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CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference
BRANFORD, Conn.
(Map)
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CLN-8: Phase II Multicenter Trial of Belinostat (PXD101) in Combination with Carboplatin and Paclitaxel (BelCaP) for Patients with Relapsed Ovarian Cancer
Phase II results for CLN-8 were presented by Neil J. Finkler, MD, FACOG,
FACS, Investigator and Director of the Gynecologic Oncology Program at Florida
Hospital Cancer Institute in
Reduction in tumor size was seen in 15 of 16 patients by radiologic assessment. To date, objective response has been observed in 8 patients, including 2 partial responses confirmed by RECIST and 6 additional responses that are pending radiologic confirmation. At the time of presentation, 13 additional patients have treatment ongoing with continued radiologic assessment of tumor to determine best response. Activity and responses have been observed in patients with platinum sensitive and platinum resistant disease. CuraGen also announced today that trial has reached the target enrollment.
"We are very encouraged by the level of activity we have seen with BelCaP
for the treatment of relapsed ovarian cancer, including activity against
platinum resistant tumors," commented
"The activity of belinostat in preclinical ovarian studies, either alone
or in combination with carboplatin and paclitaxel and in platinum sensitive
and platinum resistant cell lines, represents some of the most compelling
preclinical data we have developed with belinostat and we are pleased to see
it translating into potential clinical benefit for patients with relapsed
ovarian cancer," said
NCI-Sponsored Phase II trial Belinostat in Patients with Refractory or Relapsed Platinum Resistant Epithelial Ovarian Tumors (EOC) and Micropapillary/Borderline (LMP) Ovarian Tumors
Data was reported from a Phase II trial evaluating the activity of IV
belinostat monotherapy in two ovarian cancer populations that had received up
to three prior lines of chemotherapy: patients with Micropapillary/Borderline
(LMP) ovarian tumors or patients with refractory or relapsed platinum
resistant (progression within 6 months of last platinum treatment) Epithelial
Ovarian Tumors (EOC). Primary endpoints of the study were objective response.
Secondary endpoints included stable disease rate, survival, tolerability and
assessment of molecular changes with therapy. Tumor response was assessed by
RECIST and CA-125 criteria every two cycles. This Phase II trial is an open-
label study being led by
During the poster presentation it was reported that 12 patients with LMP tumors received a median of 4 treatment cycles (range 1 to 13). To date, one LMP patient achieved a partial response (PR), one patient had a CA125 response, nine had SD, and two were not evaluable. Six patients remain on study. Objective responses to belinostat monotherapy were not observed in a heavily pre-treated well-defined platinum-resistant population of patients with EOC. Belinostat was safe and generally well-tolerated in these two ovarian cancer populations.
CLN-9: A Phase I Study of Oral Belinostat (PXD101) in Patients with Advanced Solid Tumors
Initial clinical trial results from the ongoing Phase I study evaluating
oral belinostat for the treatment of solid tumors were presented by
The Phase I study is an open-label, multi-center dose-escalation trial designed to establish the maximum tolerated dose (MTD) for oral belinostat administered once or twice daily in one of two regimens (either continuous daily dosing or dosing days one through 14 in a 21-day cycle). Primary objectives for the study include evaluation of the safety, tolerability and pharmacokinetics of oral belinostat. Secondary objectives include assessment of the pharmacokinetic profile of oral belinostat administered once or twice daily at various dose levels and evaluation of anti-tumor activity. Comprehensive serial ECGs to evaluate the effect of belinostat on QTc interval were also performed.
At the time of the poster presentation, data were available on 60 patients enrolled into the dose-escalation study with 46 patients on the continuous daily regimen and 14 patients dosed days one through 14 in a 21-day cycle. Patients received a median of two treatment cycles (range 1 - 11) with fifteen patients ongoing. The most frequent adverse events reported were fatigue, anorexia and nausea. More than 2400 ECGs were collected in this trial, with no grade 3 or 4 QTc changes noted.
During the study, 15 patients (25%) achieved SD for greater than or equal to 12 weeks, with no RECIST-defined objective responses currently reported. Dose-escalation performed with 250 mg capsules of oral belinostat resulted in a presumptive continuous dosing MTD of 250 mg twice daily. The MTD for dosing of oral belinostat on days one through 14 in a 21-day cycle has not yet been reached. The investigators concluded that oral belinostat has been safe and well-tolerated at doses that may provide flexibility to complement the intravenous formulation of belinostat which is currently in Phase II development.
NCI-sponsored Phase I trial of Belinostat in Combination with Bortezomib in Patients with Advanced Solid Tumors and Lymphoma
Data on 17 patients, of which 14 were evaluable, were reported from this
ongoing dose-escalation trial. The primary objective of the trial was
evaluation of the safety profile and determination of the MTD of belinostat in
combination with bortezomib for patients with advanced solid tumors or
lymphomas, which are refractory to standard therapies or for which no standard
treatment exists. Secondary endpoints included pharmacokinetics (PK),
biological markers and anti-tumor activity. This Phase I trial is an open-
label, dose-escalation study being led by
The investigators concluded that intravenous belinostat and bortezomib were well tolerated in combination at doses up to 600 mg/m2 belinostat and 1.3 mg/m2 bortezomib, with ongoing enrollment of patients into this dosing cohort. Activity of the combination reported included one patient with Ewing's Sarcoma that has maintained SD for 4 cycles, and two patients, one with peritoneal and one with appendiceal carcinoma, that have maintained SD for 3 cycles. Adverse events were generally grades 1-2 and reversible. No grade 4 non-hematologic toxicities were reported.
Reprints of the poster presentations will be made available on CuraGen's website at http://www.curagen.com or by emailing info@curagen.com
Conference Call Details and Dial-in Information
Date: Thursday, October 25, 2007
Time: 5:00 p.m. Eastern time
Dial-in: 877-272-5391 (domestic)
706-758-4315 (international)
Passcode: 21928842
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
About Belinostat
Belinostat is a small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, cis-retinoic acid, azacitidine 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 cutaneous and peripheral T-cell lymphomas,
B-cell lymphomas, AML, mesothelioma, soft tissue sarcoma, MDS, and liver,
colorectal, and ovarian cancers, either alone or in combination with anti-
cancer therapies. An oral formulation of belinostat is also being evaluated
in a Phase I clinical trial for patients with advanced solid tumors. In
About CuraGen
CuraGen Corporation (Nasdaq: CRGN) is a dedicated clinical-stage biopharmaceutical company developing diverse approaches for the treatment of cancer including belinostat and CR011-vcMMAE. By leveraging 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.
About TopoTarget
TopoTarget (OMX - The Nordic Exchange: TOPO) is a biopharmaceutical
company, headquartered in
Safe Harbor
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or prospects,
including statements relating to CuraGen's belinostat programs, including the
results of its Phase I and Phase II clinical trials, the quality of data from
such trials, the clinical benefits to patients and the potential for future
registration and commercialization 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
Contacts:
Glenn Schulman, PharmD
Director of Investor Relations
gschulman@curagen.com
(888) 436-6642
CRGN-P
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