Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Serono SA
(Switzerland;
NYSE:SRA)

Raptiva (FDA-approved)

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

Psoriasis

73% of patients who remained on therapy for 36 months achieved a 75% or greater improvement of PASI 75; also, the CLEAR trial demonstrated that high-need patients benefit from treatment (5/23)

CANCER

Adherex
Technologies
Inc.
(AMEX:ADH)

Exherin (ADH-1)

Cadherin antagonist; small peptide, tumor/ vascular-targeting agent of repeated doses (5/11)

Various tumor types

Began Phase II trial in up to 60 patients in Canada to evaluate the antitumor activity and tolerability

Alizyme plc
(UK; LSE:AZM)

ATL-104

Recombinant plant protein designed to stimulate growth of cells that line the gastrointestinal tract

Mucositis in cancer patients

Stage one of a Phase IIa trial demonstrated safety in 27 patients (5/26)

Antisoma plc
(UK; LSE:ASM)

AS1404

Vascular-targeting agent designed to disrupt tumor blood vessels

Cancer

Phase I trial in New Zealand demonstrated tolerability and effects on tumor blood vessels (ASCO)

Antisoma plc
(UK; LSE:ASM)

AS1405 (formerly AngioMab)

Radiolabeled antibody that binds to a protein found around new tumor blood vessels

Brain cancer

The company dropped the drug and suspended trials (5/5)

Astex
Technology
Ltd.*
(UK)

AT7519

Cell-cycle inhibitor

Refractory solid tumors

The company is starting a Phase I trial in patients (5/23)

Ardana plc
(UK; LSE:ARA)

Teverelix LA

Gonadotropin-releasing hormone antagonist

Advanced prostate cancer

Phase II trial in 14 patients showed drug can attain and maintain suppression of testosterone to castration levels (5/12)

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 (Stage IIIb)

Phase IIb data showed the median survival of best supportive care patients was 13.3 months; at two years, median survival had not been reached in vaccine patients (ASCO)

Cyclacel Group
plc*
(UK)

Seliciclib (CYC202)

Small-molecule inhibitor of multiple CDK cell- cycle targets

Non-small-cell lung cancer

Initial data from Phase IIa trial in Europe showed the feasibility of drug with gemcitabine and cisplatin, and showed activity (ASCO)

Immuno-
Designed
Molecules SA*
(France)

Uvidem

Vaccine consisting of mature dendritic cells loaded with lysates of tumor cell lines

Melanoma

Phase II trial in 60 Stage IV patients in France and Australia demonstrated tolerability and immune responses (ASCO)

Lorus
Therapeutics
Inc.
(Canada;
TSE:LOR)

Virulizin

Immunotherapy agent

Pancreatic cancer

Phase III data showed how Virulizin induced production of IL-17E to enhance antitumor activity (ASCO)

Lorus
Therapeutics
Inc.
(Canada;
TSE:LOR)

GTI-2040

Antisense oligonucleotide complementary to the R2 component of ribonucleo- tide reductase

Non-small-cell lung cancer

Clinical data showed GTI-2040 in combination with docetaxel had no dose-limiting toxicities (ASCO)

Meditech
Research Ltd.
(Australia; ASX:MTR)

HyDox and HyFive

Products containing hyaluronic acid with doxorubicin and 5-FU, respectively

Cancers

Phase I trials demonstrated safety of the drugs; antitumor responses were noted in several patients (5/19)

MethylGene Inc.
(Canada; TSE:MYG)

MGCD0103

Isotypic-selective small- molecule inhibitor of histone deacetylase

Non-Hodgkin's lymphoma and advanced solid tumors

Phase I data demonstrated safety, tolerability and pharmacokinetics (ASCO)

Novagali
Pharma*
(France)

--

Oral formulation of paclitaxel

Advanced cancers

Began Phase I trial in the Netherlands to assess tolerability and pharmacokinetics (5/31)

Onyvax
Ltd.*
(UK)

Onyvax-P

Cell vaccine; an immunotherapy

Metastatic, hormone- resistant prostate cancer

Second cohort of 20 patients in Phase II trial demonstrated benefits on progression-free survival and PSA velocity (ASCO)

Oxford
Biomedica plc
(UK; LSE:OXB)

TroVax

Vaccine that delivers an antigen (5T4) using a pox- virus vector

Colorectal cancer

Phase II data show that maximum antibody levels targeted against the 5T4 tumor antigen are significantly higher than in the Phase I/II trial (ASCO)

PharmaMar SA
(Spain; subsidiary
of Zeltia Group)

Yondelis

Trabectedin; ET-743; derived from the sea squirt Ecteinascidia turbinata

Advanced prostate cancer

Clinical data suggest the compound is effective in reducing PSA and alleviating pain in about 12% of men with advanced prostate cancer (ASCO)

PharmaMar SA
(Spain; subsidiary
of Zeltia Group)

