[Please keep entries up to date! See updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: BMY (Apixaban).
AMGN – Denosumab: Three-year data from phase III PMO trials (vs. alendronate) 1Q08; three-year data from phase III PMO fracture study: 2H08; Presentation of data from phase III HALT trial in breast cancer: 1H08; Data from phase III HALT trial in prostate cancer: 2H08.
AMLN – LAR NDA submission: mid 2009 if bioequivalence study needed; earlier if not needed.
BMY – Apixaban phase-3 in orthopedic surgery: fall 2008; phase-2 in ACS: Dec 2008 at ASH.
CEGE - VITAL1 GVAX prostate phase III interim "1H/'early' 2008. Final analysis ?09 - GVAX + MDX010 P1 results ?08 - oncolytic virus (bladder cancer) P1 results at AUA(5/08)
DDSS – Tramadol NDA: second approvable letter received 5/31/07. New clinical trial likely. Ph III Trazodone results 2nd qtr/08
DNA – Avastin sBLA in breast cancer PDUFA date: 2/23/08 (advisory panel voted 5-4 against on 12/5/07); Avastin adjuvant CRC interim look Q2 08; Rituxan in Primary Progressive MS Ph III Results Q2 08.
ELN – AAAB001- final phase II data Q3 08 AB-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.)
GILD – Viread in HBV: FDA PDUFA date 8/11/08; EMEA action date expected 2Q08. (NDA and MAA submitted 10/11/07.)
GILD – GS9190 polymerase inhibitor for HCV: new phase-1 trial to test QT-prolongation announced 10/18/2007; no start date yet.
GTCB – ATryn phase-3 for HD in US: report top-line data any day, submit BLA mid 2008.
GTCB – US Atryn partnership announcement: 1Q08 (presumably after top-line data report).
GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: enrollment complete end 2008.
GTCB – Merrimack MM-093 results of phase-2 extension trial in RA: July 2008.
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.
IDIX – IDX899 for HIV: report final results from 7-day phase-1b monotherapy and interim results from phase-2a monotherapy study at CROI in Feb 2008; start 6-week phase-2 head-to-head vs Sustiva: 1H08.
IDIX – IDX184 nucleotide polymerase inhibitor for HCV: file IND 1H08.
IDIX – Protease inhibitor for HCV: file IND in 2008.
IDIX – Tyzeka vs Baraclude phase-4 (12 weeks PK): report data late 2008 (?).
ITMN – ITMN-191 Phase-1b: enrollment of 3rd dosing cohort complete by end of Jan 2008. (Data from first two cohorts reported 1/7/08.)
ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results Late 2008 (72 week treatment period). No interim analysis planned, though monitored for safety.
LBPFF – see DDSS
MCU/MPH.to - Medicure - MC-1 Lead drug candidate for cardiovascular reperfusion is in PH 3 trial /w 3000 patients, one of the largest trials in Canadian History. Full enrollment completed Sept. 14 with Top Line Data expected by Late February /08 or Mid March at the latest.
MEDX - Ipilimumab BLA submission sometime in 2008 (phase-3 data reported 12/10/07).
Merrimack: see GTCB
MNTA – Meeting with FDA re Lovenox ANDA: date not specified, but soon.
MNTA — Lovenox patent appeal (Sanofi v Amphastar): oral arguments began 1/8/08.
MNTA – M118 phase-2 data in stable angina to be presented at unspecified medical conference in 2008.
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.
NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).
Pharming – Rhucin in EU: appeal of EMEA rejection to be submitted by 2/11/08;
Pharming – Rhucin in US: phase-3 top-line data 1Q08; BLA submission in 2008 if warranted by data.
PHRM – Satraplatin MAA to EMEA to be filed 2/08 following analysis of final OS data.
PPHM - Update/presentation on completed phase 1B, (top line info was released 5/07), and interim data on phase 1A to be presented Feb8’08, at 10th Intl. Symposium on Anti-Angiogenic Agents.
RPRX– Proellex *Initiate US PII Endometriosis trial (Enrollment Oct 2007) *One year extension data (Q1 2008) *Initiate Fibroids Pivotal PIII trials (?) *Initiate Anemia Pivotal PIII trial(s) (? – New IND required)
RPRX – Androxal *Initiate Pivotal PIII trials (?)
RPRX – Other: select alternate Proellex-class compound for advancement into breast cancer studies via potential partner TBA.
SGP – Boceprevir ph-2 trial in treatment-naïve HCV: 12-week data reported on 10/18/07 (#msg-23788779); end-of-treatment data due in 2008 and SVR data in late 2008 or early 2009.
SRDX - Novocell phase-1/2 trial in type-1 diabetes: top-line data due in 2008 (enrollment complete 8/30/06).
TH.TO -Complete enrollment confirmatory TH9507 HIV Associated Lipodystropy trial 3rd qtr/07, final results 1st qtr/08.
VRTX – Interim data from BID-dosing phase-2 Telaprevir trial conducted by Tibotec: 2H08.
-- Procedure For Updating Clinical-Trials List
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