Cerebrolysin appears ischemic stroke treatment potential but prion diseases risk

Stroke Rounds: Post-Acute Peptide Tx Reduces Disabilityby Crystal PhendSenior Staff Writer, MedPage Today This article is a collaboration between MedPage Today® and: Medpage Today Neuropeptide injections improved arm function and global function when given in the month after ischemic stroke, a phase II trial showed. Injections of the product sold as Cerebrolysin in Russia, China, and surrounding countries had a "large" effect size on the Action Research Arm Test (ARAT) score on day 90 compared with placebo (Mann-Whitney estimator 0.71, P<0.0001). "The multivariate effect size on global status, as assessed using 12 different outcome scales, indicated a small-to-medium superiority of Cerebrolysin, (Mann-Whitney estimator 0.62; 95% CI 0.58-0.65; P<0.0001)," Dafin F. Muresanu, PhD, of "Iuliu Hatieganu" University of Medicine and Pharmacy in Napoca, Romania, and colleagues found. The proportion of patients with minimal disability at 90 days, marked by a modified Rankin Scale (mRS) score of 0 to 1, was 42.3% with the injections compared with 14.9% on placebo, the researchers reported online in Stroke. The intervention likewise up-shifted the proportion of patients with a "good" functional outcome marked by mRS scores of 2 or less. Cerebrolysin is a mixture of low molecular weight neuropeptides and free amino acids derived from pig brain tissue through a standardized manufacturing process. "No one knows exactly what's in there, nevertheless it has a very strong track record in animal models," commented Costantino Iadecola, MD, director of Cornell's Brain and Mind Research Institute in New York City. The findings were promising as there's little other than rehabilitation to offer patients in the post-acute phase, he said. "Many of the drugs we have were originally developed from biological material and we had to use molecular biology to develop recombinant forms and control adverse effects." But he warned against trying to import the substance, as one Alzheimer's group has noted can be done. "Before the I's are dotted and the T's are crossed, don't rush into treatment," Iadecola cautioned, noting that the small studies done so far are not enough to establish safety in terms of antibody development and even possibly prion diseases, which could take years to show up. The CARS trial randomized 208 moderate-to-severe stroke patients to double-blind treatment with Cerebrolysin (once-daily 30 mL injections) or saline placebo for 21 days, starting 24 to 72 hours after onset, along with a standardized rehabilitation program for all patients. Baseline stroke severity, disability, and other characteristics were similar between groups. "Cerebrolysin was safe and well tolerated," the researchers noted, pointing to a 3.8% rate of premature discontinuation. "This study was planned as an exploratory phase II trial," Muresanu's group wrote. "This design limits the degree of evidence obtained; thus, the results should be confirmed in a large-scale phase III trial. In addition, the generalizability of our results to other regions and stroke populations should be evaluated in future research."

雙語能力人有較佳中風預後!!

Stroke Rounds: Bilingual Brains Sustain Less Stroke Damage by Salynn BoylesContributing Writer This article is a collaboration between MedPage Today® and: Medpage Today Speaking more than one language might protect against cognitive injury related to stroke, according to findings from an Indian registry study. Compared to patients who spoke only one language, bilingual stroke patients were more than twice as likely to have normal cognition following their stroke and they also performed better on tests measuring post-stroke attention and function. But the two groups had similar frequencies of aphasia, at 11.8% among monolinguals and 10.5% among bilinguals (P=0.354), which might be explained by a higher level of cognitive control in patients speaking two or more languages, Suvarna Alladi, DM, of Nizam's Institute of Medical Sciences in Hyderabad, India, and colleagues wrote online in Stroke. "The only outcome not influenced by bilingualism was the frequency of aphasia," the researchers wrote. "Although this might look surprising at first sight, this finding is in-line with current research, suggesting that the mechanism underlying the protective effect of bilingualism is not because of better linguistic but executive functions acquired through a lifelong practice of language switching." 'Intriguing, But Not Conclusive' Jose Biller, MD, chair of the Loyola University department of neurology, which lists him as trilingual, told MedPage Today that another recently published, small (n=174 patient) study from the U.K. showed bilingual stroke patients to have poorer post-stroke language skills. Biller, who is also a spokesman for the American Stroke Association, was not involved with either study. "There is a great deal of interest in the impact of bilingualism on cognitive aging and now stroke outcomes," he said. "But it is important to be cautious in interpreting findings. These are small studies, and while the findings are intriguing, they are far from conclusive." Several previous studies have suggested that bilingualism might protect against Alzheimer's disease and general age-related cognitive decline, but little is known about the impact of bilingualism, if any, on cognitive outcomes in stroke, the researchers wrote. The study included ischemic stroke patients enrolled in a stroke registry in Hyderabad, India, who were evaluated 3 to 24 months after their strokes during the study period from 2006 to 2013. The evaluations included a detailed history and clinical assessment conducted by behavioral neurologists, stroke specialists, and trained psychologists using a structured diagnostic protocol adapted from the Cambridge Memory Clinic Model. Of the 608 patients included in the study, 189 (31.1%) had vascular dementia and 159 (26.2%) had mild cognitive impairment. Sixty-seven (11%) had aphasia and 193 (31.7%) were determined to have normal cognitive function. Twice as many bilinguals had normal cognition compared to patients who spoke only one language (40.5% versus 19.6%, P<0.0001), and monolinguals were more likely to have vascular dementia and mild cognitive impairment (77.7% versus 49.0%, P<0.0009). Other Dementia Risk Factors Older age, lower educational and occupational status, monolingualism, and vascular risk factors were all found to be significant risk factors for post-stroke cognitive impairment (P<0.003). In an attempt to assess whether bilingualism was independently associated with post-stroke cognitive impairment, the researchers performed a series of logistic regression analyses. "These regression models demonstrated variance of 31%, 24% and 28%, respectively," the researchers wrote. "Significant variables from the analyses were entered into a final logistic regression analysis. Following a Bonferroni correction, bilingualism and age were found to be significant independent predictors." The study participants came from Hyderabad, India, where several languages are routinely spoken, including Hindi, English, Telugu, and Urdu. Because of this, the researchers noted that the findings may not be applicable to bilingual people who live in areas like the U.S., where it is common to speak only one language. "Bilingualism is the norm in many parts of the world," Biller said. "We know from previous research that bilingualism induces certain plastic changes in the brain. However, the functional significance of these changes remains the subject of debate."

