Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

AtheroGenics
Inc.
(AGIX)

AGIX-4207

Oral treatment; an
intravenous compound
derived from the
v-protectant technology platform

Rheumatoid arthritis

Phase II data showed the treatment inhibited by 92% the increase in erythrocyte sedimentation rate observed in placebo patients; the treatment was safe and well tolerated (7/16)

Biogen Inc.
(BGEN) and
Elan Corp. plc (Ireland)

Antegren

Natalizumab; a
humanized
monoclonal antibody

Crohn's disease

Phase III data showed Antegren did not meet its primary endpoint of a response, although it did show biological activity similar to what was seen in earlier Phase II work (7/24)

Can-Fite
BioPharma
Ltd.*
(Israel)

CF101

A synthetic agonist that
targets the A3 adenosine receptor

Rheumatoid arthritis

Company initiated a Phase II trial (7/23)

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

Raptiva

Efalizumab; recombinant humanized monoclonal antibody

Moderate to severe plaque psoriasis

Phase III data showed that 44% of 368 patients treated with Raptiva for up to 24 weeks achieved a 75% or greater improvement in their Psoriasis Area and Severity Index score (7/28)

Merrimack Pharmaceuticals Inc.*

MM-093

A recombinant version of human alpha-fetoprotein

Autoimmune diseases

Company began a Phase I trial (7/29)

Neurocrine Biosciences Inc. (NBIX)

NBI-5788

An altered peptide ligand

Relapsing
multiple sclerosis

Company began a Phase II trial (7/28)

Vertex Pharmaceuticals
Inc.
(VRTX) and Aventis SA
(France)

Pralnacasan

Oral anti-cytokine therapy;
an interleukin-beta-
converting enzyme inhibitor

Rheumatoid arthritis

Company began enrollment in a Phase IIb trial in the U.S. and Canada (7/10)

CANCER

BTG (unit of
BTG plc; UK; LSE:BGC)

BGC 9331

A non-polyglutamatable thymidylate synthase
inhibitor

Gastric cancer

Company began a Phase I/II trial (7/11)

Cancer Vac (subsidiary of
Prima Biomed
Ltd.; Australia; ASX:PRR)

--

Immunotherapy

Advanced
cancer

Phase Ib data showed no significant side effects; the therapy is showing positive effects on tumors in some patients (7/15)

Cel-Sci Corp. (AMEX:CVM)

Multikine

Immunotherapy drug;
natural mixture of human cytokines, including interleukin-2

Primary head and neck cancer

Phase I/II data showed that the use of Multikine prior to surgical intervention made the residual tumor cells more susceptible to follow-on treatment with radiation and possibly chemotherapy (7/9)

Curacyte AG* (Germany)

PHP

Pyridoxalated hemoglobin polyoxyethylene

Metastatic renal cell carcinoma or melanoma

Company will begin a Phase I trial in the U.S. (7/23**)

Cyclacel
Ltd.*
(UK)

CYC202

R-roscovitine; a CDK
inhibitor drug candidate

Cancer

Clinical data showed the drug induced cancer cell apoptosis, and seven patients with various tumors experienced stabilization (7/14)

Dendreon
Corp.
(DNDN)

APC8024

Immunotherapy;
vaccine designed to
induce an immune response against
tumor cells that show
increased amounts of
the protein antigen Her-2/neu

Breast, colon
and ovarian cancer

Phase I data showed continued clinical benefit (7/14)

Enzon
Inc.
(ENZN)

PEG-
Camptothecin

Prodrug form of the topoisomerase inhibitor camptothecin; prodrug
aims to overcome
solubility problems

Gastric and gastroesophageal junction cancers

Phase II data showed PEG-Camptothecin met its safety and efficacy criteria and will be advanced for the indication (7/24)

Genta
Inc.
(GNTA)

Genasense

Oblimersen sodium;
antisense compound
geared toward blocking
the production of Bcl-2

