Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Biogen Inc.
(BGEN)

Amevive

Alefacept; novel immunomodulatory agent that selectively targets the CD45RO+ subset of T cells

Psoriasis

Biogen said that 76% of 21 patients with psoriasis achieved "clear" or "almost-clear" results based on preliminary data (11/22)

Serono SA
(NYSE:SRA)
and Pfizer Inc.

Rebif (FDA-
approved)

Interferon beta-1a

Multiple sclerosis

Clinical results showed that Rebif was more effective than Avonex in reducing relapses and active brain lesions in patients with relapsing remitting MS (11/26)

Teva Pharmaceutical Industries Ltd. (Israel; TEVA)

Copaxone (FDA-
approved)

Oral formulation of
glatiramer acetate

Primary progressive multiple
sclerosis

An interim analysis showed it was "improbable" that the study would reach statistical significance (11/7)

CANCER

AltaRex Corp.
(Canada; TSE:AXO)

OvaRex
MAb

Immunotherapeutic; oregovomab; a fully foreign monoclonal anti- body that targets CA125

Metastatic ovarian cancer

Clinical results showed that OvaRex MAb patients demonstrated a near doubling in time to disease relapse as compared with placebo patients (11/22)

Aton Pharma
Inc.*

SAHA

An inhibitor of histone
deacetylase

Solid tumors, lymphomas and leukemias

Phase I results demonstrated that the oral formulation is readily bioavailable and results in prolongation of acetylated histone accumulation in peripheral blood mononuclear cells compared to an identical dose administered intravenously (11/21)

Biomira Inc.
(Canada; BIOM; TSE:BRA)

BLP25

Synthetic MUC1 therapeutic vaccine consisting of the 25-amino-acid sequence of the MUC1 cancer mucin, encapsulated in liposomes

Non-small-cell lung cancer

Company completed enrollment of 168 patients in its Phase IIb trial (11/13)

Celgene Corp.
(CELG)

Revimid

Orally available agent; immunomodulatory drug

Multiple
myeloma

Phase I/II results showed that 17 of 24 patients, or 71%, experienced at least a 25% reduction in paraprotein (11/1)

Cell Therapeutics
Inc.
(CTIC)

Trisenox
(FDA-
approved)

Arsenic trioxide

Myelodysplasia and chronic myeloid leukemia

Clinical trial results showed an overall objective response rate of 67% (11/8)

Cell Therapeutics
Inc.
(CTIC)

Xyotax

Links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer

Ovarian
cancer

Company plans to conduct a Phase III trial of Xyotax in frontline treatment of ovarian cancer (11/5); Phase II data show that Xyotax may have fewer and less-severe side effects when compared to paclitaxel (11/14)

Cell Therapeutics
Inc.
(CTIC)

Xyotax

Links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer

Non-small-cell lung cancer

Company began Phase III studies (11/22)

Cell Therapeutics
Inc.
(CTIC)

Xyotax

Links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer

Solid tumors

Phase I data showed that 11 of 13 evaluable patients achieved durable disease control, with five patients achieving a partial remission and six patients with stable disease (11/25)

EntreMed Inc.
(ENMD)

ENMD
0995

A derivative of thalidomide

Multiple
myeloma

Company began a Phase I study (11/13)

Essential Therapeutics
Inc.
(ETRX)

ETRX
101 and neutropenia

A small molecule designed to restore lowered blood cell counts due to myelosuppression

Cancer complications, such as mucositis

Company initiated a Phase I trial (11/7)

Eximias Pharmaceutical Corp.*

Thymitaq

Nolatrexed
dihydrochloride

Hepatocellular carcinoma

Company said that 223 patients were enrolled in a Phase III trial, achieving 50% recruitment (11/7)

FeRx Inc.*

--

Hepatic intra-arterial delivery of doxorubicin hydrochloride absorbed to magnetic targeted carriers

Hepatocellular carcinoma

Phase I/II data showed that in 21 lesions on 19 patients there was one complete response, two partial responses, seven minor responses, seven patients with stable disease and four patients with progressive disease (11/20)

Genta Inc.
(GNTA) and Aventis SA (Germany)

