Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Genentech Inc.
(NYSE:DNA) and
Biogen Idec
Inc.
(BIIB)

Rituxan (FDA-approved)

Rituximab; antibody that targets and depletes CD20- positive B cells

Multiple sclerosis

Phase II trial in 104 relapsing- remitting MS patients showed a statistically significant reduction in gadolinium enhancing T1 lesions (8/28)

Kemia Inc.*

KC706

Anti-inflammatory agent; inhibitor of p38 MAP kinase

Various indications

Phase I trial demonstrated safety, tolerability and bioavailability in healthy volunteers (8/23)

La Jolla
Pharmaceutical
Co.
(LJPC)

Riquent

Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA

Lupus

Began Phase III trial under FDA SPA that will evaluate time to renal flare in 600 patients from 10 countries (8/9)

Millennium
Pharmaceuticals
Inc.
(MLNM)

MLN0415

Selective, small-molecule inhibitor of IKK2

Various indications

Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in up to 72 healthy volunteers (8/30)

CANCER

Abeille
Pharmaceuticals
Inc.*

AB-1001

Transdermal patch that delivers a commercially available 5HT3-antagonist

Chemotherapy- induced nausea and vomiting

Began Phase II irritation and sensitization study in 240 healthy volunteers (8/9)

Allos
Therapeutics
Inc.
(ALTH)

PDX

Pralatrexate; next- generation antifolate

Advanced peripheral T-cell lymphoma

Began pivotal Phase II trial under FDA SPA to evaluate responses and survival in 100 patients (8/29)

Argos
Therapeutics
Inc.*

AGS-003

Second-generation, dendritic cell-based personalized immunotherapy

Advanced kidney cancer

Began Phase I/II trial to evaluate activity and safety in 26 patients with newly diagnosed, metastatic disease (8/17)

Avantogen Oncology Inc.
(OTC BB:AVTO)

RP101

Antiviral drug marketed in Europe that downregulates the STAT3 and APEX genes

Advanced pancreatic cancer

Phase I trial with gemcitabine in patients established the dose for further testing (8/17)

Celldex
Therapeutics
Inc.*

CDX-110

Epidermal growth factor receptor variant III peptide

Ovarian and prostate cancers

Phase I trial demonstrated tolerability and induction of specific immune responses in patients expressing the mutant receptor (8/23)

Cell
Therapeutics
Inc.
(CTIC)

Xyotax

Paclitaxel linked to a biodegradable polyglutamate polymer

Esophageal and gastric cancers

Four of 12 patients in Phase I trial with radiation had a complete response, and seven had a partial response (8/23)

Cell
Therapeutics
Inc.
(CTIC)

Pixantrone

Anthracycline agent designed to have improved properties

Relapsed non- Hodgkin's lymphoma

Phase III EXTEND trial will continue after encouraging response data were seen in a review of the first 40 patients (8/8)

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

PXD101

Small-molecule histone deacetylase inhibitor

Aggressive B-cell lymphoma

Began Phase II trial to evaluate tolerability and responses in up to 40 refractory patients (8/24)

CuraGen
Corp.
(CRGN) and
TopoTarget

A/S
(Denmark;
CSE:TOPO)

PXD101

Small-molecule histone deacetylase inhibitor

Advanced solid tumors

Began Phase I trial to evaluate safety, tolerability and pharmacocokinetics, as well as antitumor activity (8/10)

CuraGen
Corp.
(CRGN) and
TopoTarget

A/S
(Denmark;
CSE:TOPO)

PXD101

Small-molecule histone deacetylase inhibitor

Advanced hematologic malignancies

Began Phase I trial to evaluate safety and tolerability in combination with azacitidine in up to 15 patients (8/8)

Enzon
Pharmaceuticals
Inc.
(ENZN)

Oncaspar (FDA-approved)

PEG-enhanced version of the naturally occurring enzyme L-asparaginase

Advanced solid tumors and lymphomas

Began Phase I trial to evaluate safety and dosing in combination with Gemzar (8/1)

Exelixis Inc.
(EXEL)

XL647

Small-molecule inhibitor of the HER2, EGF, VEGF and EphB4 receptor tyrosine kinases

Metastatic non- small-cell lung cancer

Began Phase II trial in advanced patients to evaluate safety and tolerability, as well as responses and survival (8/1)

GPC Biotech
AG
(Germany;
FSE:GPC) and
Spectrum
Pharmaceuticals
Inc.
(SPPI)

Satraplatin

Oral platinum compound

Advanced non- small-cell lung cancer

Began Phase II trial to evaluate drug with Tarceva as a first-line therapy in patients 70 years of age and older (8/2)

Hana
Biosciences
Inc.
(HNAB)

