AMLN – LAR NDA submission: mid 2009 if bioequivalence study needed; earlier if not needed.
Bayer – Maxy-Seven FVIIa analogue: phase-1 trial in UK to start 2H08. (Go-ahead to start received 6/11/08.)
BMY – Apixaban phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): failure reported by PR 8/26/08, full data at ASH Dec08.
CEGE - GVAX prostate: VITAL-2 failure reported 8/27/08; unplanned futility analysis of VITAL-1 to be reported any day. - GVAX pancreas: leukemia P2 data 2H08.
CRXX - CRx-401 Ph ii as add on in diabetes in 80 patients - expected to announce results in 2H08.
ELN – AAB-001 phase-3: Interim data 2H09 (est.), final data 2H10 (est.). (First patient dosed 12/21/07.) ELN – ELND005 for AD phase-2: Interim data mid 2009 (est.), final data 1H10 (est.) (First patient dosed 12/21/07.)
GENZ – Myozyme sBLA for second production site: FDA advisory panel 10/21/08 (manufacturing discussion closed to the public); PDUFA date 11/19/08.
GILD – GS-9525 HCV NS4A inhibitor: see ACHN.
GILD – GS-9190 HCV polymerase inhibitor: new phase-1 trial to test QT-prolongation announced 10/18/2007; further details pending.
GTCB – FDA action on ATryn BLA: PDUFA date is 2/7/09. GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: report data 2H09. GTCB – Merrimack MM-093: results of phase-2 extension trial in RA: any day (?); results of pilot study in uveitis: late 2008. GTCB – Protexia: see PIP.
HGSI – Phase-3 Albuferon: report data from genotype-2/3 phase-3 trial: end 2008; report data from genotype-1 phase-3 trial: spring 2009; submit BLA fall 2009.
INSM - Iplex trial in MMD phase IIb, data expected late 2008, final results Q109.(optin moment at that time by ipsen/genentech) . INSM - NDGA phase II trial run by UCSF in prostate cancer started May 2008. Primary data May 2009.
ITMN – ITMN191 Final MAD monotherapy data at AASLD in Oct08 (data from first four cohorts announced at EASL 4/1/08). Data from 14-day triple- combination study: late 2008 (probably not in time for AASLD; trial started 5/29/08). ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results January 2009 (72 week treatment period).
MAXY – See Bayer.
Merrimack – See GTCB.
MNT – PureTox botulinum toxin: submit BLA calendar 4Q10 after completion of two ongoing phase-3 trials. (First phase-3 trial reported positive data 10/1/08.)
MNTA – FDA decision on Lovenox ANDA 1Q09. (Response to FDA was submitted on 9/26/08.) MNTA – M118: report phase-2 data in stable angina: 2Q09; ink partnership deal: mid 2009. MNTA – Copaxone ANDA: possible FDA decision in 2009-2010 (ANDA accepted for review on 7/11/08).
NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).
OXGN - 4Q 08 File IND for Zybrestat topical in ophthalmology OXGN - 2H 08 Phase 1 results Zybrestat/Rad. therapy/Cetuximab OXGN - 2H 08 Partnership (listen to 2Q CC)
PFE – Apixaban program: see BMY
Pharming – Rhucin submission to FDA late 2008; resubmission to EMEA with new data early 2009.
PIP – Protexia start phase-1 any day (guidance was 9/08).
RDEA – Start phase-2b combination study of RDEA806 in HIV: 4Q08; start phase-1 of RDEA 427 (2nd-gen NNRTI for HIV) 4Q08. ‘ RPRX– Proellex * Anemia Pivotal PIII trials - results expected by end of 2008 RPRX - Proellex endometriosis ph ii (enrollment ended early (Aug 08) so results estimated by late 4Q08 or early 1Q09) RPRX - Proellex Uterine Fibroids ph iii (clinicaltrials.org expected end date is March 09) RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008
SGP – Boceprevir ph-2 trial in treatment-naïve HCV: SVR data for 48-week arms: late 2008 or early 2009. (SVR data for the 28-week arms and SVR12 data for the 48-week arms were reported on 8/4/08: #msg-31189981.)
SNTA - Elesclomol Phase III metastatic melanoma: Safety and Futility Interim Analysis (PFS) late 4Q08; Complete enrollment (630) ~ early 1Q09; final PFS analysis (primary endpoint) early 2009; interim OS analysis early 2009 (secondary endpoint)
TARG - PDUFA date for Oritavancin: 12/8/08
UTHR - PDUFA date for Inhaled Treprostinil: 04/30/09 UTHR - Unblind Oral Treprostinil (combo trial) App. Mid November, 2008 [per 9/22/08 UBS conference last patient dosed about 8 weeks to gather and report data]. Note the Oral monotherapy trial will probably complete late Q1/early Q2 (est.)
VRTX – PROVE-3 trial in treatment-experienced HCV: SVR data 4Q08, presumably at AASLD. (EoT and some SVR12 data were reported on 6/9/08.) VRTX – Interim data from BID-dosing phase-2 Telaprevir trial conducted by Tibotec: 2H08.
ZGEN – IFN-Lambda in HCV: report interim ph1 monotherapy data at AASLD in Oct 2008. ZGEN – IL21 w Nexavar in RCC: interim ph2 data at EORTC in Oct 2008. ZGEN – IL21 in melanoma: interim ph2 data at ZGEN’s R&D Day Dec 2008. ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09) ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09 ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10. ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10
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