Genasense

Antisense compound geared toward blocking the production of Bcl-2

Colorectal cancer and solid tumors

Companies are initiating two trials of Genasense in combination with platinum-based chemotherapy (11/6)

Genta Inc.
(GNTA)

Genasense

Antisense compound geared toward blocking the production of Bcl-2

Small-cell lung cancer

Clinical data showed Genasense was well tolerated when used with standard doses of carboplatin/etoposide; 10 out of 12 patients achieved a major anti-tumor response (11/22)

GenVec Inc.
(GNVC)

TNFerade

Delivers the human tumor necrosis factor-alpha gene to tumors, using GenVec's adenovector gene delivery technology

Esophageal
cancer

Phase Ib results showed 73% of patients had objective tumor shrinkage (11/11); company began a Phase II trial in non-metastatic esophageal cancer (11/14)

GenVec Inc.
(GNVC)

TNFerade

Delivers the human tumor necrosis factor-alpha gene to tumors, using GenVec's adenovector gene delivery technology

Soft tissue
sarcoma

Phase I data showed the product was well tolerated with no dose-limiting toxicities (11/25)

Genzyme
Molecular
Oncology (GZMO)

--

Vaccine made from combining the patient's own cancer cells with immune- stimulating cells to fight the disease

Kidney
cancer

Company began a Phase I/II trial with 20 patients (11/6)

Immuno-Designed Molecules SA* (France)

Uvidem

Vaccine; cell drug containing dendritic cells that have been generated using IDM's technology in the presence of interleukin-13

Melanoma

Company launched a Phase II trial (11/4)

ImmunoGen
Inc.
(IMGN)
and British Biotech plc (UK; BBIOY; LSE:BBG)

huN901-
DM1

Monoclonal antibody-based chemotherapy agent

Small-cell lung cancer

Companies completed the Phase I portion of the Phase I/II study (11/22)

Kosan
Biosciences Inc.
(KOSN) and F. Hoffmann-La Roche Ltd. (Switzerland)

KOS-862

Epothilone D; a polyketide natural product

Cancer

Phase I data showed no apparent myelosuppression (11/20)

Maxim Pharmaceuticals Inc. (MAXM)

Ceplene

Histamine dihydrochloride

Advanced metastatic melanoma

Phase II results demonstrated that combination therapy with Ceplene and interleukin-2 induced significant and measurable increases in the number and function of key activated immune cells that are known to target cancer cells (11/11)

Millennium Pharmaceuticals Inc. (MLNM) and BZL Biologics LLC*

MLN2704

Designed to deliver the maytansanoid chemotherapeutic agent DM1 directly to prostate cancer cells through the MLN691 delivery mechanism, a targeting monoclonal antibody vehicle that binds specifically to the prostate-specific membrane antigen

Prostate
cancer

Companies initiated a Phase I trial (11/21)

NeoPharm Inc.
(NEOL)

IL13-PE38

Tumor-targeting agent

Malignant
glioma

Phase I/II data indicated that it was well tolerated, and that evidence of tumor necrosis and prolonged patient survival was observed (11/26)

NeoPharm Inc.
(NEOL)

LE-SN38

NeoLipid liposomal formulation of SN38, the active metabolite of the cancer drug CPT-11

Colorectal
cancer

Company initiated a Phase I/II trial of LE-SN38 (11/18)

NewBiotics
Inc.*

Thymectacin

Derived from NewBiotics' Enzyme Catalyzed Therapeutic Activation technology

Colon
cancer

Phase I data showed the drug was well tolerated at all dose levels tested (11/20)

Onyx Pharmaceuticals Inc. (ONXX) and Bayer Corp.

