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. Only half a million TV Viewers? And thats an increase? I knew Indycar was struggling but I didn't know it was that bad. Hell, if NASCAR hits 5 Million viewers everyone starts freaking out saying its going down hill. It has a long way to before Indycar even hits NASCAR's bad days.

  2. IU has been talking that line for years with no real progress even with the last Dean, Dr. Brater. Why will an outsider, Dr. Hess, make a difference? With no proof of additional resources (cash in the bank), and a concrete plan to move an academic model that has been outdated for decades with a faculty complacent with tenure and inertia, I can count on IU to remain the same during the tenure of Dr. Hess. One ought to look to Purdue and Notre Dame for change and innovation. It is just too bad that both of those schools do not have their own medical school. Competition might wake up IU. My guess is, that even with those additions to our State, IU will remain in its own little world squandering our State's tax dollars. Why would any donor want to contribute to IU with its track record? What is its strategy to deal with the physician shortage for our State? New leadership will not be enough for us to expect any change.

  3. How do you think the Bridges got approved? I spent a couple days researching PAC's and individual contributions to some city council members during that time. My printouts were inches thick on the two I concentrated on. Finally gave up. Was disgusted with all the donations, and who they were from. Would have taken me days and days to compile a complete list. Tried to give it to the Star reporter, but he thought it was all just fine. (and apparently he was treated well himself) He ended up being laid off or fired though. And then of course, there was land donated to the dad's club, or city, as a partial payoff. All done in the shining example of "charity." No, none of these contributions are a coincidence.

  4. I agree what kind of help or if any will be there for Dr. Ley's patients. I was a patient myself.

  5. What about the hundreds of patients who sought this doctor for the right reasons, to quit drugs. what option do these patients now have, experience horrible withdrawl or return to heroin?? those are the choices. what about the children of these former addicts who's parent(s) WILL not b able to maintain their job, for @ least 2 weeks.. There needs to b an emergency clinic opened for these patients.

ADVERTISEMENT