Marqibo

Vincristine sulfate liposomes injection

Advanced acute lymphoblastic leukemia

Began Phase II trial with pulse dexamethasone to evaluate efficacy in up to 44 patients (8/17)

Hana
Biosciences
Inc.
(HNAB)

Sphingosome Encapsulated Vinorelbine

Targeted liposomal formulation of the microtubule inhibitor vinorelbine

Advanced solid tumors

Began Phase I trial to evaluate safety, tolerability and preliminary efficacy in patients (8/3)

Medarex Inc.
(MEDX) and
Ono Pharma-
ceutical Co.
Ltd. (Japan)

MDX-1106 (ONO-4538)

Fully human anti-PD-1 antibody

Cancer

Starting Phase I trial to evaluate pharmacokinetics and safety in up to 39 patients (8/1)

MethylGene
Inc.
(Canada;
TSE:MYG)

MGCD0103

Oral histone deacetylase inhibitor

Advanced Hodgkin's lymphoma

Began single-agent Phase II trial to evaluate responses and other endpoints in up to 35 patients who failed other therapies (8/22)

Oncolys
BioPharma
Inc.*
(Japan)

Telomelysin

Adenovirus carrying human telomerase gene promoter sequence

Solid tumors

Is starting Phase I trial in patients resistant to other treatments (8/28)

Raven
Biotechnologies
Inc.*

RAV12

High-affinity IgG1 chimeric antibody

Adeno- carcinomas

Interim Phase I data from 15 patients showed a partial remission in one patient and stable disease in three patients (8/15)

SGX
Pharmaceuticals
Inc.
(SGXP)

Troxatyl

Troxacitabine; nucleoside analogue

Acute myelogenous leukemia

Monitors in Phase II/III trial evaluating drug in third-line setting said drug was unlikely to show efficacy; the trial was discontinued (8/28)

YM BioSciences
Inc.
(Canada;
TSE:YM)

Tesmilifene

Small molecule designed to augment the activity of chemotherapy agents

Advanced breast cancer

Monitors in pivotal Phase III trial of drug with chemotherapy recommended continuation of study, following their second safety and efficacy review(8/22)

CARDIOVASCULAR

Cytokinetics
Inc.
(CYTK)

CK-1827452

Oral formulation; direct cardiac myosin activator

Heart failure

Began Phase I trial to evaluate pharmacokinetics in healthy volunteers (8/23)

Decode
Genetics Inc.
(Iceland; DCGN)

DG051

Small-molecule inhibitor of leukotriene A4 hydrolase

Prevention of heart attack

Began Phase I trial to evaluate safety, tolerability and pharmacokinetics (8/14)

Icagen Inc.
(ICGN)

ICA-17043

Small-molecule ion channel inhibitor

Sickle cell disease

Monitors recommended ending enrollment in Phase III trial for those not on concurrent hydroxyurea therapy, about half the patients, due to lack of efficacy (8/4)

Inspire
Pharmaceuticals
Inc.
(ISPH)

INS50589 Antiplatelet

Inhibitor of the platelet P2Y12 adenosine diphosphate receptor

For use in cardiac surgery

Phase II trial was terminated after interim analysis showed bleeding complications (8/7)

Predix
Pharmaceuticals
Inc.
(merged
with Epix Pharma-
ceuticals Inc.)

PRX-08066

Small-molecule serotonin 5-HT2B antagonist

Pulmonary hypertension

Began Phase II trial to evaluate efficacy and safety in 72 patients with PH associated with chronic obstructive pulmonary disease (8/7)

CENTRAL NERVOUS SYSTEM

Accera Inc.*

Ketasyn (AC-1202)

Neuronal cell-targeting agent that acts to increase mitochondrial activity

Age-associated memory impairment

Began Phase IIa trial to evaluate safety and efficacy in patients ages 50 to 85 (8/23)

Adolor
Corp.
(ADLR)

ADL5859

Oral Delta opioid receptor agonist

Pain

Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in healthy volunteers (8/30)

BioDelivery
Sciences
International
Inc.
(BDSI)

BEMA LA

Long-acting formulation of an undisclosed analgesic

Pain

Proof-of-concept study in normal volunteers produced positive pharmacokinetic results (8/16)

Corcept
Therapeutics
Inc.
(CORT)

Corlux

Mifepristone; oral GR-II antagonist with potential mitigating effects on cortisol

Psychotic major depression

First of three Phase III trials failed to demonstrate efficacy vs. placebo for both primary and secondary endpoints (8/25)

NovaDel
Pharma Inc.
(AMEX:NVD)

Zolpidem oral spray

Formulation of the active ingredient in Ambien

Insomnia

Began bioequivalance trial to evaluate pharmacokinetic profile vs. Ambien in healthy volunteers (8/8)

Pain
Therapeutics
Inc.
(PTIE)
and King
Pharmaceuticals
Inc.

