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Expected NDA filing mid-2014.
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Granted Orphan designation by the FDA as a conditioning treatment for use in autologous transplant for patients with multiple myeloma. If approved, will be the only drug approved for this indication.
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In a previous clinical study, Captisol-enabled melphalan met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan.
HENDERSON, NV, USA I October 30, 2013 I Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, announced today the completion of enrollment for the pivotal trial of Captisol-enabled®, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma.
“We are very pleased to have the patient enrollment completed ahead of schedule,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Melphalan remains a high priority for Spectrum; if approved, Captisol-enabled melphalan would be the only drug approved as a conditioning agent for stem cell transplant in multiple myeloma. This product will also fit seamlessly into our existing commercial and research infrastructure.”
The phase 2 pivotal trial is a multi-center trial evaluating safety and efficacy in 60 patients. The primary objective of the study is to determine the overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m2 of Melphalan HCl for Injection (Propylene Glycol-Free) as myeloablative therapy prior to autologous stem cell transplantation (ASCT). The secondary objective is to evaluate the efficacy of Melphalan HCl (Propylene Glycol-Free) in this patient population as measured by multiple myeloma response rate (according to International Myeloma Working Group [IMWG] criteria), myeloablation, and engraftment. Several endpoints require 90-100 day follow-up of patients on the trial.
There are an estimated 20,000 new cases of multiple myeloma in the United States each year, with an incidence of new cases increasing by approximately 1.7% per year.1 The current intravenous melphalan market is approximately $130 million annually, with predominant use in stem cell transplants. The rate of autologous stem cell transplants for patients with multiple myeloma is growing by approximately 3.3% annually.2
About Captisol-Enabled Melphalan
Captisol-enabled, PG-free melphalan is a novel intravenous formulation of melphalan being investigated for the multiple myeloma transplant setting, for which it has been granted Orphan designation by the FDA. This formulation avoids the use of propylene glycol, which has been reported to cause renal and cardiac side effects that limit the ability to deliver higher doses of therapeutic compounds. The use of the Captisol® technology to reformulate melphalan is anticipated to allow for slower infusion rates and longer administration durations, potentially enabling clinicians to safely achieve a higher dose intensity of pre-transplant chemotherapy.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis®, Baxter International’s Nexterone® and Pfizer’s Vfend® IV. There are also more than 30 Captisol-enabled products currently in clinical development.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market four oncology drugs ─ FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights and MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion, for which the Company has worldwide marketing rights. Spectrum’s strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
SOURCE: Spectrum Pharmaceuticals
Post Views: 35
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Expected NDA filing mid-2014.
-
Granted Orphan designation by the FDA as a conditioning treatment for use in autologous transplant for patients with multiple myeloma. If approved, will be the only drug approved for this indication.
-
In a previous clinical study, Captisol-enabled melphalan met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan.
HENDERSON, NV, USA I October 30, 2013 I Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, announced today the completion of enrollment for the pivotal trial of Captisol-enabled®, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma.
“We are very pleased to have the patient enrollment completed ahead of schedule,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Melphalan remains a high priority for Spectrum; if approved, Captisol-enabled melphalan would be the only drug approved as a conditioning agent for stem cell transplant in multiple myeloma. This product will also fit seamlessly into our existing commercial and research infrastructure.”
The phase 2 pivotal trial is a multi-center trial evaluating safety and efficacy in 60 patients. The primary objective of the study is to determine the overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m2 of Melphalan HCl for Injection (Propylene Glycol-Free) as myeloablative therapy prior to autologous stem cell transplantation (ASCT). The secondary objective is to evaluate the efficacy of Melphalan HCl (Propylene Glycol-Free) in this patient population as measured by multiple myeloma response rate (according to International Myeloma Working Group [IMWG] criteria), myeloablation, and engraftment. Several endpoints require 90-100 day follow-up of patients on the trial.
There are an estimated 20,000 new cases of multiple myeloma in the United States each year, with an incidence of new cases increasing by approximately 1.7% per year.1 The current intravenous melphalan market is approximately $130 million annually, with predominant use in stem cell transplants. The rate of autologous stem cell transplants for patients with multiple myeloma is growing by approximately 3.3% annually.2
About Captisol-Enabled Melphalan
Captisol-enabled, PG-free melphalan is a novel intravenous formulation of melphalan being investigated for the multiple myeloma transplant setting, for which it has been granted Orphan designation by the FDA. This formulation avoids the use of propylene glycol, which has been reported to cause renal and cardiac side effects that limit the ability to deliver higher doses of therapeutic compounds. The use of the Captisol® technology to reformulate melphalan is anticipated to allow for slower infusion rates and longer administration durations, potentially enabling clinicians to safely achieve a higher dose intensity of pre-transplant chemotherapy.
About Captisol®
Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis®, Baxter International’s Nexterone® and Pfizer’s Vfend® IV. There are also more than 30 Captisol-enabled products currently in clinical development.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market four oncology drugs ─ FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights and MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion, for which the Company has worldwide marketing rights. Spectrum’s strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
SOURCE: Spectrum Pharmaceuticals
Post Views: 35