BAY
43-9006

A small-molecule Raf kinase inhibitor

Hepatocellular carcinoma

Phase I data showed that 27 out of 114 patients treated at higher doses remained on the drug with no disease progression after more than six months, and seven patients had been treated for more than one year with no disease progression (11/20)

Pharmagenesis
Inc.*

PG490-
88Na

A derivative of a compound from an herb widely used in Chinese medicine

Advanced
solid tumors

Company began Phase I trials (11/6)

Progen Industries (Australia; PGLAF)

PI-88

Semi-synthetic sulfated oligosaccharide that has several modes of action

Cancer

Phase I/II data showed PI-88 was well tolerated and demonstrated encouraging anticancer activity in some patients with advanced cancer (11/25)

Telik Inc.
(TELK)

TLK286

A small-molecule antitumor drug that is activated by GST P1-1

Colorectal
cancer

Phase II data showed a median time to tumor progression of 2.9 months, an increase over both oxaliplatin and 5-FU/LV; the drug also showed an improvement in median survival time (11/20)

Telik Inc.
(TELK)

TLK286

A small-molecule antitumor drug that is activated by GST P1-1

Ovarian
cancer

A Phase II trial in 36 patients had not reached median survival yet, but median survival exceeds 16 months; 63% of patients were still alive (11/20)

Telik Inc.
(TELK)

TLK286

A small-molecule antitumor drug that is activated by GST P1-1

Non-small-cell lung cancer

Phase II data showed the product prolonged expected survival and had significant single-agent activity in patients with highly resistant disease; median survival was nine months, with 38% of patients alive at one year (11/20)

Transgene SA (France; TRGNY)

MVA-Muc1- interleukin-2 vaccine

Uses the highly attenuated MVA vaccinia virus vector to express the Muc1 tumor- associated antigen and the cytokine interleukin-2 (IL-2) in order to stimulate specific T-cell responses

Metastatic
renal cell carcinoma

Company initiated a Phase II trial (11/5)

CARDIOVASCULAR

Alexion Pharmaceuticals Inc. (ALXN)

Pexelizumab

An anti-inflammatory C5 inhibitor monoclonal antibody fragment

Acute myocardial infarction

Phase II data showed the product missed endpoints of infarct size reduction measured at 72 hours, but the trials showed a reduction in 90-day mortality (11/18)

Alteon Inc.
(AMEX:ALT)

ALT-711

A.G.E. crosslink breaker

Systolic hypertension

Company reached the targeted enrollment of 450 patients in a Phase IIb trial (11/12)

CollaGenex Pharmaceuticals Inc. (CGPI)

Periostat
(FDA-
approved)

Doxycycline hyclate

Acute coronary syndrome

Pilot trial results showed Periostat significantly lowered levels of the inflammatory marker C-reactive protein among acute coronary syndrome patients (11/19)

Corvas International
Inc.
(CVAS)

rNAPc2

Recombinant nematode anticoagulant protein c2

Acute coronary syndrome

Company began a Phase II trial to investigate the safety and efficacy of rNAPc2 (11/5)

CV Therapeutics Inc. (CVTX)

CVT-3146

Selective, short-acting A2A adenosine receptor agonist

For patients undergoing cardiac catheterization

Phase II results showed the drug produced a dose-dependent in- crease in coronary blood flow velocity (11/19)

CV Therapeutics Inc. (CVTX)

Tecadenoson

Selective A1-adenosine receptor agonist

Paroxysmal supraventricular tachycardia

Phase III results showed all five dosing regimens converted back into a normal heart rhythm (11/20)

GenVec Inc.
(GNVC)

Biobypass

Angiogenic gene therapy that delivers vascular endothelial growth factor 121

Coronary
artery disease

Phase II data showed an improvement in total time to chest pain on the treadmill and total exercise time on a treadmill at both three and six months (11/20)

Genzyme Biosurgery (division of Genzyme Corp.; GENZ)

--

Autologous cell therapy that uses a transplant of a patient's own cells to stop or reverse damage

Heart
disease

Clinical results showed an improvement in ejection fraction in the 10 patients treated (11/18)

Millennium Pharmaceuticals Inc. (MLNM)

Integrilin
(FDA-
approved)

Eptifibatide; prevents reocclusion of the stented artery by blocking certain receptors, known as GP IIb-IIIa, on platelets responsible for thrombus development

Myocardial infarction

Company started a 6,000-patient Phase III trial of Integrilin (11/11)

The Medicines Company Inc. (MDCO)

Angiomax
(FDA-
approved)

Bivalirudin; anticoagulant

Coronary angioplasty
and stenting

Angiomax was found to be superior to heparin on its own, yielded similar clinical outcomes as com- pared to current standards of care and reduced bleeding and a need for transfusion; the company expects to submit a supplement to update product labeling for Angiomax (11/18)

