Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Biogen Idec
Inc.
(BIIB) and
Fumapharm
AG*
(Switzerland)

BG-12

Oral fumarate derivative with an immunomodulatory mechanism of action

Psoriasis

Phase III trial in 175 patients demonstrated a statistically significant improvement in median psoriasis severity score after 16 weeks (4/7)

Biogen Idec
Inc.
(BIIB) and
Fumapharm
AG*
(Switzerland)

BG-12

Oral fumarate derivative with in immunomodulatory mechanism of action

Multiple sclerosis

Began a Phase II trial in 250 patients in Europe with relapsing-remitting MS that will assess brain lesion activity at six months (4/7)

Genelabs
Technologies
Inc.
(GNLB)

Prestara

Prasterone; synthetic equivalent of dehydro- epiandrosterone

Lupus

Phase III trial conducted by Genelabs' licensee in Taiwan failed to demonstrate a statistically significant benefit vs. placebo (4/6)

Isotechnika
Inc.
(Canada;
TSE:ISA)

ISA247

Immunosuppressive agent

Plaque psoriasis

Data from 200 patients in Canadian Phase III SPIRIT trial showed PASI scores were reduced (4/25)

CANCER

Abiogen Pharma (Italy)

ABIO 05/01

Cytotoxic cell line derived from the cells of a child with a rare form of T-cell leukemia

Peritoneal carcinosis

Began Phase I/II trial in Italy in 18 * patients with advanced tumors to evaluate safety and dosing (4/18)

Adventrx
Pharmaceuticals
Inc.
(AMEX:ANX)

CoFactor

Form of folic acid designed to enhance the antitumor effects of 5-FU

Metastatic colorectal cancer

Began a Phase II trial in Europe to evaluate safety and efficacy with 5-fluorouracil in 300 patients (4/15)

Antisense
Pharma GmbH*
(Germany)

AP 12009

TGF-beta2 antisense inhibitor

Cancers

Began Phase I/II trial in Germany in patients with pancreatic carcinoma and malignant melanoma (4/29)

Argos
Therapeutics
Inc.*

--

RNA-loaded dendritic- cell vaccine made for a patient's own tumor RNA and immune cells

Stage IV melanoma

An investigator-sponsored trial of the product began in Germany (4/6)

Ariad
Pharmaceuticals
Inc.
(ARIA)

AP23573

Small molecule designed to inhibit cell-signaling protein mTOR

Various cancers

Began two Phase Ib trials in Europe to evaluate the drug and dosing with two standard cancer agents in up to 110 patients (4/20)

Biomira Inc.
(Canada; BIOM)
and Merck KGaA
(Germany)

BLP25

Therapeutic vaccine encapsulating a sequence of the MUC1 cancer mucin in a liposomal delivery system

Non-small-cell lung cancer

Began trial in Canada in 20 patients to evaluate the safety of the formulation to be used in the upcoming Phase III study (4/20)

BioVex Ltd.*
(UK)

Immuno
VEXtrimelan

Vaccine using herpes simplex virus to deliver melanoma-associated antigens to dendritic cells

Malignant melanoma

Began Phase I/II trial in the UK and Canada to evaluate safety and biological activity in 50 patients (4/27)

BioVex Ltd.*
(UK)

OncoVEX

Oncolytic virus that delivers the gene for GM-CSF

Solid tumors

Data from Phase I/II trial showed the agent was well tolerated and produced biological effects (4/19)

CureTech Ltd.*
(Israel)

CT-011

Humanized monoclonal antibody directed against a B7 family- associated protein

Advanced hematological malignancies

Phase I trial in 17 patients in Israel demonstrated safety and tolerability; clinical responses were seen in five patients (4/11)

Cytopia Ltd.*
(Australia)

CYT997

Oral agent believed to both directly kill cancer cells and starve the cancer of its blood supply

Solid tumors

Began a Phase I trial in Australia to evaluate safety, tolerability, dosing and activity in up to 30 patients (4/27)

