Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Abbott
Laboratories

Humira
(FDA-approved)

Adalimumab; fully human antibody designed to block TNF-alpha

Plaque psoriasis

Phase II trial showed 64% of patients dosed every other week achieved at least a 75% improvement in disease extent and severity after 24 weeks (7/29)

Genentech
Inc.
(NYSE:DNA)
and XOMA Ltd.
(XOMA)

Raptiva (FDA-approved)

Efalizumab; humanized antibody designed to block T cells implicated in psoriasis

Chronic plaque
psoriasis

Preliminary 30-month results from open-label study showed 75% or greater improvement on PASI scores in 78% (124/159) of patients (7/29)

Hemispherx
Biopharma
Inc.
(AMEX:HEB)

Alferon N

Purified mixture of natural alpha interferons

Multiple sclerosis

Got FDA authorization for open-label Phase IIb trial to test safety and efficacy in patients with relapsing-remitting MS who stopped interferon-beta therapy (7/20)

Isotechnika
Inc.
(Canada
TSE:ISA)

TAFA-93

Prodrug of the mTOR inhibitor rapamycin

Various conditions

Got approval for a Phase Ib trial that is expected to start after completion of a Phase Ia trial in Canada (7/7)

Isotechnika
Inc.
(Canada
TSE:ISA)

Trans-ISA247

Immunosuppressive agent

Psoriasis and renal transplantation

SAD trial in healthy volunteers confirmed new formulation was more potent than original mixture, without adverse events (7/6)

The Immune
Response Corp.
(IMNR)

NeuroVax

T-cell receptor peptide vaccine; combines three TCR peptides with an adjuvant

Multiple sclerosis

Presented early Phase II data showing immunological activity and potential inducement of regulatory T cells (7/1)

ZymoGentics
Inc.
(ZGEN) and
Serono SA
(Switzerland;
NYSE:SRA)

TACI-Ig

Soluble fusion protein linking the extracellular portion of the TACI receptor to the Fc portion of human immunoglobulin

Lupus

Began Phase Ib trial in 32 patients to assess systemic and local tolerability, as well as to test pharmacokinetics and effects on biological markers (7/27)

CANCER

Adherex
Technologies
Inc.
(Canada;TSE:AHX)

Exherin

Cadherin antagonist; small-peptide, tumor-vascular-targeting agent

Cancers

Began Phase I trial to test tolerability and pharmacokinetics, as well as activity, in up to 20 patients (7/6)

Celgene Corp.
(CELG)

Thalomid

Thalidomide

Prostate
cancer

Published Phase II results in 75 patients showed combination vs. docetaxel alone improved PSA levels and overall survival (7/1)

Cell Genesys
Inc.
(CEGE)

GVAX

Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF

Prostate cancer

Began Phase III VITAL-1 trial to test GVAX vs. docetaxel in 600 patients with metastatic hormone-refractory disease (7/15)

GTx Inc.
(GTXI)

Acapodene

Toremifene citrate; small-molecule non-steroidal selective estrogen receptor modulator

Prostate cancer

Presented new data from Phase IIa trial in 514 men with high-grade prostatic intraepithelial neoplasia; data suggest drug may be effective in preventing prostate cancer (7/15)

Kosan
Biosciences
Inc.
(KOSN)

DMAG

17-allylamino-17-demethoxy-geldanamycin; second-generation
heat-shock protein 90 inhibitor

Advanced solid tumors

Began first Phase I trial to assess safety, pharmacokinetics and pharmacodynamics of escalating doses (7/21)

Kosan
Biosciences
Inc.
(KOSN)

KOS-862

Epothilone D, a polyketide

Advanced solid tumors

Began Phase Ib trial to evaluate KOS-862 in combination with carboplatin to assess safety, dosing and potential benefit (7/19)

Kosan
Biosciences
Inc.
(KOSN)

KOS-953

17-allylamino-17-demethoxy
-geldanamycin; inhibits
heat-shock protein 90

Multiple
myeloma

Began Phase I trial to evaluate a
new formulation of the drug in
patients with relapsed and refractory disease (7/14)

