Welcome members and clients of OMMP PIF. Due to increased costs, our website has moved to this server, Thanks go to our Friend and colleague, Wired57, for making this possible. If you have any questions or concerns, please start a new topic in 
Thank you 
05-14-2012, 10:07 PM
http://abcnews.go.co...08#.T7HjoVJr12B
More at the bottom of page like this one
http://clinicaltrial...how/NCT00736775
This one is better, longer with more on cognitive disorders
Another study of the same story from Columbia
crenezumab
ACI-01-Ab7; ACI-01-Ab7 (intravenous); ACI-01-Ab7 (subcutaneous); Alzheimer's MAb (intravenous), AC Immune/Genentech; Alzheimer's MAb (subcutaneous), AC Immune/Genentech; Alzheimer's MAb, AC Immune; Alzheimer's MAb, AC Immune/Genentech; Alzheimer's MAb, Genentech; Anti-Abeta; anti-Abeta (intravenous), AC Immune/Genentech; anti-Abeta (subcutaneous), AC Immune/Genentech; anti-Abeta, AC Immune; crenezumab; crenezumab (intravenous); crenezumab (subcutaneous); MABT-5012A; MABT-5012A (intravenous); MABT-5012A (subcutaneous); MABT5102A; MABT5102A (intravenous); MABT5102A (subcutaneous); RG-7412; RG-7412 (intravenous); RG-7412 (subcutaneous); RG7412; RG7412 (intravenous); RG7412 (subcutaneous) crenezumab (MABT-5012A; ACI-01-Ab7; RG-7412) is a humanized anti-Abeta (-amyloid) MAb, under development by AC Immune for the passive immunotherapy of Alzheimer's disease (AD) (Company Web Page, AC Immune, 7 Jun 2005 & 1 Sep 2008; Company Web Page, Genentech, 11 Apr 2008).
OriginatorAC ImmunePhase II Clinical Trial
LicenseeHoffmann-La RochePhase II Clinical Trial
DiseasesAlzheimer's diseasePhase II Clinical Trial Latest Change03 Feb 2012: Ongoing Phase II development and filing plans updated History12 May 2011 Names GrantedMABT-5012A10 May 2011 Change in Global StatusPhase II Clinical trial 15 Aug 2008 Change in Global StatusPhase I Clinical Trial11 Dec 2006 Development Continuing 07 Dec 2006 New LicenseesGenentech, Worldwide18 Sep 2006 No Development Reported 07 Jun 2005 New Product Therapeutic ClassMonoclonal antibody, humanizedPhase II Clinical Trial Cognition enhancerPhase II Clinical Trial Mechanism of ActionBeta amyloid protein antagonist DeliveryRoute:Injectable
Injectable, intravenous
Injectable, subcutaneous Biological Targetamyloid beta (A4) precursor protein
Entrez Gene ID: 351
Target Families: Enzyme > Protease/peptidase Chemical DataOrigin: Biological, protein, antibody
NCE: No
CAS registry number: 1095207-05-8
Chemical Name: Immunoglobulin G4, anti-(human 1-40--amyloid/human 1-42--amyloid) (human-mouse monoclonal MABT5102A heavy chain), disulfide with human-mouse monoclonal MABT5102A light chain, dimer Major Market Information Country DataCountryStatusLicensing AvailabilityArgentina- NoAustralia- NoAustria- NoBelgium- NoBrazil- NoCanadaPhase II Clinical Trial NoChile- NoChina- NoColombia- NoDenmark- NoFinland- NoFrance- NoGermany- NoGreece- NoHong Kong- NoIndia- NoIreland- NoIsrael- NoItaly- NoJapan- NoLuxembourg- NoMalaysia- NoMexico- NoNetherlands- NoNew Zealand- NoNorway- NoPeru- NoPhilippines- NoPortugal- NoRussian Federation- NoSouth Africa- NoSouth Korea- NoSpain- NoSweden- NoSwitzerlandPreclinical NoThailand- NoTurkey- NoUKPhase II Clinical Trial NoUSAPhase II Clinical Trial NoVenezuela- No MarketingFilings
________________
AC Immune; Hoffmann-La Roche
Alzheimer's disease
Worldwide; a registration filing for AD is expected after 2016 (Company pipeline, Roche, 1 Feb 2012, http://www.roche.com...ma_pipeline.htm).
