Curis, Inc. Announces Initiation of Expansion Cohort in Collaborator Genentech's Phase I Clinical Trial of a Systemically Administered Hedgehog Antagonist
Tuesday October 16, 8:00 am ET
Curis to receive $3 million payment

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Curis, Inc. (NASDAQ: CRIS - News), a drug development company focused on seeking to develop proprietary targeted medicines primarily for cancer treatment, today announced that Genentech has initiated an expansion cohort in its ongoing Phase I clinical trial of a systemically administered Hedgehog antagonist. As a result, Curis will receive a $3 million cash payment from Genentech under the parties' June 2003 collaboration agreement.


Genentech began a Phase I clinical trial in January 2007, which 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, to establish the maximum tolerated dose and dose limiting toxicities and to characterize the pharmacokinetic and pharmacodynamic properties of the drug candidate. The initial objectives of the Phase I clinical trial have been achieved and the Phase I clinical trial expansion cohort is expected to enroll additional patients.

Genentech is obligated to make the $3 million cash payment because it determined that the Phase I clinical trial expansion cohort satisfied the criteria for a Phase II clinical trial under the parties' collaboration agreement.

"We are pleased that the Phase I systemic Hedgehog antagonist drug candidate has achieved its primary Phase I clinical trial objectives and that Genentech has elected to initiate a Phase I expansion cohort," said Curis President and CEO Dan Passeri. "While we realize that we are still in an early phase of human clinical testing, we continue to remain optimistic that this Hedgehog antagonist drug candidate may provide an effective therapeutic benefit to cancer patients in the future. We are also pleased with the receipt of $3 million in additional capital."

About the Genentech Curis Collaboration

In June 2003, Curis and Genentech entered into a collaboration for the development of Hedgehog pathway antagonists with a current focus on the clinical testing of a drug candidate in a variety of cancer types. Numerous preclinical reports have linked abnormal activation of the Hedgehog pathway to the growth of several cancers.

Under the terms of the parties' June 2003 collaboration agreement, Genentech previously paid Curis a $3 million cash payment after filing the IND application for this Phase I drug candidate. Should this drug candidate successfully continue its development into subsequent stages of clinical testing and regulatory approval, Curis would be eligible to receive additional cash payments. In addition, in the event the drug candidate is successfully commercialized, Curis would be eligible to receive royalties on product sales.

About Curis, Inc.

Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new medicines, primarily for cancer. In expanding its drug development efforts in the field of cancer through its Targeted Cancer Drug Development Platform, the Company is building upon its previous experiences in targeting signaling pathways in the areas of cancer, neurological disease and cardiovascular disease. For more information, visit www.curis.com.

Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's expectations regarding the potential benefits of the Phase I clinical trial candidate to cancer patients. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "will", "may" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors that may cause the Company's actual results to be materially different from those indicated by such forward-looking statements including, among other things:

* adverse results, delays and/or failures in the Company's and its strategic collaborators' and licensees' product development programs, including without limitation its Hedgehog pathway antagonist program currently under Phase I clinical development with Genentech and its preclinical Targeted Cancer Drug Development Platform programs, including CUDC-101;
* difficulties or delays in obtaining or maintaining required regulatory approvals;
* the Company's ability to obtain or maintain intellectual property protection necessary for the development and commercialization of products based on its technologies;
* changes in, or the Company's inability to execute, its business plan;
* the risk that Curis does not obtain the additional funding required to conduct research and development of its product candidates and execute its business plan;
* unplanned cash requirements and expenditures which, among other things, could shorten the estimated period in which the Company will have cash to fund its operations;
* risks relating to the Company's ability to enter into and maintain important strategic collaborations, and the risk that its current and future collaborators and licensees will not perform adequately, including its current collaborations with Genentech and Wyeth;
* competitive pressures; and
* other risk factors identified in the Company's most recent Current Report on Form 10-Q and its other reports periodically filed with the Securities and Exchange Commission.

In addition, any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.


Contact:

Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial Officer
mgray@curis.com

Source: Curis, Inc.

Drew,

That was a pretty quickly executed phase I after the slow start (not counting the expansion cohort ). DNA is pretty tight lip. Have you been able to see the numbers anywhere? Do you have any ideas about the parameters of the expansion? What is your guess on phase II start, 1st half of 2008 is kind of vague.

Hey Peter how are you doing?


No numbers other than a few investigational sites.

My ideas about the expansion are the following. Because phase I trial was against cancers that have metastasized and or don't not respond to current medication could be a number of cancers. They also had A LOT of preclinical data on Pancreatic and small cell lung cancer. Both of which have a very poor prognosis. I also wouldn't be surprised if they looked into a certain type of leukemia. Beachy et al (hedgehog consulted of DNA), published some great data.

As for the vagueness... Clinical trials are usually intended to treat one indication. For example, Her2 inhibitor for pancreatic cancer. It seems like they filed a generic clinical trial design for numerous indications. One way they might get away with this is if you are treating cancers that don't respond to current therapy. As we know the Hh pathway has been implicated in numerous cancers and has show promise. They could also be hiding the clinical trial from competitors such as infinity. This maybe the case but curis holds such a strong patent portfolio.

As phase II actually starts we should be able to obtain information at the clinicaltrials.gov website.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Curis, Inc. (NASDAQ: CRIS - News), a drug development company focused on seeking to develop proprietary targeted medicines primarily for cancer treatment, today announced that its collaborator, Genentech, has notified Curis of its decision to progress a systemically administered Hedgehog antagonist drug candidate into Phase II clinical testing in the first half of 2008. The drug candidate will be evaluated in one or more solid tumor indications. Upon Phase II initiation, Curis will be eligible to receive additional cash milestone payments from Genentech under the parties’ June 2003 collaboration agreement. Should the current drug candidate successfully continue its development into subsequent stages of clinical testing and regulatory approval, Curis would be eligible to receive additional cash milestone payments. In addition, in the event the drug candidate is successfully commercialized, Curis would be eligible to receive royalties on product sales.

“We are pleased with Genentech’s decision,” said Curis President and CEO Daniel R. Passeri, MSc., J.D. “This represents an important development for Curis as our business model and portfolio continue to evolve. We continue to remain optimistic about our Hedgehog antagonist drug candidate, and look forward to providing further updates on this program upon initiation of Phase II clinical testing.”