NeoRx Corp.
(NERX)

Skeletal
Targeted
Radiotherapy

Bone-targeting molecule
DOTMP with radioactive
substance holmium-166

Metastases to the bone

Filed IND for Phase II trial in breast cancer that has spread, and reported encouraging data from a small study in Stage IV disease (7/6)

Onconova
Therapeutics
Inc.*

ON 01910.Na

Non-ATP competitive kinase inhibitor that targets specific checkpoints in the cell cycle

Advanced cancers

Began Phase I trial to evaluate safety in up to 28 patients with advanced or metastatic disease (7/26)

Pharmacyclics
Inc.
(PCYC)

Xcytrin (motexafin gadolinium)

Small-molecule, tumor-targeted agent from the texaphyrin class

Renal-cell carcinoma

Began Phase II trial to evaluate single-agent efficacy and safety in about 40 patients with metastatic disease (7/8)

Prima BioMed
Ltd.
(Australia;
ASX:PRR) and
Biomira Inc.
(Canada; BIOM)

--

MUC1-based immunotherapy
vaccine

Progressive
ovarian cancer

Prima subsidiary CancerVac began a Phase II trial in up to 20 patients who will be treated for one year; CA-125 levels will be measured to assess effect (7/29)

Seattle Genetics
Inc.
(SGEN)

SGN-15

Antibody-drug conjugate that provides targeting to doxorubicin

Non-small-cell lung cancer

Began Phase II trial in 30 patients that will use a biomarker to help evaluate dosing in combination with Taxotere (7/23)

Xenova
Group plc
(UK; XNVA)

TransMID

Modified diphtheria toxin
conjugated to transferrin

Glioblastoma multiforme

Began Phase III trial in up to 323 patients with nonresectable or progressive disease (7/7)

CARDIOVASCULAR

Alexion
Pharmaceuticals Inc.
(ALXN) and Procter & Gamble Pharmaceuticals Inc.

Pexelizumab

Monoclonal antibody; terminal complement inhibitor

Coronary artery bypass graft surgery and acute myocardial infarction

Began pivotal Phase III PRIMO- CABG-2 trial in 4,000 patients in Europe and North America; also began pivotal APEX-AMI Phase III trial in AMI in 8,500 patients worldwide (7/20)

Cardiome
Pharma Corp.
(CRME)

Oxypurinol

Xanthine oxidase inhibitor that is the active metabolite of allopurinol

Congestive heart failure

Monitors recommended the Phase II trial evaluating the product as an add-on therapy continue, after completing a safety analysis (7/9)

Cardiome Pharma
Corp.
(CRME)

RSD1235

Intravenous agent designed to selectively block ion channels
in the heart

Atrial fibrillation

Partner Fujisawa Healthcare Inc. began ACT 3, the third Phase III trial of the drug, to test safety and efficacy in recent-onset patients (7/7)

Corautus
Genetics Inc.
(AMEX:CAQ)

--

Vascular endothelial growth factor-2

Severe cardiovascular disease

Got FDA OK for Phase IIa trial of drug delivered via Boston Scientific Corp.'s Stiletto catheter in up to 404 patients with Class III or IV angina (7/15)

Endovasc
Inc.
(OTC BB:EVSC)

Liprostin

Liposome-encapsulated form of prostaglandin E1

Peripheral vascular disease

Initial assessment from Phase II trial showed improvement in walking distance and pain-free walking (7/19)

Guilford
Pharmaceuticals
Inc.
(GLFD)

Aggrastat (FDA-approved)

Glycoprotein IIb/IIIa receptor antagonist; tirofiban
hydrochloride

Acute coronary conditions

Published data from ADVANCE trial showing significantly reduced primary composite endpoint with heparin vs. heparin and placebo in patients undergoing percutaneous coronary intervention; published data from separate 100- patient trial suggested high-dose tirofiban may be as effective as abciximab for 30-day recovery of left ventricular function in patients undergoing primary coronary angioplasty for STEMI (7/29)