AC Immune
USA; fast-track status for mild-to-moderate AD (Press release, AC Immune, 4 Dec 2008). LicensingAgreements
________________
Hoffmann-La Roche
Worldwide; it is exclusively licensed to Genentech (Hoffmann-La Roche) for development and commercialization. Genentech will pay AC Immune a royalty on sales, upfront and regulatory milestone fees, and will fund a multi-year collaborative research programme, covering all clinical development costs (Press release, AC Immune, 7 Dec 2006; Scrip Daily Online, 11 Dec 2006, S00943102). Roche has the right to opt into development (Company pipeline, Roche, 10 Feb 2009). Key Clinical Information Phase IIAlzheimer's disease
AC Immune; Hoffmann-La Roche
It is in a Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter, biomarker Phase II study (BLAZE, ABE4955g) of crenezumab iv and sc in 72 patients with mild to moderate AD in the US. Primary endpoint includes change in brain amyloid load from baseline to 69wk (ClinicalTrials.gov, 3 Feb 2012, http://clinicaltrial...how/NCT01397578; Company presentation, Roche, 1 Feb 2012, Slide 140, http://www.roche.com...120201_full.pdf).
It is in a Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter, cognition study (ABBY) to evaluate the efficacy and safety of crenezumab iv and sc in 372 subjects with mild to moderate AD in Canada, the UK and the US. Primary endpoint includes change in cognition (ADAS-cog) and CDR-SOB score from baseline to 73wk (ClinicalTrials.gov, 29 Apr 2011, http://clinicaltrial...how/NCT01343966; Company Web Page, AC Immune, 10 May 2011, http://www.acimmune.com/content/?p=41; Company presentation, Roche, 1 Feb 2012, Slide 140, http://www.roche.com...120201_full.pdf). Phase IGenentech (Hoffmann-La Roche)
A US Phase I, single-dose, randomized, parallel-group, open-label study (ABE4662g) of the safety, tolerability, pharmacokinetics, and bioavailability of crenezumab iv and sc in 22 healthy volunteers is complete. It was well tolerated and showed a favorable pharmacokinetics/pharmacodynamics profile (ClinicalTrials.gov, 18 Oct 2010, http://clinicaltrial...how/NCT00997919; Company Web Page, AC Immune, http://www.acimmune.com/content/?p=41).
Alzheimer's disease
Genentech (Hoffmann-La Roche)
A randomized, placebo-controlled, double-blind, US Phase I trial (ABACUS) in 56 patients with mild-to-moderate AD to assess safety, tolerability, pharmacokinetics and immunogenicity is complete (ClinicalTrials.gov, 28 Oct 2010, http://clinicaltrial...how/NCT00736775; Company Web Page, Roche, 8 Feb 2010; Half Year Res, Roche, 23 Jul 2009).
PreclinicalIn vivo
It was active in animal models of AD, and induced the transition of insoluble -amyloid to the soluble form (Press release, AC Immune, 7 Dec 2006; Scrip Daily Online, 11 Dec 2006, S00943102). Supporting URLs<li class="ListItem">http://www.roche.com/research_and_development/pipeline/roche_pharma_pipeline.htm?ta=%25&Ph...
