Expected Biologics License Application filing on track for 2007
PRINCETON, NJ, USA | Jan 04, 2006 | Medarex, Inc. (Nasdaq: MEDX – News) today announced that enrollment has been completed in a pivotal, registrational clinical trial evaluating ipilimumab (MDX-010) as monotherapy for the second-line treatment of metastatic melanoma.
"Completion of enrollment for the monotherapy registrational study represents a milestone in the development of ipilimumab and is a testament to the shared enthusiasm and dedication of the Medarex and Bristol-Myers Squibb partnership," said Irwin Lerner, Chairman of the Board of Directors and Interim President and CEO of Medarex. "Both companies are keenly aware of the acute need for new treatment options in this setting. This study is part of a comprehensive clinical development program that we have undertaken to understand the potential for ipilimumab to address this unmet medical need."
About the Monotherapy Registrational Trial
The open label, single-arm, monotherapy registrational clinical trial is designed to evaluate 150 patients with unresectable Stage III or Stage IV advanced melanoma who have progressed after at least one prior regimen of a melanoma treatment other than ipilimumab. Patients will receive a dose of 10 mg/kg of ipilimumab once every three weeks for up to four doses. Subsequently, eligible patients who have not experienced disease progression at week 24 will continue in a maintenance phase where a single dose of ipilimumab will be administered once every 12 weeks until disease progression. The study is designed to assess best objective response rate (complete and partial responses) as the primary endpoint. Secondary endpoints include disease control rate (complete and partial responses plus stable disease), progression-free and overall survival, as well as duration of best objective responses.
In March 2006, the registrational clinical trial was reviewed by the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) concerning the suitability of the trial design to support regulatory approval. In December 2006, the FDA granted Fast Track status to this program which provides for expedited regulatory review for new drugs that demonstrate the potential to address unmet medical needs for the treatment of serious or life- threatening conditions.
About Ipilimumab
Ipilimumab (also known as MDX-010) is a fully human antibody against human CTLA-4, a molecule on T cells that suppresses the immune response. Medarex and Bristol-Myers Squibb are investigating the potential of ipilimumab to enable the immune systems of certain types of cancer patients to help suppress tumor growth. Ipilimumab is currently in three separate registrational studies for metastatic melanoma as a second-line monotherapy treatment, as a first-line treatment in combination with dacarbazine, and as a second-line treatment in combination with a melanoma-peptide vaccine. Ipilimumab is also involved in multiple Phase II clinical trials to investigate the product’s potential activity in other tumor types, as well as in combination studies with other chemotherapy, immunotherapy and vaccines. Further information regarding Medarex’s ipilimumab program can be found in Medarex’s public disclosure filings with the U.S. Securities and Exchange Commission (SEC).
About Medarex
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb® technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. Thirty-five of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with six of the most advanced product candidates currently in Phase III clinical trials. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world’s unmet healthcare needs. For more information about Medarex, visit its website at www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential;" "believe;" "anticipate;" "intend;" "plan;" "expect;" "estimate;" "could;" "may;" or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with whether ipilimumab will help the immune systems of cancer patients to suppress or eradicate cancer tumors, product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of ipilimumab in patients, uncertainties related to product manufacturing as well as risks detailed from time to time in Medarex’s public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex’s public disclosure filings are available from its investor relations department.
Medarex®, the Medarex logo and UltiMAb® are registered trademarks of Medarex, Inc. All rights are reserved.
SOURCE: Medarex, Inc.
Post Views: 1,037
Expected Biologics License Application filing on track for 2007
PRINCETON, NJ, USA | Jan 04, 2006 | Medarex, Inc. (Nasdaq: MEDX – News) today announced that enrollment has been completed in a pivotal, registrational clinical trial evaluating ipilimumab (MDX-010) as monotherapy for the second-line treatment of metastatic melanoma.
"Completion of enrollment for the monotherapy registrational study represents a milestone in the development of ipilimumab and is a testament to the shared enthusiasm and dedication of the Medarex and Bristol-Myers Squibb partnership," said Irwin Lerner, Chairman of the Board of Directors and Interim President and CEO of Medarex. "Both companies are keenly aware of the acute need for new treatment options in this setting. This study is part of a comprehensive clinical development program that we have undertaken to understand the potential for ipilimumab to address this unmet medical need."
About the Monotherapy Registrational Trial
The open label, single-arm, monotherapy registrational clinical trial is designed to evaluate 150 patients with unresectable Stage III or Stage IV advanced melanoma who have progressed after at least one prior regimen of a melanoma treatment other than ipilimumab. Patients will receive a dose of 10 mg/kg of ipilimumab once every three weeks for up to four doses. Subsequently, eligible patients who have not experienced disease progression at week 24 will continue in a maintenance phase where a single dose of ipilimumab will be administered once every 12 weeks until disease progression. The study is designed to assess best objective response rate (complete and partial responses) as the primary endpoint. Secondary endpoints include disease control rate (complete and partial responses plus stable disease), progression-free and overall survival, as well as duration of best objective responses.
In March 2006, the registrational clinical trial was reviewed by the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) concerning the suitability of the trial design to support regulatory approval. In December 2006, the FDA granted Fast Track status to this program which provides for expedited regulatory review for new drugs that demonstrate the potential to address unmet medical needs for the treatment of serious or life- threatening conditions.
About Ipilimumab
Ipilimumab (also known as MDX-010) is a fully human antibody against human CTLA-4, a molecule on T cells that suppresses the immune response. Medarex and Bristol-Myers Squibb are investigating the potential of ipilimumab to enable the immune systems of certain types of cancer patients to help suppress tumor growth. Ipilimumab is currently in three separate registrational studies for metastatic melanoma as a second-line monotherapy treatment, as a first-line treatment in combination with dacarbazine, and as a second-line treatment in combination with a melanoma-peptide vaccine. Ipilimumab is also involved in multiple Phase II clinical trials to investigate the product’s potential activity in other tumor types, as well as in combination studies with other chemotherapy, immunotherapy and vaccines. Further information regarding Medarex’s ipilimumab program can be found in Medarex’s public disclosure filings with the U.S. Securities and Exchange Commission (SEC).
About Medarex
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb® technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. Thirty-five of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with six of the most advanced product candidates currently in Phase III clinical trials. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world’s unmet healthcare needs. For more information about Medarex, visit its website at www.medarex.com.
Medarex Statement on Cautionary Factors
Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential;" "believe;" "anticipate;" "intend;" "plan;" "expect;" "estimate;" "could;" "may;" or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with whether ipilimumab will help the immune systems of cancer patients to suppress or eradicate cancer tumors, product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of ipilimumab in patients, uncertainties related to product manufacturing as well as risks detailed from time to time in Medarex’s public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that other developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex’s public disclosure filings are available from its investor relations department.
Medarex®, the Medarex logo and UltiMAb® are registered trademarks of Medarex, Inc. All rights are reserved.
SOURCE: Medarex, Inc.
Post Views: 1,037