Chronic lymphocytic leukemia

Company began a Phase II trial of Genasense in combination with Rituxan and fludarabine (7/30)

IVAX Corp. (AMEX:IVX)

Talampanel

Blocks the effect of
glutamate

Brain cancer

Company began a
Phase II trial (7/10)

Millennium Pharmaceuticals
Inc.
(MLNM) and Xenova Group plc (UK; XNVA)

MLN944

A DNA-targeting agent that demonstrated anti-tumor activity

Advanced solid tumors

Companies initiated a Phase I trial (7/3)

Millennium Pharmaceuticals
Inc.
(MLNM)

Velcade
(FDA-
approved)

Blocks the proteasome, an enzyme complex involved in degrading proteins that control cellular processes

Mantle-cell lymphoma

Company initiated a
Phase II trial (7/2)

Onyvax
Ltd.*
(UK)

Onyvax-P

Cancer vaccine consisting
of three inactivated cell
lines that target a range of prostate cancer-associated antigens

Prostate cancer

Phase IIa data showed that 20 out of 26 patients had no evidence of clinical deterioration, with a median time to progression of the disease projected in excess of 48 weeks (7/3)

Oxford
BioMedica plc
(UK; LSE:OXB)

MetXia

Cancer gene therapy products; MetXia delivers the gene CYP286 directly to solid tumors, where it generates an enzyme that converts the prodrug cyclophosphamide into its active, cytotoxic form

Breast cancer

Phase I/II data were positive (7/3)

Oxford
BioMedica plc
(UK; LSE:OXB)

TroVax

TroVax is based on a gene for the tumor-associated antigen OBA1

Colorectal
cancer

Phase I/II data of the intradermal delivery of TroVax showed all primary endpoints were achieved (7/14)

Phoenix Pharmacologics
Inc.*

Arginine deiminase

A protein; an enzyme that degrades the amino acid arginine

Hepatocellular carcinoma

Phase II data showed that two of 19 patients were in complete remission without any clinical evidence of disease; seven experienced a greater-than-50% remission of their tumor, and seven had stable disease (7/24)

Point
Therapeutics Inc.
(OTC BB: POTP)

PT-100

Orally active small
molecule, which stimulates
the proliferation of hematopoietic progenitor
cells and the differentiation
of neutrophils

B-cell hematologic malignancies

Company enrolled the first patient in a Phase I/II trial investigating PT-100 and Rituxan (7/8)

Progen Industries Ltd. (Australia; PGLAF)

PI-88

Semi-synthetic sulfated oligosaccharide that has several modes of action

Multiple
myeloma

Company completed a Phase II trial, which achieved the primary efficacy endpoints (7/8)

SuperGen Inc. (SUPG)

Dacogen

Decitabine; inhibitor of DNA methyltransferase

Chronic myelogenous leukemia

Phase II data showed there was no significant difference in the response rates among dose levels in the accelerated and blastic phase patients (7/30)

SuperGen Inc. (SUPG)

Nipent
(FDA-
approved)

Pentostatin for injection

Non-Hodgkin's lymphoma

Phase II data
demonstrated activity with acceptable toxicity (7/9)

TransMolecular Inc.*

131-I-TM-601

Radiopharmaceutical containing a synthetic
version of chlorotoxin, a substance derived from scorpion venom

Glioma

Company completed enrollment in a Phase I/II trial (7/10)

Vion
Pharmaceuticals
Inc.
(VION)

VNP4010M

DNA-damaging agent

Advanced leukemia

Company initiated a Phase I trial (7/23)

CARDIOVASCULAR

Agenix Ltd.
(Australia; ASX:AGX)

ThromboView

Blood clot imaging agent

Deep-vein thrombosis

Phase Ib data showed ThromboView successfully detected a deep-vein thrombosis of a patient; it also was shown to be safe and well tolerated (7/10)

Alteon Inc. (AMEX:ALT)

