Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Array
BioPharma
Inc.
(ARRY)

ARRY-438162

Small-molecule inhibitor of the protein kinase MEK

Inflammatory diseases

Phase I trial in 20 healthy volunteers met its primary objectives; studies in patients were being planned (10/19)

Aspreva
Corp.
(Canada;
ASPV) and
Hoffmann-La
Roche Inc.

CellCept

Mycophenolate mofetil; an immunosuppressant

Myasthenia gravis

80-patient trial showed no difference in efficacy between drug and prednisone vs. prednisone alone (10/11); 176-patient Phase III trial failed to meet either primary or secondary endpoints (10/26)

Biogen Idec
Inc.
(BIIB) and
Elan Corp.
plc (Ireland)

Tysabri
(FDA-approved)

Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells

Crohn's disease

Data showed drug maintained remission for longer than two years (10/24)

Biogen Idec
Inc.
(BIIB) and
Elan Corp.
plc (Ireland)

Tysabri (FDA-approved)

Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells

Multiple sclerosis

Data from Phase III AFFIRM trial showed drug significantly reduced corticosteroid use and hospitalizations, and decreased disease activity (10/6)

ChemoCentryx
Inc.*

Traficet-EN (CCX282-B)

Oral anti-inflammatory agent that targets the CCR9 chemokine receptor

Crohn's disease

Phase II trial showed a drop in disease activity and in blood levels of C-reactive protein (10/24)

Osiris
Therapeutics
Inc.
(OSIR)

Prochymal

Intravenous formulation of mesenchymal stem cells

Crohn's disease

Pilot Phase II study in those who didn't respond to other therapies showed a statistically significant decrease in disease activity (10/19)

CANCER

Alfacell Corp.
(ACEL)

Onconase

Ranpirnase; cytotoxic ribonuclease

Malignant mesothelioma

Further analysis of Phase IIIa trial showed greater median survival times for drug vs. doxorubicin (10/24)

Allos
Therapeutics
Inc.
(ALTH)

Efaproxyn

Efaproxiral; small molecule designed to sensitize hypoxic areas of tumors during radiation therapy

Brain metastases originating from breast cancer

Monitors recommended pivotal Phase III ENRICH trial continue to completion, following a second interim analysis (10/23)

Antisoma plc
(UK; LSE:ASM)

AS1404

Small molecule derived from xanthenone acetic acid; vascular disrupting agent

Ovarian cancer

Phase II trial showed a response rate of 75% vs. 63% for patients receiving chemotherapy alone (10/15)

AVEO
Pharmaceuticals
Inc.*

AV-412

Next-generation, oral tyrosine kinase inhibitor of EGFR/HER2

Solid tumors

Began Phase I trial to evaluate safety, tolerability and dosing in patients (10/23)

Biogen Idec
Inc.
(BIIB) and
Schering AG
(Germany)

Zevalin (FDA-approved)

Ibritumomab tiuxetan; monoclonal antibody targeting CD20, combined with radioisotope

Diffuse large-B- cell lymphoma

Began Phase III ZEAL trial to evaluate survival in patients taking Zevalin after chemotherapy regimen (10/4)

Biovest
International
Inc.
(OTC BB:BVTI)

BiovaxID

Personalized vaccine; tumor antigen conjugated to KLH administered with GM-CSF

Non-Hodgkin's follicular lymphoma

20 of 25 indolent patients in Phase II trial developed an anti-idiotype immune response; second complete responses were significantly longer than first responses (10/19)

Celgene
Corp.
(CELG)

Revlimid (FDA-approved)

Lenalidomide; derivative of Thalomid (thalidomide)

Advanced non- Hodgkin's lymphoma

Seven of 22 evaluable patients in open-label Phase II trial exhibited an objective response (10/2)

Cellgate Inc.*

CGC-11047

Polyamine analogue that targets proliferating cells

Advanced solid tumors and lymphomas

Began Phase Ib trial to evaluate safety and pharmacokinetics with individual chemotherapeutics, in 70 patients (10/2)

