Printer Friendly
The Free Library
19,604,530 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Curis Announces Collaborative Agreement between Genentech and National Cancer Institute on GDC-0449.


CAMBRIDGE, Mass. -- Curis, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: CRIS), a drug development company seeking to develop next generation proprietary targeted medicines for cancer treatment, today announced that Curis' collaborator Genentech, Inc. and the National Cancer Institute's (NCI See Liberate. ) Division of Cancer Treatment and Diagnosis (DCTD DCTD Division of Cancer Treatment and Diagnosis
DCTD Draft Conformance Test Document
) are planning to enter into a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation).

A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together.
 (CRADA CRADA Cooperative Research And Development Agreement ) which will allow the NCI to explore GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, in a number of cancer indications.

"We are very pleased that Genentech is planning to enter into this CRADA with NCI to advance the development efforts of GDC-0449. Genentech has a broad GDC-0449 Phase II clinical program, including trials in colorectal cancer colorectal cancer

Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat.
, advanced ovarian cancer ovarian cancer

Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast
 and advanced basal cell carcinoma basal cell carcinoma
n.
A slow-growing, locally invasive, but rarely metastasizing neoplasm of the skin derived from basal cells of the epidermis or hair follicles. Also called basal cell epithelioma.
, and we believe that this agreement with the NCI may allow for GDC-0449 to be tested in many additional cancer indications," said Curis President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  Dan Passeri. "We believe that such trials can have a significant impact on the overall development of GDC-0449, since they provide an opportunity to generate additional data in tumor types not already under investigation by Genentech. We look forward to the possible future initiation of clinical trials under this NCI collaboration, which we hope will build on the exciting biological activity previously reported in advanced basal cell carcinoma."

A DCTD-sponsored Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I
 is expected to be initiated to evaluate dose and safety of GDC-0449 in pediatric patients with medulloblastoma. Medulloblastoma is a rare but highly malignant brain tumor Brain Tumor Definition

A brain tumor is an abnormal growth of tissue in the brain. Unlike other tumors, brain tumors spread by local extension and rarely metastasize (spread) outside the brain.
 that occurs most often in children. In addition to this Phase I medulloblastoma clinical trial, the NCI plans to sponsor additional clinical trials under this CRADA, including clinical trials in patients with small cell lung and pancreatic cancers, among others. Trial details of the medulloblastoma Phase I trial are available on clinicaltrials.gov. Other trial information is expected to be posted to clinicaltrials.gov as the respective trial nears initiation.

About the Curis-Genentech Collaboration

Under Curis' ongoing collaboration agreement with Genentech, Curis provided broad intellectual property rights relating to the Hedgehog pathway, including several classes of proprietary small molecule inhibitors. Through this collaboration, GDC-0449 was discovered by Genentech and was jointly validated by the parties through a series of preclinical studies preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
. Genentech and Roche collaborate on the clinical development and commercialization of GDC-0449. Curis is eligible to receive cash payments upon successful achievement of certain clinical development and regulatory approval milestones and royalties upon commercialization of GDC-0449. Curis is not entitled to receive additional cash payments on the initiation of clinical trials conducted under this collaboration with NCI.

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 for cancer. In expanding its drug development efforts in the field of cancer through its targeted cancer drug development platform, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. For more information, visit Curis' website at www.curis.com.

Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995, including without limitation statements regarding the Company's expectation that additional clinical studies will be conducted under the CRADA and that data resulting from such trials will be valuable to the development of GDC-0449. The Company may use words such as "believes", "expects", "anticipates", "plans", "seeks", "estimates", "will", "may" or similar expressions to identify these forward-looking statements. There are important factors that may cause actual results to be materially different from those indicated by such forward-looking statements including, among other things, risks relating to: the potential for adverse results, delays and/or failures in the Company's targeted cancer drug development program, including without limitation unplanned delays and/or failures in its clinical trial of CUDC-101 and its ongoing preclinical studies of CUDC-305; the success of the Company's collaboration with Genentech, including the risks that Genentech may experience adverse results, delays and/or failures in the Hedgehog Pathway Inhibitor program currently under clinical development and that the Company may have no control over, or foreknowledge fore·knowl·edge  
n.
Knowledge or awareness of something before its existence or occurrence; prescience.


foreknowledge
Noun

knowledge of something before it actually happens

Noun 1.
 of, the progress of this program; difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through the Genentech collaboration; the Company's ability to obtain or maintain necessary intellectual property protection; adverse changes in the Company's ability to successfully execute its business plan, including the Company's ability to obtain the substantial additional funding required for such execution; 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 and which could also adversely affect the Company's estimated operating expenses Operating expenses

The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted.
 for 2008 and beyond; risks relating to the Company's ability to enter into and maintain planned collaborations and maintain its current collaborations with Genentech; and competitive pressures. The Company also faces other risk factors identified in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2008 and other filings that it periodically makes 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 the views as of any subsequent date. Curis 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.
COPYRIGHT 2009 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2009 Gale, Cengage Learning. All rights reserved.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Feb 9, 2009
Words:902
Previous Article:Ascend SQ Relaunches with a Free Monthly Virtual Career Development Workshop.
Next Article:WhipTail Technologies Announces New Alternative in Solving Disk Contention and Latency Issues.
Topics:

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles