BRANFORD, Conn., June 12, 2007 /PRNewswire-FirstCall/ -- CuraGen Corporation , a clinical-stage biopharmaceutical company focused on oncology, presented today an update on the clinical development program for belinostat, a histone deacetylase (HDAC) inhibitor, and reported updated results suggesting clinical activity of belinostat against cutaneous T-cell lymphoma (CTCL), peripheral T-cell lymphoma (PTCL), and ovarian cancers.
A conference call is being hosted at 8:30 a.m. Eastern time on June 12, 2007, to review these results including data presented at the 2007 Pan Pacific Lymphoma Conference being held this week in Maui, HI, and data presented at the 2007 American Society of Clinical Oncology (ASCO) meeting.
"We are very impressed by the emerging data on intravenous belinostat in the treatment of solid and hematologic cancers, both as a single agent and in combination with other chemotherapeutic agents. These results, along with additional data actively being generated, are helping us to refine the potential indications for belinostat and to enable us to develop an appropriate plan for our Phase III program," commented Frank Armstrong, M.D., President and Chief Executive Officer of CuraGen.
CLN-6: Phase II trial evaluating intravenous belinostat for T-cell Lymphomas
The interim results reported on 14 patients with CTCL and 12 patients with PTCL. In the CTCL arm in patients who had received an average of six prior lines of therapy, four of 14 patients achieved an objective response for an objective response rate of 29% including one complete response (CR) and three partial responses (PR). Time to response ranged from 8-57 days. As demonstrated by a decrease in SWAT score, 77% of evaluable patients showed an improvement in skin burden of CTCL. Five out of six patients with significant pruritus at baseline had a cl inically meaningful reduction in pruritus scores. As previously announced in December 2006, based on the clinical activity observed in the first phase of the study, the CTCL arm is now enrolling up to 34 patients to further refine the magnitude of the objective response rate.
In the PTCL arm, 2 of 11 evaluable patients achieved an objective response including one CR and one PR, with best responses not yet determined in 2 patients whose treatment is ongoing. CuraGen today announced that based on a recent review of this data by the Company and the study investigators, the degree of activity observed in the first phase of this study meets the predefined criteria to expand enrollment of the PTCL arm to a total of 34 patients.
"We are very encouraged by the single agent activity demonstrated in both CTCL and PTCL, and intrigued by the rapidity with which most responses are observed, an important finding given the symptomatic and debilitating nature of both diseases as well as the unmet need that exists. We look forward to further characterizing the clinical benefit patients with T-cell lymphoma can receive from treatment with intravenous belinostat," commented Dr. Francine Foss, Principal Investigator and Professor of Medical Oncology, at Yale Cancer Center.
CLN-8: Phase Ib/II trial evaluating intravenous belinostat in combination with paclitaxel and carboplatin
Phase Ib dose-escalation results on 23 patients with advanced solid tumors were presented at ASCO and indicate that the combination of intravenous belinostat plus standard doses of carboplatin and paclitaxel are generally well tolerated. Two PRs (1 pancreatic and 1 rectal cancer) were noted and one patient with mixed mullerian cancer of ovarian origin achieved an 81% reduction in CA-125 levels. In addition, 11 patients achieved stable disease (SD), including one patient with bladder cancer (SD for 20 cycles), and one patient with carcinoma of unknown primary (SD for 17 cycles and ongoi ng).
The Phase II portion of this trial for ovarian cancer has been initiated with 16 patients having been treated with 13 patients continuing on study and undergoing assessment to determine response to treatment. This trial utilizes a Simon Two Stage Design and is initially enrolling up to 18 patients. Two of the ongoing patients have achieved an objective response and upon confirmation the Company expects to expand the trial and enroll up to 32 patients to further define the objective response rate and tolerability of belinostat in combination with carboplatin and paclitaxel.
Furthermore, this Phase II study has been broadened to include an additional arm that will enroll up to 15 patients with transitional cell cancer of the bladder in order to evaluate the activity of belinostat in combination with carboplatin and paclitaxel in this patient population. Interim results are anticipated during the first half of 2008.
