Medivation har her for få minutter siden præsenteret fase 3 data for Dimebon i alzherimers. Det er nok ikke nogen overdrivelse at med de fase 2 data der har været præsenteret så er fase 3 data formentligt de vigtigste data der har været ventet i HELE pharma/biotech industrien her i år. For fase 2 data var intet mindre end imponerende. Måske også for imponerende. Der har i hvert fald været en del skeptisme rundt om kring. Og jeg selv gav også udtryk for det her
http://www.proinvestor.com/boards/25738/Huntexil-praesenteret-paa-amerikansk-konference#25789
De resultater som netop er blevet præsenteret er nok de DÅRLIGSTE fase 3 resultater jeg nogensinde har set. Forskellen mellem placebo og Dimebon var 0,1 point på Adas-cog skalaen. Verdens pt bedst sælgende alzherimers stof Aricept giver en forbedring på ca 3 point. Så stoffet er game over. Man kan lige så godt tage en placebo.
Der må ganske enkelt have været fusk bag de præsenterede fase 2 data. Godt nok var jeg selv relativ skeptisk omkring validiteten af de russiske data. Men at stoffet skulle falde FULDSTÆNDIGT sammen havde jeg nu ikke ventet. Puha det bliver grimt når Nasdaq åbner. Vi taler vel et fald på 75-90% selvom de også har et andet fase 3 stof. Men man kan ikke fortænke folk i at tænkie tanke om der også har været fusk bag cancer stoffet.
Pfizer som står bag Aricept købte sig i 2008 også ind i Dimebon for et absurd stort upfront beløb på $225 mio. De kommer også til at lide på det her.
Bort set fra der alt andet lige har været fusk med i spillet omkring fase 2 data, så viser det her bare en gang til at alzherimers (sammen med slagtilfælde) er de 2 store "gravgårde" indenfo CNS forskning. Det er bare SÅ svært at komme igennem fase 3 indenfor disse 2 indikationer. Så derfor er risikoen bare generelt højere når vi snakker Alzheimers forskning. Modsat HVIS mn kommer igennem med noget godt så er markedet nærmest uendelgt stort.
Jeg har tagget indlægget med Neurosearch da imebon også er undervejs i Huntington patienter hvor måle netop er at behandle de kognitive aspekter. Det program får også et slag over snuden med dagens resultater
Pfizer And Medivation Announce Results From Two Phase 3 Studies In Dimebon (latrepirdine*) Alzheimer's Disease Clinical Development Program
In CONNECTION Study, Dimebon Does Not Meet Primary and Secondary Efficacy Endpoints
Separate Phase 3 Safety Study Demonstrates Dimebon's Tolerability When Used Alone or in Combination with Approved Alzheimer's Disease Medicines
Medivation to Hold Investor Call at 8:30 a.m. EST
NEW YORK & SAN FRANCISCO, Mar 03, 2010 (BUSINESS WIRE) -- Pfizer Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) today announced results from two Phase 3 trials of the investigational drug dimebon (latrepirdine*) in patients with Alzheimer's disease (AD). In the CONNECTION trial, dimebon did not meet its co-primary or secondary efficacy endpoints compared to placebo. Co-primary endpoints were measures of cognition and global function.
"The results from the CONNECTION study are unexpected, and we are disappointed for the Alzheimer's community," said Dr. David Hung, president and chief executive officer of Medivation. "We are working with our colleagues at Pfizer to better understand the CONNECTION data and we plan to present these data at an upcoming medical meeting."
Dimebon was well tolerated in both the CONNECTION study and in a separate Phase 3 safety and tolerability study, which confirmed dimebon's tolerability when dosed alone or in combination with approved Alzheimer's disease medicines.
"We are evaluating the CONNECTION data with Medivation. After that review, Pfizer will be in a position to determine appropriate next steps regarding the dimebon program," said Dr. Briggs W. Morrison, senior vice president, clinical development, Primary Care Business Unit at Pfizer. "We recognize the significant medical need, and we are committed to advancing treatment options for Alzheimer's disease."
