Final top-line data confirm that the primary endpoint was met for the belinostat pivotal trial for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) with an encouraging objective response rate
COPENHAGEN, Denmark I March 5, 2013 I A Special Protocol Assessment agreement with the US Food and Drug Administration (FDA) required the CLN-19 BELIEF trial to reach an ORR of at least 20%. The FDA has granted belinostat Orphan Drug and Fast Track designation for the treatment of PTCL. All patients who received at least one dose of belinostat and had a confirmed PTCL diagnosis by the central pathology review were included in the efficacy analysis set. The responses have been confirmed by central independent radiology review. Final data have been submitted for presentation to the 2013 ASCO annual meeting.
“Our belief in belinostat has never wavered and the encouraging objective response rate together with the earlier announced favorable safety profile further supports the potential of our product. We strive to improve the lives of cancer patients and this is a large step in the right direction" said Anders Vadsholt, CEO of Topotarget.
Favorable safety profile
On January 24, 2013, Topotarget announced that preliminary safety data from the BELIEF trial in PTCL, presented at the T-Cell Lymphoma Forum 2013 in San Francisco, USA, showed that belinostat has a favorable safety profile and that the compound has the potential to become a well-tolerated alternative for the treatment of PTCL. The favorable safety outcome from this trial, as well as experience from earlier belinostat trials, shows that full doses of belinostat can be combined with other cytotoxic regimens making combination therapy for cancer patients feasible. The low incidence of myelosuppression is of special notice as this offers the opportunity to combine belinostat with other cytostatic agents for the treatment of patients with PTCL.
New Drug Application
Belinostat is currently being developed jointly by Topotarget and Spectrum Pharmaceuticals. Spectrum possesses the commercial rights to market belinostat in North America and India. A New Drug Application (NDA) for belinostat in PTCL is expected to be filed with the FDA by Spectrum in mid-2013.
Background information
About Topotarget
Topotarget (NASDAQ OMX: TOPO) is an international biopharmaceutical company headquartered in Copenhagen, Denmark, dedicated to clinical development and registration of oncology products. In collaboration with Spectrum Pharmaceuticals, Inc., Topotarget focuses on the development of its lead drug candidate, belinostat, which has shown positive results in the treatment of hematological malignancies and solid tumors, obtained by both mono- and combination therapy. For more information, please refer to www.topotarget.com.
About belinostat
Belinostat is a novel pan-HDAC inhibitor in late-stage clinical development with more than 1,000 patients treated. Belinostat has a promising safety profile which allows combination with traditional chemotherapy. Preclinical experiments demonstrated belinostat to be effective against multiple cancers by inhibiting cell proliferation and inducing programed cell death (apoptosis) in tumor cells. Belinostat has been tested in a number of phase I/II clinical trials in hematological cancers and solid tumors both in mono- and combination therapy. Data from these trials have provided evidence of the anti-tumor effect of belinostat, including as monotherapy in PTCL and cutaneous T-cell lymphoma (CTCL), liver cancer, and thymoma.
About PTCL
PTCL is a hematological disease including a heterogeneous group of malignancies of T-cell origin that represents approximately 10-15% of all cases of non-Hodgkin’s lymphoma. PTCL is an aggressive, high-grade type of cancer with a poor prognosis of expected average survival of approximately two years from diagnosis without treatment. The projections for annual cancer incidences point to 15,500 new cases of PTCL in the US, Japan, and Europe.
About the BELIEF trial
BELIEF is a pivotal, open-label, multi-center, single-arm efficacy and safety trial of i.v. belinostat in patients with relapsed or refractory PTCL. FDA has granted belinostat Orphan Drug and Fast Track designation for the treatment of PTCL. The trial was initiated in December 2008 and recruitment was completed with 129 patients in September 2011. In total, the study included approximately 100 clinical centers globally.
About FOLOTYN™
FOLOTYN™ (pralatrexate), a folate analogue metabolic inhibitor, was discovered by the Sloan-Kettering Institute for Cancer Research, SRI International and Southern Research Institute and developed by Allos Therapeutics. In September 2009, the FDA granted accelerated approval for FOLOTYN™ for use as a single agent for the treatment of patients with relapsed or refractory PTCL. The indication is based on an overall response rate of 27%1. FOLOTYN™ has been available to patients in the US since October 2009. Allos Therapeutics was acquired by Spectrum Pharmaceutical in September 2012.
About ISTODAX®
ISTODAX® (romidepsin), an HDAC inhibitor, was developed by Gloucester Pharmaceuticals. In June 2011, the FDA granted accelerated approval for a Supplemental New Drug Application (sNDA) for an additional indication for ISTODAX® for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. ISTODAX® is also approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. These indications are based on response rates. The PTCL response rate was 25%2. Gloucester Pharmaceuticals was acquired by Celgene in January 2010.