Myogen
Inc.
(MYOG)

Darusentan

Type-A selective endothelin receptor antagonist and inhibitor of endothelin- induced vasoconstriction

Resistant systolic hypertension

Began Phase IIb trial in 105 patients to assess effectiveness of reducing systolic blood pressure (7/15)

NitroMed
Inc.
(NTMD)

BiDil oral agent

Nitric oxide-enhancing

Heart failure

Phase III A-HeFT trial in African-Americans was stopped after a statistically significant survival benefit was seen with the drug (7/19)

Northfield
Laboratories
Inc.
(NFLD)

PolyHeme

Oxygen-carrying blood substitute derived from human blood

Blood loss

Monitors recommended Phase III suburban ambulance trial continue without modification, after an initial review of data (7/21)

Nuvelo
Inc.
(NUVO)

Alfimeprase

Modified fibrolase delivered via catheter; thrombolytic agent

Occluded central venous catheters

Closed Phase II trial early, with 56 patients, after preliminary efficacy and no safety concerns were seen (7/12)

TargeGen Inc.*

TG100-115

Selective kinase inhibitor

Heart attack

Got FDA OK for Phase I/II trial in 100 patients (7/19)

Titan
Pharmaceuticals
Inc.
(AMEX:TTP)

DITPA

3,5-diiodothyropropionic acid; thyroid hormone analogue

Congestive heart failure

The U.S. Department of Veterans Affairs began a 150- patient Phase II trial vs. placebo (7/26)

CENTRAL NERVOUS SYSTEM

Aderis
Pharmaceuticals
Inc.*

Rotigotine

Dopamine receptor agonist delivered transdermally via a patch

Restless legs syndrome

Partner Schwarz Pharma AG said Phase IIb trial in 310 patients demonstrated a statistically significant reduction in symptoms (7/12)

Boston Life
Sciences Inc.
(BLSI)

Axosine

Small-molecule axonal growth factor

Motor function recovery after a stroke

Filed IND for 27-patient Phase I trial that would test three dose levels (7/26)

Cobalis Corp.
(OTC BB:CBSC)

PreHistin

Product believed to mediate IgE synthesis

Migraine

Planning Phase II trial to test the product's ability to mitigate the onset of migraine (7/26)

Endo
Pharmaceuticals
Inc.
(ENDP)

Oxymorphone

Extended-release formulation of oxymorphone

Pain

Reached agreement with FDA on trial to assess safety and efficacy as called for in 2003 approvable letter (7/7)

KetoCytonyx
Inc.*

KTX 0101

Sodium beta-hydroxybuty-rate; a ketone used as an alternative energy system

Cognitive impairment in CABG surgery

Began Phase I trial to evaluate tolerability and pharmacokinetics in up to 20 volunteers (7/7)

Metaphore
Pharmaceuticals
Inc.*

M40403

Small molecule that mimics the activity of superoxide dismutase

Post-operative pain

Began Phase II trial in combination with morphine in 300 patients following first metatarsal bunion-ectomy surgery (7/8)

Myriad
Genetics
Inc.
(MYGN)

Flurizan (MPC-7869)

R-flurbiprofen; acts on NFkB, a transcriptional activator

Alzheimer's disease

Presented 21-day Phase I data from 48 healthy older persons showing the drug was safe and well tolerated (7/20)

Neurochem
Inc.
(Canada; NRMX)

Alzhemed

Small molecule designed to interfere with association between glycosaminoglycans and A-beta protein

Alzheimer's disease

Presented interim data from open-label Phase II trial showing stabilized or improved cognitive function even after 20 months (7/18)

Vernalis plc
(UK; VNLS)

Frova

Frovatriptan; 5HT 1B/1D agonist

Menstrually associated migraine

Published Phase III results demonstrated the drug significantly reduced the incidence of MAM in women who took it preventively (7/28)

