Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


CANCER

Ardana
Bioscience
plc
(UK; LSE:ARA)

Teverelix LA

Long-acting gonadotrophin
-releasing antagonist

Prostate cancer

13 of 14 patients in a Phase II trial showed reduced levels of testosterone equivalent to those of castrated men (2/17)

Australian
Cancer
Technology Ltd.
(Australia; ASX:ACU)

RP101

Antiviral drug marketed in Europe that down- regulates the STAT3 and APEX genes

Late-stage pancreatic cancer

Phase I/II trial in 13 patients showed a doubling of survival time with gemcitabin and cisplatin vs. those agents alone (2/9)

ChemGenex
Pharmaceuticals
Ltd.
(Australia;
ASX:CXS)

Quinamed

Naphthalimide analogue; topoisomerase II inhibitor

Advanced cancers

Presented updated Phase I/II data showing positive benefits when combined with standard cancer drugs (2/8)

Cougar
Biotechnology
Inc.*

CB7630

Abiraterone acetate; targeted oral therapy

Prostate cancer

Published results of Phase I trial in the UK showed treatment suppressed testosterone levels (2/21)

GPC Biotech
AG
(Germany;
GPCB)

1D09C3

Anti-major histocom- patibility complex Class II monoclonal antibody

B-cell lymphomas

Began Phase I study in Switzerland, Germany and Italy in patients with relapsed or refractory disease (2/1)

Maxim
Pharmaceuticals
Inc.
(MAXM)

Ceplene

Histamine dihydrochloride in combination with interleukin-2

Metastatic renal- cell carcinoma

Phase II trial in Denmark showed trend toward improved survival but not tumor response vs. IL-2 alone; Phase II trial in the UK showed no difference in either endpoint (2/8)

Oncolytics
Biotech Inc.
(Canada; ONCY)

Reolysin

Formulation of the human reovirus

Advanced cancers

Got OK to start Phase I trial in the UK to evaluate feasibility, safety and antitumor activity in combination with radiation (2/18)

Oncoscience
AG*
(Germany)
and YM
BioSciences Inc.
(Canada; TSE:YM)

TheraCIM
h-R3

Humanized anti-epidermal growth factor receptor monoclonal antibody

Brain cancer in children

Phase II trial showed a 35.3% response rate in 17 evaluable children who had failed other treatments (2/28)

PharmaMar
SA
(Spain;
subsidiary of
Zeltia Group)

Aplidin

Antitumor agent derived from the marine tunicate Aplidium albicans

Bladder cancer

Began Phase II trial in Europe to evaluate tumor response in 42 patients with advanced disease (2/17)

pSivida Ltd.
(Australia;
ASX:PSD)

BrachySil

Micron-sized particle in which the isotope 32- phosphorus is immobilized

Liver cancer

Data from four patients in Phase IIa trial showed average tumor regression by volume of 80% (2/14)

Transgene
SA
(France;
TRGNY)

MVA-Muc1-IL2

Recombinant MVA virus containing sequences encoding for the human MUC1 antigen and the cytokine IL-2

Non-small-cell lung cancer

13 of 35 patients in a Phase II trial experienced a partial response and 11 had disease stabilization for more than 12 weeks; the drug was used with cisplatin and vinorelbine (2/23)

Viragen Inc.
(AMEX:VRA)

Multiferon

Multisubtype, human alpha interferon derived from white blood cells

Malignant melanoma

Filed for approval in Sweden to expand labeling to include firstline adjuvant treatment, following dacarbazine after surgical removal of tumors (2/4)

Xenova
Group plc
(UK; XNVA)

TransMID
(SOT-107)

Modified diphtheria toxin conjugated to transferrin

Glioma

Partner Sosei Co. Ltd. was granted orphan drug status in that indication in Japan (2/14)

CARDIOVASCULAR

Cytos
Biotechnology
AG
(Switzerland;
SWX:CYTN)

CYT006-AngQb

Vaccine designed to produce an anti-angiotensin II antibody response

Hypertension

Pilot trial in 16 volunteers showed the drug was safe, well tolerated and immunogenic (2/14)

D-Pharm Ltd.*
(Israel)

DP-b99

Neuroprotective agent based on selective modution of calcium, zinc, copper and iron homeostasis

Acute stroke

Began confirmatory Phase IIb trial in 150 patients in Europe and Israel (2/8)