Cerus Corp.
(CERS)

CRS-100

Attenuated strain of Listeria monocytogenes; immunotherapy

Cancers that metastasized to the liver

Began Phase I trial to evaluate dosing, safety and tolerability in patients (10/10)

Cougar
Biotechnology
Inc.*

CB7630

Abiraterone acetate; oral inhibitor of the steroidal enzyme 17 alpha- hydroxylase/C17,20 lyase

Advanced prostate cancer

Eight of 12 patients in Phase I trial experienced reduced PSA levels of greater than 50%; treatment was well tolerated (10/8)

CuraGen Corp.
(CRGN) and
TopoTarget
A/S
(Denmark;
CSE:TOPO)

PXD101

Small-molecule histone deacetylase inhibitor

Cancers

Preliminary data from a Phase II trial and two Phase Ib/II trials, in solid tumors and multiple myeloma, showed encouraging results (10/26)

EntreMed
Inc.
(ENMD)

MKC-1

Small-molecule cell-cycle inhibitor

Non-small-cell lung cancer

Began Phase I/II trial to evaluate safety and dosing with pemetrexed (Alimta); Phase II portion will assess antitumor activity and progression- free survival in up to 60 patients (10/25)

Genmab A/S
(Denmark;
CSE:GEN)

HuMax-EGFr

Zalutumumab; human antibody that targets the epidermal growth factor receptor

Advanced head and neck cancer

Began Phase I/II trial in 36 patients to evaluate first-line treatment in combination with radiotherapy and cisplatin (10/24)

Genta Inc.
(GNTA)

G4460

Antisense agent that targets the oncogene c-myb

Advanced hematologic cancers

Began Phase I trial to evaluate dosing, safety, activity and down-regulation of c-myb in patients(10/13)

Gloucester
Pharmaceuticals
Inc.*

Romidepsin (FK228)

Depsipeptide; histone deacetylase inhibitor

Metastatic hormone- refractory prostate cancer

Data from 22 patients in ongoing Phase II trial showed one partial response, two with stable disease and seven with disease stabilization(10/4)

Hana
Biosciences
Inc.
(HNAB)

Talvesta (PT-523)

Talotrexin; nonclassical antifolate; analogue of aminopterin

Advanced acute lymphoblastic leukemia

Began Phase II trial to evaluate remission rates, as well as other efficacy endpoints (10/31)

ImmunoGen
Inc.
(IMGN)

AVE1642

Antibody that binds to the insulin-like growth factor 1 receptor

Cancers

Partner Sanofi-Aventis SA began clinical testing of the antibody (10/4)

Innovive
Pharmaceuticals
Inc.
(OTC BB:IVPH)

INNO-305

WT1 peptide therapeutic vaccine designed to stimulate both CD8 and CD4 T cells

Hematologic malignancies and solid tumors

Began Phase I trial to study safety, tolerability, pharmacokinetics and preliminary efficacy in WT1-expressing cancers (10/27)

MethylGene
Inc.
(Canada;
TSX:MYG) and
Pharmion
Corp.
(PHRM)

MGCD0103

Class I-specific histone deacetylase inhibitor

Solid tumors

Began Phase I/II trial to evaluate the agent with Gemzar, first testing safety and dosing; the Phase II portion will assess responses in up to 60 patients (10/25)

Northwest
Biotherapeutics
Inc.
(OTC BB:NWBT)

DCVax-Brain

Dendritic cell-based immunotherapy made from patients' cells

Glioblastoma multiforme

Updated trial data showed 44% of drug patients were progression-free vs. 11% for historical controls; survival at two years was improved (10/30)

Novacea Inc.
(NOVC)

Asentar (DN-101)

High-dose oral formulation of calcitriol

Cancers

Phase I trial demonstrated safety and tolerability (10/30)

