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首页 » 癌症研究 » 小公司也有大潜力,OncoSec肿瘤免疫疗法2期临床前景光明

小公司也有大潜力,OncoSec肿瘤免疫疗法2期临床前景光明

来源:生物谷 2014-12-09 11:36

2014年12月9日讯/生物谷BIOON/--OncoSec 医疗上周五宣布,该公司治疗转移性黑色素瘤的DNA背景免疫疗法ImmunoPulse IL-12在二期临床试验中表现出非常好的应用前景。在意大利举行的2014年度黑色素瘤会议上,OncoSec的首席科学家Dr. Robert H. Pierce公布了第一批2期临床为期6个月的数据,该数据反映了2期和3期转移性黑色素瘤患者用药后的有效性和安全性。

通过实体瘤疗效评估标准,来自30个病人的阳性结果如下:31%最佳整体有效率、14%完全有效率。实体瘤反应评估标准主要是用来评价患者用药后改善(反应)、维持(稳定)和恶化(肿瘤发展)的指标。

OncoSec还公布了1期临床试验阶段患者长期存活率数据,该数据可以评估ImmunoPulse LI-12治疗转移性黑色素瘤的有效性,结果表明该免疫疗法可以延长患者生存期。在1期临床试验中,患者的整体平均存活期是23.9个月。

OncoSec表示,接下来的2期临床试验b阶段将会对比ImmunoPulse IL-12和默克公司的Keytruda效果。对于OncoSec这样的小公司而言,一旦ImmunoPulse IL-12获得FDA批准,将会给公司带来极高的利润,也为公司发展注入了强心剂。

全球产业分析公司估计,2017年全球肿瘤治疗市场将会达到2250亿美元,与13年相比,产业规模将会增加147%;与此同时,肿瘤免疫疗法将会在2023年带来350亿美元的产值。

OncoSec的ImmunoPulse IL-12会面临几家大公司的激烈竞争,其中包括默克的Keytruda和百时美施贵宝的Yervoy。然而,一旦ImmunoPulse IL-12在2期临床阶段能成功挑战默克Keytruda的霸权地位,也就能在这一激烈竞争的领域斩获一席之地。

上个月Keytruda的2期临床试验结果公布,在治疗晚期黑色素瘤的效果上超越Yervoy。因此ImmunoPulse IL-12只要能胜过Keytruda,完爆Yervoy也就不是梦。(生物谷Bioon.com)

详细英文报道

OncoSec Announces Promising Phase 2 Result For Cancer Immunotherapy

OncoSec Medical Inc (OTCMKTS:ONCS) announced on Friday that its DNA-based cancer immunotherapy, ImmunoPulse IL-12, which is being designed to treat patients with metastatic melanoma, had exhibited promising results in its Phase 2 trials. The top line six months data from Phase 2 trials, conducted to evaluate the efficacy and safety of the experimental treatment on patients with stage 3 and 4 metastatic melanoma, was reported by Dr. Robert H. Pierce, OncoSec's chief scientific officer, at the Melanoma Bridge 2014 conference in Italy.

The positive results from 30 patients include: 31% best overall response rate (bORR) and 14% complete response rate as measured by Response Evaluation Criteria In Solid Tumors (RECIST) in patients with metastatic melanoma who were given the experimental drug. RECIST is a set of published rules “that define when cancer patients improve (respond), stay the same (stable) or worsen (progression) during treatments.”

The company also announced that the analysis of long-term survival results of Phase 1 study, which evaluated ImmunoPulse LI-12’s efficacy in treating patients with metastatic melanoma in 2007, revealed that the drug may prolong survival in melanoma patients. The average overall survival for patients in Phase 1 study was 23.9 months.

The company also announced its plan to compare the efficacy of ImmunoPulse IL-12 with that of Merck & Co’s Keytruda in Phase 2b trial.

This is great news for the small company, OncoSec, because the drug, if approved by the FDA, may rake in higher profits from the highly lucrative cancer market.

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