Oregovomab:反- ca - 125单克隆抗体B43.13——AltaRex B43.13, MAb B43.13,单克隆抗体B43.13。

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Oregovomab:反- ca - 125单克隆抗体B43.13——AltaRex B43.13, MAb B43.13,单克隆抗体B43.13。

药物R d . 2006; 7 (6): 379 - 83。

PubMed ID

17073521 (在PubMed

]

文摘

ViRexx医疗集团发展鼠单克隆抗体oregovomab [OvaRex, MAb B43.13]治疗卵巢癌。Oregovomab目标循环肿瘤相关抗原CA 125,是从人类卵巢癌细胞表面的脱落;抗体引起广泛的细胞和体液免疫反应对CA 125通过复杂的形成。与自由CA 125 CA 125 - oregovomab复合物可以'树突细胞,导致下游激活的T细胞。抗体是接受先进的临床开发。oregovomab AltaRex,发起人,被,收购和合并成ViRexx医疗集团在2004年12月。AltaRex(现在ViRexx医疗集团)建立了几个战略发展企业联盟和/或oregovomab商业化。Unither制药、联合治疗公司的子公司,进入一个与2002年4月ViRexx许可协议。协议覆盖了全球大部分地区,除了欧洲和中东,这是由其他协议(见下文);ViRexx保留了大多数欧盟成员国的权利和某些其他国家。 In August 2003, the agreement was extended, granting United Therapeutics Corporation development rights for Germany. AltaRex and Dompe entered into a distribution agreement for oregovomab in July 2004. Territories included in the agreement are Italy, Spain, Portugal, Hungary, Poland, Czech Republic, Switzerland, Austria and certain other Eastern European countries. Under the terms of the agreement, ViRexx retains responsibility for product development and registration of the antibody, upon commercialisation in the agreed territory. The two companies will work closely to achieve product registration throughout Europe. In June 2001, Dompe entered into a sublicensing agreement with FAES for the commercialisation of oregovomab in Spain and Portugal. ViRexx is also seeking collaboration partners for Northern European markets. Medison Pharma and AltaRex entered into an agreement in April 2002. Under the terms of the agreement, the two companies will establish a joint venture to market oregovomab in Israel and the Middle East. ViRexx also has an agreement with Genesis Pharma covering the commercialisation of the antibody in Greece, Turkey, Cyprus and the Balkans. Unither Pharmaceuticals has completed trial enrollment for its two pivotal phase III trials investigating oregovomab for the treatment of advanced ovarian cancer. In June 2006, Unither reached its enrollment goal of 177 patients for the IMPACT II study, the second of two identical double-blind, placebo-controlled trials. The IMPACT I study achieved its enrollment target in December 2005. Both IMPACT studies are designed to assess the effect of oregovomab on time to disease relapse in patients with advanced ovarian cancer (stage III/IV) who have achieved an optimal response with front-line chemotherapy, and are being conducted at over 60 sites across the US. Data from the studies are intended to support registration of the antibody in the US. ViRexx also plans to utilise results from the IMPACT studies to support regulatory filings in Europe and in other countries. In addition, a phase II trial is being conducted to evaluate two dosing regimens of adjunctive oregovomab plus platinum-based first-line chemotherapy in patients with advanced ovarian cancer. The enrollment target of 40 patients has been achieved; primary study analysis is anticipated to be completed by the end of 2006. Several phase II trials with oregovomab as monotherapy or in combination with other chemotherapeutics have been completed across the US and Canada. Clinical trials have also been conducted in the EU, but ViRexx has suspended such EU studies on the basis of commercial considerations. Oregovomab has orphan drug status for the treatment of ovarian cancer; designation was granted by the US and the EU in 1996 and 2002, respectively. In addition, the US FDA granted fast-track status to the antibody in 1998. AltaRex (now ViRexx Medical Corp) has been awarded the US patent covering the company's technology for administering a low dose of foreign antibody to patients expressing the CA 125 antigen. A second US patent has also been issued for oregovomab covering the technique of photoactivation using ultraviolet light to modify antibodies and enhance specific beneficial immune responses. Furthermore, AltaRex was granted a 'multi-epitopic' patent application covering oregovomab by the European Patent Office (EPO) in October 2003. The patent covers the company's technology of IV administration of a low-dose foreign antibody, such as oregovomab, to patients expressing the target tumour-associated antigen CA 125. The EPO's grant of the patent for the European Union enables intellectual property protection of oregovomab in the great majority of worldwide markets.

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药物

Oregovomab

药物靶点

药物	目标	类	生物	药理作用	行动
Oregovomab	Mucin-16	蛋白质	人类	未知的	不可用	细节