GERMANTOWN, Md.--(BUSINESS WIRE)--Amarex today announced its work on behalf of Gibson Oncology has resulted in an Orphan Drug Designation (ODD) by the United States Food and Drug Administration (FDA) for the drug LMP744.

马里兰州日耳曼敦（商业新闻短讯）--Amarex今天宣布，其代表吉布森肿瘤学的工作导致美国食品和药物管理局（FDA）为LMP744药物指定了孤儿药（ODD）。

LMP744 treats gliomas, readily crossing the blood brain barrier (BBB) at 10 times the concentration required to kill cancer cells and sustains a high concentration for over 24 hours per dose.

LMP744治疗神经胶质瘤，容易以杀死癌细胞所需浓度的10倍穿过血脑屏障（BBB），并且每剂量维持高浓度超过24小时。

“For decades glioblastoma brain cancer patients have not seen appreciable increases in overall survival rates with Temodar, the current standard of care treatment,” said Mr. Randall Riggs, President & CEO of Gibson Oncology. “Our goal is to advance both LMP400 and LMP744 to market via the shortest and quickest path, thus benefiting cancer patients in need.”.

吉布森肿瘤学总裁兼首席执行官兰德尔·里格斯先生说：“几十年来，胶质母细胞瘤脑癌患者使用目前的标准治疗方法Temodar的总生存率没有明显提高。”。“我们的目标是通过最短和最快的路径将LMP400和LMP744推向市场，从而使有需要的癌症患者受益。”。

Obtaining ODD for LMP744 for all gliomas underscores the promising and novel treatment of the drug to inhibit two cancer targets: TOPO 1 and downregulate cMyc overexpression through the drug’s potent binding of the G4 quadruplex of cMyc.

为所有神经胶质瘤获得LMP744的ODD强调了该药物抑制两种癌症靶标的有希望和新颖的治疗方法：TOPO 1并通过该药物与cMyc的G4四联体的有效结合来下调cMyc的过表达。

“This crucial designation could not come at a more critical time for the families who are fighting this disease,” said Dr. Kush Dhody, President, Amarex. “Reaching this milestone sets the company up for future success and, most importantly, poises Gibson Oncology to continue its path to commercialization of this life-saving treatment.”.

Amarex总裁Kush Dhody博士说：“对于正在与这种疾病作斗争的家庭来说，这一至关重要的任命来得正是时候。”。“达到这一里程碑将为公司未来的成功奠定基础，最重要的是，吉布森肿瘤学将继续其这种挽救生命的治疗方法的商业化道路。”。

Through a multi-year collaboration with cMyc expert, Dr. Danzhou Yang of Purdue University, Gibson Oncology discovered that LMP400, which received ODD earlier in the year, and LMP744 are potent nM inhibitors of both TOPO 1 and cMyc oncogene. Together, the teams determined that LMP744, a small molecule, selectively targets two well-known drivers of human cancers, cMyc oncogene and TOPO 1..

通过与cMyc专家普渡大学杨丹舟博士的多年合作，吉布森肿瘤学发现今年早些时候接受ODD治疗的LMP400和LMP744是TOPO 1和cMyc癌基因的有效nM抑制剂。研究小组共同确定，LMP744是一种小分子，可选择性靶向两种众所周知的人类癌症驱动因素，即cMyc癌基因和TOPO 1。。

The discovery of this compound’s unique anti-cancer mechanism of action (MOA) allowed Gibson Oncology to better position LMP744 and LMP400 to cancer targets with high unmet medical needs.

这种化合物独特的抗癌作用机制（MOA）的发现使吉布森肿瘤学能够更好地将LMP744和LMP400定位于未满足医疗需求的癌症靶标。

Presently, LMP744 and LMP400 is positioned to enter a Phase 2 human clinical trial in recurrent gliomas in collaboration with the National Institutes of Health (NIH).

