which are affecting less than 200,000 people in America. It provides benefits and incentives like prescription drug user fee waiver and tax credits for clinical trial cost.

For the uninitiated, NuCana plc is a clinical-stage biopharmaceutical company, which is focusing on enhancing treatment outcomes for patients suffering from cancer by applying the company’s ProTide Technology. It supposedly helps in transforming largely prescribed nucleoside analogs, chemotherapy agents into safer and more effective medicines.

Biliary tract cancer is reportedly a type of cancer that starts in the bile duct system connecting to liver, gallbladder and small intestine carrying digestive fluid through the liver.

 

Source Credit: https://www.globenewswire.com/news-release/2019/06/12/1868106/0/en/NuCana-Receives-Orphan-Drug-Designation-from-the-U-S-Food-and-Drug-Administration-for-Acelarin-for-the-Treatment-of-Biliary-Tract-Cancer.html

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

US senator pleas investigation over TikTok’s Musical.ly acquisition
US senator pleas investigation over TikTok’s Musical.ly acquisition
By Mateen Dalal

Musical.ly is a social media service which was released in 2014 in Shanghai and is incorporated in Santa Monica, California. The service was acquired by ByteDance and has been operating as TikTok for overseas markets. However, the viral social media...

Midatech initiates Phase 1 trial of a new hormonal cancer therapy
Midatech initiates Phase 1 trial of a new hormonal cancer therapy
By Mateen Dalal

Cancer treatment is one of the biggest challenges for the 21st century. There have been many advancements in the field of cancer treatment over the past few years. Clinical trial indeed plays a pivotal role in discovering new drugs, especially for tr...

DISH Network inks Multi-Year Carriage Agreement with Fox Corp.
DISH Network inks Multi-Year Carriage Agreement with Fox Corp.
By Mateen Dalal

Sports channels are one of the few types of TV broadcasts that people prefer live. No channel is more vital to sports fans than a regional sports network that views their favorite teams. However, a dispute emerged recently between Dish Network and Fo...