Clinical-trial / regulatory calendar:
[Please see updating procedure at the end of this post.]
Edits: Add entries for ABGX/AMGN: PACCE trial and “408” trial final survival.
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ABGX - PACCE trial (chemo+Avastin+/-Pani) in 1st-line CRC: first interim RR 4Q05; Pani “408” trial in 3rd-line CRC (the trial that just caused all the commotion) final survival: 2Q06.
AGEN - 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.
AMGN – See ABGX
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 – Nuvigil PDUFA date in EDS: 1/06; Oravescent Fentanyl PDUFA date: 7/6/06.
COR - Approx Year end 2005: Results of IIa ADHD CX-717 Ampakine trial.
COR - Early 2006: PET scan results - IIa Alzheimer's 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 iii of RU-486 on Psychotic MD
CRME - Phase III RSD1235 ACT 2 CABG data in Q4/05 or Q1/06
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 – Phase-3 Milnacipran in fibromyalgia, second phase-3 study (either 3-mo or 6-mo of follow-up) 3Q06 (maybe —Dew).
DNA - Rituxan ph III results in RA in Q3 05
DNA- Rituxan in RA PDUFA 2/28/06
DNA- Rituxan in FL Agg NHL PDUFA 2/22/06
DNA - Lucentis phase-3 ANCHOR (predom.-classic AMD) in 4Q05.
DNA- Lucentis sblA filing 4Q 05
DNA- Avastin 2nd line mCRC sBLA filing 4Q 05
DNA- Avastin 1st line mNSCLC sBLA filing 1Q 06
DNA- Avastin 1st line MBC sBLA filing 1Q 06
DNA- Herceptin adjuvant breast cancer sBLA filing 1Q 06
DNDN - 1H 06 - Results for Ph iii of Provenge efficacy on PSADT in ADPC
FRX - Milnacipran in fibromyalgia: see CYPB.
GENR – Interim data in phase-2 “209” study: early 2006.
GPCB – Satraplatin SPARC trial: interim PFS 1Q06, final PFS 2Q04, final survival 2007.
GTCB – EMEA opinion on ATryn: Feb. 2006; Merrimack phase-2b MM-093 in RA: mid 2006.
IDBE -begin pivotal Fluinsure trials this winter.
IMCL – Erbitux PFS in (Merck KGaA) CRSYTAL trial in first-line CRC: 2H06; Erbitux H&N PDUFA date: end of Feb 06 (sBLA submitted 8/30/05).
INSM – Approvable letter received—orphan status pending.
ISTKF – 12-week Phase III ISA247 psoriasis results reported in August. 24-week results due in 4Q05.
LBPFF -report Tramadol Phase III U.S. results 2nd half as well as European launch 4th qtr.
Merrimack: see GTCB
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 Q4 05
NKTR – Exubera: endorsed by advisory panel 9/8/05 by 7-2 vote; FDA action by late 1/06.
NVS – LAF237 pivotal data in diabetes: early 2006.
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
SPPI – See GPCB.
SRDX - Phase-1 DME data for I-vation w Triamcinilone: mid 2006; Novocell start of phase-1/2 trial in type-1 diabetes: imminent.
TELK - Telcyta 3rd line NSCLC and 3rd line Ovarian results 1H06
Therion (private) – PanVac phase-3 survival results in second-line pancreatic cancer: 1Q06; ProstVac phase-2 (TTP) results of 120-patient trial in asymptomatic HRPC: 1Q06; start of ProstVac phase-3, 600-patient NCI trial in HDPC: 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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