Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Alexion
Pharmaceuticals
Inc.
(ALXN)

Eculizumab

A humanized monoclonal
antibody C5 complement
inhibitor

Rheumatoid arthritis

Phase IIb study met primary endpoint in the monthly dosing arm; biweekly dosing arm did not improve ACR20 scores (1/28)

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

Antegren (natalizumab)

Humanized monoclonal antibody; alpha-4 antagonist from the selective adhesion molecule inhibitor class

Crohn's disease

Phase III ENACT-2 trial met primary endpoint of response maintenance at six months; the trial followed 428 ENACT-1 patients (1/29)

Celltech Group
plc
(UK; LSE:CCH)

CDP870

Product that uses pegylated antibody fragment technology to target TNF-alpha

Crohn's disease

Company began first of two Phase III trials, named PRECISE-1; the trials are expected to include 1,300 patients at sites around the world (1/6)

ChemoCentryx Inc.*

Traficet-EN

Small molecule that binds to a chemokine receptor involved in trafficking lymphocytes to the bowel

Inflammatory bowel disease

Company started two Phase I trials in 72 healthy volunteers in the UK to assess safety and pharmacokinetics (1/13)

Human Genome
Sciences Inc.
(HGSI)

LymphoStat-B

Human antibody to B-
lymphocyte stimulator

Rheumatoid arthritis

Company began Phase II trial in about 230 patients who have failed prior therapy (1/8)

Isis Pharmaceuticals
Inc.
(ISIS)

ISIS 104838

Antisense TNF-alpha inhibitor

Rheumatoid arthritis

Phase II trial in 157 RA patients showed a statistically significant decrease in disease activity (1/5)

Targeted Genetics
Corp.
(TGEN)

tgAAC94

Product designed to use adeno-associated viral vector
to deliver the DNA sequence encoding an inhibitor of TNF-alpha

Rheumatoid arthritis

Company got approval in U.S. and Canada for Phase I trial expected to be conducted in up to 32 adult subjects who will get a single injection in the affected joint (1/20)

CANCER

Abgenix Inc.
(ABGX) and Amgen
Inc.
(AMGN)

ABX-EGF

Fully human monoclonal antibody that targets the epidermal growth factor receptor

Colorectal cancer

Amgen began a pivotal trial of the drug as a third-line monotherapy; a second trial is being started outside the U.S. (1/20)

Allos Therapeutics
Inc.
(ALTH)

RSR13 (efaproxiral)

Radiation sensitizer; small molecule designed to decrease hemoglobin-oxygen binding affinity

Non-small-cell lung cancer

Allos began a Phase I trial of drug and supplemental oxygen with concurrent chemoradiation therapy in 22 patients with advanced disease (1/28)

Celsion
Corp.
(AMEX:CLN)

ThermoDox

Temperature-sensitive liposomal formulation of doxorubicin

Liver cancer

Company began a Phase I study of the product in combination with radiofrequency ablation (1/8)

Cytokinetics Inc.*

SB-715992

Small molecule directed against kinesin spindle protein, a cytoskeletal protein needed for DNA division

Various tumor types

Partner GlaxoSmithKline plc began a broad Phase II program encompassing various regimens and cancers (1/14)

Dendreon
Corp.
(DNDN)

Provenge

Immunotherapy

Prostate cancer

Updated data from Phase III trial showed an 89% increase in survival compared to placebo in patients with Gleason scores of 7 or less (1/12)

FeRx Inc.*

--

Magnetic target
carriers and mitomycin
C delivered with MagneTarg system

Non-small-cell lung cancer

Company got approval for Phase I/II trial in up to 50 patients who no longer respond to conventional treatments (1/9)

GenVec
Inc.
(GNVC)

TNFerade

Contains TNF-alpha gene and a radiation-responsive promoter

Pancreatic cancer

Data showed product was well tolerated when administered by endoscopic ultrasound or percutaneous injection directly into the tumor; dose-related benefits were seen (1/23)