ALT-711

A.G.E. (advanced glycation end-product) crosslink breaker

High blood pressure

Phase II data showed ALT-711 missed its primary endpoint and did not demonstrate statistical significance in the reduction of systolic blood pressure (7/17)

Amylin Pharmaceuticals
Inc.
(AMLN)

AC2592

Uses a continuous subcutaneous infusion of glucagon-like peptide-1

Congestive
heart failure

Phase II data showed general improvement in a composite score designed to quantify quality of life and cardiac function while receiving study medication (7/29)

Avant Immunotherapeutics Inc. (AVAN)

CETi-1

Cholesterol ester transfer protein vaccine

To raise HDL cholesterol

Phase I data support the feasibility, immunogenicity and safety of CETi-1 (7/17)

Esperion Therapeutics
Inc.
(ESPR)

ETC-1001

Small molecule

Lipid disorders

Company began a Phase I trial (7/25)

Valentis
Inc.
(VLTS)

Del-1

Angiogenesis gene

Peripheral
arterial disease

Company initiated a Phase II trial (7/17)

Vasogen Inc. (AMEX:VSV)

--

Immune modulation
therapy

Heart failure

Company began
enrollment in a Phase III trial to evaluate the
therapy in reducing mortality and morbidity in advanced chronic heart failure patients (7/9)

CENTRAL NERVOUS SYSTEM

Celgene Corp. (CELG)

Focalin LA (FDA-
approved)

Dexmethylphenidate hydrochloride extended-release
capsules

Attention
deficit disorder/attention deficit hyperactivity disorder

Company began a
pivotal trial in adults (7/2)

Ionix Pharmaceuticals Ltd.*

IX-1003

Intranasal formulation
of the opioid agonist buprenorphine

Post-operative pain

Company completed
Phase I studies (7/16)

NeuroSearch A/S (Denmark; CSE:NEUR)

NS2359

Enhances the activity
of the neurotransmitters dopamine, noradrenaline and serotonin

Attention deficit hyperactivity disorder

Company concluded a Phase I trial (7/23**); it began a Phase II study (7/28)

SkyePharma plc (UK; SKYE) and GlaxoSmithKline plc (UK)

Requip

Oral, controlled-release version that uses SkyePharma's drug
delivery technology

Parkinson's disease

Companies began
Phase III trials (7/23**)

INFECTION

AEterna Laboratories Inc. (Canada; AELA)

Impavido

Miltefosine

Leishmaniasis

Phase III data showed a higher cure rate for patients treated with Impavido than those patients in the placebo group (7/29)

Gilead Sciences
Inc.
(GILD)

Emtriva

Emtricitabine;
antiretroviral agent
dosed once daily

HIV

Phase III data showed
that Emtriva is signficantly more potent in
suppressing replication
of the virus when compared with stavudine and in combination with other antiretroviral agents (7/14)

Hemispherx Biopharma Inc. (AMEX:HEB)

Ampligen

Immunotherapeutic; double-stranded
synthetic RNA
compound poly 1;
poly C124

HIV

Phase IIb data showed that patients who have completed at least nine months of Ampligen therapy were able to stay off HAART regimens for a mean of 29 weeks, while a control group had earlier HIV rebound with a mean duration of 18.7 weeks (7/15)

Immtech International Inc. (AMEX:IMM)

DB289

Oral anti-infective;
dicationic
pharmaceutical
compound

Malaria

Company completed enrollment of patients in a Phase IIa trial (7/11)

Maxim Pharmaceuticals
Inc.
(MAXM)

Ceplene

Histamine
dihydrochloride

Hepatitis C

Company completed enrollment in a Phase II
trial (7/29)

Micrologix Biotech Inc. (Canada; TSE:MBI)

MBI 226

A cationic peptide

Bacterial and fungal bloodstream infections

Company failed to hit its endpoint in a Phase III
trial against povidone iodine, the standard of
care (7/23)

Savient Pharmaceuticals
Inc.
(SVNT)

