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振奋人心!Advaxis公布ADXS-HPV治疗肛门癌早期研究数据

  1. advaxis
  2. 肛门癌
  3. 肿瘤免疫

来源:生物谷 2015-03-18 11:11

最近,著名的肿瘤免疫疗法公司Advaxis公布了利用公司开发的ADXS-HPV疗法结合放疗、化疗治疗肛门癌的临床一期研究数据。

振奋人心!Advaxis公布ADXS-HPV治疗肛门癌早期研究数据

2015年3月18日讯/生物谷BIOON/--最近,著名的肿瘤免疫疗法公司Advaxis公布了利用公司开发的ADXS-HPV疗法结合放疗、化疗治疗肛门癌的临床一期研究数据。

数据显示参与实验的25名患者都对这一联合疗法都表现出了完全反应,更令人瞩目的是所有患者至今都没有复发的迹象。Advaxis公司的此次研究是和美国布朗大学医学院联合进行的,旨在研究公司新开发的ADXS-HPV的有效性和安全性。

作为肿瘤疾病中的罕见类型,肛门癌具有肿瘤复发率高的特点,而此次公司选取的25名志愿者都患有这种高复发型的肿瘤类型。根据实验设计,这些志愿者都要接受长达6个月的联合治疗并对其术后复发情况进行随访。

公司此次开发的ADXS-HPV疗法是基于Advaxis公司独有的 Lm-LLO肿瘤免疫技术。这种 Lm-LLO是通过一种人工构建的减毒李斯特菌作为肿瘤抗原为基础的肿瘤免疫技术科学家们利用这种细菌能够抑制髓源性抑制细胞(MDSC)等细胞,而后者在肿瘤细胞逃避免疫监控的过程中扮演着重要角色。

根据美国肿瘤协会提供的数据,目前发现的大多数鳞状细胞肛门癌都与人乳头瘤病毒(HPV)有关。而后者也是导致妇女宫颈癌的元凶之一。事实上,许多患有HPV-宫颈癌的妇女都有很大的风险患上肛门癌。数据显示,美国2014年新增7210例肛门癌患者,有950人死于这一疾病。

Advaxis公司致力于开发新的肿瘤免疫疗法,而上面提到的 Lm-LLO肿瘤免疫技术则是其手中的利器。目前,公司正在利用ADXS-HPV进行三个方面的临床早期研究,分别是治疗肛门癌、浸润性宫颈癌和头颈癌三种肿瘤类型。而FDA此前也已经授予ADXS-HPV治疗这三种罕见肿瘤类型的孤儿症药物地位。(生物谷Bioon.com)

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详细英文报道:

Data Highlighted in Oral Presentation at the International Anal Neoplasia Society Scientific Meeting 2015

" PRINCETON, N.J., March 16, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (ADXS), a clinical-stage cancer immunotherapy company, presented preliminary data from the Phase 1/2 clinical study of its lead immunotherapy product candidate, ADXS-HPV (ADXS11-001), in 10 patients with HPV-associated locally advanced anal cancer indicating that all patients who have completed treatment in the study have had a complete response with no evidence of recurrence to date (follow-up ranging from 0.5 -- 24 months). The preliminary data also show that the investigational immunotherapy was well tolerated by the treated patients, and all treatment-related toxicities were within 24 hours of dosing, the most frequent of which include chills/rigors, fever and nausea.

The data were highlighted in an oral presentation by Kimberly Perez, M.D., Assistant Professor of Medicine at the Alpert Medical School, Brown University, during the recent International Anal Neoplasia Society (IANS) Scientific Meeting 2015, in Atlanta, Georgia.

Dr. Perez stated, "Though preliminary, the data we have observed thus far are extremely encouraging as all treated patients enrolled since April 2013 have had a complete response with no recurrence of the cancer. ADXS-HPV has the potential to be an important advancement in the treatment of HPV-associated anal cancer, and we look forward to reporting the full safety and efficacy data set once all 25 patients have completed the dosing regimen."

BrUOG 276 (ClinicalTrials.gov Identifier: NCT01671488) is a Phase 1/2 non-randomized, open-label, multi-center study being conducted by the Brown University Oncology Group with financial support from The Farrah Fawcett Foundation. The study is designed to determine the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for locally advanced anal cancer in approximately 25 patients who have a high risk of recurrence based on their disease characteristics. The primary efficacy objective of the study is to assess the proportion of patients maintaining a clinical complete response at the 6-month mark.

David J. Mauro, M.D., Ph.D., Chief Medical Officer of Advaxis stated, "We are very pleased with the preliminary data from this Phase 1/2 study of ADXS-HPV in HPV-associated anal cancer as it adds to the encouraging data that we have observed in our additional ADXS-HPV programs and across our broader Lm-LLO cancer immunotherapy portfolio. We look forward to reviewing the full data set from this trial in support of the continued clinical development of ADXS-HPV in HPV-associated anal cancer."

About HPV and Anal Cancer

According to the American Cancer Society, most squamous cell anal cancers seem to be linked to infection by the human papilloma virus (HPV), the same virus that causes cervical cancer. In fact, women with a history of cervical cancer (or pre-cancer) have an increased risk of anal cancer. Anal cancer is fairly rare -- much less common than cancer of the colon or rectum. About 7,210 new cases will be diagnosed and about 950 people are expected to die of anal cancer in the United States during 2014.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm-LLO platform technology. The Lm-LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead Lm-LLO immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug designation for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 immunotherapy study to evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis's ADXS-HPV as a treatment for patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

Advaxis's second Lm-LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis entered into a clinical trial collaboration agreement with Merck & Co., Inc. ("Merck"), known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's PD-1 checkpoint inhibitor KEYTRUDA(R) (pembrolizumab). The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.

Advaxis is also developing Lm-LLO immunotherapy ADXS-HER2, to target the HER2 receptor expressing cancers. HER2 is expressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal-health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for pet therapeutics.

 

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