(加速M&A) 藥商 舉債(收購金額) 2000億美元!

生技業併購熱潮持續 行情即將引爆 MoneyDJ新聞 2015-11-20 17:24:37 記者 徐伯豫 報導 美國聯準會日前公布10月份FOMC會議記錄，暗示可能在12月升息。此消息使得不確定因素可望消除，投資人因而提高加碼意願，其中又以第四季將進入旺季的生技股，在併購題材發酵搭配新藥上市等利多簇擁下，發揮吸金效應，帶動NBI指數漲幅超越標普500指數。投信業者認為，生技類股這波旺季，可望引爆新一波的行情。瑞銀投信投資部主管張繼文認為，即使聯準會將於12月啟動升息，但因為後續升息力道可望較先前預期更為和緩，這對美股是一大利多，因此在最新會議記錄公布後，美股呈現開高走高的大漲局面，其中NBI指數上漲將近3%，是盤中表現最強勁的類股之一，主要是受惠併購題材發酵，激勵投資人回籠加碼。保德信全球醫療生化基金經理人江宜虔表示，華爾街日報於上月底披露輝瑞考慮收購愛力根之後，雙方也承認確有討論過合併事宜，這樁併購案若成真，可能創下全球醫療產業史上最大規模的併購案，預估併購金額將超過1,000億美元。除了輝瑞與愛力根的併購案之外，根據彭博社統計，大型生技業者潛在舉債將用來收購的金額高達1250億美元，製藥商潛在舉債將用來收購金額則上看2000億美元，目前已知的整體生技製藥產業併購規模，就超過3000億美元。 另外，根據金融時報的專欄，美國大型生技公司如Gilead及Biogen管理階層，已在本次季報公佈後，指出未來可能透過併購方式來增加旗下產品線深度；Celgene近期也已啟動數起購併，未來可能透過新藥授權或合作研發模式來擴增產品線；最後該專欄亦點出Amgen年底前也可能會物色一筆100億美元以下的交易。此外，彭博社亦有專欄分析師表示，大型製藥商及大型生技公司可能趁著利率尚在相對低點之際，舉債收購中小型生技公司，豐富公司旗下的新藥產品線。張繼文表示，上述的這些動作，顯示製藥商及大型生技業者極可能利用近期市場利率及公司股價尚在相對低點，啟動收購動作，讓自家公司未來的營收及獲利展望更佳。與其他產業較為不同的地方，就是即便生技與製藥公司同屬醫療健保產業，但各家公司主攻藥物產品線大多不同，合併對雙方都有利，因此不論是收購與被收購者，股價都會上漲。張繼文指出，時序已接近年底，多數企業已經開始展望2016年，對於大型生技製藥業者而言，增加旗下新藥產品線的深度與廣度將是提升未來企業獲利展望的不二法門；張繼文並認為，生技製藥業的購併案熱潮一旦開始啟動，整體產業估值可望再度上修，對於企業股價將產生極大正面助益。除了併購議題可望帶動生技產業外，江宜虔認為，醫療保健產業中長期有三大驅動力：一、人口高齡化趨勢；二、新興市場國家對醫療產業的需求隨所得提高而增加；三、生技、製藥、醫療器材等技術不斷創新，基本面優異，仍具投資價值。

