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: MNT MNTA PIP.


ACHN – ACH-1095 (a.k.a. GS-9525) HCV NS4A inhibitor: start phase-1 4Q08.

ACHN – ACH-1625 HCV protease inhibitor: start phase-1 1Q09.

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

APPA---3Q08--reports results of its pivotal Phase 3 study in chemotherapy-induced nausea and vomiting (CINV) comparing the efficacy of APF530 (a proprietary, sustained release formulation of granisetron) with Aloxi for the prevention of acute and delayed onset CINV in both moderate and highly emetogenic chemotherapy treatments.

BMY – Apixaban phase-3 ADVANCE-1 trial (VTE prevention following in orthopedic surgery): failure reported by PR 8/26/08, full data at ASH Dec08.

CEGE
- GVAX prostate: VITAL-2 failure reported 8/27/08; unplanned futility analysis of VITAL-1 to be reported Sep08.
- GVAX pancreas: leukemia P2 data 2H08.

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

CRXX - CRX-102 (Synavive) in Osteoarthritis COMET-1 expected to announce data (per company) in Oct 08
CRXX - Synavive Extension to COMET-1 (in Osteoarthritis) expected 9 months after COMET-1 (so approx Aug 09).
CRXX - CRx-401 Ph ii as add on in diabetes in 80 patients - expected to announce results in 2H08.

DNDN – Provenge 9902b study: interim analysis October 2008; 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.)

GENZ – Myozyme sBLA for second production site: FDA advisory panel 10/21/08 (manufacturing discussion closed to the public); PDUFA date 11/19/08.

GILD – GS-9525 HCV NS4A inhibitor: see ACHN.

GILD – GS-9190 HCV polymerase inhibitor: new phase-1 trial to test QT-prolongation announced 10/18/2007; further details pending.

GTCB – FDA action on ATryn BLA: PDUFA date is 2/7/09.

GTCB – ATryn phase-2 DIC trial by Leo Pharma in Europe/Canada: report data 2H09.

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

GTCB – Protexia: see PIP.

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 – See #msg-31933767

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

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.

ITMN – ITMN191 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).

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: submit BLA calendar 4Q10 after completion of two ongoing phase-3 trials. (First phase-3 trial reported positive data 10/1/08.)

MNTA – FDA decision on Lovenox ANDA 1Q09. (Response to FDA was submitted on 9/26/08.)

MNTA – M118: report phase-2 data in stable angina: 2Q09; ink partnership deal: mid 2009.

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

NVAX - Phase 2 data for pandemic-flu vaccine... safety and immune response in 230 volunteers next month (august?)

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

OXGN - 4Q 08 File IND for Zybrestat topical in ophthalmology
OXGN - 2H 08 Phase 1 results Zybrestat/Rad. therapy/Cetuximab
OXGN - 2H 08 Partnership (listen to 2Q CC)

PFE – Apixaban program: see BMY

Pharming – Rhucin submission to FDA late 2008; resubmission to EMEA with new data early 2009.

PIP – Protexia start phase-1 any day (guidance was 9/08).

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 – Start phase-2b combination study of RDEA806 in HIV: 4Q08; start phase-1 of RDEA 427 (2nd-gen NNRTI for HIV) 4Q08.
‘
RPRX– Proellex
* Anemia Pivotal PIII trials - results expected by end of 2008
RPRX - Proellex endometriosis ph ii (enrollment ended early (Aug 08) so results estimated by late 4Q08 or early 1Q09)
RPRX - Proellex Uterine Fibroids ph iii (clinicaltrials.org expected end date is March 09)
RPRX - Androxal Phase 2b in male fertility and testicular function: initiated June 2008

SGP – Boceprevir ph-2 trial in treatment-naïve HCV: SVR data for 48-week arms: late 2008 or early 2009. (SVR data for the 28-week arms and SVR12 data for the 48-week arms were reported on 8/4/08: #msg-31189981.)

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

SNTA - Elesclomol Phase III metastatic melanoma: Safety and Futility Interim Analysis (PFS) late 4Q08; Complete enrollment (630) ~ early 1Q09; final PFS analysis (primary endpoint) early 2009; interim OS analysis early 2009 (secondary endpoint)

TARG - PDUFA date for Oritavancin: 12/8/08

UTHR - PDUFA date for Inhaled Treprostinil: 04/30/09
UTHR - Unblind Oral Treprostinil (combo trial) App. Mid November, 2008 [per 9/22/08 UBS conference last patient dosed about 8 weeks to gather and report data]. Note the Oral monotherapy trial will probably complete late Q1/early Q2 (est.)

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.

ZGEN - Atacicept 26 week Ph ii in RA TNF-naive patients 1H10 (but clinicaltrials.org expects in 2H09)

ZGEN - Atacicept 26 week Ph ii in RA TNF inadequate-responders in 2H09

ZGEN - Atacicept small Ph ii in RA in combo with Rituxan. 25 week study with results expected per clinicaltrials.org in 2H10.

ZGEN - Atacicept 48 week Ph ii in MS - clinicaltrials.org expects data 1H10

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