NCI P7267: Phase II trial evaluating intravenous belinostat monotherapy for micropapillary/borderline low malignant potential (LMP) ovarian carcinoma or advanced platinum resistant ovarian tumors
The Phase II trial is an open-label study evaluating belinostat as a single agent treatment for patients with either micropapillary/borderline LMP ovarian carcinoma or advanced platinum resistant ovarian tumors. The primary endpoint for the study is determination of objective response, as evaluated by RECIST and GCIG CA125 criteria. Secondary endpoints include evaluation of safety and tolerability of belinostat, stable disease rates, duration of response, progression-free survival, as well as median and overall survival. Enrollment of patients is ongoing into both arms of the trial. An objective clinical response has been recently observed in the LMP arm and is pending confirmation and review. This study is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen, and being conducted unde r contract with the Princess Margaret Hospital.
Timothy M. Shannon, M.D., Executive Vice President and Chief Medical Officer of CuraGen commented, "Treatment of ovarian cancer cell lines with belinostat, both as a single agent and in combination with carboplatin and paclitaxel, represented some of our more compelling preclinical data. It is gratifying to see this research translating into potential clinical benefit for patients with advanced ovarian cancer. We look forward to continuing to generate data in ovarian cancer and determining potential registrational opportunities based on the results in the second half of this year."
CLN-4: Phase Ib/II trial evaluating intravenous belinostat in combination with 5-fluorouracil (5-FU)
Phase Ib dose-escalation results on 25 patients with advanced solid tumors were presented at ASCO and indicate that the combination of intravenous belinostat plus 5-FU is generally well tolerated. Two dose limiting toxicities, including one Grade 3 stomatitis and one Grade 3 angina were reported in the highest dose group evaluating 1000 mg/m2/day belinostat plus 1000 mg/m2/d 5-FU. All patients received extensive pre- and post-treatment ECG monitoring with no Grade 3 QTc prolongation noted.
Of the 23 evaluable patients, a total of seven patients achieved SD (range 2 - 8 cycles), with 2 patients currently on treatment, and no objective responses noted. No consistent effect has been seen on the expression of thymidylate synthase (TS) in peripheral blood mononuclear cells from this population. Enrollment of patients is continuing into the 1000 mg/m2/d belinostat and 500 mg/m2/d 5-FU dose cohort. Six additional patients are planned to be enrolled at this dose to determine whether there is any effect on the expression of TS in tissue samples.
Conference Call Details and Dial-in Information Date: Tuesday, June 12, 2007 Time: 8:30 a.m. ET Dial-in: 877-272-5391 (domestic) 706-758-4315 (international) Passcode: 2474675 Webcast: Access to the live webcast and presentation are available at http://www.curagen.com
A replay of the conference call will be available starting at 11:30 a.m. Eastern time on Tuesday, June 12, 2007 through Sunday, August 12, 2007 by dialing 800-642-1687 (domestic) or 706-645-9291 (international). The passcode for the replay is 2474675. An archive of the webcast will also be accessible at http://www.curagen.com.
Belinostat is a promising small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, including 5-FU, carboplatin, paclitaxel, cis-retinoic acid, azacitidine, doxorubicin and Velcade(R) (bortezomib) for Injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes and have been shown to: arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti- cancer agents.
Intravenous belinostat is currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T- and B-cell lymphomas, AML, mesothelioma, liver, soft tissue sarcoma, colorectal, ovarian cancers, either alone or in combination with anti-cancer therapies. An oral formulation of beli nostat is also being evaluated in a Phase I clinical trial for patients with advanced solid tumors. In August 2004, CuraGen signed a Clinical Trials Agreement with the NCI under which the NCI is currently sponsoring multiple clinical trials investigating belinostat for the treatment of various cancers, both as a single-agent and in combination chemotherapy regimens. In May 2005, TopoTarget announced the signing of a Cooperative Research and Development Agreement (CRADA) with the NCI to conduct preclinical and nonclinical studies on belinostat in order to better understand its anti- tumor activity and to provide supporting information for clinical trials.
CuraGen Corporation 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 www.curagen.com.
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements regarding interim clinical results, future development efforts and regulatory filings related to belinostat 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," "esti mate," "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, uncertainty of additional funding, CuraGen's history of incurring losses and the uncertainty of achieving profitability, government regulation and healthcare reform, technological uncertainty and product development risks, product liability exposure, 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.
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