Cornerstone Pharmaceuticals Receives FDA Orphan Drug Designation - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Cornerstone Pharmaceuticals Receives FDA Orphan Drug Designation



Cornerstone Pharmaceuticals, a cancer metabolism-based therapeutics company, has been granted orphan-drug designation by FDA for CPI-613, the company's altered energy metabolism directed (AEMD) drug candidate for treating myelodysplastic syndrome (MDS).

Cornerstone Pharmaceuticals previously received orphan-drug designation for the use of CPI-613 in the treatment of acute myeloid leukemia and pancreatic carcinoma. CPI-613 induces cancer-specific inhibition of pyruvate dehydrogenase and alpha ketoglutarate dehydrogenase, key mitochondrial enzymes involved in cancer-cell metabolism. CPI-613 is currently being evaluated in Phase I, I/II, and Phase II trials in hematologic malignancies and solid tumors.

Source: Cornerstone Pharmaceuticals

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
10%
All of the above.
43%
No government involvement in patient treatment or drug development.
10%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Click here