s********d
发帖数: 103 | 1 Alnylam and Ascletis collaborate to develop ALN-VSP for liver cancers in
China
US RNAi therapeutics specialties Alnylam Pharmaceuticals (Nasdaq: ALNY) and
Ascletis Pharmaceuticals, a privately held US-China joint venture
pharmaceutical company, have formed a strategic collaboration for the
development of ALN-VSP, a first-in-class, systemically delivered RNAi
therapeutic for the treatment of liver cancers including hepatocellular
carcinoma (HCC), a significant area of unmet need in China.
This collaboration provides Ascletis with the exclusive rights to develop
and commercialize ALN-VSP in China including Hong Kong, Macau and Taiwan.
Alnylam will retain all rights in the rest of the world, and is eligible to
receive milestones and royalties based on product sales. Financial terms of
the accord were not revealed.
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Given that ALN-VSP eventually come comes to market, it would compete with
drugs such as Bayer and Onyx Pharma’s Nexavar (sorafenib) in the liver
cancer drug market. Nexavar was approved in the USA in 2006 and in the
European Union in 2007, and generated sales of 725 million euros ($892
million) for the German drug major last year.
“We believe Ascletis has the appropriate expertise in place to advance ALN-
VSP through that region’s clinical and regulatory system. As an
organization, they aim to develop first-in-class medicines for the Chinese
market and, given the encouraging clinical data seen to date with ALN-VSP,
this represents a unique opportunity for them to make a significant impact,
” said Laurence Reid, senior vice president and chief business officer of
Alnylam. “With this collaboration, we are able to develop ALN-VSP globally
through the product’s advancement in a region where HCC is a particular
challenge. As we retain all rights in the rest of the world, this partnering
strategy provides multiple future opportunities for Alnylam to advance this
novel therapeutic in other markets,” he added.
“Liver cancers, and specifically HCC, are a major unmet need in China,
which has the highest incidence of this aggressive cancer in the world,”
said Jinzi Wu, president and chief executive of Ascletis.
Positive Ph I results
ALN-VSP has completed a Phase I study in patients with advanced malignancy
with liver involvement and patients that achieved stable disease or better
have been enrolled into an extension study. Results of the Phase I study in
41 patients were presented at the American Society of Clinical Oncology (
ASCO) Annual Meeting in 2011 and demonstrated proof of RNAi mechanism based
on liver biopsy samples and disease control (stable disease or better after
first two months) in 13/31 (42%) patients treated at doses greater than or
equal to 0.4 mg/kg.
Data were presented recently at the ASCO Annual Meeting in 2012 from the
ongoing extension study with ALN-VSP. Results showed disease control lasting
more than six months in the majority of patients treated on the extension
study, including a complete response (CR) in an endometrial cancer patient
who had multiple liver metastases. Results also showed that chronic bi-
weekly dosing with ALN-VSP, including a patient treated for 23 months, was
generally safe and well tolerated. | s********d
发帖数: 103 | 2 以前我用过RNAi，一直认为进入细胞及有效抑制性和毒性是两个不可能解决的问题。有
人参与这个Trial吗，给讲一讲。 | d*p
发帖数: 534 | 3 他们在我们这里做了几个病人，没什么效果，倒是误导性地解读了一些数据，实际没有
效果。 | s********d
发帖数: 103 | 4 现在这个公司和中国人合作进入中国准备做临床了，我最担心的是美国没批，中国批了
，又让人笑话了。这样的事儿发生在腺病毒治疗肿瘤上。P53的故事希望不要从演了。 | m****n
发帖数: 1066 | 5 请教一下，
这个没效果是是指没有抑制肿瘤吗？stable disease?
没临床效果正常。抑制一个分子怎么能控制整个肿瘤？
【在 d*p 的大作中提到】
: 他们在我们这里做了几个病人，没什么效果，倒是误导性地解读了一些数据，实际没有
: 效果。
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