Xenome Ltd.*
(Australia)

Xen2174

Agent from the chi cono-peptide class, derived from the venom of the coneshell, that selectively inhibits the norepinephrine transporter

Nueropathic pain

Began Phase I trial in Australia to evaluate safety and tolerability in up to 20 healthy males (7/20)

XenoPort
Inc.*

XP13512

Transported produg of the approved agent gabapentin (Pfizer Inc.'s Neurontin)

Restless legs syndrome and post-herpetic neuralgia

Began Phase IIa trial to assess safety, tolerability, pharmacokinetics and preliminary efficacy in each indication (7/14)

Xenova Group
plc
(UK; XNVA)

TA-NIC

Therapeutic vaccine

Nicotine addiction

Phase I trial in 60 smokers showed dose-dependent anti-nicotine antibody responses, as well as increased quit rates; a dose was selected for further trials (4/14)

DIABETES

Amylin
Pharmaceuticals
Inc.
(AMLN) and Eli Lilly
and Co.

Exenatide

Incretin mimetic; synthetic exendin-4

Type II diabetes

Six-month study comparing exenatide and insulin glargine showed similar glycemic control, and weight- loss benefits in the exenatide group (7/26)

ConjuChem
Inc.
(Canada;
TSE:CJC)

DAC:GLP-1

Insulinotropic hormone GLP-1 created with firm's DAC technology

Type II diabetes

Phase II monotherapy trial met endpoints related to glucose control, but nausea was seen as a dose-limiting factor (7/15)

Cytomedix
Inc.
(CYME)

AutoloGel
System

Autologous platelet gel composed of growth factors and fibrin matrix

Diabetic foot ulcers

Began treatment phase of a trial comparing product to standard of care (7/14)

Ligand Pharmaceuticals
Inc.
(LGND) and Eli Lilly
and Co.

Naveglitazar (LY818; formerly LY519818)

Oral peroxisome proliferator-activated receptor modulator; gamma dominant, alpha-gamma dual agonist

Type II diabetes

FDA guidance calling for data on two-year rodent studies before long-term trials of PPAR drugs will delay development 18-24 months; Ligand also said Phase II trial produced statistically significant results in primary and secondary endpoints (7/8)

INFECTION

AnorMED Inc.
(Canada; TSE:AOM)

AMD070

Agent targeting CXCR4 chemokine receptor to prevent HIV from entering and infecting healthy cells

HIV

Phase Ia trial in 30 healthy volunteers showed drug generally was safe and well absorbed; Phase Ib/II trial is being planned (7/9)

Epimmune
Inc.
(EPMN)

EP HIV-1090

DNA vaccine encoding 21 CTL epitopes from conserved regions of multiple HIV proteins

HIV

Presented preliminary Phase I data showing drug appeared to be safe and well tolerated in HIV patients (7/13)

ID
Biomedical Corp.
(Canada; IDBE)

FluINsure

Nonliving, subunit vaccine for intranasal administration

Influenza

Field study in 1,349 healthy subjects in Canada demonstrated encouraging results (7/20)

GenVec Inc.
(GNVC)

--

HIV vaccine candidate that uses GenVec's gene delivery technology

HIV

An NIH unit began a Phase I trial to assess safety and immune response (7/28)

Gilead Sciences
Inc.
(GILD)

Viread and Emtriva (both FDA-approved)

Nucleotide and nucleoside reverse transcriptase inhibitors, respectively

HIV

Published data from Study 903 showed comparable success in suppressing HIV for Viread and stavudine at 144 weeks; Study 301a showed a regimen with Emtriva was superior to one containing stavudine (d4T) (7/11)

Idun
Pharmceuticals
Inc.*

IDN-6556

Inhibitor of caspase enzymes that mediate apoptosis

Hepatitis C-induced liver damage

Began Phase II trial in up to 200 HCV patients to test if the drug can decrease liver damage (7/29)

Incyte Corp.
(INCY)