<li class="ListItem">http://www.roche.com/irp3q10e.pdf
<li class="ListItem">http://www.acimmune.com/content/?p=41
<li class="ListItem">http://clinicaltrials.gov/ct2/show/NCT00736775
<li class="ListItem">http://www.roche.com/irp110202.pdf
<li class="ListItem">http://www.roche.com/irp1q11e.pdf
<li class="ListItem">http://www.gene.com/gene/pipeline/status/neuroscience/anti-abeta/
<li class="ListItem">http://clinicaltrials.gov/ct2/show/NCT01343966
<li class="ListItem">http://clinicaltrials.gov/ct2/show/NCT01397578
<li class="ListItem">http://www.roche.com/irp2q11e.pdf
<li class="ListItem">http://www.roche.com/irp120201_full.pdf
More at the bottom of page like this one
http://clinicaltrial...how/NCT00736775
This one is better, longer with more on cognitive disorders
Another study of the same story from Columbia
crenezumab
ACI-01-Ab7; ACI-01-Ab7 (intravenous); ACI-01-Ab7 (subcutaneous); Alzheimer's MAb (intravenous), AC Immune/Genentech; Alzheimer's MAb (subcutaneous), AC Immune/Genentech; Alzheimer's MAb, AC Immune; Alzheimer's MAb, AC Immune/Genentech; Alzheimer's MAb, Genentech; Anti-Abeta; anti-Abeta (intravenous), AC Immune/Genentech; anti-Abeta (subcutaneous), AC Immune/Genentech; anti-Abeta, AC Immune; crenezumab; crenezumab (intravenous); crenezumab (subcutaneous); MABT-5012A; MABT-5012A (intravenous); MABT-5012A (subcutaneous); MABT5102A; MABT5102A (intravenous); MABT5102A (subcutaneous); RG-7412; RG-7412 (intravenous); RG-7412 (subcutaneous); RG7412; RG7412 (intravenous); RG7412 (subcutaneous) crenezumab (MABT-5012A; ACI-01-Ab7; RG-7412) is a humanized anti-Abeta (-amyloid) MAb, under development by AC Immune for the passive immunotherapy of Alzheimer's disease (AD) (Company Web Page, AC Immune, 7 Jun 2005 & 1 Sep 2008; Company Web Page, Genentech, 11 Apr 2008).
OriginatorAC ImmunePhase II Clinical Trial
LicenseeHoffmann-La RochePhase II Clinical Trial
DiseasesAlzheimer's diseasePhase II Clinical Trial Latest Change03 Feb 2012: Ongoing Phase II development and filing plans updated History12 May 2011 Names GrantedMABT-5012A10 May 2011 Change in Global StatusPhase II Clinical trial 15 Aug 2008 Change in Global StatusPhase I Clinical Trial11 Dec 2006 Development Continuing 07 Dec 2006 New LicenseesGenentech, Worldwide18 Sep 2006 No Development Reported 07 Jun 2005 New Product Therapeutic ClassMonoclonal antibody, humanizedPhase II Clinical Trial Cognition enhancerPhase II Clinical Trial Mechanism of ActionBeta amyloid protein antagonist DeliveryRoute:Injectable
Injectable, intravenous
Injectable, subcutaneous Biological Targetamyloid beta (A4) precursor protein
Entrez Gene ID: 351
Target Families: Enzyme > Protease/peptidase Chemical DataOrigin: Biological, protein, antibody
NCE: No
CAS registry number: 1095207-05-8
Chemical Name: Immunoglobulin G4, anti-(human 1-40--amyloid/human 1-42--amyloid) (human-mouse monoclonal MABT5102A heavy chain), disulfide with human-mouse monoclonal MABT5102A light chain, dimer Major Market Information Country DataCountryStatusLicensing AvailabilityArgentina- NoAustralia- NoAustria- NoBelgium- NoBrazil- NoCanadaPhase II Clinical Trial NoChile- NoChina- NoColombia- NoDenmark- NoFinland- NoFrance- NoGermany- NoGreece- NoHong Kong- NoIndia- NoIreland- NoIsrael- NoItaly- NoJapan- NoLuxembourg- NoMalaysia- NoMexico- NoNetherlands- NoNew Zealand- NoNorway- NoPeru- NoPhilippines- NoPortugal- NoRussian Federation- NoSouth Africa- NoSouth Korea- NoSpain- NoSweden- NoSwitzerlandPreclinical NoThailand- NoTurkey- NoUKPhase II Clinical Trial NoUSAPhase II Clinical Trial NoVenezuela- No MarketingFilings
________________
AC Immune; Hoffmann-La Roche
Alzheimer's disease
Worldwide; a registration filing for AD is expected after 2016 (Company pipeline, Roche, 1 Feb 2012, http://www.roche.com...ma_pipeline.htm).
