CuraGen Presents New Preclinical Data on Velafermin at the 17th Annual International Symposium on Supportive Care in Cancer
Posted on: Thursday, 30 June 2005, 18:00 CDT
-- Activity for the prevention of radiation-induced enteritis demonstrated in
animal models --
NEW HAVEN, Conn., June 30 /PRNewswire-FirstCall/ CuraGen Corporation announced today that scientists from the Company reported new preclinical data on velafermin (CG53135), CuraGen's Phase II clinical product being developed for the prevention of oral mucositis (OM), suggesting that velafermin may protect the gastrointestinal tract and decrease associated toxicity, including enteritis and diarrhea, following exposure to radiation.
In a poster presentation entitled, "Parenteral administration of velafermin (rhFGF-20) reduces radiation-induced gastrointestinal syndrome in vivo," it was reported that the incidence of enteritis and diarrhea for animals treated with velafermin was reduced up to 50%. The poster, presented this week at the 17th Annual International Symposium on Supportive Care in Cancer held by the Multinational Association of Supportive Care in Cancer (MASCC) and the International Society of Oral Oncology (ISOO), June 30 - July 2 in Geneva, Switzerland, was also selected for the Best of MASCC Poster Award: Questions in Mucositis Research, and will be featured in an oral presentation on Saturday, July 2 from 11:40 - 11:50am.
"Both chemotherapy and radiation could affect the entire length of a cancer patient's gastrointestinal tract. These results suggest that velafermin may play a broader role in cancer supportive care by addressing not only oral mucositis, but potentially for the management of enteritis and diarrhea," stated Timothy M. Shannon, M.D., Executive Vice President and Chief Medical Officer at CuraGen. "As we continue to advance velafermin through Phase II for the prevention of oral mucositis, these data will support our future intentions of evaluating velafermin for additional indications."
Reprints of the poster presentation are available by emailing info@curagen.com. Additional information about CuraGen's ongoing clinical trials and pipeline of therapeutics are available on the Company's website, http://www.curagen.com/.
Background on Velafermin and Oral Mucositis (OM)
Velafermin is a novel fibroblast growth factor discovered by CuraGen that appears to promote both epithelial and mesenchymal cell proliferation. Velafermin is currently being investigated in clinical trials for the prevention and treatment of OM, a side effect experienced by cancer patients undergoing chemotherapy or radiation therapy. OM is characterized by inflammation and ulceration of the tissue lining the mouth and throat, leading to bleeding, pain, and difficulty eating and drinking, but may also affect the entire lining of the gastrointestinal tract. OM is sometimes a cause for clinicians to interrupt patients' cancer treatment regimens, potentially limiting the success of therapeutic plans. 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.
Velafermin is currently in a Phase II randomized, placebo-controlled clinical trial investigating its role in the prevention of OM for patients receiving high-dose chemotherapy followed by a bone marrow transplantation. This trial is expected to be complete during the first half of 2006. Velafermin is also being evaluated in a Phase I study for the treatment of OM by being administered to patients after the onset of early signs of OM in order to assess its safety and potential effect on the duration of and progression to severe OM. CuraGen expects to complete this trial by the end of 2005.
About CuraGen
CuraGen Corporation is a biopharmaceutical 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, and diabetes. CuraGen has established broad development alliances with Abgenix, TopoTarget, and Bayer, and its experienced preclinical and clinical teams are advancing the Company's pipeline of products for unmet medical needs. The Company is located in New Haven and Branford, CT. For additional information please visit http://www.curagen.com/.
Safe Harbor
This press release contains forward-looking statements including statements about the ability of velafermin to protect the gastrointestinal tract and decrease associated toxicity, including enteritis and diarrhea, following exposure to radiation; the ability of velafermin to play a broader role in cancer supportive care by addressing not only OM, but potentially for the management of enteritis and diarrhea; the ability of data from the Phase II study of velafermin to support our future intentions of evaluating velafermin for additional indications; the potential of an effective therapy for OM to treat debilitating symptoms, to allow cancer patients to better tolerate the appropriate doses of cancer treatment, and to decrease hospitalization time; our expectation that our Phase II clinical trial of velafermin will be complete during the first half of 2006; and our expectation that our Phase I trial of velafermin will be complete by the end of 2005. We caution 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: the risk that any one or more of the drug development programs of CuraGen will not proceed as planned for technical, scientific or commercial reasons or due to patient enrollment issues or based on new information from nonclinical or clinical studies or from other sources; the success of competing products and technologies; technological uncertainty and product development risks; uncertainty of additional funding; CuraGen's history of incurring losses and the uncertainty of achieving profitability; CuraGen's stage of development as a genomics-based pharmaceutical company; government regulation; patent infringement claims against CuraGen's products, processes and technologies; the ability to protect CuraGen's patents and proprietary rights; uncertainties relating to commercialization rights; and product liability exposure. Please refer to CuraGen's Quarterly Report on Form 10-Q for the period ended March 31, 2005 for a complete description of these risks. CuraGen disclaims 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.
CuraGen Contact: Glenn Schulman, Pharm.D. Marketing & Investor Relations gschulman@curagen.com 1-888-GENOMICS
CuraGen Corporation
CONTACT: Glenn Schulman, Pharm.D., Marketing & Investor Relations ofCuraGen, +1-888-GENOMICS, gschulman@curagen.com
Web site: http://www.curagen.com/
Source: PRNewswire
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