Talon治疗公司宣布其Marqibo（硫酸长春新碱脂质体注射液）的新药申请（NDA）已提交给美国食品和药物管理局（FDA），寻求加速批准Marqibo用于成人PH–ALL的第二次或更多次复发或是在两种或两种以上的抗白血病治疗后恶化的情况。
Talon治疗的董事会成员、主席、行政总裁Steven R. Deitcherr医学博士表示，提交Marqibo的新药申请对于Talon而言是一个举足轻重的成就。我们正在寻求进行治疗的患者人群的预后严重，与一些最严重的实体肿瘤如转移性胰腺癌和胃癌的预后相当，并且缺乏标准方案或已批准的产品，目前可提供的三线、单剂量疗法只能诱导极低的反应（小于或等于4％）并有较强的毒性。Marqibo在恶化的、严重的和经过预先治疗的人群，包括那些需要3线至7线治疗的体力状况ECOG评分为0-3的患者中进行了关键研究，结果显示整体缓解率为20％，并有可预见的和可控的副作用而没有意外的毒性。Deitcher博士得出结论：“我们相信，对这种罕见的血液系统恶性肿瘤的一个重要的未满足的医疗需要而言，Marqibo可能提供重要的益处。
Marqibo
Treatment for non-Hodgkin's Lymphoma
INEX and Enzon Announce Marqibo to be Reviewed by FDA's Oncologic Drugs Advisory Committee
NCOUVER, 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.
About ODAC
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.
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer.
About Enzon
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases.
Posted: September 2004
美国生物科学公司花8月12日，急性淋巴细胞白血病（ALL）针对“Marqibo”第2阶段的患者56月底登记“造势”注射长春新碱脂质体已计划已经公布。
“Marqibo”是一种抗肿瘤长春新碱黑色素瘤和所有观察到的效果，是在一个新的法律optisomal脂质体配方技术封装。药物的金额可以封装在一个比传统长春新碱穿透肿瘤部位容易聚合脂质体配方。出于这个原因，被认为是非常有效的，甚至少量。
第44届美国临床肿瘤学会举行的今年（ASCO）淘汰33谁是以前评价，10（30％）在（完全缓解）国际台或（在CR患者骨髓原始细胞年会上，球是低于5％，国家还没有恢复血液）据报到达。在初步结果，而且生存和响应时间也获得了良好的效果和安全性。
据该公司介绍，获得最终，如果你能确认明年上半年有效性的最终数据，2010年新药申请（NDA），将被提交。