United
Therapeutics

Corp.
(UTHR)

Remodulin
(FDA-
approved)

Treprostinil sodium; subcutaneous
treatment

Pulmonary arterial hypertension

Data showed that patients treated with Remodulin increased their survival rate to 69.8% at three years (11/20)

Vasogen Inc. (Canada; AMEX: VSV; TSE:VAS)

--

Immune modulation
therapy

Advanced chronic heart failure

Company plans to start a Phase III trial (11/19)

CENTRAL NERVOUS SYSTEM

Aderis Pharmaceuticals Inc.*

Rotigotine
CDS

Constant delivery system; a once-a-day skin patch; a transdermal dopamine agonist

Restless legs syndrome

Phase II data showed the drug was well tolerated at all dose levels and induced a statistically significant reduction in symptoms (11/25)

Avanir Pharmaceuticals Inc. (AMEX:AVN)

Neurodex

An orally administered combination of dextromethorphan and quinidine sulfate

Pseudobulbar affect

Phase II/III results showed Neurodex had statistically greater improvements in the primary end-point (11/19)

CeNeS Pharmaceuticals
plc
(UK; LSE:CEN)

M6G

Morphine-6-glucuronide; a metabolite of morphine

Pain

Phase II data showed the compound has comparable analgesic effects, but with a better side-effect profile, than morphine; the company plans to enter Phase III trials (11/19)

DOV Pharmaceutical
Inc.
(DOVP)

Ocinaplon

A chemically distinct molecule that differentially modulates specific subsets of GABA-A receptors

Generalized anxiety
disorder

Phase II results showed statistically significant reductions in anxiety as compared to placebo after 14 days of dosing (11/4)

Guilford Pharmaceuticals Inc. (GLFD)

GPI 1485

A neuroimmunophilin
ligand

Parkinson's disease

Company initiated a Phase II trial (11/6)

Neurocrine Biosciences Inc. (NBIX)

Indiplon-
IR

Capsules; acts on the
GABA-A receptor

Insomnia

Phase III data demonstrated a statistically significant improvement in the latency to persistent sleep endpoint, and in the latency to sleep onset endpoint (11/14)

Neurogen Corp.
(NRGN)

NGD
97-1

Designed to selectively reduce the activity of the neurotransmitter gamma-aminobutyric acid in the memory centers of the brain

Alzheimer's disease

The drug failed to show a therapeutic effect in a Phase II study (11/12)

NeuroSearch
A/S*
(Denmark)
and Boehringer Ingelheim International GmbH (Germany)

NS2330

Therapeutic compound that increases the
activity of acetylcholine, dopamine and noradrenaline

Alzheimer's disease

Company initiated a Phase IIb trial (11/4)

Oxford GlycoSciences plc (UK; OGSI; LSE:OGS)

OGT 923

N-butylgalactonorjirimycin; an iminosugar and an analogue of Zavesca

Nervous
system diseases, such as Sandhoff and Tay Sachs disease

Company began a Phase I study (11/5)

Repligen Corp.
(RGEN)

RG1068

Human synthetic secretin

Autism

Results of a 12-patient trial showed that secretin is active in the central nervous system and potentiates activity in the amygdala (11/1)

DIABETES

Theratechnologies Inc. (Canada; TSE:TH)

ThGRF

Induces the production of growth hormone in a natural and pulsatile fashion

Diabetes

Company completed the clinical part of its Phase II study (11/28)

INFECTION

Acambis plc
(UK; LSE:ACM)

ChimeriVax- DEN2

Component of Acambis' ChimeriVax-Dengue vaccine

Dengue
fever

Company completed a Phase I trial that showed the vaccine was well tolerated and there were no serious side effects (11/25)

AuRx Inc.*

--

Vaccine

Genital
herpes

Phase I/II data from the low-dose arm showed the recurrence rate was reduced 84% from the previous year and 37.5% of the treated patients had no recurrent episodes, or complete prevention of all symptoms (11/12)

BioMarin Pharmaceutical Inc. (BMRN) and Genzyme General (GENZ)