PTI-202

Long-acting, abuse- resistant opioid agent

Pain

Began Phase I trial to evaluate the agent in humans (8/2)

Pharmos
Corp.
(PARS)

Cannabinor (PRS-211,375)

CB2-selective synthetic cannabinoid agent

Pain

Began second Phase IIa trial to evaluate analgesic activity and safety in healthy subjects with capsaicin-induced pain (8/10)

TorreyPines
Therapeutics
Inc.

NGX426

Oral prodrug of tezampanel, an AMPA/ kainate receptor antagonist

Migraine and neuropathic pain

Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in 30 healthy volunteers (8/7)

Transition
Therapeutics
Inc.
(Canada;
TSE:TTI)

AZD-103

Scyllo-cyclohexanehexol; oral agent that acts on beta amyloid

Alzheimer's disease

Is starting Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in healthy volunteers (8/1)

DIABETES

Advanced Viral
Research Corp.
(OTC BB:ADVR)

AVR118

Peptide-nucleic acid complex with immuno-modulatory properties

Type II diabetes

Interim Phase I data demonstrated safety; no effects were seen on blood glucose levels in those receiving oral hypoglycemic therapies (8/10)

Alantos
Pharmaceuticals
Holdings Inc.*

ALS 2-0426

Small-molecule inhibitor of dipeptidyl peptidase IV

Type II diabetes

Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in 50 healthy volunteers (8/16)

INFECTION

Advancis
Pharmaceutical
Corp.
(AVNC)

Amoxicillin Pulsys

Amoxicillin formulation delivered with once-daily pulsatile Pulsys technology

Pharyngitis/ tonsillitis

Phase III trial in patients with strep throat achieved its desired microbiological and clinical end-points (8/10)

Ambrilia
Biopharma
Inc.
(Canada;
TSE:AMB)

PPL-100

HIV protease inhibitor

HIV

Phase I trial demonstrated safety, tolerability and a favorable pharmacokinetic profile (8/17)

Anacor
Pharmaceuticals
Inc.*

AN2690

Small-molecule, boron-based topical agent

Onychomycosis

No drug was detected in the bloodstream of 15 patients in a Phase I trial (8/9)

Cerexa Inc.*

Ceftaroline

Next-generation, broad- spectrum, injectable cephalosporin agent

Complicated skin and skin structure infections

Phase II trial in 100 patients showed a clinical cure rate of 96.8% vs. 88.9% for those treated with vancomycin (8/2)

Cubist
Pharmaceuticals
Inc.
(CBST)

Cubicin (FDA-approved)

Daptomycin for injection; a bactericidal antibiotic

S. aureus bacteremia and endocarditis

Phase III trial vs. dual-therapy standard of care demonstrated non-inferiority (8/16)

Enzo
Biochem Inc.
(NYSE:ENZ)

StealthVector HGTV43

Retrovirus-based vector used to transfer three antisense genes

HIV

Data from Phase I trial showed long- erm presence of the engineered CD34+ stem cells and engineered CD4+ immune cells; Phase I/II trial is under way (8/15)

GenVec Inc.
(GNVC)

--

HIV vaccine using GenVec's adenoviral vector technology with a DNA prime vaccine

HIV

The Vaccine Research Center began the first human studies, which will evaluate safety and immunogenicity in 15 patients (8/22); data from Phase I trials showed favorable safety and immunogenicity results (8/31)

Genzyme
Corp.
(GENZ)

Tolevamer

Non-antibiotic polymer therapy

C. difficile- associated diarrhea

Phase II trial demonstrated a similar treatment outcome as vancomycin in time to resolution of diarrhea, and a trend toward reduced recurrence (8/15)

Iomai Corp.
(IOMI)

--

Vaccine patch

Travelers' diarrhea

Began Phase II trial to evaluate safety and frequency of E. coli infection in volunteers traveling to Mexico and Guatemala (8/15)

Tanox Inc.
(TNOX)

TNX-355

Humanized anti-CD4 monoclonal antibody; viral entry inhibitor

HIV

Phase II trial with optimized background regimen produced a sustained virologic response through 48 weeks (8/17)

Theravance
Inc.
(THRX)

Telavancin

Lipoglycopeptide; bactericidal injectable antibiotic

Complicated skin and skin structure infections

Phase III ATLAS I and ATLAS II trials in 1,867 patients demonstrated better rates of cure and microbio- logical eradication than vancomycin (8/22)

VaxGen Inc.(PK:VXGN)

rPA102

Recombinant protective antigen anthrax vaccine

Anthrax infection

Phase I trial showed a relationship between the dose and the immune response; no toxicity was seen (8/14)

