- Enrollment completed in Phase II trial evaluating a single dose of
velafermin for the prevention of severe oral mucositis - - Continued focus to define registrational path for belinostat in the
treatment of cancer - - Conference call and webcast to be held today at 6:00 p.m. Eastern Time -
BRANFORD, Conn., Aug. 6 /PRNewswire-FirstCall/ -- CuraGen Corporation (Nasdaq: CRGN), a clinical-stage biopharmaceutical company focused on oncology, today announced that a conference call will be hosted at 6:00 p.m. Eastern time to provide an update on its clinical pipeline. Dr. Frank Armstrong, President and Chief Executive Officer, and Dr. Timothy Shannon, Executive Vice President and Chief Medical Officer, will provide an update on the Company's clinical programs including:
Velafermin for the prevention of severe oral mucositis (OM):
Enrollment has been completed in the Phase II randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of a single infusion of velafermin for the prevention of severe OM. A total of 390 patients at 33 centers were enrolled throughout the United States. Primary safety and efficacy assessments of treated patients will be concluded at participating centers during August with preliminary, top-line efficacy results from the completed trial available in mid-October of 2007. Patients will be followed for an additional year to assess long term outcome with results available during the fourth quarter of 2008. The Phase II trial is designed to assess the reduction in the incidence of severe WHO Grade 3 or 4 OM in patients receiving high-dose chemotherapy, with or without total body irradiation (TBI), prior to autologous bone marrow transplantation (BMT). Patients enrolled in the trial were randomized to receive a single infusion of either placebo or one of three doses of velafermin (10 mcg/kg, 30 mcg/kg or 60 mcg/kg) administered 24 hours after BMT.
"We believe that the ability to recruit nearly 400 patients in 13 months speaks to the unmet need in the severe OM market, and feel there is a substantial opportunity for a product like velafermin, which could provide a convenient single dose regimen for the prevention of severe OM," commented Dr. Shannon. "We look forward to reporting top-line efficacy and safety results in mid-October, which we hope will confirm the data observed previously with 30 mcg/kg velafermin in our first Phase II trial for the prevention of severe OM."
Belinostat in combination with Velcade(R) (bortezomib) for Injection against Multiple Myeloma (MM):
In the Phase II open-label clinical trial evaluating intravenous belinostat in combination with Velcade(R) (bortezomib) for Injection in patients with advanced, refractory MM, two out of four patients enrolled developed acute deterioration in already existing renal insufficiency (ARI) in the first cycle of combination treatment. ARI is a common complication in the treatment of MM patients due to deposition of myeloma protein in the kidney. Three similar events were seen in previously conducted single agent studies with belinostat in patients with MM. No ARI has been observed in any other indication for which intravenous or oral belinostat is being evaluated.
An ongoing Phase I NCI-sponsored clinical trial evaluating intravenous belinostat plus Velcade(R) (bortezomib) for Injection against solid tumors and lymphoma remains open for enrollment and is continuing to treat patients with the combination. This trial is being conducted under a Clinical Trials Agreement between the NCI and CuraGen.
Dr. Shannon further commented, "Our data show that this finding is limited to patients with multiple myeloma, a population known to be at risk of this complication due to pre-existing renal changes. Until we know more about how to prevent the complication in this specific patient population, we have decided not to enroll further patients and will focus our resources onto the other ongoing studies in cancer indications where belinostat is demonstrating a therapeutic benefit. We have reported positive preliminary safety and efficacy data from three indications including single agent activity against peripheral T-cell lymphoma and cutaneous T-cell lymphoma, as well as the combination of IV belinostat with carboplatin and paclitaxel in the treatment of ovarian cancer. We are very excited about the activity reported in these indications, as we feel they represent potential registrational paths for belinostat and look forward to reporting updated results in the fourth quarter of 2007."
Belinostat in combination with carboplatin and paclitaxel against ovarian cancer:
To date, three partial responses (two confirmed, one unconfirmed) have been achieved in the 23 heavily pretreated patients with recurrent ovarian cancer enrolled, of which 14 patients remain on study with best response yet to be determined. The response rate observed in Stage I of the study design has triggered expansion of enrollment to a total of 32 patients in this Phase II Simon-Two stage design clinical trial in order to gain a better estimate of the objective response rate and duration of response. CuraGen anticipates presenting updated results during the fourth quarter of 2007.
Belinostat in combination with carboplatin and paclitaxel against bladder cancer:
Patient treatment was recently initiated in this Phase II open-label trial. A total of 15 patients with transitional cell cancer of the bladder will be enrolled to evaluate the safety and efficacy of intravenous belinostat in combination with carboplatin and paclitaxel.
Dr. Shannon further remarked, "We are excited by the extent of activity we have seen with belinostat in combination with carboplatin and paclitaxel, and look forward to further assessing the activity of the combination from the maturing data in recurrent ovarian cancer and transitional cell cancer of the bladder."