AC Immune
USA; fast-track status for mild-to-moderate AD (Press release, AC Immune, 4 Dec 2008). LicensingAgreements
________________
Hoffmann-La Roche
Worldwide; it is exclusively licensed to Genentech (Hoffmann-La Roche) for development and commercialization. Genentech will pay AC Immune a royalty on sales, upfront and regulatory milestone fees, and will fund a multi-year collaborative research programme, covering all clinical development costs (Press release, AC Immune, 7 Dec 2006; Scrip Daily Online, 11 Dec 2006, S00943102). Roche has the right to opt into development (Company pipeline, Roche, 10 Feb 2009). Key Clinical Information Phase IIAlzheimer's disease
AC Immune; Hoffmann-La Roche
It is in a Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter, biomarker Phase II study (BLAZE, ABE4955g) of crenezumab iv and sc in 72 patients with mild to moderate AD in the US. Primary endpoint includes change in brain amyloid load from baseline to 69wk (ClinicalTrials.gov, 3 Feb 2012, http://clinicaltrial...how/NCT01397578; Company presentation, Roche, 1 Feb 2012, Slide 140, http://www.roche.com...120201_full.pdf).
It is in a Phase II, randomized, double-blind, placebo controlled, parallel-group, multicenter, cognition study (ABBY) to evaluate the efficacy and safety of crenezumab iv and sc in 372 subjects with mild to moderate AD in Canada, the UK and the US. Primary endpoint includes change in cognition (ADAS-cog) and CDR-SOB score from baseline to 73wk (ClinicalTrials.gov, 29 Apr 2011, http://clinicaltrial...how/NCT01343966; Company Web Page, AC Immune, 10 May 2011, http://www.acimmune.com/content/?p=41; Company presentation, Roche, 1 Feb 2012, Slide 140, http://www.roche.com...120201_full.pdf). Phase IGenentech (Hoffmann-La Roche)
A US Phase I, single-dose, randomized, parallel-group, open-label study (ABE4662g) of the safety, tolerability, pharmacokinetics, and bioavailability of crenezumab iv and sc in 22 healthy volunteers is complete. It was well tolerated and showed a favorable pharmacokinetics/pharmacodynamics profile (ClinicalTrials.gov, 18 Oct 2010, http://clinicaltrial...how/NCT00997919; Company Web Page, AC Immune, http://www.acimmune.com/content/?p=41).
Alzheimer's disease
Genentech (Hoffmann-La Roche)
A randomized, placebo-controlled, double-blind, US Phase I trial (ABACUS) in 56 patients with mild-to-moderate AD to assess safety, tolerability, pharmacokinetics and immunogenicity is complete (ClinicalTrials.gov, 28 Oct 2010, http://clinicaltrial...how/NCT00736775; Company Web Page, Roche, 8 Feb 2010; Half Year Res, Roche, 23 Jul 2009).
PreclinicalIn vivo
It was active in animal models of AD, and induced the transition of insoluble -amyloid to the soluble form (Press release, AC Immune, 7 Dec 2006; Scrip Daily Online, 11 Dec 2006, S00943102). Supporting URLs<li class="ListItem">http://www.roche.com/research_and_development/pipeline/roche_pharma_pipeline.htm?ta=%25&Ph...
<li class="ListItem">http://www.roche.com/irp3q10e.pdf
<li class="ListItem">http://www.acimmune.com/content/?p=41
<li class="ListItem">http://clinicaltrials.gov/ct2/show/NCT00736775
<li class="ListItem">http://www.roche.com/irp110202.pdf
<li class="ListItem">http://www.roche.com/irp1q11e.pdf
<li class="ListItem">http://www.gene.com/gene/pipeline/status/neuroscience/anti-abeta/
<li class="ListItem">http://clinicaltrials.gov/ct2/show/NCT01343966
<li class="ListItem">http://clinicaltrials.gov/ct2/show/NCT01397578
<li class="ListItem">http://www.roche.com/irp2q11e.pdf
<li class="ListItem">http://www.roche.com/irp120201_full.pdf