About the CONNECTION Study
CONNECTION is a Phase 3, multi-national, double-blind, placebo-controlled safety and efficacy trial involving 598 patients with mild-to-moderate AD at 63 sites in North America, Europe, and South America. Patients had a mean age of 74.4 years and a mean score of 17.7 on the Mini-Mental State Examination (MMSE) upon entry into the study. More than 40 percent of the patients enrolled were in the United States. In the study, patients were randomized to one of three treatment groups, receiving dimebon 20 mg three times a day (TID), dimebon 5 mg TID, or placebo TID for six months. The 5 mg arm was included in the study to help define the effective dose range for dimebon treatment.
No statistically significant improvements for the 20 mg TID group relative to placebo were achieved on the co-primary endpoints. One primary endpoint evaluated the effect of dimebon on cognition, as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), and showed that dimebon-treated patients achieved a 0.1 point difference from patients receiving placebo (p=0.86). Neither group was significantly changed from baseline. The other primary endpoint evaluated the effect of dimebon on independently-rated global function over the course of the six-month trial, as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus; p=0.81). According to the CIBIC-plus scale, 64.9 percent of the patients treated with dimebon 20 mg TID showed improvement or no change at Week 26 compared to 65.4 percent of placebo-treated patients. Results for the dimebon 5 mg dose were similar to the dimebon 20 mg and placebo, although they were numerically lower.
The 20 mg TID dimebon-treated patients also showed no statistically significant differences compared to placebo on the secondary efficacy endpoints. After six months of treatment, patients treated with dimebon showed a 0.4 point difference from patients taking placebo on activities of daily living (p=0.61), as measured by the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL). Neither group was significantly changed from baseline. The dimebon-treated group showed a 1.6 point improvement on behavior compared to placebo (p=0.17), as measured by the Neuropsychiatric Inventory (NPI). Compared to baseline, each group was improved, but this change was only significant for the dimebon group. On the Mini Mental State Examination (MMSE), another measure of cognition, both groups improved significantly over baseline (dimebon 0.7; placebo 1.2). The difference favoring placebo was not significant (p=0.10). Results for the dimebon 5 mg dose were similar to dimebon 20 mg and placebo, although they were numerically lower. Dimebon, 20 mg orally three-times daily, was well tolerated in the study. The number of patients with at least one adverse event was similar in the dimebon 20 mg and placebo groups (72.0% vs. 74.2%, respectively). The most frequently reported adverse events (>5%) in patients in the 20 mg dimebon group occurring more commonly than in the placebo group included somnolence (11.0% vs. 10.1%), dry mouth (8.5% vs. 6.6%), headache (9.5% vs. 5.6%), dizziness (7.5% vs. 5.1%), constipation (5.5% vs. 3.5%), cough (7.5% vs. 3.5%) and depression (6.0% vs. 3.5%). Similar rates of adverse events were observed for the 5 mg TID group. No clinically significant findings were noted in assessment of vital signs, clinical laboratories or on electrocardiography (ECG).
About the Phase 3 Safety and Tolerability Study
In a separate multi-center, placebo-controlled Phase 3 safety and tolerability study, dimebon was well tolerated when given alone or in combination with a variety of other AD medicines, including cholinesterase inhibitors, memantine, or both. Previous studies have confirmed the tolerability of dimebon alone. The Phase 3 safety and tolerability study enrolled 742 patients with mild-to-moderate Alzheimer's disease in the United States and Canada. In this study, patients were randomized to either dimebon 20 mg three-times daily or placebo and were treated for a period of either three or six months. Approximately 85 percent of patients were taking one or more currently approved Alzheimer's disease medicines while participating in this study.
