Curis Announces Presentation at CHI's ''Discovery on Target: Developing Inhibitors for Promising Drug Targets'' Conference
On October 16, 2007, Curis scientists presented a poster entitled "Potent Anti-Cancer Activity In Vitro and In Vivo by a Novel, Small Molecule Inhibitor of HDAC, EGFR and Her2" during a Poster Session. This presentation included in vivo efficacy and pharmacodynamic preclinical study results of CUDC-101, Curis' proprietary small molecule drug candidate. CUDC-101 is an HDAC, EGFR and Her2 inhibitor, which displays potency improvements over FDA-approved EGFR and EGFR/Her2 inhibitors as well as over a FDA-approved HDAC inhibitor in multiple cell lines across several cancer types including lung, breast, prostate, colon, liver, pancreas and others. Curis believes that CUDC-101 is the first single agent under development to simultaneously inhibit HDAC, EGFR and Her2, three clinically validated cancer targets.
At the CHI meeting, Curis presented CUDC-101 in vivo data, which demonstrated that administration of CUDC-101 results in the inhibition of in vivo growth of various human cancers in standard mouse tumor xenograft models. In these xenograft models, human cancer cells are transplanted into the mouse and allowed to grow into established tumors, at which point Curis scientists intravenously administer CUDC-101. In these cancer xenograft models, CUDC-101 has been demonstrated to inhibit HDAC, EGFR and Her2 in a manner similar to that previously observed in Curis' in vitro studies. In addition, in vivo efficacy observed in these mouse xenograft models is proportionate to the dose administered.
Curis researchers also presented data showing that the administration of CUDC-101 in xenograft models results in inhibition of tumor cell proliferation as well as an increase in apoptosis, or programmed cell death. The poster presentation included data demonstrating that, after treatment with CUDC-101, tumor regression has been observed in two non-small cell lung cancer tumor models which have been reported in third-party publications as sensitive to EGFR inhibitors. Tumor regression has also been observed in a liver cell xenograft cancer model.
Data was also presented demonstrating that tumor inhibition effects of CUDC-101 have also been observed in two non-small cell lung cancer xenograft tumor models that have been reported in third-party publications as insensitive or resistant to the marketed EGFR or EGFR/Her2 inhibitors. Curis believes that this is particularly important since overcoming drug resistance observed with existing EGFR and/or EGFR/Her2 inhibitors or having the ability to treat cancers that are not effectively treated by these existing drugs could, assuming that CUDC-101 clinical evaluations are successful, provide a significant benefit to cancer patients as well as provide a broad market opportunity to Curis.
"We continue to generate meaningful CUDC-101 data that support our ongoing belief that CUDC-101 is a promising clinical candidate and may prove to be beneficial in treating cancer patients," Daniel R. Passeri, President and Chief Executive Officer, stated. "We have recently initiated IND-enabling toxicology studies and continue to work towards seeking to file an IND for CUDC-101 during the first quarter of 2008."
Reprints of the poster presentations will be made available on Curis' website at http://www.curis.com or by emailing email@example.com.
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 timeline to file an IND for CUDC-101, Curis' belief that CUDC-101 is potentially suitable for future clinical development for various cancer indications and that CUDC-101 may provide future benefit to cancer patients as well as a market opportunity for Curis. 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 in 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.
Michael P. Gray, 617-503-6632
CFO & COO
Posted: October 2007