ILEX Oncology Inc. (ILXO)

Eflornithine (DFMO)

Orally delivered difluoro- methylornithine; selective irreversible inhibitor of ornithine decarboxylase

Superficial bladder cancer

ILEX stopped a Phase III trial conducted with the National Cancer Institute, after the drug failed to beat placebo (1/15)

Immunomedics
Inc.
(IMMU)

Labetuzumab

Humanized monoclonal antibody against carcino- embryonic antigen, labeled with iodine-131

Colorectal cancer

Phase II data showed median survival of 54.2 months in 19 patients who had their liver metastases from colorectal cancer surgically removed; the drug was given after surgery (1/26)

Introgen Therapeutics
Inc.
(INGN)

Advexin

Adenoviral vector containing the p53 tumor-suppressor gene

Non-small-cell lung cancer

Phase II study combining drug and radiation therapy showed 60% of primary tumors regressed or disappeared at three months after treatment (1/26)

Lorus Therapeutics
Inc.
(Canada; TSE:LOR)

GTI-2040

Antisense drug that targets
the R2 component of ribonucleotide reductase

Advanced, end- stage renal- cell cancer

Interim results from Phase II trial in combination with capecitabine showed more than half of 21 pat- ients had disease stabilization (1/12)

Millennium
Pharmaceuticals
Inc. (MLNM)

Velcade (FDA-approved)

Bortezomib; proteasome
inhibitor

Refractory, metastatic colorectal cancer

Company stopped further accrual in Phase II trial after interim data failed to meet predefined efficacy criteria (1/6)

Pharmacyclics
Inc.
(PCYC)

Xcytrin (motexafin gadolinium)

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

Malignant gliomas

Company started a Phase I trial of the drug in combination with Temodar in 25 patients (1/28)

Progen Industries Ltd. (Australia; ASX:PGL)

PI-88

Anti-angiogenesis
drug

Melanoma

Company started a Phase II study in Australia and the U.S. in patients with advanced disease (1/20)

Pro-Pharmaceuticals
Inc.
(AMEX:PRW)

Davant

Carbohydrate compound that targets sugar-specific binding sites on cancer cells

Refractory colorectal cancer

Company started a Phase II trial of drug in combination with 5-FU as a third-line therapy (1/8)

Seattle Genetics
Inc.
(SGEN)

SGN-30

Monoclonal antibody that targets CD30+ hematologic malignancies

Hodgkin's disease and anaplastic large- cell lymphoma

Company began a Phase II trial of the drug as a single agent in up to 40 patients in each indication who have relapsed or are refractory to prior therapies (1/22)

Vion
Pharmaceuticals
Inc.
(VION)

Triapine

Inhibitor of ribonucleotide reductase

Hematologic malignancies

Trials began in collaboration with the National Cancer Institute; the first is a Phase I study with fludarabine in relapsed and refractory disease (1/20)

YM BioSciences Inc. (Canada; TSE: YM)

Tesmilifene (DPEE)

Small molecule designed to augment the activity of chemotherapy agents

Metastatic breast cancer

Published Phase III data showed tesmilifene plus doxorubicin was statistically superior to doxorubicin alone in terms of overall survival (1/29)

CARDIOVASCULAR

Curacyte
AG*
(Germany)

PHP

Pyridoxalated hemoglobin polyoxyethylene

Distributive shock

Phase IIc data confirmed tolerability and showed favorable trends in future primary endpoints (1/21)

Myogen
Inc.
(MYOG)

Ambrisentan

Type-A selective endothelin receptor antagonist

Pulmonary arterial hypertension

Company began pivotal Phase III program that will include the ARIES I and II trials; each will enroll 186 patients and test different doses; the primary endpoint is exercise capacity (1/8)

Schering
AG
(Germany)

Ad5FGF-4 (Generx)

Angiogenic gene therapy product acquired from Collateral Therapeutics Inc.