Dimebon was well tolerated in the study. The most frequently reported adverse events (>5%) in the dimebon group occurring more commonly than in the placebo group were somnolence (5.1% vs. 1.9%) and fatigue (5.1% vs. 2.4%). No clinically significant findings were noted in assessment of vital signs, clinical laboratories or on electrocardiography (ECG).
http://www.proinvestor.com/boards/25738/Huntexil-praesenteret-paa-amerikansk-konference#25789
De resultater som netop er blevet præsenteret er nok de DÅRLIGSTE fase 3 resultater jeg nogensinde har set. Forskellen mellem placebo og Dimebon var 0,1 point på Adas-cog skalaen. Verdens pt bedst sælgende alzherimers stof Aricept giver en forbedring på ca 3 point. Så stoffet er game over. Man kan lige så godt tage en placebo.
Der må ganske enkelt have været fusk bag de præsenterede fase 2 data. Godt nok var jeg selv relativ skeptisk omkring validiteten af de russiske data. Men at stoffet skulle falde FULDSTÆNDIGT sammen havde jeg nu ikke ventet. Puha det bliver grimt når Nasdaq åbner. Vi taler vel et fald på 75-90% selvom de også har et andet fase 3 stof. Men man kan ikke fortænke folk i at tænkie tanke om der også har været fusk bag cancer stoffet.
Pfizer som står bag Aricept købte sig i 2008 også ind i Dimebon for et absurd stort upfront beløb på $225 mio. De kommer også til at lide på det her.
Bort set fra der alt andet lige har været fusk med i spillet omkring fase 2 data, så viser det her bare en gang til at alzherimers (sammen med slagtilfælde) er de 2 store "gravgårde" indenfo CNS forskning. Det er bare SÅ svært at komme igennem fase 3 indenfor disse 2 indikationer. Så derfor er risikoen bare generelt højere når vi snakker Alzheimers forskning. Modsat HVIS mn kommer igennem med noget godt så er markedet nærmest uendelgt stort.
Jeg har tagget indlægget med Neurosearch da imebon også er undervejs i Huntington patienter hvor måle netop er at behandle de kognitive aspekter. Det program får også et slag over snuden med dagens resultater
Pfizer And Medivation Announce Results From Two Phase 3 Studies In Dimebon (latrepirdine*) Alzheimer's Disease Clinical Development Program
In CONNECTION Study, Dimebon Does Not Meet Primary and Secondary Efficacy Endpoints
Separate Phase 3 Safety Study Demonstrates Dimebon's Tolerability When Used Alone or in Combination with Approved Alzheimer's Disease Medicines
Medivation to Hold Investor Call at 8:30 a.m. EST
NEW YORK & SAN FRANCISCO, Mar 03, 2010 (BUSINESS WIRE) -- Pfizer Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) today announced results from two Phase 3 trials of the investigational drug dimebon (latrepirdine*) in patients with Alzheimer's disease (AD). In the CONNECTION trial, dimebon did not meet its co-primary or secondary efficacy endpoints compared to placebo. Co-primary endpoints were measures of cognition and global function.
"The results from the CONNECTION study are unexpected, and we are disappointed for the Alzheimer's community," said Dr. David Hung, president and chief executive officer of Medivation. "We are working with our colleagues at Pfizer to better understand the CONNECTION data and we plan to present these data at an upcoming medical meeting."
Dimebon was well tolerated in both the CONNECTION study and in a separate Phase 3 safety and tolerability study, which confirmed dimebon's tolerability when dosed alone or in combination with approved Alzheimer's disease medicines.
"We are evaluating the CONNECTION data with Medivation. After that review, Pfizer will be in a position to determine appropriate next steps regarding the dimebon program," said Dr. Briggs W. Morrison, senior vice president, clinical development, Primary Care Business Unit at Pfizer. "We recognize the significant medical need, and we are committed to advancing treatment options for Alzheimer's disease."
