-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FZmosakoPPl1tgv2mYCxlsL1T8AHu6E2fx4es5YCevV7eT8Akr82x1HByYZ/9DUV 20TBb5bxBYW7IhhK/OzaFA== 0001193125-04-169106.txt : 20041008 0001193125-04-169106.hdr.sgml : 20041008 20041008153959 ACCESSION NUMBER: 0001193125-04-169106 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20041007 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041008 DATE AS OF CHANGE: 20041008 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CURAGEN CORP CENTRAL INDEX KEY: 0001030653 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 061331400 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23223 FILM NUMBER: 041072212 BUSINESS ADDRESS: STREET 1: 555 LONG WHARF DRIVE STREET 2: 11TH FL CITY: NEW HAVEN STATE: CT ZIP: 06511 BUSINESS PHONE: 2034013330 MAIL ADDRESS: STREET 1: 555 LONG WHARF DRIVE CITY: NEW HAVEN STATE: CT ZIP: 06511 8-K 1 d8k.htm FORM 8-K Form 8-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 7, 2004

 


 

CuraGen Corporation

(Exact name of registrant as specified in its charter)

 


 

Delaware   0-23223   06-1331400

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

 

555 Long Wharf Drive, 11th Floor

New Haven, Connecticut 06511

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (203) 401-3330

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 



Item 7.01. Regulation FD Disclosure.

 

On October 7, 2004, CuraGen announced that clinical data from Phase I of its CG53135 clinical trial for oral mucositis will be presented at the 46th Annual Meeting of the American Society of Hematology (ASH) taking place December 4th – 7th, 2004 in San Diego, California.

 

A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1, and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(c) The following exhibit is furnished with this report:

 

Exhibit Number

 

Description


99.1   Press release of Registrant dated October 7, 2004.


SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    CURAGEN CORPORATION
    (Registrant)

Date: October 8, 2004

  By:  

/s/ David M. Wurzer


    Name:   David M. Wurzer
    Title:  

Executive Vice President and

Chief Financial Officer

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO     

 

CuraGen Contact:

Glenn Schulman, Pharm.D.

gschulman@curagen.com

(888) GENOMICS

 

FOR IMMEDIATE RELEASE

 

CuraGen Announces Clinical Progress with CG53135 for Oral Mucositis

 

- Clinical data to be presented in December at the 46th American Society of Hematology (ASH) Annual Meeting -

 

New Haven, Conn. – October 7, 2004 CuraGen Corporation(Nasdaq: CRGN) announced today that clinical data from Phase I will be presented at the 46th Annual Meeting of the American Society of Hematology (ASH) taking place December 4th – 7th , 2004 in San Diego, California.

 

“We are very pleased with the progress we have achieved with CG53135 for oral mucositis and look forward to sharing the results of our Phase I program at ASH,” stated William Hahne, M.D., Vice President of Clinical Development at CuraGen. “The clinical data we have obtained has sparked the interest of several investigators who are eager to work with us in Phase II, and we are in the process of making the necessary preparations to transition the program later this year.”

 

In Phase I, the safety, tolerability and potential activity of CG53135 were explored in two studies involving different populations at risk for oral mucositis: patients undergoing autologous bone marrow transplantation for hematologic malignancies and patients receiving chemotherapy for metastatic gastrointestinal cancers. Both studies explored the effect of a single dose of CG53135 administered intravenously. Data from both studies will be published as part of the meeting proceedings. The bone marrow transplant study data will be disclosed as a poster at the meeting.

 

“We look forward to exploring the ability of a single dose of CG53135 to prevent oral mucositis in a double-blind, randomized, placebo controlled trial in Phase II” stated Tim Shannon, M.D., Executive Vice President of Research and Development and Chief Medical Officer at CuraGen. “In addition to CG53135, we believe our pipeline as a whole is making significant progress with PXD101, our promising histone deacetylase (HDAC) inhibitor for the treatment of multiple cancers, transitioning into Phase II in the first half of 2005, and CR002, our fully human monoclonal antibody for the treatment of kidney inflammation, expected to enter Phase I later this year.”

 

Background on CG53135 and Oral Mucositis (OM)

 

CG53135, a novel growth factor discovered by CuraGen that appears to promote both epithelial and mesenchymal cell proliferation, is currently being investigated for the prevention of OM, a side effect experienced by cancer patients undergoing chemotherapy or radiation therapy. The disease is characterized by inflammation and ulceration of the tissue lining the mouth and throat, leading to


bleeding, pain, and difficulty eating and drinking. OM is sometimes a cause for clinicians to interrupt patients’ cancer treatment regimens, thus limiting the success of therapeutic plans. CG53135 is being investigated for the prevention of OM by being administered to patients before the onset of symptoms in order to decrease the incidence and duration of the disease. Animal studies suggest that CG53135 may also be effective for the treatment of OM when it is administered after the onset of early signs of OM in order to decrease the duration and progression to severe OM. An effective therapy for OM has the potential to treat debilitating symptoms, to allow cancer patients to better tolerate the appropriate doses of cancer treatment, and to decrease hospitalization time.

 

About CuraGen

 

CuraGen Corporation (NASDAQ: CRGN) is a genomics-based pharmaceutical company dedicated to improving the lives of patients by developing a pipeline of novel protein, antibody, and small molecule therapeutics in the areas of oncology, inflammatory diseases, obesity and diabetes. CuraGen’s therapeutics are based on targets from the human genome that are believed to play a role in important mechanisms underlying disease, including cell proliferation, anti-angiogenesis and peripheral metabolism. CuraGen has established broad development alliances with Abgenix, TopoTarget, and Bayer, and its experienced preclinical and clinical teams are rapidly advancing the Company’s pipeline of products for unmet medical needs. CuraGen’s expertise in systems biology, genomics and bioinformatics is now being used to prioritize therapeutic candidates with the highest chance of reaching the market and to help predict efficacy and safety in clinical trials. CuraGen’s technology and expertise has been used in partnerships with more than a dozen leading biotechnology and pharmaceutical companies including Bayer, Biogen, Genentech, GlaxoSmithKline, Hoffmann-La Roche and Pfizer. The Company is headquartered in New Haven, CT and additional information is available at http://www.curagen.com.

 

Safe Harbor

 

This press release may contain forward-looking statements, including statements about our ability to make the necessary preparations to transition CG53135 to Phase II trials later this year, our plan to explore the ability of a single dose of CG53135 to prevent oral mucositis in a double-blind, randomized, placebo controlled trial in Phase II, and our expectation to advance PXD101, our promising histone deacetylase (HDAC) inhibitor for the treatment of multiple cancers, into Phase II trials in the first half of 2005, and CR002, our fully human monoclonal antibody for the treatment of kidney inflammation, into Phase I trials later this year. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. CuraGen cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: CuraGen’s stage of development as a genomics-based pharmaceutical company, uncertainties of clinical trials, government regulation and healthcare reform, technological uncertainty and product development risks, product liability exposure, uncertainty of additional funding, CuraGen’s history of incurring losses and the uncertainty of achieving profitability, reliance on research collaborations and strategic alliances, competition, patent infringement claims against CuraGen’s products, processes and technologies, CuraGen’s ability to protect its patents and proprietary rights and uncertainties relating to commercialization rights. Please refer to our Quarterly Report on Form 10-Q for the period ended June 30, 2004 for a description of these risks. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

 

- ### -

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