Cerulean Pharma Inc. (NASDAQ:CERU) has announced FDA Fast Track Designation (FTD) award for its drug candidate CRLX101, which is being developed as a therapy for recurrent ovarian carcinoma. It is worth noting that FTD is a dream of every drug developer but not everyone attains that important milestone.
In the case of Cerulean’s CRLX101, the candidate also boasts Orphan Drug Designation (ODD) in addition to FTD. The FDA issued the candidate with ODD status in 2015 and the ODD regards treatment of ovarian cancer.
How does FTD help?
Drug candidates bearing FTD label enjoy accelerated review before the FDA. The idea behind FTD is to facilitate faster review process and ultimately development of a promising drug candidate. The FDA makes the extraordinary move to award FTD only where it is reasonable grounds to believe that a drug has potential to address unmet medical need. There is a huge gap to fill in the treatment of ovarian cancer and that is the target of Cerulean’s CRLX101.
Because of accelerated review process, it might take Cerulean Pharma Inc. (NASDAQ:CERU) a shorter time to bring to CRLX101 market. A shorter than usual period of drug development also means reduced costs for the developer. Therefore, what you see is that Cerulean has multiple benefits to enjoy with the FTD tag on its CRLX101 candidate.
What’s the target indication?
Cerulean is developing CRLX101 to treat platinum-resistant ovarian cancer. For that indication, the candidate is being developed as a combination therapy with paclitaxel. The candidate is presently in Phase 1b/2 clinical trial.
Does Cerulean Pharma Inc. (NASDAQ:CERU) have what it takes to bring CRLX101 to market?
With positive data from the early stage trial of CRLX101, the question is whether Cerulean Pharma Inc. (NASDAQ:CERU) has what it takes to complete the development of the drug. If you look at the company’s balance sheet as of the end of last quarter, you see that it had more than $60.5 million in cash balance, which declined from more than $75.9 million in the prior quarter. But the available cash still looks adequate to fund the clinical studies.