Rexahn Corp.*

RX-0201

Signal inhibitor that blocks production of the protein kinase Akt

Cancers

Successfully concluded Phase I trial in patients with advanced cancers (10/17)

Vion
Pharmaceuticals
Inc.
(VION)

Cloretazine (VNP40101M)

Sulfonylhydrazine DNA alkylating agent

Advanced small- cell lung cancer

Initial data on 36 patients from single-agent Phase II trial showed a response rate of 32% (10/26)

Ziopharm
Oncology
Inc.
(ZIOP)

ZIO-101

Organic arsenic agent

Solid tumors

Data from ongoing Phase I trial showed benefit in eight of 29 patients (10/3)

ZymoGenetics
Inc.
(ZGEN)

--

Interleukin-21

Metastatic stage IV renal cell cancer

Began Phase I/II trial to evaluate safety and activity of the agent in combination with the approved drug Nexavar (sorafenib) (10/17)

CARDIOVASCULAR

Amgen Inc.
(AMGN)

AMG 531

Peptibody protein designed to stimulate the thrombopoietin receptor

Immune thrombocytopenic purpura

Phase I/II trial demonstrated increased blood platelet counts (10/19)

AVI
BioPharma
Inc.
(AVII)

Resten-MP

Intravenous delivery of AVI-4126, an antisense drug targeting the c-myc transcription factor

Cardiovascular indications

Preliminary data from Phase II APPRAISAL trial demonstrated encouraging safety and delivery results (10/31)

AVI
BioPharma
Inc.
(AVII)

AVI-5126

New generation of antisense drug

For use in coronary artery bypass grafting

Began pivotal trial to evaluate the product in 600 patients under-going CABG procedures (10/18)

CardioVascular
BioTherapeutics
Inc.
(OTC BB:CVBT)

--

Formulation containing Cardio Vascu-Grow, a stimulator of angiogenesis

Peripheral artery disease

Began Phase I trial to evaluate safety and the growth of new blood vessels in the legs of 24 patients (10/24)

CoGenesys
Inc.*

Cardeva

Long-acting form of B-type natriuretic peptide

Heart failure

Began Phase I/II trial to evaluate safety and tolerability in up to 80 stable patients with Class II or III heart failure (10/11)

Corautus
Genetics Inc.
(VEGF)

VEGF-2

Vascular endothelial growth factor in the form of naked plasmid DNA

Severe angina

Final data from GENASIS Phase IIb trial failed to show statistical significance in improving exercise tolerance time in any dose group (10/10)

DeCode
Genetics Inc.
(Iceland; DCGN)

DG031 (veliflapon)

Inhibitor of 5-lipoxygenase activating protein, or FLAP

Prevention of heart attack

Voluntarily suspended Phase III trial due to an unexpected formulation problem with the tablets being used in the trial (10/5)

Metabasis
Therapeutics
Inc.
(MBRX)

MB07811

Liver-targeting thyroid hormone receptor agonist

Hyperlipidemia

Began Phase I trial to evaluate safety and tolerability in healthy volunteers (10/30)

Momenta
Pharmaceuticals
Inc.
(MNTA)

M118

Anticoagulant agent that binds to anti-thrombin III and thrombin

Acute coronary syndromes

Began Phase I trial in up to 36 healthy adult males to evaluate safety, tolerability and pharmaco- kinetics (10/10)

Omrix Bio-
pharmaceuticals
Inc.
(OMRI)

--

Topical, human plasma- derived thrombin

For use in general surgeries

Pivotal Phase III trial demonstrted equivalence to bovine thrombin; a BLA filing was planned for November (10/16)

Paion AG*
(Germany) and
Forest
Laboratories Inc.

