CuraGen Corporation
(Nasdaq: CRGN) today announced that Michael W Schuster, MD, Principal
Investigator, Professor of Clinical Medicine in the Division of
Hematology/Oncology at the Weill Medical College of Cornell University, and
Director of Stem Cell Transplantation at NewYork-Presbyterian Hospital/Weill
Cornell Medical Center presented the final Phase I results for a single-dose
of velafermin (CG53135) for the prevention of oral mucositis (OM) in patients
receiving high dose chemotherapy (HDCT) followed by autologous hematopoietic
stem cell transplantation (AHSCT) at the American Society of Clinical Oncology
(ASCO) Annual Meeting in Orlando, FL. The final results from this Phase I
study suggest velafermin (CG53135) is well tolerated following intravenous
administration with data supporting the Company's ongoing Phase II trial and
strategy of investigating a single-dose of velafermin (CG53135) for the
prevention of OM.
"Based on our experience with velafermin in Phase I, we are pleased to be
taking part in the Phase II trial to evaluate this investigational drug for
the prevention of OM," stated Michael W. Schuster, M.D. "Oral mucositis is a
severe side effect that frequently occurs as a result of the high-dose
chemotherapy administered to patients prior to bone marrow transplantation.
Fibroblast growth factors, including velafermin, represent a new class of
drugs that show promise for potentially avoiding or ameliorating OM and
avoiding complications associated with this condition, such as pain and
infection, and improving patients' quality of life."
"As we continue to advance velafermin through Phase II, we are pleased
with the progress being made in the program and remain on track to complete
this trial during the first half of 2006," stated Timothy M. Shannon, M.D.,
Executive Vice President of Research and Development and Chief Medical Officer
at CuraGen. "In addition to exploring the efficacy of a single-dose of
velafermin for the prevention of OM, we are also evaluating the safety of
velafermin in a Phase I study for the treatment of active OM, specifically in
patients who develop OM as a result of the chemotherapy they receive for the
treatment of their cancer."
Data on 30 patients dosed with velafermin (CG53135) were presented in a
poster entitled, "Phase I Trial of CG53135-05 (Velafermin) to Prevent
Mucositis in Patients Undergoing High-dose Chemotherapy (HDCT) and Autologous
Peripheral Blood Stem Cell Transplantation (PBSCT)." Primary objectives for
the study were the evaluation of safety, tolerability, and pharmacokinetics
following a single-dose of velafermin (CG53135). As a secondary objective,
the study assessed the development of OM using the WHO OM assessment scale.
Patients received a single-dose of 0.03, 0.1, 0.2, or 0.33 mg/kg velafermin
(CG53135) administered intravenously one day after infusion of blood stem
cells following high-dose chemotherapy.
Of the 30 patients (male = 21, female = 9) presented in this poster, the
median age was 55 years (range 25-75) with diagnoses including multiple
myeloma (n=16), non-Hodgkin's lymphoma (n=12), acute myelogenous leukemia
(n=1) and desmoplasmic round cell tumor (n=1). High-dose chemotherapy
conditioning regimens included high-dose melphalan (Mel 200), carboplatin and
thiotepa, cyclophosphamide, carmustine, and etoposide, and busulfan and
cyclophosphamide. No serious drug-related adverse events were noted following
treatment with velafermin (CG53135). Mild to moderate reactions including
nausea, vomiting, tachycardia, hypotension, chills, and fever were observed.
Following administration of a single-dose of velafermin (CG53135), 22 of 30
patients (73%) did not develop severe grade 3 or 4 OM.
Based on results from Phase I, the 0.03, 0.1 and 0.2 mg/kg single doses of
velafermin (CG53135) are currently being evaluated in a randomized, double-
blind, placebo-controlled, multi-center Phase II clinical trial for the
prevention of OM in approximately 200 patients receiving HDCT followed by
AHSCT. This trial is expected to be complete during the first half of 2006.
Reprints of the poster presentation and published abstracts, as well as
information about ongoing clinical trials are available on the Company's
website, curagen, or by emailing infocuragen.
Background on Velafermin (CG53135) and OM
Velafermin (CG53135), a novel fibroblast growth factor discovered by
CuraGen that appears to promote both epithelial and mesenchymal cell
proliferation, is currently being investigated for the prevention and
treatment 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. Velafermin (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 velafermin (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, 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. CuraGen's technology and expertise have
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 curagen.
Safe Harbor
This press release contains forward-looking statements including
statements about the potential for fibroblast growth factors, including
velafermin (CG53135), to avoid or ameliorate OM and avoid complications
associated with this condition and improving patients' quality of life;
CuraGen's expectation that it will advance velafermin (CG53135) through Phase
II and that this trial will be complete during the first half of 2006; and the
potential for 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. 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 Annual Report on Form 10-K for
the period ended December 31, 2004 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.
gschulmancuragen
(888) GENOMICS
CuraGen Corporation
curagen