Curis, Inc. Announces Genentech Filing of Investigational New Drug Application for Systemic Administration of a Hedgehog Antagonist
Business Editors/Medical Editors

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 5, 2006--Curis, Inc., (NASDAQ: CRIS), a therapeutic drug development company focusing on cancer, neurological and dermatological disease indications, announced today that Genentech, a collaborator, has filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to initiate Phase I clinical testing of a systemically administered small molecule Hedgehog antagonist for the treatment of cancer. Under the terms of the parties' June 2003 collaboration agreement, Genentech will pay Curis a $3 million dollar cash payment after filing the IND application. Should this small molecule drug candidate successfully continue its development into subsequent stages of clinical testing and regulatory approval, Curis would be eligible to receive additional cash payments. Should this drug candidate be commercialized, Curis would also receive royalties on any product sales.

"We believe that the IND filing demonstrates Genentech's continued interest in the importance of the Hedgehog pathway as a potential therapy for the treatment of various cancers," said Curis President and CEO Dan Passeri. "We're extremely pleased that our Hedgehog antagonist collaboration with Genentech has produced a clinical candidate for systemic administration and we are looking forward to working with Genentech in seeking to advance the drug candidate through the clinic. Cancer is a serious healthcare challenge in the U.S., and we are hopeful that our Hedgehog antagonist technologies will one day provide an effective treatment for a variety of cancers."

Curis anticipates providing additional information about the program, including information on the expected Phase I clinical trial, within its third quarter earnings conference call and press release.


http://phx.corporate-ir.net/phoenix.zhtml?c=123198&p=irol-newsArticle&t=Regular&id=912454&

Recent Developments and Third Quarter 2006 Highlights

-- In October 2006, Genentech paid Curis a $3 million payment
after it filed an IND with the Food and Drug Administration to
initiate Phase I clinical testing of a systemically
administered small molecule Hedgehog antagonist for the
treatment of cancer. Should this small molecule drug candidate
successfully continue its development into subsequent stages
of clinical testing and regulatory approval, Curis would be
eligible for additional payments. Curis also has the right to
receive royalties on any product sales.

The Phase I trial is designed as an open-label study of a systemic Hedgehog antagonist in patients with locally advanced or metastatic cancers that are refractory to standard therapy or for whom no standard therapies exist. The primary objectives of the Phase I trial are to evaluate the safety and tolerability of escalating doses of the Phase I molecule and to establish the maximum tolerable dose and dose limiting toxicities. The trial is expected to enroll approximately 50 patients spread across several dose-escalating cohorts. The successful completion of the Phase I trial will be dependent upon, among other things, the patient enrollment rate as well as the number of patients that will ultimately need to be treated to achieve the Phase I trial objectives.

hedgehog,

Trials usually start around 30 days after IND because they usually get a go ahead by then. I can't really imagine why we have not heard anything from DNA for 3 1/2 months. I guess they have so many irons in the fire that Systemic is just another molecule in the pipeline to move along as they are able to fit it in the fold. Of course for CURIS, to me this is a make it or break it deal. Curis can't continue to expand its timetables. Did you see the deal SGEN got from DNA after just a phase I? Of course CURIS as we know it today has yet to complete one.

Hi Peter,

I find it very strange too. Could be a few things.

My first guess is that DNA is taking complete control over this and isn't telling curis anything. This is just based on the last clinical trial that curis sort of screwed up their relationship with DNA for a little while.

If it was important to DNA then they could move it FAST. Big companies can pump out drugs if it is a top priority.

http://biz.yahoo.com/bw/070131/20070131005516.html?.v=1

Dosing was announced today. As usual DNA treats CURIS like a step child. I guess DNA made a phonce call to CURIS that was forwarded to the PR department. DNA made no announcement themselves. If you pull a quote on yahoo under the DNA ticker, this news item will no even show up. But heh, at least CRIS can claim a first, systemically administered Hh antagonist. So I will go ahead and cheer up a bit.

Hi Peter,

I hope DNA announces some in-term data if good and maybe a fast track status.

did you see the latest curis presentation post today or yesterday? They sure talk about there new multitarget drugs.

http://www.pathway2curis.com/pdf/Curis_CorporatePresentation_2007.pdf