Belinostat in combination with idarubicin against Acute Myelogenous Leukemia (AML):
A Phase I/II clinical trial evaluating belinostat in combination with the idarubicin for the treatment of AML is being initiated at multiple sites in the EU. Patients under the age of 60 with relapsed or refractory AML, or patients over 60 with newly diagnosed or previously treated AML, are eligible for enrollment in the trial. Up to 70 patients will be enrolled and receive intravenous treatment in one of two regimens. Patients will either receive intravenous belinostat administered once daily for five days in combination with idarubicin or a continuous infusion of belinostat with or without idarubicin. Enrollment into the treatment arms will occur in parallel to define the maximum tolerated dose (MTD) for each treatment regimen.
CR011-vcMMAE Phase I/II trial for the treatment of metastatic melanoma:
Enrollment in the Phase I dose-escalation trial to determine the maximum tolerated dose (MTD) of CR011-vcMMAE in patients with unresectable Stage III or IV metastatic melanoma is ongoing. Upon establishment of the MTD, the trial will be advanced into Phase II to further define the safety and efficacy of CR011-vcMMAE. CuraGen anticipates presenting Phase I dose-escalation results in the fourth quarter of 2007.
Reiterating 2007 Financial Guidance and Expectations for 2008
The following statements are based on CuraGen's current expectations. These statements are forward-looking and actual results may differ materially. Please see the note regarding Forward-Looking Statements in this release for a description of certain important risk factors that could cause actual results to differ and refer to CuraGen's periodic reports on file with the Securities and Exchange Commission for a more complete description of the risks.
The Company reiterated its 2007 financial guidance previously provided on July 26, 2007. During the second half of 2007, CuraGen anticipates using approximately $14 to $17 million of cash and investments to fund continuing operations. For the full year 2007, cash and investments used in continuing operations are expected to be approximately $38 to $41 million in 2007. The Company had approximately $155.2 million in cash and investments as of June 30, 2007.
Preliminary estimates for use of cash and investments to fund continuing operations during 2008 currently range from $20 to $30 million and are dependent on the progress of velafermin, belinostat and CR011-vcMMAE as each product is advanced toward Phase III clinical trials. Detailed financial guidance for 2008 will be provided throughout the remainder of 2007 as additional clinical trial results become available.
Conference Call and Webcast Details
A live conference call and webcast will begin at 6:00 p.m. Eastern time on Monday, August 6, 2007 and will be accessible at http://www.curagen.com.
Dial-in: 877-272-5391 (domestic)
A replay of the conference call will be available starting at 9:00 p.m. Eastern time on Monday, August 6, 2007 through Thursday, September 6, 2007 by dialing 800-642-1687 (domestic) or 706-645-9291 (international). The passcode for the replay is 12395297. An archive of the webcast will be available for 30 days at http://www.curagen.com.
Upcoming 2007 Milestones
Product Phase Indication Regimen Milestone
Velafermin II Prevention of Single infusion Top-line results
Severe OM mid-October 2007
Belinostat II Peripheral T- IV monotherapy Updated results
cell lymphoma anticipated Q4 2007
Belinostat II Cutaneous T- IV monotherapy Updated results
cell lymphoma anticipated Q4 2007
Belinostat II Ovarian cancer IV with Updated results
carboplatin anticipated Q4 2007
Belinostat I Solid tumors Oral Results anticipated Q4
CR011- I/II Metastatic IV monotherapy Results anticipated Q4
vcMMAE melanoma 2007
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stage biopharmaceutical company developing diverse approaches, including novel protein, antibody, antibody-drug conjugate and small molecule therapeutics for the treatment of cancer and for cancer supportive care. CuraGen is currently conducting clinical trials to investigate the potential of velafermin, belinostat and CR011-vcMMAE. By leveraging the drug development strengths cultivated over the years, CuraGen expects to make a difference by advancing its promising therapeutics to address the unmet medical needs of cancer patients. CuraGen Corporation is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the Company's Phase II clinical trial for velafermin, enrollment and data relating to clinical trials for belinostat, enrollment in the Company's Phase I clinical trial for CR011-vcMMAE, projected timing of updated clinical trial results for velafermin, belinostat, and CR011-vcMMAE and statements relating to cash and investments to fund continuing operations for second half of 2007 and year ending December 31, 2007 and for fiscal year 2008, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including the risk that any one or more of CuraGen's drug development programs 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, CuraGen's stage of development as a biopharmaceutical company, 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, as well as those risks, uncertainties and factors referred to in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2007, filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by CuraGen from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. CuraGen is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise
Glenn Schulman, Pharm.D.
Director of Investor Relations
|SOURCE CuraGen Corporation|
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