[Please see updating procedure at the end of this post.]
Edits: AMGN Pani data delayed; deleted PFE/NKTR Exubera entries (already approved); added CEPH panel meeting for Sparlon; minor updates to entries for CONR, GTCB, NVS, and SRDX.
ABGX – See AMGN.
AGEN – Top line results for Phase III of Oncophage treating RCC Mar'06.
AGIX - 1H 06 - Ph iii of 1067 on MACE should hit 900+ events for the end of the trial.
ALKS – Vivitrol approvable letter issued 12/28/05—approval expected 2Q06.
AMGN – PACCE non-registrational trial (Avastin+FOLFOX+/-Pani) in 1st-line CRC: 2H06 (previously promised 4Q05); Pani “408” registrational trial in 3rd-line CRC: final survival: 2H06 (PFS was reported 11/05).
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.
AZN--see RNVS
BIIB – Tysabri (resubmission) PDUFA date 3/25/06
BOMSF -reporting pivotal MBP8298 results 2 years roughly
CEPH – Sparlon (Provigil for ADHD in kids): panel meeting 3/23/06 (approvable letter issued 10/21/05); Nuvigil for EDS PDUFA date end of 1/06; Oravescent Fentanyl PDUFA date: 7/6/06. Vivitrol: see ALKS.
CONR – CE Mark (EU approval) of CoStar stent: ? (was expected late 2005). Final pleadings in U.K. patent litigation: ? (was expected mid-Dec 2005).
COR - Approx Late Feb 2006: Results of Phase IIa 60 patient ADHD CX-717 Ampakine trial. COR - Approx Late Feb 2006: Results of Phase IIa Simulated Night Shift Work (Sleep Disorder) CX-717 Ampakine trial (funded by DARPA). COR - Mid 2006 or later: PET scan results of Phase IIa 10 patient Alzheimer's CX-717 Ampakine trial (very slow enrollment).
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 - begin FDA pivotal stage of IDE trial this qtr, report on 100+ patients mid year, extend European launch 1st half 06.
CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 results: mid 2007 (#msg-9132392).
DNA - Lucentis: FDA decision on Priority Review expected Feb 2006 (BLA was submitted 12/30/05). Results of PIER study (quarterly dosing) 2Q06.
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
DNA - Rituxan in RA PDUFA 2/28/06 DNA - Rituxan in FL Agg NHL PDUFA 2/22/06.
DNDN - 1H 06 - Results for Ph iii of Provenge efficacy on PSADT in ADPC
DSCO - 2ndQ 06 - Approval for IRDS and market rollout, Phase II ARDS data due in March
ELN – See BIIB
FRX - Milnacipran in fibromyalgia: see CYPB.
GENR – Interim data in phase-2 “209” study: spring 2006.
GPCB – Satraplatin SPARC trial: interim PFS 1Q06/2Q06, final PFS 2H06, final overall survival 2H07.
GTCB – EMEA opinion on ATryn on or about 2/24/06 (CHMP meets 2/20/2-23); Merrimack phase-2b MM-093 in RA: mid 2006.
IDBE -begin pivotal Fluinsure trials this winter.
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 H&N cancer. sBLA pending; PDUFA date is 3/1/06.
LBPFF – PDUFA date for Tramadol NDA: 9/28/06.
Merrimack: see GTCB
MYOG - Ambrisentan phase-3 trials in PAH: ARIES-1 in 2Q06; (ARIES-2 was reported on 12/12/05).
NMTI – Top-line results from MIST migraine trial: March/April 2006.
NVS – Galvus (LAF237) pivotal data in diabetes: early 2006. 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
RHEO – Pivotal trial in dry AMD: data being cleaned – expected report 1Q06.
RNVS-CHANT Phase IIb safety trial during the first quarter of 2006; 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 Triamcinilone: mid 2006; 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: 1H06 (all 3 to be announced simultaneously).
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): triggering events reached 11/14/05; data now in cleanup and analysis.
XNPT 1H2006 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.
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