Stable exertional angina

Schering stopped Phase IIb/III trial after interim look led to conclusion efficacy was not going to be reached (1/30)

SuperGen
Inc.
(SUPG)

Nipent

Pentostatin for injection

Myelodysplatic syndrome

Published data showed a regimen including Nipent provided benefit in allogeneic bone marrow transplant patients (1/23)

Synthetic Blood International
Inc.
(OTC BB:SYBD)

Oxycyte

Perfluorocarbon-
based blood substitute and therapeutic oxygen carrier

Blood substitute

Phase I trial showed the product had a good safety profile (1/27)

United
Therapeutics
Corp.
(UTHR)

Remodulin (FDA-approved)

Intravenous formulation of treprostinil sodium

Pulmonary arterial hypertension

Study in normal volunteers demonstrated bioequivalence of drug delivered intravenously as compared to subcutaneously (1/26)

CENTRAL NERVOUS SYSTEM

Cephalon
Inc.
(CEPH)

R-modafinil

Single-isomer version of the active ingredient in Provigil

Narcolepsy and obstructive sleep apnea/hypopnea syndrome

Company began Phase III program, with two trials in OSA/HS and one in narcolepsy; enrollment is expected to total 800 (1/13)

GB
Therapeutics
Ltd.* (Canada)

GT 1061

Compound that mimics certain activities of nitric oxide

Alzheimer's disease

Company began a Phase I trial to test safety in aged healthy volunteers (1/6)

ExonHit
Therapeutics
SA* (France)

Ikomio

Compound believed to
prevent neuronal death

Amyotrophic lateral sclerosis

Monitors recommended a 400-patient trial in which the drug is used with Rilutek continue, after an interim analysis showed no safety concerns (1/26)

Labopharm Inc.
(Canada; TSE:DDS)

--

Once-daily formulation
of the analgesic tramadol

Pain

Phase III MDT3-002 trial met primary endpoints but Phase III trial named MDT3-003 did not; company plans an NDA filing (1/28)

Neurobiological Technologies
Inc.
(NTII) and Forest Laboratories Inc.

Namenda (FDA-approved)

Memantine; NMDA
receptor antagonist

Mild to moderate Alzheimer's disease

Phase III results of drug as monotherapy were positive, and Forest plans to seek approval based on the results (1/7)

Neurochem
Inc.
(Canada; NRMX)

Alzhemed

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

Alzheimer's disease

Company reported positive interim data from 30 patients in Phase II study who had mild to moderate disease (1/22)

Repligen
Corp.
(REGN)

RG1068

Synthetic human secretin

Autism

Phase III trial involving 132 children failed to hit either of two primary endpoints related to symptoms of autism vs. placebo (1/5)

XenoPort Inc.*

XP13512

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

Neuropathic disorders

Phase I results showed the drug was well tolerated at all doses and was rapidly absorbed (1/12)

DIABETES

Emisphere
Technologies
Inc.
(EMIS)

--

Oral insulin tablet developed with company's eligen technology

Type II diabetes

Study in 13 patients showed drug was not associated with hypoglycemic events and improved glucose control (1/29)

Tularik
Inc.
(TLRK)

T131

An oral, selective modulator of peroxisome proliferator-activated receptor gamma

Type II diabetes

Company began a Phase II trial in 60 patients whose blood glucose has not been controlled with diet and exercise (1/7)

INFECTION

Chiron
Corp.
(CHIR)

--

Vaccine designed to prime immune response by DNA immunization and then boosting with
an oligomeric-
engineered envelope protein for antibody production

HIV

Company started a Phase I trial to evaluate the safety and immuno- genicity of the vaccine, a study expected to last two years and in- clude 168 participants (1/15)

Coley
Pharmaceutical
Group Inc.*

Actilon (CPG 10101)