Kahalalide F

Peptides isolated from the Hawaiian mollusk, Elysia rufescens

Solid tumors

Phase I data showed a complete response in a patient with melanoma, and stable disease lasting more than three months in lung, colon and unknown-origin adenocarcinoma patients (ASCO)

Pharmexa A/S(Denmark; CSE:PHARMX)

GV1001

Peptide vaccine

Non-small-cell lung cancer

Phase I/II data showed no serious side effects and an immune response in 13 out of 24 patients completing four weeks of treatment (ASCO)

Progen
Industries Ltd.
(Australia; ASX:PGL)

PI-88

Anti-angiogenesis drug also designed to inhibit tumor-promoting factors

Melanoma

Pilot Phase II trial demonstrated acceptable safety; of 37 patients, one had a partial response and 10 had stable disease (ASCO)

Santaris
Pharma A/S*
(Denmark)

SPC2996

LNA-based RNA antagonist designed to reduce levels of the Bcl-2 protein

Chronic lymphocytic leukemia

Began Phase I/II trial in Europe in patients who don't respond to chemotherapy (5/19)

Viventia Biotech
Inc.
(Canada;
TSE:VBI)

Proxinium

Antibody fragment conjugated with a cancer- killing payload

Refractory head and neck cancer

Clinical data showed the compound has a good safety profile and can produce encouraging efficacy results (ASCO)

Wilex
AG*
(Germany)

Rencarex (WX-G250)

Chimeric monoclonal IgG1 antibody that binds to the MN cell-surface antigen

Metastatic renal-cell cancer

Patients who responded to treatment in a Phase II trial showed a survival benefit following extended treatment (ASCO)

YM
BioSciences Inc.
(Canada; TSE:YM)

TheraCIM h-R3

Humanized anti-epidermal growth factor receptor monoclonal antibody

High-grade malignant glioma

21 of 24 patients in a Phase I/II trial in Cuba achieved disease stabilization or an objective response (ASCO)

CARDIOVASCULAR

Myogen Inc.
(MYOG)

Ambrisentan

Type-A selective endothelin receptor antagonist

Pulmonary arterial hypertension

The product was granted orphan designation in Europe for PAH and chronic thromboembolic pulmonary hypertension (5/2)

Pharming
Group NV
(the
Netherlands;
Euronext:PHARM)

rhC1INH

Recombinant human C1 inhibitor

Hereditary angioedema

Phase II/III trials in Europe demonstrated rapid time to beginning of relief and time to resolution of HAE attacks(5/2)

CENTRAL NERVOUS SYSTEM

Corcept
Therapeutics
Inc.
(CORT)

Corlux (mifepristone)

Oral GR-II antagonist with potential mitigating effects on cortisol

Psychotic major depression

Began third Phase III trial, a study in Europe (Corcept 09) to evaluate the safety and efficacy in up to 280 patients (5/4)

Cortex
Pharmaceuticals
Inc.
(AMEX:COR)

CX717

Ampakine analogue

Sleep deprivation

Trial in the UK in 16 people showed increased wakefulness and improved performance vs. placebo (5/2)

Cytos
Biotechnology
AG
(Switzerland;
SWX:CYGN)

CAD106

Immunotherapeutic designed to induce antibodies against the beta-amyloid protein

Alzheimer's disease

Partner Novartis Pharma AG is starting a Phase I trial in Sweden that will assess safety, tolerability and antibody responses in 60 patients (5/18)

Cytos
Biotechnology
AG
(Switzerland;
SWX:CYGN)

CYT002-NicQb

Therapeutic vaccine that induces nicotine-specific antibodies that bind nicotine

Smoking cessation

Phase II trial in 341 smokers in Switzerland showed a clear correlation between antibody levels and abstinence rates (ASCO)

Enkam Pharmaceuticals
A/S*
(Denmark)

FGLL

Synthetic peptide that mimics the neural cell-adhesion molecule

Alzheimer's disease

Phase I trial in 24 healthy volunteers demonstrated safety and tolerability (5/18)

Myriad
Genetics Inc.
(MYGN)

Flurizan

Selective amyloid beta 42 lowering agent

Alzheimer's disease

Phase II trial in 189 patients in the UK and Canada failed to demonstrate statistical significance, but positive trends were seen (5/2)

DIABETES

Generex
Biotechnology
Corp.
(Canada;
GNBT)

Orallyn

Oral insulin spray formulation

Type I and II diabetes

The product was approved in Ecuador; PharmaBrand SA will market the product there (5/3)

Actelion Ltd.
(Switzerland;
SWX:ATLN)

Palosuran

Urotensin-II receptor antagonist

Diabetic nephropathy

Efficacy data from proof-of-concept study did not support initiation of a full clinical development program (5/23)

INFECTION

BioAlliance
Pharma SA*
(France)