Vical Inc.
(VICL)

--

Vaccine based on Vical's DNA delivery technology, boosted by an adenoviral vector vaccine

HIV

A Phase I trial sponsored by the National Institutes of Health was initiated (8/22); Phase I trial in 40 patients demonstrated safety, tolerability and induction of T-cell immune responses (8/31)

ViRexx
Medical Corp.
(Canada; TSE:VIR)

HepaVaxx B Vaccine

Vaccine containing a a hepatitis B viral antigen and part of a murine monoclonal antibody

Hepatitis B

No significant adverse events were seen in a Phase I trial in 15 healthy volunteers (8/9)

ViroPharma
Inc.
(VPHM)
and Wyeth

HCV-796

Oral hepatitis C virus polymerase inhibitor

Hepatitis C

Preliminary data from Phase Ib trial with pegylated interferon showed encouraging activity (8/28)

MISCELLANEOUS

Athernagen
Inc.*

ATG003

Eye-drop formulation of the anti-angiogenic agent mecamylamine

Age-related macular degeneration

Began a Phase I trial to evaluate ocular tolerability and safety (8/21)

Critical
Therapeutics
Inc.
(CRTX)

Zileuton I.V.

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

Asthma

Phase I/II trial demonstrated tolerability and improvements in lung function vs. placebo (8/23)

Halozyme
Therapeutics
Inc.
(AMEX:HTI)

Enhanze

Delivery platform based on recombinant human PH20 hyaluronidase

Agent designed to enhance absorption of large molecules

Began trial to evaluate pharmaco-kinetics, safety and tolerability of a protein drug injected both with and without rHuPH20 (8/8)

Isotechnika
Inc.
(Canada;
TSE:ISA)

TAFA93

Small-molecule mTOR inhibitor; prodrug of rapamycin

Various indications

Phase I trials demonstrated safety and tolerability in healthy volunteers (8/21)

MAP
Pharmaceuticals
Inc.*

MAP0010

Nebulized formulation of budesonide for inhalation

Asthma

Began Phase II trial to evaluate asthma control in 225 pediatric and adolescent patients (8/2)

Nastech
Pharmaceutical
Co. Inc.
(NSTK)

PYY(3-36)

Nasal spray formulation of the Y2 receptor agonist

Obesity

Began study in 12 obese subjects to evaluate pharmacokinetics, safety and efficacy measures (8/14)

Omrix Bio-
pharmaceuticals
Inc.
(OMRI)

Omr-IgG-am

Intravenous immunoglobulin

Primary immune deficiency

Partner FFE Enterprises Inc. is starting a Phase III trial (8/17)

OrthoLogic
Corp.
(OLGC)

Chrysalin (TP508)

Synthetic peptide that mimics certain attributes of the thrombin molecule

Wrist fractures

Interim data from 240 patients in Phase IIb trial did not show benefit vs. placebo; secondary end- points also were missed; the trial was discontinued (8/29)

Palatin
Technologies
Inc.
(AMEX:PTN)
and King
Pharmaceuticals
Inc.

Bremelanotide

Melanocortin receptor agonist

Female sexual arousal disorder

Phase IIa pilot study in post- menopausal women showed 73% of drug patients reported an increased level of genital arousal vs. 23% for placebo (8/3)

PDL
BioPharma Inc.
(PDLI) and
Orphan
Therapeutics
LLC*

Terlipressin

Peptide derived from the natural hormone lysine-vasopressin

Type 1 hepatorenal syndrome

Phase III trial showed a trend toward improvement but did not achieve statistical significance for primary endpoint of treatment success (8/3)

Progenics
Pharmaceuticals
Inc.
(PGNX)
and Wyeth

Oral methylnaltrexone

Peripheral mu opioid receptor antagonist

Opioid-induced constipation

Began Phase II trial to evaluate efficacy and dosing in 200 to 400 patients (8/22)

Serono SA
(Switzerland;
NYSE:SRA)

--

Recombinant human growth hormone

HIV-associated adipose redistribution syndrome

Phase III HARS trial met all primary and major secondary efficacy endpoints; a supplemental NDA is on file with the FDA (8/17)

Sirna
Therapeutics
Inc.
(RNAI)

Sirna-027

Chemically modified short interfering RNA targeting vascular endothelial growth factor receptor-1

Age-related macular degeneration

Phase I trial demonstrated safety and tolerability, and all 26 patients showed visual acuity stabilization eight weeks after a single injection (8/10)

Vyteris
Holdings Inc.
(OTC BB:VYHN)

Actyve

Transdermal drug delivery technology

Infertility

Phase I trials demonstrated the delivery of therapeutic levels of a peptide used to treat infertility (8/10)


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; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; TSE = Toronto Stock Exchange.

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