目前，LMP744和LMP400将与美国国立卫生研究院（NIH）合作，进入复发性神经胶质瘤的2期人体临床试验。

Gibson Oncology believes it is important to leverage the Orphan Drug Designation both drugs have received from the FDA for all gliomas, not just glioblastomas, which includes children with gliomas. Rapid regulatory advancement empowers LMP400 and LMP744 to the shortest and quickest path to market, thus benefiting cancer patients in need..

吉布森肿瘤学认为，重要的是要利用这两种药物从FDA获得的孤儿药名称来治疗所有神经胶质瘤，而不仅仅是胶质母细胞瘤，其中包括患有神经胶质瘤的儿童。。。

About Gibson Pharmaceuticals

关于吉布森制药

Gibson Oncology is a private biotechnology company with a unique portfolio of five small molecules for cancer therapy discovered at the National Cancer Institute and Purdue University. These agents have both TOPO 1 as well as cMyc activity and already have had five clinical trials completely supported by the NCI in recurrent solid tumors and lymphomas.

吉布森肿瘤学是一家私人生物技术公司，拥有在国家癌症研究所和普渡大学发现的用于癌症治疗的五种小分子的独特组合。这些药物具有TOPO 1和cMyc活性，并且已经在复发性实体瘤和淋巴瘤中进行了五项完全由NCI支持的临床试验。

Our lead agent, LMP744, is currently positioned for a Phase 2 trial in first recurrent glioblastoma patients, and LMP400 in first recurrent glioma patients with PTEN deficiency..

我们的主要药物LMP744目前正在首次复发性胶质母细胞瘤患者中进行2期试验，LMP400在首次复发性PTEN缺乏的胶质瘤患者中进行。。

Gibson has a second generation of newly invented and patented drugs, also showing combined TOPO 1 and cMyc activity known as the 7-Azaindenoisoquinolines (the AZAs). Discovered by Dr. Mark Cushman at Purdue University and exclusively licensed to Gibson, these agents also show TOPO 1 effects not by traditional camptothecin mechanisms found in older drugs like Irinotecan and Topotecan.

吉布森拥有第二代新发明和专利药物，也显示出TOPO 1和cMyc的联合活性，称为7-氮杂茚并喹啉（AZAs）。这些药物由普渡大学的马克·库什曼博士发现，并独家授权给吉布森，它们还显示出TOPO 1的作用，而不是伊立替康和拓扑替康等老药物中发现的传统喜树碱机制。

Gibson has demonstrated that the AZAs work on cMyc inhibition epigenetically through the G-quadruplex..

吉布森已经证明，AZAs通过G-四链体在表观遗传学上对cMyc抑制起作用。。

About Amarex Clinical Research, LLC

关于Amarex Clinical Research，LLC

Amarex Clinical Research, LLC, is a global, full-service Contract Research Organization (CRO) with significant expertise conducting clinical research. The leadership team’s combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications.

Amarex Clinical Research，LLC是一家全球性的全方位服务合同研究组织（CRO），拥有丰富的临床研究专业知识。领导团队的综合经验包括在许多治疗适应症中设计和实施数百个临床研究项目。

Amarex provides services in Project Management: Phase I-IV, BE/BA, PK/PD; Regulatory Affairs: FDA Applications and meetings, applications to International Health Authorities, GxP Compliance Audits; Clinical Operations; Adaptive Study Designs; Statistical Analysis; Data Management; Medical Monitoring; Safety and Pharmacovigilance; and General Consulting.

；监管事务：FDA申请和会议，向国际卫生机构申请，GxP合规审计；临床操作；适应性研究设计；统计分析；数据管理；医疗监测；安全和药物警戒；和一般咨询。

Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products assisted by quality, cost-efficient services. For more information visit www.amarexcro.com..

Amarex可以让您的产品通过整个审批流程，从创建监管审批策略到进行试验，再到编写营销审批申请。加入我们不断增长的客户名单，提供经认可的产品，并提供优质、经济高效的服务。。。