Synthetic Toll-like receptor- 9 agonist

Hepatitis C

Company began two Phase I trials to assess safety, tolerability and immunological, and antiviral activity; the first study will be in healthy volunteers and the second in HCV patients (1/13)

Corixa Corp. (CRXA)
and GlaxoSmithKline Biologicals

--

Vaccine combining a
recombinant tuberculosis
protein antigen and a GSK formulation of adjuvants

Tuberculosis

The FDA OK'd Phase I study to evaluate the safety and immunogenicity of the prophylactic vaccine in 20 volunteers (1/14)

CytRx Corp. (CYTR) and Advanced BioScience Laboratory Inc.*

--

HIV vaccine incorporating
DNA and protein technology licensed from ABL and the University of Massachusetts Medical School

HIV

Company said an IND was filed for Phase I trial of the HIV vaccine formulation (1/29)

Enzo Biochem Inc. (NYSE:ENZ)

HGTV43

Gene construct for
HIV infection

HIV

Phase I/II study of the gene therapy was initiated to assess the increase in engineered cells containing anti-HIV-1 antisense RNA genes (1/14)

GenoMed Inc. (OTC BB:GMED)

--

Angiotensin II blocker

Common cold

GenoMed launched a trial available to anyone with the common cold (1/26)

Gilead Sciences
Inc.
(GILD)

GS 9005 (GS 4338)

HIV protease inhibitor

HIV

Company plans Phase I trial in patients and healthy volunteers to assess oral bioavailability, pharmacokinetics, safety and efficacy (1/12)

InterMune
Inc.
(ITMN)

Actimmune

Interferon gamma-1b

Advanced liver fibrosis (cirrhosis)

Phase II study in patients who failed standard antiviral therapy did not meet its primary endpoint of reversing liver fibrosis (1/21)

Peninsula Pharmaceuticals
Inc.*

Doripenem

Inhaled version of the drug, which is from the carbapenem class of antibacterials

Lung infections

Company started a Phase I trial to evaluate safety and tolerability in healthy volunteers (1/15)

Rigel Pharmaceuticals Inc. (RIGL)

R803

Small-molecule non-
nucleoside HCV polymerase inhibitor

Hepatitis C

Phase I trial showed the drug was safe and well tolerated at doses that will be moved forward (1/26)

Trimeris Inc. (TRMS)
and Hoffmann-La
Roche Inc.

T-1249

HIV fusion inhibitor

HIV

Companies put a hold on further development of Phase I product due to formulation problem of the drug (1/5)

Vertex
Pharmaceuticals
Inc. (VRTX) and GlaxoSmithKline plc (UK)

Lexiva (GW433908; FDA-approved)

Fosamprenavir calcium;
protease inhibitor

HIV

Final 48-week results from the NEAT trial were published and showed an advantage for the drug compared to nelfinavir in combination regimens (1/20)

Vicuron
Pharmaceuticals
Inc.
(MICU)

Dalbavancin

Glycopeptide agent
from the same class as vancomycin

Gram-positive catheter-related bloodstream infections

Phase II data in 67 patients showed the drug was superior to vancomycin in combined clinical and microbiological response (1/12)

MISCELLANEOUS

Aastrom
Biosciences
Inc.
(ASTM)

Tissue Repair Cell

Stem and progenitor cells produced from samples of a patient's own bone marrow

Non-union fractures

Company began trial expected to enroll up to 20 patients to assess use of the cells to generate bone in severe leg fractures (1/14)

Adolor
Corp.
(ADLR)

Entereg (alvimopan)

Mu opioid antagonist

Postoperative ileus

Data from a fourth Phase III trial missed the primary endpoint, but Adolor and partner GlaxoSmithKline plc still plan to seek regultory approval (1/13)

Alizyme plc (UK; LSE:AZM)

Renzapride

HT4 receptor agonist/
5-HT3 receptor
antagonist

Irritable bowel syndrome

Product produced statistically significant enhancement of colonic motility in constipation-predominant IBS patients treated in a U.S. trial (1/12)

