Biotech Values

[DewDiligence]

Clinical / Regulatory / Litigation Calendar

[Please keep entries up to date! See updating procedure at the end of this post.]

NOTE: ANYONE MAY UPDATE THIS FILE


Edits: AMGN (deleted entry—HALT data out) INSM LEVP RPRX VPHM.


AMLN – LAR NDA submission: mid 2009 if bioequivalence study needed; earlier if not needed.

BMY Apixaban – phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): data at ASH Dec08; phase-2 in ACS: data at European Society of Cardiology Sep08.

CEGE
- 2H08: GVAX pancreas, leukemia P2 data
- 1H09: GVAX prostate VITAL-2 P3 enrollment completion and interim analysis
- 2H09: GVAX prostate VITAL-1 P3 Final Analysis

CYT.TO - Initiated pivotal A-fib trial Oct/06. Complete enrollment 2nd/half 07. Results 2nd half 08.

DNDN – Provenge 9902b study: interim analysis 2H08; final analysis (304 deaths) 2H09.

ELN – AAB-001 phase-3: Interim data 2H09 (est.), final data 2H10 (est.). (First patient dosed 12/21/07.)

ELN – ELND005 for AD phase-2: Interim data mid 2009 (est.), final data 1H10 (est.) (First patient dosed 12/21/07.)

GILD – Viread in HBV: FDA PDUFA date 8/11/08. (Approved in EU Apr08.)

GILD – GS9190 polymerase inhibitor for HCV: new phase-1 trial to test QT-prolongation announced 10/18/2007; further details pending.

GTCB – ATryn in US: BLA submission Jul 2008; FDA action: early 2009 (if priority review).

GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: enrollment complete end 2008, data 1H09.

GTCB – Merrimack MM-093: results of phase-2 extension trial in RA: Aug 2008; results of pilot study in uveitis: 2008.

HGSI – Phase-3 Albuferon: report data from genotype-2/3 phase-3 trial: end 2008; report data from genotype-1 phase-3 trial: spring 2009; submit BLA fall 2009.

IDIX – IDX899 phase-2 six-week head-to-head vs Sustiva (IDX899+Truvada vs Sustiva+Truvada): start enrollment 3Q08; report data at CROI Feb 2009.

IDIX – IDX184 nucleotide polymerase inhibitor for HCV: file IND/CTA mid 2008; report first data in patients by year-end 2008.

IDIX – First protease inhibitor for HCV: file IND/CTA in 1H09. (A second PI for HCV to follow soon thereafter.)

ISA.TO-European psoriasis P3 results 2008. Phase II/III Uveitis results 2008.

ITMN – ITMN-191 Final MAD monotherapy data at AASLD in Oct08 (data from first four cohorts announced at EASL 4/1/08). Data from 14-day triple- combination study: late 2008 (probably not in time for AASLD; trial started 5/29/08).

ITMN - Pirfenidone - CAPACITY Trials enrollment completed May 2007. Top-line results January 2009 (72 week treatment period).

INSM - Iplex trial in MMD phase IIb, data expected late 2008, final results Q109.(optin moment at that time by ipsen/genentech) .
INSM - Iplex in HARS on hold due to cash.
INSM - Iplex expanded acces program for ALS in italy , ALSFRS scale used to collect data, no targets or clinical endpoints set though.
INSM - NDGA phase II trial run by UCSF in prostate cancer started may 2008. Primary data may 2009.

LEVP – See VPHM.

MAXY – Maxy-Seven FVIIa analogue: phase-1 trial in UK to start 2H08. (Go-ahead to start received 6/11/08.)

Merrimack – See GTCB.

MNT – PureTox botulinum toxin: report data from first phase-3 trial calendar 4Q08; submit BLA calendar 4Q10 (after completion of two other phase-3 trials).

MNTA – Lovenox ANDA resubmission: 3Q08. (Prior FDA response received 4/28/08.)

MNTA – M118: report phase-2 data in stable angina at unspecified medical conference in 2H08.

MNTA – M118: start phase-2b in ACS in 2H08.

MNTA – Copaxone ANDA: possible FDA decision in 2009-2010 (ANDA accepted for review on 7/11/08).

MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, interim results mid 2008, trial results in 2009.

NRMX, NRM.TO – European ph-3 Alzhemed trial complete 2008 (N Amer ph-3 failed, as reported 8/26/07).

OXGN - H1 2008 File IND for Zybrestat topical in ophthalmology
OXGN - H1 2008 Results from oxi4503 phase I
OXGN - H1 2008 Final Zybrestat + Avstin phase Ib data

Pharming – Rhucin submission to FDA possibly in 2008; positive phase-3 data reported 6/16/08.

PPHM- Bavituximab (cancer): PII MBC Bavi/Docetaxel 1st stage successful. Trial moves to 2nd stage July 08
PPHM- Bavituximab (cancer): first patient dosed in PII NSC lung cancer trial w/carboplatin/paclitaxel June 08
PPHM- Bavituximab (cancer): approval received to conduct PII MBC trial w/carboplatin/paclitaxel Jan 08
PPHM- Bavituximab (cancer): phase I monotherapy trial, estimated completion Sept 08
PPHM- Bavituximab (viral): phase I trial: HCV / HIV coinfected patients: estimated completion Sept 08
PPHM- Cotara: phase II glioblastoma multiforme trial - next interim update 2H 08
PPHM- Cotara: glioblastoma multiforme US trial - data presented at ASCO 08, estimated completion Sept 08

RDEA – RDEA806 in HIV: start phase-2b combination study 2Q08; report phase-2a mono data at unspecified conference in 2008.

RPRX– Proellex
* Anemia Pivotal PIII trials - results expected by end of 2008
RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008

SGP – Boceprevir ph-2 trial in treatment-naïve HCV: full SVR data late 2008 or early 2009. (SVR12 data for the active arm only was presented at EASL in Apr2008.)

SRDX - Novocell phase-1/2 trial in type-1 diabetes: top-line data due in 2008 (enrollment complete 8/30/06).

VPHM – PDUFA date for Cinryze: 10/14/08.

VRTX – PROVE-3 trial in treatment-experienced HCV: SVR data 4Q08, presumably at AASLD. (EoT and some SVR12 data were reported on 6/9/08.)

VRTX – Interim data from BID-dosing phase-2 Telaprevir trial conducted by Tibotec: 2H08.

ZGEN – IFN-Lambda in HCV: report interim ph1 monotherapy data at AASLD in Oct 2008.

ZGEN – IL21 w Nexavar in RCC: interim ph2 data at EORTC in Oct 2008.

ZGEN – IL21 in melanoma: interim ph2 data at ZGEN’s R&D Day Dec 2008.


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Procedure For Updating Clinical-Trials List

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