Aldurazyme

Laronidase; enzyme replacement therapy

Mucopoly-
saccharidosis
I

Phase III data showed that patients maintained improvements after 50 weeks of treatment (11/25)

Gilead Sciences
Inc.
(GILD)

Hepsera
(FDA-
approved)

A nucleotide analogue; adefovir dipivoxil

Lamivudine- resistant hepatitis B
virus

Clinical results showed patients who switched to Hepsera monotherapy or added Hepsera to ongoing lamivudine therapy experienced virological, biochemical and serological improvements through 48 weeks (11/4)

Hollis-Eden Pharmaceuticals Inc. (HEPH)

HE2000

Immune-regulating hormone

Malaria

Phase II data showed that 20 of 21 patients reached the primary endpoint of the trial, and 15 of 21 patients cleared the parasites from the blood within seven days of treatment (11/21)

Human Genome Sciences Inc.
(HGSI)

Albuferon-
alpha

Created by fusing interferon alpha to albumin

Hepatitis C

Phase I results showed the product was well tolerated, had a prolonged half-life and was biologically active in adults with chronic hepatitis C (11/4)

Idenix Pharmaceuticals Inc.*

Telbivudine

A nucleoside that exhibits marked and selective activity against HBV replication in laboratory assays

Hepatitis B

Phase IIb data showed an antiviral response coupled with improvement in ALT levels in patients receiving telbivudine, either alone or in combination with lamivudine (11/5)

Immtech International Inc. (IMMT)

DB289

Oral anti-infective; dicationic pharmaceutical compound

African
sleeping
sickness
(trypano-
somiasis)

Company completed Phase IIa trials (11/13)

Inspire Pharmaceuticals Inc. (ISPH)

INS365 Respiratory

An eye drop that works by activating the P2Y receptor

Chronic bronchitis

Company is discontinuing development of INS365 for chronic bronchitis (11/18)

Inspire Pharmaceuticals Inc. (ISPH)

INS37217

Intranasal; a P2Y2 agonist designed to enhance mucosal hydration and mucociliary clearance in airway tissues by activating receptors on the mucosal surface

Upper respiratory infections

Phase II results demonstrated statistically significant improvement compared to placebo in post-nasal drip and malaise (11/6)

Inspire Pharmaceuticals Inc. (ISPH)

INS37217

Intranasal; a P2Y2 agonist designed to enhance mucosal hydration and mucociliary clearance in airway tissues by activating receptors on the mucosal surface

Allergic
rhinitis

Company began a Phase III trial (11/21)

Intercell AG*
(Austria)

--

Vaccine

Hepatitis C

Company started a Phase II study (11/25)

Isis Pharmaceuticals Inc. (ISIS)

ISIS 14803

Antisense drug;
20-base phosphorothioate oligonucleotide

Hepatitis C

Phase II results showed the drug demonstrated antiviral activity by producing up to 3.8-log reductions in plasma virus levels in patients with chronic hepatitis C virus (11/5)

Ribapharm Inc. (NYSE:RNA)

Viramidine

Antiviral drug; nucleoside analogue structurally related to ribavirin

Hepatitis C

Company plans to begin Phase II trials by the end of the year (11/4)

Romark Laboratories*

Nitazoxanide

A nitrothiazole compound

Crypto-
sporidium
infection

Clinical results showed nitazoxanide significantly reduced the duration of diarrhea and the rate of death in malnourished children (11/4)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Thymalfasin, thymosin
alpha 1

Hepatitis C

Clinical results showed Zadaxin in combination with pegylated interferon alpha increased the early virologic response rates up to 36% in hepatitis C patients who had failed prior therapy (11/4)

Trimeris Inc.
(TRMS)

Fuzeon

Enfuvirtide; a fusion inhibitor

HIV

Phase III data showed Fuzeon, in combination with other antiretrovirals, provided benefit to treatment-experienced HIV patients at 24 weeks regardless of patient demographics, base- line disease stage or treatment history (11/18)

Vertex Pharmaceuticals Inc. (VRTX)

GW433908

Protease inhibitor; calcium phosphate ester prodrug of amprenavir

HIV

Clinical results showed that 68% of HIV-positive patients achieved undetectable viral load with the compound boosted with ritonavir, compared to 65% of patients taking a comparator regimen (11/21)