Reverset

Nucleoside analogue reverse transcriptase inhibitor

HIV

Phase II Study 202 trial in 40 patients showed drug was tolerted and resulted in reduced viral load; company is enrolling 180 patients in Phase II Study 203 (7/12)

InSite Vision
Inc.
(AMEX:ISV)

AzaSite (ISV-401)

Formulation of azithromycin formulated with DuraSite delivery vehicle

Bacterial conjunctivitis

Began two pivotal Phase III trials, one with 550 patients and the other with 775 patients (7/21)

Oscient Pharmaceuticals
Corp.
(OSCI)

Ramoplanin

Naturally occurring
antibiotic

Vancomycin-resistant enterococci infections

Ended enrollment in the RAVE trial, which was designed to enroll 950 patients but was only two-thirds complete after four years (7/19)

Osel Inc.*

Lactin-V

Product exploiting naturally occurringmucosal bacteria

Bacterial vaginosis

Began Phase I trial of the product (7/19)

Panacos
Pharmaceuticals
Inc.*

PA-457

Small-molecule maturation inhibitor designed to block a step in processing of the HIV Gag protein

HIV

Presented Phase I data showing the drug was well tolerated at all doses, with good oral bioavailability and favorable pharmacokinetics (7/14)

Peninsula
Pharmaceuticals
Inc.*

Doripenem
(S-4661)

Agent from the carbapenem class of beta-lactam antibiotics

Ventilator-associated pneumonia

Began sixth and final pivotal Phase III trial, which will compare doripenem with imipenem in patients with VAP (7/13)

Trimeris Inc.
(TRMS)

Fuzeon
(FDA-approved)

Enfuvirtide; HIV fusion inhibitor

HIV

Presented data from analysis of 1,000 patients showing suppression of HIV and continuous increases in immune cells over 96 weeks (7/12)

Vertex Pharmaceuticals Inc. (VRTX)

Lexiva
(FDA-approved)

Fosamprenavir calcium;
protease inhibitor

HIV

48-week SOLO trial showed drug with ritonavir once daily provided comparable antiviral suppression to twice-daily nelfinavir (7/8); 48-week Phase III CONTEXT trial showed effective viral suppression using that combination or with lopinavir and ritonavir in patients who had failed prior PI- containing regimens (7/12); drug with abacavir and lamivudine demonstrated sustained efficacy and safety after 96 weeks of treatment (7/13)

Vical
Inc.
(VICL)

--

Prophylactic, cationic lipid- formulated, bivalent plasmid DNA vaccine

Anthrax infection

Began Phase I trial in up to 52 healthy adult volunteers to assess safety and immune responses (7/21)

ViroPharma Inc. (VPHM)

Maribavir

Benzimidazole compound; oral inhibitor of cytomega-lovirus

Prevention of CMV infection

Began Phase II program in 108 CMV-seropositive subjects who have undergone allogeneic stem cell transplantation (7/27)

MISCELLANEOUS

Arena
Pharmaceuticals
Inc.
(ARNA)

APD356

Small-molecule, selective 5HT2C serotonin receptor agonist

Obesity

Phase Ia trial showed a pharmacological effect and positive tolerability data (7/14); began Phase Ib trial to evaluate safety over 14-day dosing period in otherwise healthy overweight volunteers (7/26)

BioMarin
Pharmaceutical
Inc.
(BMRN)

6R-BH4

Enzyme co-factor; the active ingredient in the company's investigational agent

Phenylketonuria

Pilot study in 20 patients showed positive effect on phenylalanine blood levels (7/20)

CollaGenex
Pharmaceuticals
Inc.
(CGPI)

Periostat (FDA-approved)

Doxycycline hyclate

Periodontitis

180-patient trial showed a statistically significant benefit for drug, Atridox and scaling and root planning vs. SRP alone (7/6)

ConjuChem Inc. (Canada; TSE:CJC)

