[Please keep entries up to date! See updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: DNDN IDIX.
ACHN – See GILD
ADLR – Approvable letter for Entereg issued 11/6/06 requesting safety data due in 2Q07.
AGIX – ARISE data at ACC March 24-27, 2007.
AMGN – Vectibix PACCE trial in 1st-line CRC (Avastin+FOLFOX+/-Vectibix) interim PFS based on 25% of events: 2Q07 (probably ASCO). (PACCE showed no benefit vs control in RR.) Vectibix final OS from ‘408’ study: any day (low chance of hitting endpoint).
AMLN – Phase-3 LAR results: 2H07; Byetta monotherapy results: 2H07.
ANDS – ANA975 for HCV placed on hold 6/26/06 due to preclinical safety issue; human trials expected to resume at end of 2H07 following FDA analysis of animal tox study.
ANDS – ANA380 in HBV: phase-2b to begin “sometime in 2007.”
ANOR / AOM.TO – pivotal AMD3100 results any day.
ASPM – Interim data from BRITE trial in depression: scientific conference in 2Q07.
BMY – Plavix litigation: trial began 1/22/07.
BMY – Erbitux: see IMCL.
BOMSF -reporting pivotal MBP8298 results 2 years roughly
CEPH – Nuvigil for EDS approvable letter received 4/30/06; on 12/7/06, FDA said it was still studying one case of suspected SJS in Sparlon data set.
CLSC - Two phase 3 Trials 1600-2000 patients to complete in calendar Q4 with public " top line data" on results anticipated for calendar Q1 07. This is a 10 week trial.
COLY – Phase-3 PF-3512676 in NSCLC (by PFE): late 2007 or 2008 (2 trials).
COR – CX-717 tox report to be submitted to FDA in March. (FDA clinical hold was partially lifted 10/9/06.)
CORT – Phase-3 trials of Corlux for psychotic major depression: ‘06’ trial results any day. (The first phase-3 trial called ’07’ reported failed results on 8/25/06; the 2nd phase-3 trial called ‘09’ reported failed results 9/29/06).
CRME - IV RSD1235 NDA refiled, FDA decision likely 4th qtr/07.
CVTX - Ranexa MERLIN data at ACC March 24-27, 2007.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Results timing, will update when company provides timeline.
CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 results: mid 2007 (#msg-9132392).
DDSS (formerly LBPFF) – Response to and appeal of Tramadol approvable letter submitted 12/20/06.
DNA – Avastin in breast cancer: FDA requested additional data confirmation on 9/11/06; resubmission by DNA pending.
DNDN – Provenge BLA: advisory panel 3/29/07; PDUFA date 5/15/07.
DNDN – 9902b study: enrollment complete in 2007; interim data look 1H08.
GPCB – Satraplatin SPARC trial: final overall survival: fall 2007. (The trial hit the primary PFS endpoint on 9/24/06; interim OS look announced on 6/8/06 failed to meet threshold for unblinding.) NDA submitted 2/16/07.
GTCB – ATryn EU launch for HD: June, 2007.
GTCB – ATryn DIC program in EU: start of ph-2 (by Leo Pharma) any day.
GTCB – ATryn ph-3 for HD in U.S.: complete enrollment 1H07, submit BLA 2H07.
GTCB – Merrimack MM-093 phase-2b in RA, phase-2 in psoriasis to be presented at EULAR in June 2007.
GTOP – Final MyVax results Dec 07.
IDIX – Sebivo in EU: endorsed by CHMP 2/23/07; approval expected April-May. (Approved in U.S. 10/06 and in China 3/07.)
IDIX – NM283+ribavirin drug-interaction study: top-line data by PR late June 2007; full data at medical conference in fall 2007 (probably AASLD).
IDIX – Tyzeka phase-3 in decompensated liver disease: enrollment complete in 1Q07 (75% complete as of 9/27/06).
IMCL – (See #msg-9218093 for selected Erbitux trials): 1) CRSYTAL trial in first-line CRC hit its PFS endpoint (announced 1/10/07); full data release at ASCO in June, 2007. 2) Erbitux in NSCLC. OS in 1st-line FLEX study: 2H07. 3) Erbitux in pancreatic cancer, SWOG trial: 1Q07.
ISA.TO - Begin European/Cdn pivotal psoriasis trials this qtr, begin U.S. pivotal psoriasis 07, complete enrollment in renal Phase IIb & also interim renal data 1st qtr 07.
ITMN – Phase-1 PK data for ITMN-191: 2H07.
JNJ: CoStar (CONR) data from U.S. pivotal trial: March 2007 at ACC
LBPFF – see DDSS
Merrimack: see GTCB
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, possible interim results 2007, trial results in 2008.
Novocell – see SRDX
NRMX, NRM.TO – North American Alzhemed trial complete Jan 07, results to follow. European Alzhemed trial complete 1H08 (?). Kiacta (Fibrillex) received an approvable letter on 8/11/06.
NRPH – NRP104 in pediatric ADHD: approvable letter 10/6/06; full approval pending DEA scheduling.
PPHM - Bavituximab phase 1B HCV; four doses monotherapy over 14 days, followed for 12 weeks post-therapy, in previous non-responders/relapsers. Patient enrollment completed Oct 24, trial results due 1Q 07.
PPHM - solid tumor 8-week chemo & Bavituximab combination therapy, info due 1Q '07.
RPRX Proellex *Uterine Fibroids Phase 2 (U.S.) Full Phase 2 data (mid-2007) *One year extension data (4Q2007) *Initiate pivotal trials (YE2007) *Endometriosis Phase 1/2 (Europe) Full Phase 1/2 data (3Q2007) *Initiate U.S. Phase 2 (mid-2007)
Androxal *Male Secondary Hypogonadism Non-pivotal Phase 3 (U.S.) Full non-pivotal Phase 3 data (3Q2007) *Initiate first pivotal Phase 3 (around YE2007)
SGP – Ph-2 data for SCH 503034 in HCV: 2H07
SNY – Acomplia PDUFA date: 4/26/07.
SNY – Plavix litigation: trial began 1/22/07.
Speedel – See NVS.
SPPI – See GPCB.
SRDX - Novocell phase-1/2 trial in type-1 diabetes: late summer 2007 (enrollment complete 8/30/06).
TH.TO -Begin confirmatory TH9507 HIV Associated Lipodystropy trial 1st qtr/07
VRTX – PROVE-1/PROVE-2/PROVE-3 timetable: see #msg-12267294
YMI – AeroLEF final results any day (interim results announced on 9/27/06 failed to meet threshold).
-- 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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