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加拿大Allon Therapeutics Inc.
Allon Therapeutics Inc. (溫哥華,Vancouver)是著重在神經(jīng)系統(tǒng)保護(hù)的科技公司,也就是The Neuro Protection Company? 。公司宣布已擴(kuò)大進(jìn)行中臨床測(cè)試范圍,將增加阿爾滋海默癥病人列入受測(cè)對(duì)象,并研究AL–108在這些病人身上的藥物動(dòng)力學(xué)。Allon宣布2008年1月10日已在一項(xiàng)額外的臨床測(cè)試中啟動(dòng)用藥,評(píng)估在正常健康個(gè)體中,施用AL–108 及 AL–208這兩個(gè)藥物對(duì)腦脊液(cerebrospinal fluid,CSF)及血漿藥物動(dòng)力學(xué)(plasma pharmacokinetics,PK)產(chǎn)生的影響。公司執(zhí)行長(zhǎng)兼總裁Gordon McCauley先生指出,增加阿爾滋海默癥病人為受測(cè)對(duì)象,反應(yīng)出公司正在強(qiáng)化現(xiàn)行臨床計(jì)劃,同時(shí)也是要確保公司在進(jìn)入阿爾滋海默癥病人臨床第IIB期藥物有效性測(cè)試設(shè)計(jì)之前,己取得有力的證據(jù)數(shù)據(jù)。公司預(yù)定在2008年本季取得公司藥物在阿爾滋海默癥前身的健忘型輕度知能障礙(amnestic mild cognitive impairment, aMCI)病人的臨床第IIA期有效性測(cè)試資料之后,會(huì)在2008年內(nèi)正式啟動(dòng)阿爾滋海默癥病人臨床第IIB期測(cè)試。 公司執(zhí)行長(zhǎng)兼總裁McCauley先生補(bǔ)充指出,在PK研究中增加阿爾滋海默癥病人,將可以看出阿爾滋海默癥病人在用藥安全方面和健康成人是否有差別,同時(shí)也讓公司了解當(dāng)進(jìn)入到阿爾滋海默癥病人臨床第IIB期測(cè)試時(shí),該期待那些結(jié)果。在這項(xiàng)PK研究中增加阿爾滋海默癥病人,也讓公司了解到一些在阿爾滋海默癥病人腦脊液出現(xiàn)的生物標(biāo)識(shí)分子,進(jìn)一步可以去觀察在這項(xiàng)人類疾病病理動(dòng)作的一些分子修飾機(jī)制。
Allon Therapeutics Inc. is a clinical-stage biotechnology company developing treatments for major neurodegenerative conditions. Allon’s drug davunetide intranasal (AL-108) has demonstrated human efficacy in amnestic mild cognitive impairment, a precursor to Alzheimer’s disease. Allon has Phase II human efficacy programs pursuing large underserved markets: Alzheimer’s disease, frontotemporal dementia, and schizophrenia-related cognitive impairment. The Company is listed on the Toronto Stock Exchange under the trading symbol “NPC” (Neuro Protection CompanyTM) and based in Vancouver.
Allon's milestones for 2009 include:
Execute a partnership agreement with a major pharmaceutical company
Initiate a Phase II study in frontotemporal dementia
Commence a Phase IIb study in AD with a partner
Initiate a Phase II PET study in AD patients
Announce top-line results from the Phase II study in schizophrenia-related cognitive impairment
Alzheimer’s disease
The first drug to treat Alzheimer’s disease came out in 1993. Since then, drugs have been developed that offer some symptomatic relief, but have no impact on the disease process or its progression. (Source: Paul Aisen, MD. Director, the Alzheimer’s Disease Cooperative Study, U.S. National Institutes of Health. Professor, School of Medicine, Department of Neurosciences, University of California, San Diego.)
“The combination of the symptomatic impact shown in this clinical trial and Allon’s pre-clinical data showing an impact on plaques and tangles, the classic hallmarks of Alzheimer’s disease, highlights the potential of davunetide intranasal (AL-108) as a disease-modifying therapy”.
(Donald Schmechel, MD. Adjunct Professor of Medicine (Geriatics), Duke University Medical Center, Durham, North Carolina. Medical Director, The Falls Neurological and Memory Center, Caldwell Memorial Hospital, Lenoir, North Carolina.)
Human efficacy
Allon released positive results from a Phase IIa clinical trial that showed two daily 15 mg doses of davunetide intranasal (AL-108) over 12 weeks of treatment resulted in statistically significant, dose-dependent and durable improvements on key endpoints that measure short-term recall and working memory — two types of memory that are clinically relevant in Alzheimer’s disease – in patients diagnosed with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease.
Reduces “tangles”, increases memory
In July 2008, Allon’s scientific presentations at the International Conference on Alzheimer’s Disease and Related Disorders (ICAD 2008) in Chicago demonstrated that the Phase IIa aMCI clinical trial data support the results of several studies in animals that show davunetide intranasal (AL-108) reduced the classic Alzheimer’s “tangles” pathology and also increased memory function.