[Please see updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: DNA – update PDUFA dates for Lucentis and for Avastin in 2nd/3rd-line CRC.
ACEL - Second Interim Analysis Imminent Clinical Trial Report due for Onconase Phase-III trial will reach 211 patient events in April – June
AGIX - 1H 06 - Ph iii of 1067 on MACE should hit 900+ events for the end of the trial.
AMGN – “408” final OS 2H06; (PFS was disclosed 11/3/05). PACCE non-registrational Panitumumab trial (Avastin+FOLFOX+/-Pani) in 1st-line CRC: 2H06.
AORMF -pivotal AMD3100 results 2nd half 06.
ASPM – Interim data from BRITE trial in depression: scientific conference in 2Q07.
AVN – NDA for PBA PDUFA date: 7/30/06.
AZN – see RNVS
BIIB – FDA action date on Tysabri: 6/28/06.
BOMSF -reporting pivotal MBP8298 results 2 years roughly
CBST – FDA reply to Cubicin complete response letter due end May 2006 (submission 3/27/06).
CEPH – Nuvigil for EDS PDUFA date 4/30/06 (delayed from 1/31/06). Oravescent Fentanyl PDUFA date: 7/6/06. (Sparlon/ADHD negative panel vote 3/23/06.)
CONR – Reporting of CoStar data from U.S. pivotal trial: March 2007 at ACC; litigation calendar: see #msg-9738343 (first UK case vs ANPI was decided in COR’s favor 2/24/06).
COR - April 2006: Results of Phase IIa Simulated Night Shift Work (Sleep Disorder) CX-717 Ampakine trial (funded by DARPA). Trial is complete - i.e. was not affected by FDA hold.
CORT - 1H 06 - Results of Ph iii of RU-486 on Psychotic MD
CRME - RSD1235 FDA decision likely 1st qtr. 07. NDA submitted March 06.
CYAHF - Cryocath expanding feasibility stage of STOP AF trial by 15 patients, Will have European update Apr 20-22, extending European launch this qtr.
CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 results: mid 2007 (#msg-9132392).
CYTO--interim phase 1 data for Quadramet combined with Velcade in myeloma to be presented at ASCO in June.
DNA – Lucentis PDUFA date 6/30/06; results of PIER study (quarterly dosing) 2Q06. DNA – Avastin PDUFA date for 2nd/3rd-line CRC: 6/20/06.
DNDN - 2H06 - Results for P-11 of Provenge efficacy on PSADT in ADPC
DSCO – Infant RDS: 2nd approvable letter received 4/5/08 re CMC section if NDA.
ELN – See BIIB
FRX - Milnacipran in fibromyalgia: see CYPB.
GNTA — CLL PDUFA date 10/28/06; melanoma in EU: acceptance of MAA for review will start 120-day clock for receipt of questions from EMEA.
GPCB – Satraplatin SPARC trial: interim PFS late April 06, final PFS 2H06, final overall survival 2H07.
GTCB – EMEA appeal: submission end 4/06, decision end 6/06. Merrimack phase-2b MM-093 in RA: mid 2006.
IDIX – Telbivudine NDA/MAA for HBV: FDA PDUFA date Oct 2006; EMEA action date early 2007.
IMCL – See #msg-9218093 for list of Erbitux trials: 1) Erbitux in CRC. a) PFS in 1st-line CRSYTAL trial: 2H06; b) OS in 2nd-line EPIC study: 2H06; c) OS in refractory monotherapy study (“025”): 2H06. 2) Erbitux in NSCLC. OS in 2nd-line FLEX study: late 2006/early 2007. 3) Erbitux in pancreatic cancer, SWOG trial: 2H06.
ISA.TO - Final Cdn. psoriasis results 2nd half 06, Begin European pivotal psoriasis trials this qtr, begin U.S. pivotal psoriasis trials 2nd half 06, complete enrollment in renal Phase IIb 06, results in 07.
LBPFF – PDUFA date for Tramadol NDA: 9/28/06.
Merrimack: see GTCB
MLNM- see CYTO
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, possible interim results 2007, trial results in 2008.
NRMX, NRM.TO - Fibrillex NDA submitted Feb 06, 6 month review. FDA decision 3rd/4th qtr. 06. North American Alzhemed trial complete Jan 07, results to follow. European Alzhemed trial complete enrollment fall 06, trial complete 18 months later.
NVS – Galvus (LAF237) PDUFA date late Nov 2006 (accepted for review 3/30/06). Lucentis: ex-U.S. pivotal results: 2H06 (see DNA entry for U.S. trials.).
PDLI - Q2 06 volociximab ph II for solid tumors
PFE – Torcetrapib phase-3 program: IVUS and lipid data in 2006; “outcomes” data in 2008.
PHRM – See GPCB.
PTN- Q2 2006 ph.IIb results for PTN-141 in male erectile dysfunction
RNVS - AZN to file regulatory applications for Cerovive (NXY-059) during the first half of 2007.
SCLN - Second HCV ph-3 trial data May 06; (first HCV reported 12/14/05).
SPPI – See GPCB.
SRDX - Phase-1 DME data for I-vation w/ Triamcinalone: ~Sept 2006 (enrollment completed 3/22); Novocell phase-1/2 trial in type-1 diabetes: (CC on 1/25/06 reported that dosing had started).
TELK – ASSIST-1 -2 and -3 phase-3 results: Q2/Q3 (all 3 to be announced simultaneously).
Therion (private) – PanVac phase-3 survival results in second-line pancreatic cancer: 2Q06; ProstVac phase-2 (TTP) results of 120-patient trial in asymptomatic HRPC: 2Q06; start of ProstVac phase-3, 600-patient NCI trial in HDPC: 2Q06.
TH.TO -report ThGrf Phase III Hiv-associated lipodystrophy results late 06.
VSGN - Celacade phase-3 in chronic HF (ACCLAIM): triggering events reached 11/14/05; data now in cleanup and analysis.
XNPT 1H06 1) Initiate Phase 3 study in RLS for XP13512 2) Phase 2a results in GERD for XP19986 3) Partnership for either XP13512 or XP19986
YMI - Tesmilifene met breast cancer pivotal study fully enrolled. The first of three planned interim analyses of data from this trial will occur in mid calendar 2006 with the others expected during the balance of the year." Via SPA, approval as early as 2007. YMI – AeroLEF phase-2b data report: 2Q06.
-- Procedure For Updating Clinical-Trials List
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old list. You can find a pointer to this list in the iBox at the top of the main message-board screen.
2. Make your additions or modifications, inserting any new items in alphabetical order.
3. Post the updated text in a new message in reply to the message with the old list.
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