MISCELLANEOUS

Adolor Corp.
(ADLR)

Alvimopan

Small-molecule opioid
receptor antagonist

Opioid bowel dysfunction

Phase III results showed 43% of patients receiving alvimopan 0.5 mg and 55% of those receiving alvimopan 1 mg had at least one bowel movement within eight hours of each dose, as compared to 29% of those taking placebo (11/11)

Alexion Pharmaceuticals Inc. (ALXN)

Eculizumab

C5 complement
inhibitor

Membranous nephritis

The drug did not reach its primary clinical efficacy endpoint of proteinuria reduction after four months of therapy, but the remission rate was 27% for the 55 evaluable patients who were treated with eculizumab for six months or longer (11/4)

Amgen Inc.
(AMGN)

Aranesp
(FDA-
approved)

Darbepoetin alfa; a recombinant erythropoietic protein

Anemia in chronic kidney disease

Clinical results showed 96% of patients receiving Aranesp reached and maintained target hemoglobin levels (11/4)

AnorMED Inc.
(Canada;
TSE:AOM)

Fosrenol

Lanthanum carbonate;
a phosphate binder

Renal disease

Fosrenol was shown to be effective in reducing high phosphate levels associated with end-stage renal disease (11/4)

AVI BioPharma
Inc.
(AVII)

AVI-4126

Neugene antisense drug

Polycystic kidney disease

The drug was safe in adult patients (11/21)

Exhale Therapeutics Inc.*

ETX-100

A pulmonary therapeutic

Genetic emphysema

Company initiated Phase I trials (11/21)

Galileo Laboratories Inc.*

GLI-8545

Targets C-reactive protein reduction

End-stage
renal failure

Clinical results showed a 52% reduction in serum CRP when orally administered to patients diagnosed with dialysis-dependent end-stage renal disease (11/18)

GenVec Inc.
(GNVC)

AdPEDF

A modified adenovirus,
carrying the transgene
encoding for the PEDF
protein

Age-related macular degeneration

Company began a Phase I trial (11/26)

Hemosol Inc. (Canada; HMSL TSE:HML)

Hemolink

Hemoglobin raffimer; oxygen therapeutic

For patients having orthopedic surgery

Company will begin a Phase II trial (11/20)

Inflazyme Pharmaceuticals Ltd. (Canada; TSE: IZP) and Aventis Pharma AG (Germany)

IPL512,602

Leukocyte-suppressing anti-inflammatory drug

Asthma

Phase Ia and Ib results showed IPL512,602 was safe and well tolerated (11/8)

Isis Pharmaceuticals Inc. (ISIS)

ISIS 2302

Alicaforsen; an antisense inhibitor of intercellular
adhesion molecule-1

Ulcerative
colitis

Company initiated a Phase II trial (11/21)

Novactyl Inc.*

PCL-016

A member of a class of
agents that targets zinc-finger proteins involved in infective disorders

Acne

Company began enrolling patients in a Phase IIa trial (11/26)

SR Pharma plc
(UK; LSE:SPA) and Genesis Research and Development Corp. (New Zealand; ASX:GEN)

SRP299

A killed Mycobacterium
vaccae suspension

Dermatitis

Companies began a Phase II trial (11/25)

Sucampo Pharmaceuticals Inc.*

RU-0211

Part of a class of functional
fatty acids

Occasional constipation

Phase III results showed the agent was effective in treating occasional constipation (11/12)

Transkaryotic Therapies Inc. (TKTX)

Replagal

Agalsidase alfa; enzyme replacement therapy

Fabry's
disease

Phase III data showed no statistical difference between the treatment and placebo in the primary endpoint of renal function (11/27)

Vivus Inc.
(VVUS)

TA-1790

Phosphodiesterase Type 5 inhibitor

Erectile dysfunction

Clinical results showed that peak efficacy response was comparable to or greater than that observed with Viagra (11/7)

Vivus Inc.
(VVUS)

VI-0162

Oral product

Premature ejaculation

Company initiated a trial to evaluate VI-0162 (11/20)


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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange