MarqiboTreatment for Acute Lymphoblastic Leukemia
Update: Marqibo (vincristine sulfate liposome injection) Now FDA Approved - August 9, 2012
INEX and Enzon Announce Marqibo to be Reviewed by FDA's Oncologic Drugs Advisory Committee
VANCOUVER, British Columbia & BRIDGEWATER, N.J., September 27, 2004 - Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) and Enzon Pharmaceuticals, Inc. ("Enzon"; NASDAQ: ENZN) announced today the United States Food and Drug Administration (FDA) will review Marqibo, (formerly referred to as Onco TCS), at its upcoming Oncologic Drugs Advisory Committee (ODAC) session scheduled for December 1, 2004. Marqibo is being developed as a single-agent treatment for patients with relapsed aggressive non-Hodgkin's lymphoma (NHL) previously treated with at least two combination chemotherapy regimens.
The New Drug Application (NDA) for Marqibo was submitted to the FDA on March 12, 2004 and accepted on May 21, 2004. The FDA has established a target date of January 15, 2005 for completion of its review of the NDA.
About Marqibo (vincristine sulfate liposomes injection)
Marqibo is a proprietary drug comprised of the widely used off-patent anticancer drug vincristine encapsulated in INEX's sphingosomal drug delivery technology. INEX's technology is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are intended to increase the effectiveness and reduce the side effects of the encapsulated drug.
In the completed multi-center pivotal Phase 2/3 clinical trial, 119 patients with aggressive NHL who had not responded to their previous therapy or had responded and subsequently relapsed were treated with Marqibo. Prior to enrolment in this study, patients had received on average four other therapies. After treatment with Marqibo as a single-agent, an overall response rate of 25% was attained. Currently, there is no standard treatment for patients with aggressive NHL who have not responded to or have relapsed following at least two prior treatment regimens.
The results of this pivotal trial were released in June 2003 and presented in December 2003 at the American Society of Hematology annual conference along with interim results from two ongoing Phase 2 trials in relapsed Hodgkin's disease and relapsed B-cell lymphoma.
In addition to the lead indication, relapsed aggressive NHL, Enzon and INEX intend to develop Marqibo for use as a single-agent therapy or in combination therapy for several cancers in which vincristine is now used.
The Oncologic Drugs Advisory Committee (ODAC) is a committee formed by the FDA of external experts to advise the FDA in the evaluation of marketed and investigational drugs for use in the treatment of cancer. The Committee is comprised of a core of thirteen voting members from the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics and other related professions.
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer.
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases.
Posted: September 2004
- FDA Approves Marqibo for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia - August 9, 2012
- Talon Therapeutics Receives Notification of Three Month PDUFA Date Extension for Marqibo - May 7, 2012
- Tekmira Provides Update on Licensed Product Candidate, Marqibo - April 2, 2012
- FDA Issues Not Approvable Letter for Marqibo - January 19, 2005
- INEX and ENZON Announce ODAC Does Not Support Accelerated Approval for Cancer Drug Marqibo - December 1, 2004
- INEX and Enzon Announce FDA Acceptance of Onco TCS New Drug Application - May 21, 2004
- INEX and Enzon Complete the Filing of a New Drug Application for Onco TCS - March 15, 2004