Portola
Pharmaceuticals
Inc.*

--

Oral Factor Xa inhibitor

Venous thrombosis

Began a Phase Ib trial in the UK; the drug is being developed as an anticoagulant (2/7)

CENTRAL NERVOUS SYSTEM

Axonyx
Inc.
(AXYX)

Phenserine

Inhibitor of acetylcholin-
esterase and beta-amyloid precursor protein

Alzheimer's disease

Phase III trial in 384 patients in Europe showed positive trends, but failed to demonstrate statistical significance following 26 weeks of treatment (2/7)

Orexo AB*
(Sweden)

OX 22

Sublingual formulation of an undisclosed agent

Insomnia

Company said it completed an efficacy trial with positive results (2/28)

INFECTION

Anadys
Pharmaceuticals
Inc.
(ANDS)

ANA975

Oral prodrug of Anadys' isatoribine, an agonist of Toll-like receptor 7

Hepatitis C

Began Phase I trial in the UK to test safety, tolerability and pharmacokinetics in 18 healthy volunteers (2/2)

Bioenvision
Inc.
(BIVN)

Virostat

Antiviral agent

Hepatitis C

Began Phase II trial in Europe and Egypt to assess viral load reduction and quality of life in patients with chronic disease (2/16)

Cangene Corp.
(Canada; TSE:CNJ)

WinRho SDF (FDA-approved)

Antibody to certain types of red blood cells

Dengue hemorrhagic fever

Trial in the Philippines met its primary endpoint of increasing platelet counts by 20,000 at 48 hours after dosing (2/15)

Gilead
Sciences Inc.
(GILD)

Truvada (FDA-approved)

Fixed-dose combination of the company's approved Viread and Emtriva drugs

HIV

The European Commission approved the drug in all 25 member states of the European Union for use in combination regimens (2/23)

Millenia Hope
Inc.
(OTC BB:MLHP)

MMH Malarex

Antimalaria agent

Malaria

Began extended trial in the Republic of Central Africa testing the drug in 360 pediatric patients (2/22)

Targeted Genetics Corp.
(TGEN)

tgAAC09

Gene therapy using AAV vector to elicit immune system responses

HIV

Phase I trial in 30 volunteers in Belgium and Germany showed no safety concerns and that the vaccine was well tolerated (2/22)

Targeted
Genetics Corp.
(TGEN)

tgAAC09

Gene therapy using AAV vector to elicit immune system responses

HIV

International partnership began Phase I trial in India to test safety in 30 volunteers (2/7)

MISCELLANEOUS

Arexis AB*
(Sweden)

BSSL

Human enzyme-replacement therapy; bile salt-stimulated lipase

Fat malabsorption in cystic fibrosis patients

The European Commission granted orphan status to the drug in that indication (2/9)

Biolipox AB*
(Sweden) and
NicOx SA
(France;
NM:NICOX)

NLA Nasal Spray (NCX 1510)

Antihistamine agent delivered via nasal spray

Allergic rhinitis

Trial in 12 volunteers showed the product had an onset of effect within five to 10 minutes (2/22)

IDEA AG*
(Germany)

IDEA-070

Topical dermatological agent

Inflammatory skin diseases

Began Phase II study to examine safety and efficacy in various conditions in 225 patients in Germany (2/10)

Manhattan
Pharmaceuticals
Inc.
(OTC BB:MHTT)

Oleoyl estrone

Oral therapeutic for weight loss

Obesity

Began Phase I trial in Switzerland to evaluate safety and tolerability in 36 obese volunteers (2/3)

Pharmaxis Inc.
(Australia; ASX:
PXS)

Bronchitol

Mannitol formulation delivered via an inhalation device

Cystic fibrosis

Began a Phase II trial in the UK that will compare the drug to Pulmozyme in 42 patients (2/9)

Topigen
Pharmaceuticals
Inc.*
(Canada)

ASM8

Inhaled dual antisense drug designed to block two pathways of the inflammation response

Asthma

Began Phase I trial in Canada to evaluate safety (2/17)

Vivus Inc.
(VVUS)

Testosterone MDTS

Transdermal testosterone spray

Hypoactive sexual desire disorder

Phase II trial with 261 premenopausal women in Australia demonstrated a statistically significant increase in satisfactory sexual events at week 16 for the second highest dose vs. placebo (2/9)


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.

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NM = Nouveau Marche; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange.