SPA Directory Part 3: L-R

Here is the 3rd portion of the SPA Directory for companies L-R.  As always I welcome your comments on any SPA agreements that are not shown here, especially active ongoing studies.

LCI	Lannett	C-Topical	Local anesthesia	http://www.streetinsider.com/Corporate+News/Lannett+(LCI),+FDA+Reach+Agreement+Over+SPA+for+C-Topical+Phase+III/7054155.html	YES	n/a	n/a
nil	Lantheus	Flurpiridaz F18	Myocardial perfusion imaging	http://www.lantheus.com/News-Press-2011-0311.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01347710?term=Flurpiridaz+F18&rank=1	Dec-12
CSE:VELO	LifeCycle Pharma	LCP-Tacro	Kidney Transplant	http://www.news-medical.net/news/20100812/FDA-grants-LifeCycle-Pharma-SPA-for-LCP-Tacro-pivotal-Phase-3-study-in-de-novo-kidney-transplant-patients.aspx	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01187953?term=LCP-tacro&rank=8	Mar-13
nil	Macrocure	CureXcell	Chronic diabetic ulcers	https://sos.cision.com/node/499686	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01421966?term=macrocure&rank=3	Feb-15
TSE:4508	Mitsubishi Tanabe Pharma Co	Collategene	Advanced PAD	http://www.anges-mg.com/en/news/pdf/20121024.pdf	Yes	n/a	n/a
nil	Nanotherapeutics	Ramoplanin	C Diff	http://www.nanotherapeutics.com/products_pipeline_ramoplanin.php	Yes	n/a	n/a
NLNK	New Link Genetics	HyperAcute immunotherapy	Pancreatic cancer	http://www.linkp.com/products/hyperacute-pancreas.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01072981?term=hyperacute+pancreas&rank=1	Jan-14
nil	NovaRx	Lucanix	Advanced NSCLC	http://www.prnewswire.com/news-releases/novarx-completes-enrollment-in-lucanix-pivitol-phase-iii-therapeutic-vaccine-trial-for-post-frontline-maintenace-therapy-in-non-small-cell-lung-cancer-159688685.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00676507?term=NovaRx&rank=2	Oct-12
OXGI	Oncogenix	Custirsen	Cancer pain in mCRPC	http://oncogenex.com/physicians/custirsen-ogx-011	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01188187?term=Custirsen&rank=6	Dec-13
nil	Onconova	Estybon	Myelodysplastic Syndromes	http://www.eurekalert.org/pub_releases/2010-10/poc-oaf100410.php	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01241500?term=onconova&rank=13	Oct-13	Interim analysis
ONXX	Onyx Pharma	Carfilzomib	2L MM +lenolidomide	http://www.onyx.com/view.cfm/626/onyx-pharmaceuticals-receives-fda-accelerated-approval-of-kyprolis-carfilzomib-for-injection-	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01568866?term=carfilzomib&phase=2&rank=1	Jan-15
OREX	Orexigen	Contrave	Obesity	http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&id=1656731	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01601704?term=orexigen&rank=1	Sep-13
OXGN	Oxigene	Zybrestat	Anaplastic Thyroid Cancer	http://investor.oxigene.com/releasedetail.cfm?ReleaseID=707372	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01701349?term=oxigene&rank=5	Dec-16
nil	Paratek	Omadacycline	ABSSSI	http://www.paratekpharm.com/press/032812_SPA_ECCMID_release.pdf	Yes	n/a	n/a
nil	Paratek	Omadacycline	CABP	http://www.paratekpharm.com/press/032812_SPA_ECCMID_release.pdf	Yes	n/a	n/a
n/a	Pervasis	Vascugel	Fistula/Graft failure prevention	http://www.prnewswire.com/news-releases/pervasis-receives-fda-fast-track-status-for-vascugel-to-prevent-arteriovenous-access-failure-in-patients-undergoing-hemodialysis-115553949.html	Yes	n/a	n/a
PXSL	Pharmaxis	Bronchitol	Bronchiectasis	http://www.prnewswire.com/news-releases/pharmaxis-concludes-special-protocol-assessment-with-fda-for-bronchitol-phase-3-trial-57511597.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00669331?term=pharmaxis&phase=2&rank=4	Jun-13
nil	Polaris Group	ADI-PEG 20	Advanced HCC	http://www.prnewswire.com/news-releases/fda-approves-special-protocol-assessment-for-phase-3-trial-of-polaris-groups-cancer-therapeutic-adi-peg-20-in-the-treatment-of-hepatocellular-carcinoma-118979494.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01287585?term=Polaris+group&rank=1&submit_fld_opt=	Jun-13
PVCT	Provectus	Rose Bengal	Melanoma	http://www.pvct.com/pressrelease.html?article=20121002	pending	n/a	n/a
RPTP	Raptor	DR Cysteamine	Nephropathic Cystinosis	http://ir.raptorpharma.com/releasedetail.cfm?releaseid=633905	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01000961?term=raptor&rank=11	Jun-11
RPRX	Repros	Androxal	Hypogonadism	http://www.reprosrx.com/pr_20120912_repros_updates_androxal_phase_3.php	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01534208?term=REPROS&rank=30	Jul-13

SPA Directory Part 2

Thank-you to everyone who has taken the time to review my last posting.  Below is an update to the directory for companies D-K.

TASE:DPRM	D-Pharm	DP-b99	Acute Ischemic Stroke	http://www.dpharm.com/News.asp?mode=1&type=0&id=133&Year=2011	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00893867?term=D-Pharm&rank=3	Feb-13	Futility analysis
ENDP	Endo Pharma	Urocidin	Bladder ca	http://bioniche.com/news_item.cfm?id=2215		http://www.clinicaltrials.gov/ct2/show/NCT01284205?term=bioniche&rank=5&submit_fld_opt=	n/a	Study withdrawn
EPCT	Epicept	Ceplene	AML	http://investor.epicept.com/releasedetail.cfm?ReleaseID=604432	Pending	n/a	n/a
EPCT	Epicept	Amiket	CIPN	http://investor.epicept.com/releasedetail.cfm?ReleaseID=641427	Pending	n/a	n/a
nil	Essentialis	Diazoxide Choline CR	VHTG's	http://essentialistherapeutics.com/media/Essentialis%20SPA%20Press%20Release%2010-25-10.pdf	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00973271?term=Essentialis&rank=5	Jun-14	My estimate
GALE	Galena	NeuVax	Early stage node+ low-expression HER2 breast cancer	http://www.galenabiopharma.com/pipeline	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01479244?term=NeuVax&rank=1	May-15
GNBT	Generex	AE37	Breast Cancer	http://www.prnewswire.com/news-releases/generex-provides-update-on-company-initiatives-including-the-ae37-breast-cancer-vaccine-program-179098191.html	Pending	n/a	n/a
nil	Helsinn	Netupitant and Palonosetron	CINV	http://www.prnewswire.co.uk/news-releases/fda-agrees-to-special-protocol-assessment-spa-to-evaluate-the-safety-and-efficacy-of-a-fixed-dose-combination-fdc-of-netupitant-and-palonosetron-in-the-prevention-of-cinv-156836265.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01376297?term=Netupitant&rank=1	Sep-12
nil	Hyperion Therapeutics	HPN-100	Urea Cycle Disorders	http://files.shareholder.com/downloads/AMDA-1412CE/0x0x585109/0f970e6e-64cd-430e-9796-995fcab86980/HPTX_News_2012_7_7_General_Releases.pdf	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00992459?term=HPN-100&rank=3	Aug-10
LSE:IMM	Immupharma	Lupuzor	SLE	http://www.immupharma.org/lupuzor	Yes	n/a	n/a
nil	Innocoll	Cogenzia	Wound infections	http://innocollinc.com/cogenzia.html	Yes	n/a	n/a
INSV	InSite Vision	Dexasite/Azasite	Blepharitis	http://phx.corporate-ir.net/phoenix.zhtml?c=86061&p=irol-newsArticle&ID=1631034&highlight=	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01408082?term=Insite+vision&rank=5&submit_fld_opt=	Dec-12
ISA.TO	Isotechnika Pharma	Voclosporin	Kidney Transplant	http://www.isotechnika.com/dnn/LinkClick.aspx?fileticket=UrRyyein3D8%3D&tabid=92&mid=671	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01586845?term=voclosporin&rank=1	Mar-15
nil	ISTA Pharma/B&L	Remura	Dry Eye Syndrome	http://www.prnewswire.com/news-releases/ista-pharmaceuticals-initiates-phase-3-clinical-program-for-remura-in-dry-eye-disease-103037129.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01212471?term=ISTA+bromfenac&rank=4	Dec-11
KERX	Keryx	Zerenex	Hyperphosphatemia in ESRD	http://www.keryx.com/page.cfm?hmid=20&smid=0&pg=4b	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01191255?term=zerenex&rank=2	Dec-12

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:

Ticker	Company	Compound	Indication	Source	SPA Agreement	NCT link	Primary End Date
ASTM	Aastrom	ixmyelocel-T	End stage CLI	http://investors.aastrom.com/releasedetail.cfm?ReleaseID=652908		http://www.clinicaltrials.gov/ct2/show/NCT01483898?term=ixmyelocel-T&rank=1	Mar-15
nil	ACT Biotech	Telatonib	Gastric ca	http://www.actbiotech.com/FINALACTASCO2011PR2.pdf	Yes	n/a	n/a
ACUS	Acusphere	Imagify	Coronary Imaging	http://www.acusphere.com/press_releases/ACUS_SPA_agreeement_FINAL.pdf	Yes	n/a	n/a
ADLS	Advanced Life Sciences	Restanza	CABP	Company suspended operations in 5/2011	Yes	n/a	n/a
AEZS	Aeterna Zentaris	AEZS-108	Endometrial ca	http://www.aezsinc.com/en/page.php?p=60&q=543	Pending	n/a	n/a
AGX:DE  OTN:GAGXF	Agennix	Talactoferrin alfa	1L NSCLC	http://www.fiercebiotech.com/press-releases/agennix-receives-fast-track-designation-fda-talactoferrin-combination-sunitinib-ren-0	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00706862?term=FORTIS-C&rank=1	Jun-15
CMXI	Cytomedix(Aldagen)	ALD-301	Critical limb ischemia	http://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-ischemia	Yes	n/a	n/a
NPCUF	Allon	Davunetide	Progressive Supranuclear Palsy	http://www.allontherapeutics.com/2012/11/patient-treatment-completed-in-pivotal-trial-evaluating-allons-davunetide/	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01110720?term=Davunetide&rank=4&submit_fld_opt=	Dec-12
ALSE/NAVB	Alseres Pharma/Navidea	Altropane	Parkinson's disease imaging	http://ir.alseres.com/releasedetail.cfm?ReleaseID=375770	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00724906?term=Altropane&rank=2	n/a
APRI	Apricus Bio	PrevOncoT	HCC	http://www.apricusbio.com/press_02172011.html	Never concluded	n/a	n/a
ABIO	ARCA Biopharma	Bucindolol	Chronic heart failure	http://www.businesswire.com/news/home/20100517005854/en/ARCA-Announces-Special-Protocol-Assessment-Agreement-FDA	Yes	n/a	n/a
nil	Argos Therapeutics	AGS-003	mRCC	http://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.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01582672?term=Argos+therapeutics&rank=8	Jun-14
ARQL	Arqule	Tivantinib	HCC	http://investors.arqule.com/common/mobile/iphone/releasedetail.cfm?ReleaseID=713700&CompanyID=ARQL&MobileID=#	Yes	n/a	n/a
OMX:BAVA	Bavarian Nordic	Prostvac	mCRPC	http://www.bavarian-nordic.com/investor/announcements/2010-40.aspx	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01322490?term=Prostvac&rank=1	Dec-14
BIIB	Biogen	Pegylated interferon	MS	http://www.biotechnologyevents.com/node/1720	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00906399?term=Biogen+BIIB017&phase=2&rank=1	Oct-12
BPAX	BioSante	Libigel	HSDD	http://www.biosantepharma.com/News-Releases.php?ID=061112	Pending	n/a	n/a
nil	Cell>Point	technetium-99m-EC-G	Lung cancer imaging	http://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/	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01394679?term=technetium-99m&phase=2&fund=2&rank=9	Jun-13
CLSN	Celsion	Thermodox	HCC	http://www.prnewswire.com/news-releases/celsion-receives-fast-track-designation-for-thermodox-development-program-to-treat-primary-liver-cancer-101369159.html	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00617981?term=THERMODOX&rank=4	Dec-12
nil	Cold Genesys	CG0070	Non muscle invasive bladder cancer	http://www.businesswire.com/news/home/20120911005169/en/Cold-Genesys-Announces-Agreement-FDA-Special-Protocol	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01438112?term=CG0070&rank=2	Dec-16
CRMD	CorMedix	CRMD001	Contrast-Induced Acute Kidney Injury	http://www.cormedix.com/pipeline_CRMD001.php	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01391520?term=CRMD001&rank=2	n/a
CYCC/P	Cyclacel	Sapacitabine	AML	http://investor.cyclacel.com/releasedetail.cfm?ReleaseID=614179	Yes	http://www.clinicaltrials.gov/ct2/show/NCT01303796?term=SEAMLESS+cyclacel&rank=1	Oct-14
CYTR	CytRx	Tamibarotene	Acute Promyelocytic Leukemia	http://www.cytrx.com/about	Yes	http://www.clinicaltrials.gov/ct2/show/NCT00520208?term=STAR-1&rank=1	Dec-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.