SOURCE: Topotarget
Post Views: 105
Final top-line data confirm that the primary endpoint was met for the belinostat pivotal trial for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) with an encouraging objective response rate
COPENHAGEN, Denmark I March 5, 2013 I A Special Protocol Assessment agreement with the US Food and Drug Administration (FDA) required the CLN-19 BELIEF trial to reach an ORR of at least 20%. The FDA has granted belinostat Orphan Drug and Fast Track designation for the treatment of PTCL. All patients who received at least one dose of belinostat and had a confirmed PTCL diagnosis by the central pathology review were included in the efficacy analysis set. The responses have been confirmed by central independent radiology review. Final data have been submitted for presentation to the 2013 ASCO annual meeting.
“Our belief in belinostat has never wavered and the encouraging objective response rate together with the earlier announced favorable safety profile further supports the potential of our product. We strive to improve the lives of cancer patients and this is a large step in the right direction" said Anders Vadsholt, CEO of Topotarget.
Favorable safety profile
On January 24, 2013, Topotarget announced that preliminary safety data from the BELIEF trial in PTCL, presented at the T-Cell Lymphoma Forum 2013 in San Francisco, USA, showed that belinostat has a favorable safety profile and that the compound has the potential to become a well-tolerated alternative for the treatment of PTCL. The favorable safety outcome from this trial, as well as experience from earlier belinostat trials, shows that full doses of belinostat can be combined with other cytotoxic regimens making combination therapy for cancer patients feasible. The low incidence of myelosuppression is of special notice as this offers the opportunity to combine belinostat with other cytostatic agents for the treatment of patients with PTCL.
New Drug Application
Belinostat is currently being developed jointly by Topotarget and Spectrum Pharmaceuticals. Spectrum possesses the commercial rights to market belinostat in North America and India. A New Drug Application (NDA) for belinostat in PTCL is expected to be filed with the FDA by Spectrum in mid-2013.
Background information
About Topotarget
Topotarget (NASDAQ OMX: TOPO) is an international biopharmaceutical company headquartered in Copenhagen, Denmark, dedicated to clinical development and registration of oncology products. In collaboration with Spectrum Pharmaceuticals, Inc., Topotarget focuses on the development of its lead drug candidate, belinostat, which has shown positive results in the treatment of hematological malignancies and solid tumors, obtained by both mono- and combination therapy. For more information, please refer to www.topotarget.com.
About belinostat
Belinostat is a novel pan-HDAC inhibitor in late-stage clinical development with more than 1,000 patients treated. Belinostat has a promising safety profile which allows combination with traditional chemotherapy. Preclinical experiments demonstrated belinostat to be effective against multiple cancers by inhibiting cell proliferation and inducing programed cell death (apoptosis) in tumor cells. Belinostat has been tested in a number of phase I/II clinical trials in hematological cancers and solid tumors both in mono- and combination therapy. Data from these trials have provided evidence of the anti-tumor effect of belinostat, including as monotherapy in PTCL and cutaneous T-cell lymphoma (CTCL), liver cancer, and thymoma.
About PTCL
PTCL is a hematological disease including a heterogeneous group of malignancies of T-cell origin that represents approximately 10-15% of all cases of non-Hodgkin’s lymphoma. PTCL is an aggressive, high-grade type of cancer with a poor prognosis of expected average survival of approximately two years from diagnosis without treatment. The projections for annual cancer incidences point to 15,500 new cases of PTCL in the US, Japan, and Europe.
About the BELIEF trial
BELIEF is a pivotal, open-label, multi-center, single-arm efficacy and safety trial of i.v. belinostat in patients with relapsed or refractory PTCL. FDA has granted belinostat Orphan Drug and Fast Track designation for the treatment of PTCL. The trial was initiated in December 2008 and recruitment was completed with 129 patients in September 2011. In total, the study included approximately 100 clinical centers globally.
About FOLOTYN™
FOLOTYN™ (pralatrexate), a folate analogue metabolic inhibitor, was discovered by the Sloan-Kettering Institute for Cancer Research, SRI International and Southern Research Institute and developed by Allos Therapeutics. In September 2009, the FDA granted accelerated approval for FOLOTYN™ for use as a single agent for the treatment of patients with relapsed or refractory PTCL. The indication is based on an overall response rate of 27%1. FOLOTYN™ has been available to patients in the US since October 2009. Allos Therapeutics was acquired by Spectrum Pharmaceutical in September 2012.
About ISTODAX®
ISTODAX® (romidepsin), an HDAC inhibitor, was developed by Gloucester Pharmaceuticals. In June 2011, the FDA granted accelerated approval for a Supplemental New Drug Application (sNDA) for an additional indication for ISTODAX® for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. ISTODAX® is also approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. These indications are based on response rates. The PTCL response rate was 25%2. Gloucester Pharmaceuticals was acquired by Celgene in January 2010.
SOURCE: Topotarget
Post Views: 105