Desmoteplase

Genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat

Acute ischemic stroke

Monitors put Phase IIb/III DIAS-2 trial on hold pending further data analysis (10/25); patient enrollment was resumed with no modification of the protocol (10/28)

Portola
Pharmaceuticals
Inc.*

--

Intravenous formulation of its ADP receptor antagonist; an antiplatelet agent

Cardiovascular indications

Began a Phase I trial of the product (10/31)

Renovis Inc.
(RNVS) and
AstraZeneca plc
(UK)

NXY-059

Neuroprotectant with free radical-trapping properties

Acute ischemic stroke

Pivotal Phase III SAINT II trial did not demonstrate a statistically significant reduction on stroke- related disability vs. placebo; secondary endpoints also were missed (10/26)

Titan
Pharmaceuticals
Inc.
(AMEX:TTN)

DITPA

Analogue of thyroid hormone (T3)

Congestive heart failure

Discontinued further enrollment in Phase II trial; resources are being focused elsewhere (10/25)

CENTRAL NERVOUS SYSTEM

Ceregene
Inc.*

CERE-120

Gene therapy consisting of an adeno-associated virus vector carrying the gene for neurturin

Parkinson's disease

Phase I trial in 12 patients showed a 40% reduction in symptoms; treatment was well tolerated (10/10)

Durect Corp.
(DRRX) and
Voyager
Pharmaceutical
Corp.*

Memryte

Durin implant technology with leuprolide acetate

Alzheimer's disease

Voyager ended Phase III trials in order to get an earlier look at potential efficacy; 600 patients had been accrued (10/19)

Medivation
Inc.
(AMEX:MDV)

Dimebon

Neuroprotectant agent that's been on the market in Russia since 1983

Huntington's disease

Began Phase I/IIa trial to evaluate safety, tolerability and preliminary efficacy in 75 patients (10/19)

Neurogen
Corp.
(NRGN)

NG2-73

Selective modulator of gamma aminobutyric (GABA) receptors

Insomnia

Began Phase II trial that will evaluate the efficacy and safety of five different dose and formulation profiles of the drug (10/30)

NeurogesX
Inc.*

Transacin (NGX-4010)

High-concentration trans- capsaicin dermal patch

Post-herpetic neuralgia

Phase III trial in 420 patients demonstrated statistically significant pain reduction vs. a control patch (10/18)

Neurologix
Inc.
(OTC BB:NRGX)

--

Adeno-associated virus delivering gene encoding glutamic acid decarboxylase

Parkinson's disease

One-year data from Phase I trial in 12 patients showed statistically significant improvement from baseline; safety and tolerability also were demonstrated (10/17)

Santhera
Pharmaceuticals
AG*
(Switzerland)

SNT-MC17

Idebenone; small molecule optimized to facilitate the transport of electrons within mitochondria

Friedreich's ataxia

Phase II trial in 48 patients demonstrated safety and a trend toward improved neurological parameters (10/6)

Somaxon
Pharmaceuticals
Inc.
(SOMX)

Silenor

Low dose of the approved depression drug doxepin

Transient insomnia

Phase III trial in 565 patients demonstrated statistically significant improvements in sleep onset vs. placebo, and on other sleep-related endpoints (10/23)

Titan
Pharmaceuticals
Inc.
(AMEX:TTP)

Probuphine

Product designed to continuously deliver the approved drug buprenorphine

Opioid dependence

Began Phase III trial to evaluate safety and efficacy vs. placebo in 150 patients (10/25)

TorreyPines
Therapeutics
Inc.
(TPTX)

Tezampanel

AMPA/kainate receptor antagonist

Acute migraine

Began Phase IIb trial to evaluate pain relief and other endpoints in 300 patients (10/16)

DIABETES

Emisphere
Technologies
Inc.
(EMIS)

--

Insulin delivered with company's oral eligen technology

Type II diabetes

Phase II trial met the company's safety and efficacy objectives (10/30)

Sirtris
Pharmaceuticals
Inc.*

SRT501

Agent that targets SIRT1, a member of the human sirtuin family of enzymes

Type II diabetes

Phase I trial in healthy volunteers demonstrated safety and tolerability; began Phase Ib trial in 90 patients to evaluate safety and pharmacokinetics (10/4)