Inovio
Biomedical
Corp.
(AMEX:INO)

MedPulser System

Electroporation-mediated method for delivering DNA-based therapies

Recurrent prostate cancer

Began Phase I/II trial in the UK to test immune responses from a DNA vaccine developed at the University of Southampton (4/4)

MGI
Pharma
Inc.
(MOGN)

Aloxi (FDA-approved)

Palonosetron hydrochloride injection; a 5-HT3 receptor antagonist

Nausea and vomiting in chemotherapy patients

Partner Helsinn Healthcare SA gained approval of the product in the European Union (4/4)

Micromet AG*
(Germany)

MT201

Adecatumumab; fully human antibody targeting the epithelial adhesion molecule Ep-CAM

Relapsed breast cancer

Began a Phase I trial in Germany and Austria in 12 patients to evaluate safety and tolerability (4/27)

Millennium
Pharmaceuticals
Inc.
(MLNM)

Velcade (FDA-approved)

Bortezomib; proteasome inhibitor

Multiple myeloma

Partner Ortho Biotech gained approval of the drug in Europe for use in second-line treatment (4/28)

Onyvax Ltd.*
(UK)

Onyvax-105 (105AD7)

Anticancer immunotherapy

Osteosarcoma

Phase I/II trial in 31 pediatric and young adult patients in the UK showed the feasibility of the treatment with chemotherapy (4/19)

Spectrum
Pharmaceuticals
Inc.
(SPPI)

EOquin

Synthetic prodrug activated by certain enzymes prevalent in hypoxic cancer cells

Superficial bladder cancer

Updated Phase I/II trial data from 12 patients in the UK suggested the drug was safe and effective (4/19)

Spectrum
Pharmaceuticals
Inc.
(SPPI) and
AEterna Zentaris
Inc.
(Canada; AEZS)

SPI-153 (D-63153)

Fourth-generation luteinizing hormone-releasing hormone

Hormone- dependent prostate cancer

Began a Phase II trial in Europe to evaluate the effects on hormonal levels, and antitumor effects (4/11)

Viragen Inc.
(AMEX:VRA)

Multiferon

Multisubtype, natural human alpha interferon

Various diseases

Drug was approved in the Philippines for the second-line treatment of any diseases in which recombinant interferon therapy failed (4/25)

CARDIOVASCULAR

Protein
Design Labs
Inc.
(PDLI)

Ularitide

Atrial natriuretic peptide

Decompensated congestive heart failure

Phase II SIRIUS trial in 221 patients in Europe showed reduced pulmonary capillary wedge pressure and improved dyspnea scores (4/18)

CENTRAL NERVOUS SYSTEM

CeNeS
Pharmaceuticals
plc
(UK; AIM:CEN)

M6G

Morphine-6-
glucuronide

Post-operative pain

Published data from trial showed analgesic potency similar to morphine with fewer side effects (4/11)

Migenix Inc.
(Canada; TSE:MGI)

MX-4509

Cytoprotective agent

Alzheimer's disease

Began Phase I/II trial in Canada to assess safety, tolerability and effects on oxidative stress markers in 14 patients (4/28)

Neuro3d*
(France)

Ocaperidone

Atypical antipsychotic

Schizophrenia

Phase II trials showed effects that were significantly better than placebo and comparable to an approved atypical antipsychotic agent, with a good side effect profile (4/12)

Prana
Biotechnology
Ltd.
(Australia;
ASX:PBT)

PBT-1 (clioquinol)

Small molecule that binds metal ions; designed to remove zinc bound to amyloid-beta

Alzheimer's disease

Company will not proceed with Phase II/III trial in the UK due to impurities that occur in the manufacturing process; any further work is being evaluated (4/11)

Synt:em*
(France)

Syn 1001

Morphine-6-glucoronide linked to a small Pep:trans peptide vector

Pain

Proof-of-concept study in human volunteers showed evidence of penetration into the brain (4/13)