DAC:GRF

Growth-releasing hormone modified with company's DAC technology

Growth hormone deficiency

Data from 30 volunteers in Phase I trial showed safety and tolerability, and increases in growth hormone and insulin-like growth factor-1 plasma levels (7/19)

Critical Therapeutics
Inc.
(CRTX)

CTI-01

Ethyl pyruvate; small molecule believed to inhibit release of cytokines

Inflammatory conditions

Began second Phase I trial to further assess safety and tolerability in 60 healthy subjects (7/20)

Dynavax Technologies
Corp.
(DVAX)

--

Inhaled immunostimulatory sequences

Asthma

Phase IIa challenge study demonstrated safety, and showed statistically significant pharmacological activity (7/28)

Indevus
Pharmaceuticals
Inc.
(IDEV)

Sanctura (FDA-approved)

Trospium chloride; anti-cholinergic compound; muscarinic receptor antagonist

Overactive bladder

Presented 12-month data showing long-term efficacy and that the product was well tolerated (7/29)

InKine
Pharmaceuticals
Co. Inc.
(INKP)

INKP-102

New-generation sodium phosphate purgative tablet

Bowel cleansing prior to colonoscopy

Phase II study in 214 adults appeared to support move into Phase III trial vs. InKine's approved product, Visicol (7/15)

Insmed
Inc.
(INSM)

SomatoKine

Composition of insulin-like growth factor-1 and its primary binding protein, BP3

Severe short stature due to growth hormone insensitivity syndrome

Six-month analysis from pivotal Phase III trial showed a statistically significant increase in height velocity in children receiving the drug (7/21)

Isolagen Inc. (AMEX:ILE)

Isolagen Process

Autologous cellular therapy

Facial contour deformities

Six-month data from Phase III trial in 146 patients showed a positive response in 82% of those treated with Isolagen (7/28)

Isolagen Inc.
(AMEX:ILE)

Isolagen Process

Autologous cellular therapy

Facial wrinkles

Began two identical pivotal Phase III trials, each with 100 patients split between drug and placebo groups (7/21)

Nymox
Pharmaceutical
Corp.
(NYMX)

NX-1207

Investigational drug for BPH

Benign prostatic hyperplasia

Said it is moving into Phase II trial following FDA approval of the protocol (7/14); data from 20 men in Phase I/II trial showed a statistically significant improvement in symptoms (7/28)

PTC
Therapeutics
Inc.*

PTC124

Oral agent that targets nonsense mutations (single-point alterations in DNA that stop translation)

Cystic fibrosis and Duchenne muscular dystrophy

Began Phase I trial to evaluate safety, tolerability, and pharmaco-kinetics in healthy volunteers (7/13)

Santarus Inc. (SNTS)

Rapinex (FDA-approved)

Immediate-release powder formulation of the proton pump inhibitor omeprazole

Heartburn

Began pivotal trial comparing 20-mg dose to delayed-release ome-prazole capsules in about 36 healthy subjects (7/15)

Tanox Inc.
(TNOX) and
Genentech Inc.
(NYSE:DNA)

Xolair (FDA-approved)

Omalizumab; humanized monoclonal antibody to IgE

Peanut allergy

Began Phase II trial to evaluate safety and efficacy in about 150 patients (7/7)

Vivus Inc.
(VVUS)

Alista

Topical formulation of alprostadil

Female sexual arousal disorder

Phase II trial in 36 premenopausal women showed a significant increase in satisfying sexual events vs. placebo (7/14)

XOMA Ltd. (XOMA)

XMP.629

Synthetic peptide derived from bactericidal/permeability-increasing protein; gel formulation

Acne

Presented data from Phase I trials showing no problems with skin irritation or systemic absorption, and a reduction in lesion counts in as few as two weeks (7/29)

Zonagen Inc.
(ZONA)

Androxal

Oral antagonist designed to induce production ofendogenous testosterone

Hypogonadism

Phase I/II study in 70 patients produced no side effects and statistically significant changes in testosterone levels (7/1)


Notes:

* Privately held

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

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange.

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