About the CONNECTION Study
CONNECTION is a Phase 3, multi-national, double-blind, placebo-controlled safety and efficacy trial involving 598 patients with mild-to-moderate AD at 63 sites in North America, Europe, and South America. Patients had a mean age of 74.4 years and a mean score of 17.7 on the Mini-Mental State Examination (MMSE) upon entry into the study. More than 40 percent of the patients enrolled were in the United States. In the study, patients were randomized to one of three treatment groups, receiving dimebon 20 mg three times a day (TID), dimebon 5 mg TID, or placebo TID for six months. The 5 mg arm was included in the study to help define the effective dose range for dimebon treatment.
No statistically significant improvements for the 20 mg TID group relative to placebo were achieved on the co-primary endpoints. One primary endpoint evaluated the effect of dimebon on cognition, as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), and showed that dimebon-treated patients achieved a 0.1 point difference from patients receiving placebo (p=0.86). Neither group was significantly changed from baseline. The other primary endpoint evaluated the effect of dimebon on independently-rated global function over the course of the six-month trial, as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus; p=0.81). According to the CIBIC-plus scale, 64.9 percent of the patients treated with dimebon 20 mg TID showed improvement or no change at Week 26 compared to 65.4 percent of placebo-treated patients. Results for the dimebon 5 mg dose were similar to the dimebon 20 mg and placebo, although they were numerically lower.
The 20 mg TID dimebon-treated patients also showed no statistically significant differences compared to placebo on the secondary efficacy endpoints. After six months of treatment, patients treated with dimebon showed a 0.4 point difference from patients taking placebo on activities of daily living (p=0.61), as measured by the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL). Neither group was significantly changed from baseline. The dimebon-treated group showed a 1.6 point improvement on behavior compared to placebo (p=0.17), as measured by the Neuropsychiatric Inventory (NPI). Compared to baseline, each group was improved, but this change was only significant for the dimebon group. On the Mini Mental State Examination (MMSE), another measure of cognition, both groups improved significantly over baseline (dimebon 0.7; placebo 1.2). The difference favoring placebo was not significant (p=0.10). Results for the dimebon 5 mg dose were similar to dimebon 20 mg and placebo, although they were numerically lower. Dimebon, 20 mg orally three-times daily, was well tolerated in the study. The number of patients with at least one adverse event was similar in the dimebon 20 mg and placebo groups (72.0% vs. 74.2%, respectively). The most frequently reported adverse events (>5%) in patients in the 20 mg dimebon group occurring more commonly than in the placebo group included somnolence (11.0% vs. 10.1%), dry mouth (8.5% vs. 6.6%), headache (9.5% vs. 5.6%), dizziness (7.5% vs. 5.1%), constipation (5.5% vs. 3.5%), cough (7.5% vs. 3.5%) and depression (6.0% vs. 3.5%). Similar rates of adverse events were observed for the 5 mg TID group. No clinically significant findings were noted in assessment of vital signs, clinical laboratories or on electrocardiography (ECG).
About the Phase 3 Safety and Tolerability Study
In a separate multi-center, placebo-controlled Phase 3 safety and tolerability study, dimebon was well tolerated when given alone or in combination with a variety of other AD medicines, including cholinesterase inhibitors, memantine, or both. Previous studies have confirmed the tolerability of dimebon alone. The Phase 3 safety and tolerability study enrolled 742 patients with mild-to-moderate Alzheimer's disease in the United States and Canada. In this study, patients were randomized to either dimebon 20 mg three-times daily or placebo and were treated for a period of either three or six months. Approximately 85 percent of patients were taking one or more currently approved Alzheimer's disease medicines while participating in this study.
Dimebon was well tolerated in the study. The most frequently reported adverse events (>5%) in the dimebon group occurring more commonly than in the placebo group were somnolence (5.1% vs. 1.9%) and fatigue (5.1% vs. 2.4%). No clinically significant findings were noted in assessment of vital signs, clinical laboratories or on electrocardiography (ECG).
3/3 2010 15:32 troldmanden 0
26646 De er vilde de amerikanere. Over 10% af aktierne er allerede handlet i bare pre marked hvor aktien er nede med ca 70%. Jeg tror den skal endnu længere ned