DIABETES

Innodia Inc.*
(Canada)

ID 1101

Agent designed to increase insulin secretion by the pancreas and decrease peripheral insulin resistance

Type II diabetes

Began a Phase Ib trial in Canada in healthy volunteers to assess safety, tolerability and pharmacokinetics; Phase Ia trial showed safety and tolerability (4/6)

INFECTION

AEterna
Zentaris Inc.
(Canada; AEZS)

Impavido

Oral miltefosine, an alkylphospholipid agent

Leishmaniasis

Presented positive data from various studies and various forms of the disease (4/14)

Anadys
Pharmaceuticals
Inc.
(ANDS) and
LG Life Sciences
Ltd. (South Korea)

ANA380 (LB80380)

Oral prodrug of the nucleotide analogue ANA317 (LB80317)

Hepatitis B

12-week data from ongoing Phase II trial showed viral load reductions of 99.9% in lamivudine- resistant patients receiving 90- mg doses (4/18)

Bioniche Life
Sciences Inc.
(Canada; TSE:BNC)

Cystistat

Sodium hyaluronate product

Urinary tract infections

Two pilot trials each showed reduced incidence of UTIs; the product is approved in Canada and Europe (4/18)

GenoMed Inc.
(PK:GMED)

--

Broad-spectrum antiviral agent

Marburg virus

Began a trial to test the drug in Angola (4/26)

The Immune
Response Corp.
(IMNR)

Remune

Immune-based therapy comprised of a whole-killed virus and an adjuvant

HIV

Phase II trial in 49 patients in Italy showed CD4+ cell counts remained stable through week 28 in drug patients, but declined in control groups (4/21)

Ipsat Therapies*
(Finland)

P1A

Product designed to inactivate beta-lactam antibiotics in the lower intestinal tract

Antibiotic resistance

Phase IIa trial showed prevention of bacterial resistance and other side effects, and demonstrated safety (4/5)

MISCELLANEOUS

Ark
Therapeutics
Group plc
(UK; LSE:AKT)

EG005

Agent designed to to increase the ability of mitochondria to produce energy

Lipodystrophy

Encouraging trends were seen in Phase II trial and open-label extension phase in HIV patients (4/14)

Genaera
Corp.
(GENR)

Lomucin

Talniflumate; anti- inflammatory drug with activity against the hCLCA1 chloride channel

Cystic fibrosis

Began pivotal Phase II trial in Ireland to evaluate safety and efficacy on pulmonary function and related symptoms in 200 patients (4/18)

Hollis-Eden
Pharmaceuticals
Inc.
(HEPH)

Neumune

Immune-regulating hormone

Acute radiation syndrome

Began a Phase I trial in the Netherlands to test safety and pharmacokinetic (4/1)

Isotechnika
Inc.
(Canada;
TSE:ISA)

ISA247

Immunosuppressive agent

For use in kidney transplantation

Starting a Phase IIb trial in Canada to compare the drug to tacrolimus in 332 newly transplanted patients (4/28)

Insmed Inc.
(INSM)

SomatoKine

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

Extreme insulin resistance

Began a Phase II trial in the UK to evaluate safety and efficacy for 16 weeks in 10 patients (4/26)

Pharmagene
plc
(UK; LSE:PGN)

PGN1164

Oral 5HT2B antagonist

Irritable bowel syndrome

Stopped development of the drug after a Phase I UK trial showed variable pharmacokinetics (4/29)

Spectrum
Pharmaceuticals
Inc.
(SPPI) and
AEterna Zentaris
Inc.
(Canada; AEZS)

SPI-153 (D-63153)

Fourth-generation luteinizing hormone- releasing hormone

Benign prostatic hypertrophy

Began a Phase II trial in Europe to evaluate safety and efficacy (4/13)


Notes:

* Privately held.

MAA = Marketing authorization application; EMEA = European Medicines Agency.

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

AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; PK = Pink Sheets; TSE = Toronto Stock Exchange.