IBJNews

FDA removes hurdle in Endocyte's path to drug approval

Back to TopCommentsE-mailPrintBookmark and Share

Endocyte Inc. can start enrolling patients again in a clinical trial of its experimental cancer drug, the company announced Monday, clearing away a hurdle to getting the drug approved in Europe.

The change comes after the U.S. Food and Drug Administration OK’d the importation of the cancer drug Doxil from Europe. Supplies of the drug, made by New Jersey-based Johnson & Johnson, have been short since last fall due to equipment failures at one of Johnson’s suppliers.

Endocyte’s Phase 3 clinical trial aims to show that its drug, EC145, when given in combination with Doxil, is a better therapy for certain ovarian cancer patients than Doxil alone. But the West Lafayette-based drug company was forced to halt new patient enrollment last fall because of the worldwide shortage of Doxil.

“This supply is expected to support enrollment through the end of the year and will serve as a bridge to the availability of new supplies of Doxil,” said Endocyte CEO Ron Ellis in a prepared statement released Monday morning. “We also continue to explore alternatives for the resumption of enrollment outside the U.S.”

Endocyte had been planning to submit EC145 for market approval in Europe based on its Phase 2 clinical trial results, rather than the more customary wait for results of the lengthy Phase 3 it is now conducting.

The European Medicines Agency has indicated it is willing to give a conditional, early approval to EC145 because many ovarian cancer patients experience no benefit from traditional platinum-based chemotherapy or from Doxil.

But the European regulators wanted Endocyte to at least be enrolling patients in a Phase 3 trial—so they could later re-evaluate whether the drug should remain on the market.

The Doxil shortage had until now prevented the company from meeting that requirement.

In the United States, the FDA has told Endoycte it wants to see Phase 3 clinical trial results before considering approval of EC145.

The timing of getting a drug to market is important for Endocyte, which currently has no revenue but is operating on $142 million it raised in two public stock offerings last year.

The company has yet to release its year-end financial report, but in the 12 months ended Sept. 30, it burned through $32.8 million.

Some analysts expect EC145 to win European market approval in 2013, but others expect approval to be pushed back until after the completion of the Phase 3 trial, which could mean 2014 or even 2015.

Concerns of a delay spiked in December when Endocyte released additional data from its Phase 2 clinical trial, which showed shorter overall survival than patients taking Doxil alone.

Endocyte officials emphasized that the clinical trial was not designed—nor did it enroll enough patients—to demonstrate overall survival. Instead, it was geared to look at the length of progression-free survival patients experienced on EC145, and showed positive results.

Endocyte’s shares plunged nonetheless, and haven’t recovered since. They closed Friday at $3.49 apiece, although they rose slightly Monday morning after the announcement of the new supplies of Doxil.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. I keep wondering why I keep hearing about this problem of corporations leaving America, and I never hear a reasonable proposal to lower corporate tax rates and raise personal rates on income from capital gains and dividends, especially for high earners. It is just too simple of a solution for Congress to embrace?

  2. Are you financially down and you need money to settle your dept,or you need money to start up a business or to invest on a huge business,we also offer Loans to individuals, Firms and cooperate bodies at low interest rate , loan terms determinant,Loan amount between the sum of $5,000.00 to $100,000,000.00. US Dollars And Euro. Loan for developing businesses a competitive edge/ business expansion. We Offer The Following Kinds Of Loans. Personal Loans (Secure and Unsecured) Business Loans (Secure and Unsecured) Consolidation Loan FIRST INFORMATIONS NEEDED ARE: BORROWER’S DATA’S INFORMATION,FILL AND RETURN FOR QUICK START UP PROCESS. Name:_________ Last Name:_________ Age:_________ Contact Address:_________ Country:_________ Amount Needed as Loan:_________ Loan Duration:_________ Phone Number__________ Monthly Income/Yearly Income:_________ Purpose for Loan:_________ Occupation:_________ How Soon is Loan Needed__________ Email via: albertbrownfirm@outlook.com

  3. is a disaster. SR37 already needs to be built to interstate standards between 465 and SR144. Southport Road is a mess each morning and evening.

  4. Bass Pro Shops would be good for the mall as well as a Giant Eagle Market District or a Jungle Jim's International Market Place grocery store like the one near Cincinnati Ohio.A Disney quest indoor theme park would be good.An Academy outdoor store would be good too.Indoor Circus shows and magic shows would be good as well. A casino with sports bar would be good.A Disney theater inside that shows movies and Broadway shows would work.Nashville Tennessee concert shops with indoor neon lights would be good.How about a theater that shows travel shows and theme parks. A train store would be good.How about a giant toy store with high tech video games.

  5. This development is in addition to Allpoints Midwest 5, Aitrtek, a recent FedEx and more in Plainfield. Greenwood and Brownsburg also have similar projects.

ADVERTISEMENT