INFECTION

Advanced
Life Sciences
Holdings Inc.
(ADLS)

Cethromycin

Second-generation ketolide antibiotic agent

Acute bacterial sinusitis

Presented data from studies that supported selection of 300-mg dose for further studies (10/13)

Alnylam
Pharmaceuticals
Inc.
(ALNY)

ALN-RSV01

RNAi agent designed to silence the RSV nucleo- capsid "N" gene; inhaled formulation

Respiratory syncytial virus

Began Phase I trial to evaluate safety, tolerability and pharmacokinetics in healthy adult volunteers (10/11)

AVI
BioPharma
Inc.
(AVII)

AVI-4065

Neugene antisense compound

Hepatitis C

Exploratory study in 12 patients failed to show efficacy; a change in protocol was planned (10/4)

Crucell NV
(the Netherlands;
CRXL)

--

AdVac-based tuberculosis vaccine; uses Ad35 adenovirus vector

Tuberculosis

Began Phase I trial to evaluate safety, tolerability and immuno-genicity in 24 healthy volunteers (10/25)

GlobeImmune
Inc.*

GI-5005

Targeted immunotherapy expressing a NS3-Core fusion protein

Hepatitis C

Phase Ib trial showed generation of cellular immune responses in 12 of 29 patients, and elicited a statistically significant improvement in alanine amino transferase levels (10/30)

Hollis-Eden
Pharmaceuticals
Inc.
(HEPH)

Neumune

Immune-regulating hormone

Infections and acute radiation syndrome

Phase I trial in healthy volunteers demonstrated positive safety and hematopoietic data (10/13)

Human
Genome
Sciences Inc.
(HGSI)

Albuferon

Long-acting form of interferon alpha, created with albumin fusion technology

Hepatitis C

Interim data from Phase IIb trial with ribavarin showed positive quality-of-life results through week 12 (10/16); Phase II data showed comparable efficacy to pegylated interferon in treatment-naïve patients (10/31)

Idenix
Pharmaceuticals
Inc.
(IDIX)

Tyzeka
(FDA-approved)

Telbivudine; oral, once-daily nucleoside analogue

Hepatitis B

Presented favorable data from the second year of the GLOBE study and from other clinical trials (10/27)

Idenix
Pharmaceuticals
Inc.
(IDIX)

Valopicitabine (NM283)

Oral nucleoside analogue

Hepatitis C

Phase IIb trial with pegylated interferon showed favorable viral suppression at 24 weeks in treatment-naïve patients (10/27)

MedImmune
Inc.
(MEDI)

CAIV-T

Trivalent vaccine; next generation of FluMist; refrigerator-stable formulation

Influenza

Trial in 52 children demonstrated higher antibody responses than the traditional injectable trivalent inactivated flu vaccine (10/13)

Pharmasset
Inc.*

R7128

Polymerase inhibitor; prodrug of the agent PSI-6130

Hepatitis C

Began Phase I trial to evaluate safety and pharmacokinetics in healthy volunteers, and antiviral activity in patients (10/27)

PowderMed
Ltd.*
(UK)

DNA-based trivalent vaccine delivered via needle-free injection device

Influenza

Is starting Phase I trial to evaluate safety, tolerability and immuno-genicity (10/2)

Sequella Inc.*

SQ109

Inhibitor of cell wall synthesis in certain microorganisms

Tuberculosis

Began Phase I trial to evaluate safety and pharmacokinetics in 46 healthy volunteers (10/3)

Starpharma
Holdings Ltd.
(Australia;
ASX:SPL)

VivaGel

Vaginal microbicide gel

Prevention of genital herpes

Began Phase I trial that will evaluate safety in 60 volunteers (10/24)

Theravance
Inc.
(THRX)

Telavancin

Lipoglycopeptide; bactericidal injectable antibiotic

Complicated skin and skin-structure infections

Additional data from Phase III ATLAS 1 and ATLAS 2 trials demonstrated non-inferiority to vancomycin (10/10)