Prosaptide

A peptide derived
from the human nerve growth protein
prosaposin

Neuropathic
pain associated with HIV/AIDS

Company initiated patient screening for a Phase II study (7/31)

Vertex Pharmaceuticals
Inc.
(VRTX)

433908

Protease inhibitor

HIV

Phase III data showed
the drug failed its primary endpoint, non-inferiority
to a comparator drug, lopinavir (7/25)

ViroPharma Inc. (VPHM)

HCV-371

Antiviral compound

Hepatitis C

Phase Ib results did not show the desired effect, with no impact on hepatitis C virus RNA levels at the dose tested (7/16)

VIRxSYS
Corp.*

VRX496

Lentiviral vector;
patient is infused
with autologous T
cells modified with
VRX- 496-enabled
CD4 T cells

HIV

Company began dosing
in a Phase I/IIa trial (7/31)

MISCELLANEOUS

BioMarin Pharmaceutical
Inc.
(BMRN)

Aryplase

Enzyme replacement
product

Mucopolysacch- aridosis-VI

Company plans to begin a Phase III trial (7/7)

CollaGenex Pharmaceuticals
Inc.
(CGPI)

COL-3

Non-antimicrobial tetracycline derivative

Rosacea

Company initiated a
Phase II trial (7/24)

NexMed Inc
(NEXM)

NexACT

Alprostadil/lidocaine/ NexACT cream
treatment

Premature ejaculation

Efficacy data showed
the ejaculatory latency
time increased to more
than two minutes in
53.5% of patients using
the cream treatment (7/18)

Ortec
International
Inc.
(OTC BB:ORTN)

OrCel
(FDA-
approved)

Bilayered cellular
matrix

Venous leg ulcer

Company completed patient enrollment in a pivotal trial (7/7)

OxiGene Inc.
(OXGN)

Combretastatin A4 Prodrug

Vascular targeting
agent

Wet age-related macular degeneration

Company began a Phase I/II trial (7/2)

Palatin
Technologies
Inc. (AMEX:PTN)

PT-141

Peptide analogue of (alpha)- MSH ([alpha]-melanocyte- stimulating hormone)

Sexual dysfunction

Company completed patient enrollment in a Phase IIb at-home study (7/24)

Rigel Pharmaceuticals
Inc.
(RIGL)

R112

The first of a new
class of drugs that
works against mast
cells

Allergic rhinitis

Company completed a Phase I/II study (7/21)

Sucampo Pharmaceuticals Inc.*

FK-506

Tacrolimus, an immuno-suppressive
agent

Dry-eye syndrome

Company began a Phase
II study (7/15)

SuperGen Inc. (SUPG)

Nipent

Pentostatin for injection

Chronic graft- vs.-host disease

Clinical data showed Nipent is active in treating children diagnosed with chronic graft-vs.-host disease refractory to standard therapy (7/28)

Targeted
Genetics Corp.
(TGEN)

tgAAVCF

Gene therapy product
that uses an adeno-associated
virus vector delivery system

Cystic fibrosis

Company began a
Phase IIb trial (7/15)

Theratechnologies Inc. (Canada; TSE:TH)

ThGRF

Growth
hormone-releasing
factor analogue

Wasting secondary to hip fracture surgery

Company completed enrollment in a Phase II study (7/9)

Vectura
Ltd.*
(UK)

VR004

Inhaled
apomorphine HCl

Erectile dysfunction

Phase IIa results showed improved erectile performance with a rapid onset of action; drug was tolerable at all doses tested (7/21)

Vivus
Inc.
(VVUS)

TA-1790

PDE5 inhibitor

Erectile dysfunction

Company began
enrollment in a study of TA-1790 (7/10)

ZymoGenetics
Inc.
(ZGEN)

rFactor XIII

A protein involved in the stabilization and
strengthening of blood clots

Factor XIII deficiency

Phase I data showed that the administration of recombinant human Factor XIII appeared to be safe with no serious adverse events (7/14)


Notes:

* Privately held

** Denotes the date the item ran in BioWorld International.

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