Thursday 29 November 2012

SPA Tracker Part 1

I have been spending some time researching companies who have a SPA agreement in place and am compiling a database which I plan to share on my blog.  So far I have about 70 companies with an agreement in place or an agreement pending FDA review.  Interestingly, I have found a significant number of companies either experience a significant delay between receiving the agreement and commencing the study, or cease operations before the the trial is ever started.  The database is a work in progress so I will be publishing it in parts alphabetically.  Here are entries from A-C:

TickerCompanyCompound IndicationSourceSPA AgreementNCT linkPrimary End Date
ASTMAastrom
ixmyelocel-T
End stage CLIhttp://investors.aastrom.com/releasedetail.cfm?ReleaseID=652908http://www.clinicaltrials.gov/ct2/show/NCT01483898?term=ixmyelocel-T&rank=1Mar-15
nilACT BiotechTelatonibGastric cahttp://www.actbiotech.com/FINALACTASCO2011PR2.pdfYesn/an/a
ACUSAcusphere
Imagify
Coronary Imaginghttp://www.acusphere.com/press_releases/ACUS_SPA_agreeement_FINAL.pdfYesn/an/a
ADLSAdvanced Life Sciences
Restanza
CABPCompany suspended operations in 5/2011Yesn/an/a
AEZSAeterna ZentarisAEZS-108Endometrial cahttp://www.aezsinc.com/en/page.php?p=60&q=543Pendingn/an/a
AGX:DE  OTN:GAGXFAgennixTalactoferrin alfa1L NSCLChttp://www.fiercebiotech.com/press-releases/agennix-receives-fast-track-designation-fda-talactoferrin-combination-sunitinib-ren-0Yeshttp://www.clinicaltrials.gov/ct2/show/NCT00706862?term=FORTIS-C&rank=1Jun-15
CMXICytomedix(Aldagen)ALD-301Critical limb ischemiahttp://www.intersouth.com/news/aldagen-reaches-agreement-with-fda-on-a-special-protocol-assessment-spa-for-phase-3-trial-of-ald-301-for-critical-limb-ischemiaYesn/an/a
NPCUFAllonDavunetideProgressive Supranuclear Palsyhttp://www.allontherapeutics.com/2012/11/patient-treatment-completed-in-pivotal-trial-evaluating-allons-davunetide/Yeshttp://www.clinicaltrials.gov/ct2/show/NCT01110720?term=Davunetide&rank=4&submit_fld_opt=Dec-12
ALSE/NAVBAlseres Pharma/NavideaAltropaneParkinson's disease imaginghttp://ir.alseres.com/releasedetail.cfm?ReleaseID=375770Yeshttp://www.clinicaltrials.gov/ct2/show/NCT00724906?term=Altropane&rank=2n/a
APRIApricus BioPrevOncoTHCChttp://www.apricusbio.com/press_02172011.htmlNever concluded n/an/a
ABIOARCA BiopharmaBucindololChronic heart failurehttp://www.businesswire.com/news/home/20100517005854/en/ARCA-Announces-Special-Protocol-Assessment-Agreement-FDAYesn/an/a
nilArgos TherapeuticsAGS-003mRCChttp://globenewswire.com/news-release/2012/07/02/272515/260946/en/Argos-Therapeutics-Receives-FDA-Approval-of-Special-Protocol-Assessment-for-AGS-003-Phase-3-Trial.htmlYeshttp://www.clinicaltrials.gov/ct2/show/NCT01582672?term=Argos+therapeutics&rank=8Jun-14
ARQLArquleTivantinibHCChttp://investors.arqule.com/common/mobile/iphone/releasedetail.cfm?ReleaseID=713700&CompanyID=ARQL&MobileID=#Yesn/an/a
OMX:BAVABavarian NordicProstvacmCRPChttp://www.bavarian-nordic.com/investor/announcements/2010-40.aspxYeshttp://www.clinicaltrials.gov/ct2/show/NCT01322490?term=Prostvac&rank=1Dec-14
BIIBBiogenPegylated interferonMShttp://www.biotechnologyevents.com/node/1720Yeshttp://www.clinicaltrials.gov/ct2/show/NCT00906399?term=Biogen+BIIB017&phase=2&rank=1Oct-12
BPAXBioSanteLibigelHSDDhttp://www.biosantepharma.com/News-Releases.php?ID=061112Pendingn/an/a
nilCell>Point
technetium-99m-EC-G
Lung cancer imaginghttp://cellpointweb.com/blog/cellpoint-announces-agreement-with-the-fda-on-a-special-protocol-assessment-for-the-phase-3-technetium-99m-ec-g-lung-cancer-imaging-trial/Yeshttp://www.clinicaltrials.gov/ct2/show/NCT01394679?term=technetium-99m&phase=2&fund=2&rank=9Jun-13
CLSNCelsionThermodoxHCChttp://www.prnewswire.com/news-releases/celsion-receives-fast-track-designation-for-thermodox-development-program-to-treat-primary-liver-cancer-101369159.htmlYeshttp://www.clinicaltrials.gov/ct2/show/NCT00617981?term=THERMODOX&rank=4Dec-12
nilCold GenesysCG0070Non muscle invasive bladder cancerhttp://www.businesswire.com/news/home/20120911005169/en/Cold-Genesys-Announces-Agreement-FDA-Special-ProtocolYeshttp://www.clinicaltrials.gov/ct2/show/NCT01438112?term=CG0070&rank=2Dec-16
CRMDCorMedixCRMD001Contrast-Induced Acute Kidney Injuryhttp://www.cormedix.com/pipeline_CRMD001.phpYeshttp://www.clinicaltrials.gov/ct2/show/NCT01391520?term=CRMD001&rank=2n/a
CYCC/PCyclacelSapacitabineAMLhttp://investor.cyclacel.com/releasedetail.cfm?ReleaseID=614179Yeshttp://www.clinicaltrials.gov/ct2/show/NCT01303796?term=SEAMLESS+cyclacel&rank=1Oct-14
CYTRCytRx
Tamibarotene
Acute Promyelocytic Leukemiahttp://www.cytrx.com/aboutYeshttp://www.clinicaltrials.gov/ct2/show/NCT00520208?term=STAR-1&rank=1Dec-12

I'll be adding to the list periodically and updating so please feel free to comment if there are any companies beginging with A-C that I may have missed.  I would welcome input into expected dates for completion where I have blanks.  I will be compiling a summary review once the whole list is published and welcome your comments.

3 comments:

  1. Does ARCA have a SPA? http://www.news-medical.net/news/20100517/ARCA-biopharma-announces-SPA-agreement-with-FDA-for-bucindolol-clinical-trial.aspx
    What about Neuralstem (CUR) Do they have a spa. It is not here but i guess the company starts with N, even though the symbol starts with C.

    ReplyDelete
  2. Great work - this is a very helpful resource

    ReplyDelete
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