Clinical-trial / regulatory calendar:
[Please see updating procedure at the end of this post.]
Edits: Changed AVN entry for new delay in NDA acceptance.
ABGX- international Panitumumab phase-3 results in refractory mCRC: late 3Q05 or early 4Q05.
AGEN - Ph III in melanoma 2H05, Ph III in RCC 1H06.
AGIX - 1H 06 - Ph iii of 1067 on MACE should hit 900+ events for the end of the trial.
ALKS – 12/30/05 PDUFA date for Vivitrex NDA.
AORMF -pivotal AMD3100 results 2nd half 06.
AVN – FDA acceptance for filing of NDA for PBA: delayed (was 10/10/05).
AXCA -pivotal Itax results 1st half 06.
BMY – 12/31/05 revised action date for Orencia (CTLA-4).
BOMSF -reporting pivotal MBP8298 results 2 years roughly
CEPH – Attenace (Provigil) PDUFA date in ADHD: 9/05; Nuvigil PDUFA date in EDS: 1/06; Oravescent Fentanyl PDUFA date: 7/6/06.
COR - Oct 2005: Interim analysis - IIa Alzheimer's CX-717 Ampakine trial.
COR - Approx Year end 2005: Results of IIa ADHD CX-717 Ampakine trial.
COR - Early 2006: Results of IIa Simulated Night Shift Work (Sleep Disorder) CX-717 Ampakine trial (funded by DARPA).
CORT - 1H 06 - Results of Ph ii of RU-486 on reversal of Alzheimers functionality
CORT - 1H 06 - Results of Ph iii of RU-486 on Psychotic MD
CRME - RSD1235 phase III data in mid September.
CNVX - Last interim look at melanoma vaccine in Q3/Q4 05
CYAHF -20 patient IDE results 4th qtr, then begin the pivotal phase 1st half 06 as well as commercial launch in Europe later this year.
CYPB – 3Q05 first Phase-3 of Milnacipran in fibromyalgia (in data analysis now); 3Q06 second (mirror) phase-3 study (either 3-mo or 6-mo of follow-up)
DNA - Rituxan ph III results in RA in Q3 05
DNA - Lucentis phase-3 ANCHOR in 4Q05.
DNDN - 1H 06 ttp data for 9902B Provenge Phase III
DNDN - 1H 06 - Results for Ph iii of Provenge efficacy on PSADT in ADPC
FRX - Milnacipran in fibromyalgia: see CYPB entry
GENR – Phase-2 AMD data from “208” trial at AAO: 10/05; start of second phase-3 AMD trial: 2H05.
GPCB – Satraplatin SPARC trial: interim efficacy 1Q06, final efficacy 2Q06. (Endpoint is a complex TTP metric.)
GTCB – EMEA opinion on ATryn: Feb. 2006
IDBE -begin pivotal Fluinsure trials this winter.
IMCL – Erbitux H&N PDUFA date: late Feb 06 (sBLA submitted 8/30/05).
INSM - pdufa date for somatokine 10/03/05
ISTKF -report interim Phase III ISA247 psoriasis results August and unblinded results in October.
LBPFF -report Tramadol Phase III U.S. results 2nd half as well as European launch 4th qtr.
LRP -report pivotal viruzulin results later this year (2005).
MYOG - Top-line data from Ambrisentan phase-3 trials in PAH: ARIES-2 in 4Q05, ARIES-1 in 2Q06.
NABI - ph iii results for vaccine against staph in Q3/Q4 05
NKTR – Exubera endorsed by advisory panel 9/8/05 by 7-2 vote, awaiting FDA action.
NVS – LAF237 pivotal data in diabetes: early 2006.
ORPH (to become JAZZ?)--2H 05-data from the clinical trial designed to evaluate Xyrem in the treatment of fibromyalgia syndrome
PDLI - Q2 06 volociximab ph II for solid tumors
PTIE - All are 2H05
Oxytrex(TM) Osteoarthritic Pain - Phase III Report top-line results
PTI-901 Irritable Bowel Syndrome - P.III Report top-line results in women
PTN- Q2 2006 ph.IIb results for PTN-141 in male erectile dysfunction
RNAI – Sirna-007 final phase-1 AMD data at AAO: 10/05.
SPPI – See GPCB.
TELK - Telcyta 3rd line NSCLC and 3rd line Ovarian results 1H06
TH.TO -report ThGrf Phase III Hiv-associated lipodystrophy results late 06.
VSGN - Celacade phase-3 in chronic HF (ACCLAIM) fiscal 1Q06 (Dec 05-Feb 06).
YMI - early 2006?--672 patients enrolled, 28 to go.YM anticipated that the trial might be completed as early as mid-2006, but seems to be potentially ahead of schedule.
YMI - report pivotal Tesmilifine breast cancer results possibly 2nd qtr 06.
YMI – AeroLEF phase-2b data report: 2Q06.
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Procedure For Updating Clinical-Trials List
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2. Make your additions or modifications, inserting any new items in alphabetical order.
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