Atrix Laboratories Inc. (ATRX)

Atrisone

Dapsone formulated with Atrix's SMP technology

Acne

Company said it successfully completed two Phase III trials and expects to submit an NDA in July (1/6)

Cellegy Pharmaceuticals Inc. (CLGY)

Cellegesic

Nitroglycerin ointment

Pain from anal fissures

Product produced a statistically significant reduction in pain vs. placebo at 21 days in the 187- patient Phase III trial (1/27)

Cytheris SA* (France)

CYT 99 007

Recombinant human
interleukin-7

Immune reconstitution

Company started a Phase I trial in cooperation with the National Cancer Institute to assess safety, immune effects and various surrogate markers (1/12)

FemmePharma Inc.* and KV Pharmaceutical Co.

--

Product using Femme's
Pardel technology

Endometriosis

Companies said a Phase II study was completed and Phase III trials have begun (1/29)

FemmePharma Inc.*

FP1096

Investigational drug
delivered intravaginally

Endometriosis

Phase II study in 30 patients demonstrated that FP1096 reduced painful symptoms of disease with minimal side effects (1/19)

ISTA Pharmaceuticals Inc. (ISTA)

Vitrase

Ovine hyaluronidase
formulation

Vitreous hemorrhage

Integrated data from two Phase III studies showed diabetic subset had a reduction in hemorrhage density; an NDA has been filed (1/30)

Nastech Pharmaceutical Co. Inc. (NSTK)

PYY3-36

Nasal-spray formulation
of a high-affinity Y2 receptor agonist

Obesity

Company started a dose-finding study in 12 overweight adults and will assess appetite and food intake, as well as safety and other endpoints (1/20)

Neurochem Inc. (Canada; NRMX)

Fibrillex

Oral agent designed to
prevent amyloid fibril
formation

Amyloid A amyloidosis

Monitors reviewing safety data from 183 patients recommended the pivotal Phase II/III trial continue (1/14)

Neurogen Corp. (NRGN)

NGD 2000-1

Oral C5a antagonist

Asthma

NGD 2000-1 did not demonstrate a therapeutic benefit in a Phase IIa trial in 142 patients (1/13)

NiCox SA (France; Nouveau Marche: NICOX)

AZD3582

COX-inhibiting nitric
oxide donator

Osteoarthritis

Advisory panel reviewing Phase II program recommended development be continued (1/27)

Nymox Pharmaceutical Corp. (NYMX)

NX-1207

Investigational drug for BPH

Benign prostatic hyperplasia

Phase I and I/II trials confirmed safety and showed most patients had statistically significant symptom improvement (1/26)

Progenics Pharmaceuticals Inc. (PGNX)

Methylnaltrexone (MNTX)

Agent designed to
block peripheral opioid
receptors

Opioid-induced constipation

Company started a second pivotal Phase III trial that will measure the ability of MNTX to induce laxation within four hours (1/13)

Sucampo Pharmaceuticals Inc. (operating company of Sucampo Group)

SPI-0211

Chloride channel
activator

Constipation

Company completed the second of two Phase IIIpivotal studies, involving 237 patients, and said it demonstrated statistical significance (1/12)

Vertex Pharmaceuticals Inc. (VRTX)

Pralnacasan

Oral inhibitor of
interleukin-1 beta-converting enzyme

Osteoarthritis

Data from Phase II trial in 522 patients with OA of the knee showed benefit but not statistically significant improvement; Vertex and partner Aventis SA will decide on next steps (1/12)

XOMA Ltd. (XOMA)

XMP.629

Synthetic peptide derived
from bactericidal/
permeability-increasing protein

Acne

XOMA started a Phase II trial in 240 people with mild to moderate acne (1/22)


Notes:

* Privately held

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

NDA = New drug application.

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

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