Vertex
Pharmaceuticals
Inc.
(VRTX)

VX-950

Telaprevir; oral HCV protease inhibitor

Hepatitis C

Phase Ib trial with pegylated interferon showed suppression of both wild-type HCV and resistant variants; also, trial showed 24 of 26 patients who took drug plus peg-FN and ribavirin had undetectable HCV RNA (10/27)

ViroPharma
Inc.
(VPHM)
and Wyeth

HCV-796

Orally dosed hepatitis C viral polymerase inhibitor

Hepatitis C

Began Phase II trial to evaluate safety, tolerability, pharmacokinetics and antiviral activity when used with pegylated interferon alfa-2b plus ribavirin (10/24)

MISCELLANEOUS

Adenosine
Therapeutics
LLC*

Apadenoson (ATL146e)

Selective adenosine A2A agonist; anti-inflammatory agent

Various conditions

Began Phase Ib trial to evaluate safety, dosing and anti-inflammatory proof of principle (10/25)

Advanced
Magnetics Inc.
(AMAG)

Ferumoxytol

Intravenously administered bioavailable iron

Iron replacement in anemic chronic kidney disease

Monitors found no safety concerns in review of data from 1,200 patients in Phase III trial (10/23)

Amylin
Pharmaceuticals
Inc.
(AMLN)

Symlin (FDA-approved)

Pramlintide acetate; an analogue of human amylin

Obesity

52-week data from Phase II trial showed a 7% to 8% weight reduction vs. 1% reduction for placebo; company plans several studies testing drug with neurohormones for obesity (10/24)

Auxilium
Pharmaceuticals
Inc.
(AUXL)

AA4500

Injectable enzyme product

Peyronie's disease

89% of patients in Phase II trial who received three treatments achieved clinical success (10/25)

Auxilium
Pharmaceuticals
Inc.
(AUXL)

TestoFilm

Testosterone replacement transmucosal film product

Hypogonadism

Development of the formulation, which was in Phase III comparative trials, was discontinued due to insufficient commercial viability (10/18)

Collegium
Pharmaceutical
Inc.*

--

Agent incorporating both a sedating and nonsedating antihistamine

Allergic rhinitis

Began proof-of-concept study of the combination product (10/4)

Critical
Therapeutics
Inc.
(CRTX)

--

Controlled-release formulation of zileuton (Zyflo), a 5-lipoxygenase inhibitor

Asthma

613-patient trial produced favorable safety and efficacy data vs. placebo and Zyflo (10/25)

Discovery
Laboratories
Inc.
(DSCO)

Surfaxin

Engineered version of natural human lung surfactant

Broncho- pulmonary dysplasia

Phase II trial in 136 premature infants demonstrated safety and tolerability, and encouraging signs of efficacy (10/11)

Dynavax
Technologies
Corp.
(DVAX)

AIC

Toll-like receptor 9 agonist linked to ragweed allergen

Ragweed allergy

Pilot study showed treatment reduced allergic responses and sustained that effect more than 12 months (10/4)

EPIX
Pharmaceuticals
Inc.
(EPIX)

PRX-07034

Highly selective 5-HT6 receptor antagonist

Obesity

Began Phase I trial to evaluate safety, tolerability and pharmacokinetics in otherwise healthy obese adults; earlier Phase I trial demonstrated tolerability (10/24)

Genaera
Corp.
(GENR)

Evizon (squalamine)

Anti-angiogenesis agent; vascular endothelial growth factor inhibitor

Wet age-related macular degeneration

Data from Phase II trial showed no significant increase in systolic or diastolic blood pressure (10/16)

Inspire
Pharmaceuticals
Inc.
(ISPH)

--

Epinastine nasal spray formulation

Seasonal allergic rhinitis

Began Phase II program that will evaluate formulations and dosing (10/10)

Manhattan
Pharmaceuticals
Inc.
(AMEX:MHA)

Oleoylestrone

Oral, synthetic form of Oleoylestrone

Obesity

Began Phase IIa trial to evaluate safety and efficacy in 24 morbidly obese male subjects (10/12)

LAB
International
Inc.
(Canada;
TSX:LAB)

LAB CGRP

Calcitonin gene-related peptide; vasodilative agent

Asthma

Crossover Phase II study in 12 patients showed statistically significant broncho-protective effects vs. placebo (10/4)

Microbia Inc.*

Linaclotide (MD-1100)

Peptide designed to act on guanylate cyclase-C, a receptor found on intestinal cells

Chronic constipation

Phase IIa trial demonstrated tolerability and safety, and improvements in bowel function (10/24)

Nabi Bio-
pharmaceuticals
(NABI)

PhosLo (FDA-approved)

Calcium acetate; phosphate binder

Stage IV kidney disease

EPICK study achieved its primary endpoint of superior serum phosphorus control vs. placebo; secondary endpoints also were met (10/16)

NicOx SA
(France;
Eurolist:NICOX)

HCT 3012 (naproxcinod)

Nitric oxide-donating derivative of naproxen

Osteoarthritis of the knee

Phase III trial demonstrated statistical significance vs. placebo on all three co-primary efficacy endpoints (10/27)

Orexigen
Therapeutics
Inc.*

Excalia

Combination of bupropion, a dopamine and norepinephrine reuptake inhibitor, and the approved anticonvulsant zonisamide

Obesity

Phase IIa trial in 127 nonsmokers demonstrated increased weight loss vs. placebo (10/22)

Regeneron
Pharmaceuticals
Inc.
(REGN)

IL-1 Trap

Agent designed to attach to and neutralize interleukin-1

CIAS1-associated periodic syndromes

Both Phase III trials met their primary endpoints of improving disease activity (10/30)

Repligen
Corp.
(RGEN)

RG1068

Synthetic human secretin

Pancreatic disease

Began study to evaluate the diagnostic utility of the product in MRI of the pancreas in 45 healthy vol-unteers and patients (10/30)

PTC
Therapeutics
Inc.*

PTC124

Oral agent that targets nonsense mutations

Duchenne muscular dystrophy

Preliminary data from Phase II trial indicated increases in dystrophin and improvements in muscle enzymes (10/21)

Tanox Inc.
(TNOX)

TNX-650

Humanized monoclonal antibody that targets interleukin-13

Asthma

Began Phase I trial to evaluate safety, tolerability and pharmacokinetics in 32 healthy volunteers (10/25)

Theravance
Inc.
(THRX)

TD-5108

Selective 5-HT4 receptor agonist

Chronic constipation

Began Phase II trial to evaluate safety and efficacy of a range of doses in 350 patients (10/9)

Trine
Pharmaceuticals
Inc.*

Crofelemer

Agent extracted from the rain- forest plant Croton lechleri

Diarrhea- predominant irritable bowel syndrome

Began Phase IIb trial to evaluate efficacy and safety in 240 women with D-IBS (10/30)

Urigen NA*

U101

Intravesical formulation of FDA- approved components

Pelvic pain of bladder origin

Phase II trial did not meet primary endpoint of improved pain and urgency; positive trends were seen (10/30)

Vivus Inc.
(VVUS)

Qnexa
(formerly
VI-0521)

Agent incorporating low doses of the approved products phentermine and topiramate

Obesity

Phase II trial demonstrated a statistically significant weight loss and a reduction in waist size; lipid levels also were reduced (10/23)

XenoPort
Inc.
(XNPT)

XP19986

Transported prodrug of the generic spasticity drug R-baclofen

Gastro- esophageal reflux disease

Phase IIa trial demonstrated tolerbility and statistically significant reductions in reflux episodes and reflux-associated heartburn symptoms (10/22)


Notes:

* Privately held.

BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment.

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSX = Toronto Stock Exchange.

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