中國,量產基因複製動物: 博雅 100萬頭克隆牛

中韓合資企業擬建全球最大克隆工廠2015/11/24 10:13 外媒報道，中韓合資的中國生物技術公司博雅(BoyaLife) 昨日宣布，計劃在天津建造全球最大克隆工廠，最終每年生產100萬頭克隆牛，還將生產狗甚至瀕危物種。一期將實現每年生產10萬頭牛，二期將實現每年生產100萬頭牛。預計該廠將於2016年投產，投資總額達到2億元人民幣。博雅首席執行官許曉椿表示，項目主要目的是大量生產優質小牛，以滿足市場對優質牛肉的需求。隨著中國逐漸變富，其牛肉消費量逐年增加。博雅的合資伙伴是韓國秀岩生命工學研究院(Sooam Biotech)。許曉椿稱，天津的實驗室將生產警犬，用於執行炸彈探測和搜救之類的任務。但它的主要經營活動將是克隆牛。阿思達克財經新聞

推動台灣生技產業 藍綠合作 提升至總統/院長層級

陳建仁：曾與王金平合推生技法案 藍綠合作台灣更好 林瑋豐 2015年11月24日 23:53 民進黨副總統參選人24日上午接受廣播專訪時，主動提到在蔡英文正式宣布他的副手的前幾天，與他同屬高雄白派的立法院長王金平曾打給他，兩人討論教育議題。晚間陳建仁上電視政論節目時，更提到身為社團法人國家生技醫療產業策進會創會會長的王金平，過去與他、蔡英文、翁啟惠合作生技法案的往事，肯定藍綠合作，讓台灣更好。陳建仁說，父親陳新安是高雄白派鼻組，王金平也是出身白派的立委，因此兩人交情本來就不錯。王金平是在蔡英文宣布副手前，打電話來與他討論教育問題，陳建仁肯定王金平關心台灣教育，也持別提到兩人過去合作生技法案。

王金平幫忙 一上午百立委連署、3週法案通過 陳建仁說，過去他在民進黨政府擔任國科會主委時，與卸任副閣揆的蔡英文和中研院長翁啟惠、經濟部長何美玥，一起寫《生技新藥產業發展條例》，寫完以後，想到可以找身為生策會創會會長的王金平幫忙提案，王一口答應後，一個上午就得到百位立委連署，3個禮拜就通過法案。陳建仁肯定地表示，藍綠如果沒有惡鬥，為了台灣更好合作起來，「那不得了，台灣會越來越好」，他強調，選舉是一回事，未來合作團結是一回事。

編列防疫醫師月薪29萬元 自己不拿終獲藍委接受 陳建仁也提到，民生法案也應該這麼做（藍綠合作），他憶起自己當衛生署長時，在SARS疫情後，衛生署和疾管局組織改造，在立院被修理很慘，當時他想在疾管局編列第一線感染症防疫醫師職位，月薪要29萬元，被藍委批評自肥，但他表示自己不可以領這筆錢，但這些人願意當第一線防疫醫師，拍手鼓掌都來不及了，這是為了國家更好，藍營立委最後就都可以接受了。

科技管理學會: 科技管理獎(個人獎) 台大 楊泮池/中醫大 蔡長海/晶心 林志明

台大校長楊泮池 獲頒「科技管理獎」 2015-11-20 23:29聯合報 記者高詩琴╱即時報導 中華民國科技管理學會於今天於清華大學舉行25週年會員大會暨科技管理論文研討會，包括清華大學賀陳弘校長、史欽泰講座教授、大同大學魏哲和講座教授、智邦科技李炎松董事長等近600人出席。會中由教育部長也是該學會理事長吳思華頒發該會最高榮譽「科技管理獎」個人獎給國立台灣大學楊泮池校長、中國醫藥大學暨醫療體系董事長蔡長海及晶心科技公司總經理林志明。大會同時頒發「科技管理獎」團隊獎，企業類由偉詮電子的「車用電子研發團隊」及中華電信研究院「無線通信研究所」獲得。學研類則由工研院組長周大鑫領導的「大氣壓電漿薄膜設備技術研發團隊」及國研院國家太空中心總計劃主持人張和本領導「福爾摩沙衛星五號計畫團隊」獲得，以表彰各團隊在科技管理領域方面之卓著績效。