Miconazole Lauriad

Oral, bioadhesive buccal tablet containing the antifungal miconazole

Oropharyngeal candidiasis

Phase III trial in France and North Africa demonstrated efficacy in head and neck cancer patients with 10 times less drug than the miconazole oral gel comparator (ASCO)

BioInvent
International AB
(Sweden; SSE:BINV)

BI-201

Human antibody that binds to the TAT protein

HIV

Starting a Phase I/II trial in the UK to evaluate safety, tolerability and pharmacokinetics in 36 previously untreated patients (5/18)

Immtech
International
Inc.
(AMEX:IMM)

DB289

Oral, dicationic antiviral agent

Malaria

Began Phase IIb trial in 120 patients in Thailand that will test the drug alone and with artesunate (5/11)

Nabi Bio-pharmaceuticals
(NABI)

StaphVAX

Staphylococcus aureus polysaccharide conjugate vaccine

To prevent S. aureus infections

Began Phase II trial in the UK to evaluate safety and antibody levels in 200 patients undergoing orthopedic surgery with a prosthetic device (5/17)

MISCELLANEOUS

Aastrom
Biosciences
Inc.
(ASTM)

Tissue Repair Cells

Autologous bone marrow-derived adult stem and progenitor cells

Severe long bone non- union fractures

Feasibility trial in Spain showed clinical and functional healing in all six patients treated (5/17)

Acologix Inc.*

AC-100 (Dentonin)

Synthetic peptide derived from a protein produced by bone and dental cells

For use in dental procedures

Began a Phase II periodontal trial in Serbia-Montenegro (5/25)

Allergy
Therapeutics
plc
(UK; AIM:AGY)

--

Ragweed allergy vaccine

Ragweed allergy

Began a Phase II trial in Canada to assess safety and efficacy in 240 patients (5/10)

Ardana plc
(UK; LSE:ARA)

Teverelix LA

Gonadotropin-releasing hormone antagonist

Benign prostatic hyperplasia

Phase II trial in 81 patients showed a statistically significant decrease in prostatic symptoms (5/26)

Cytos
Biotechnology
AG
(Switzerland;
SWX:CYTN)

CYT009-GhrQb

Therapeutic vaccine designed to produce a specific anti-ghrelin response

Obesity

Began a Phase I/II trial in 112 obese subjects to evaluate safety, tolerability and exploratory efficacy (5/11)

DeCode
Genetics Inc.
(Iceland; DCGN)

--

Compound that targets a gene implicated in development of asthma

Asthma

Began a Phase II trial in 160 patients with the at-risk variants of the gene (5/18)

Eyetech
Pharmaceuticals
Inc.
(EYET)

Macugen (FDA-approved)

Pegaptanib sodium injection; pegylated anti-VEGF aptamer

Wet age-related macular degeneration

The product was approved in Canada for treating subfoveal choroidal neovascularization secondary to neovascular AMD (5/5)

Insense Ltd.*
(UK)

Oxyzyme

System designed to clean a wound, produce oxygen and release small amounts of iodine

Chronic wounds

Data from clinical trials showed improvement and healing in a number of wounds in four weeks (5/23)

Insmed Inc.
(INSM)

SomatoKine

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

Growth hormone- insensitivity syndrome

Pivotal Phase III trial in 29 patients met its primary endpoint of change in height velocity after six months (5/31)

InterMune
Inc.
(ITMN)

Pirfenidone

Small molecule believed to inhibit collagen synthesis, down-regulate profibrotic cytokines and decrease fibroblast proliferation

Idiopathic pulmonary fibrosis

12-month Phase II trial in 107 patients was stopped at nine months after interim analysis suggested favorable effects of pirfenidone on acute exacerbations and other efficacy parameters; Shionogi & Co. Ltd. ran the trial (5/2)

Karo Bio
AB
(Sweden;
SSE:KARO)

KB2115

Compound that stimulates the thyroid hormone receptor

Obesity and related conditions

Got approval for clinical studies of the product; details were not disclosed (5/11)

Manhattan
Pharmaceuticals
Inc.
(OTC BB:
MHTT)

Oleoylestrone

Oral therapeutic for weight loss

Obesity

Completed Phase Ia trial in Switzerland and began Phase Ib trial there to evaluate safety and tolerability of defined doses (5/4)

NexMed Inc.
NXMD)

Femprox

Alprostadil cream

Female sexual arousal disorder

400-patient trial in China demonstrated statistically significant arousal success rate vs. placebo (5/23)

Threshold
Pharmaceuticals
Inc.
(THLD)

TH-070

lonidamine; an indazole-3-carboxylic acid

Benign prostatic hyperplasia

Follow-up data from Phase II trial in Italy showed BPH symptoms remained significantly improved six months following treatment (5/19)


Notes:

* Privately held.

ASCO = Data were presented at the American Society of Clinical Oncology meeting May 14-17.

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; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange.

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