Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Aphton Corp. (APHT)

­

Anti-gastrin therapeutic vaccine; neutralizes hormone G17 and Gly-extended G17

Metastatic pancreatic cancer

UK's Medicines Control Agency cleared Phase III trial of combination therapy with gemictabine vs. gemcitabine alone (4/11)

Biovector Therapeutics SA* (France)

Lipomel

Therapeutic vaccine based on lipopetidic delivery technology

Melanoma

Enrolled first patients in a Phase II trial in France (4/18)

Coley Pharmaceutical Group Inc.*

­

DNA-based cancer vaccine; intradermal injection

Melanoma

Announced initiation of clinical trial in Europe by quarter's end (4/17)

Coley Pharmaceutical Group Inc.*

CpG 7909

DNA-based immune stimulant; direct tumor injection

Metastatic melanoma or basal cell carcinoma

Announced initiation of clinical trial in Europe by quarter's end (4/17)

The Liposome Company Inc. (LIPO)

Myocet (Evacet)

Liposomal formulation of doxorubicin

Metastatic breast cancer

Committee for Proprietary Medicinal Products recommended approval in the European Union (4/14)

Transgene SA (France;TRGNY)

­

Gene therapy using adenoviral vector to deliver gene for interleukin-2

Advanced lung cancer

Reported initial results of Phase I French trial at AACR (4/5)

CARDIOVASCULAR

Cerus Corp. (CERS)

Intercept

Pathogen inactivation system that targets and inactivates bloodborne pathogens, while leaving the therapeutic properties of platelets intact; process uses light-activated psoralen compound, S-59, which disables nucleic acid

Platelets intended for transfusion

Independent Data and Safety Monitoring Board recommended continuing Phase III European trial (4/27)

InterMune Pharmaceuticals Inc. (ITMN)

Actimmune (FDA-approved)

Interferon gamma-1b

Idiopathic pulmonary fibrosis

Presented analysis of Austrian Phase II trial (4/13)

CENTRAL NERVOUS SYSTEM

Neurocrine Biosciences Inc. (NBIX) and Janssen Pharmaceutica (unit of Johnson & Johnson; NYSE:JNJ)

R121919

Corticotropin-releasing factor receptor antagonist

Depression and anxiety

Discontinued development, substituting backup compound; decision was based on observations of reversible increases in liver enzymes in two UK trial patients (4/5)

Neurotech SA* (France)

NTC-121

Cell therapy using intratumoral delivery of stable endothelial cells genetically modified to produce the human cytokine interleukin-2

High-grade gliomas

Initiated Phase I/II trial in France (4/12)

DIABETES

Flamel Technologies SA (France; FLMLY) and Novo Nordisk A/S (Denmark)

LABI (formerly Basulin)

Long-acting, subcutaneously administered formulation of human insulin based on Flamel's Medusa technology

Diabetes

Completed first clinical trial (4/18)

Generx Biotechnology Corp. (OTC BB:GNBT)

Oralin/Oralgen

Oral insulin formulation administered as a fine spray into the oral cavity using a handheld aerosol applicator

Newly diagnosed Type II diabetics

Initiated clinical trials in Italy (4/4)

INFECTION

AuRx Inc.*

AuRx HSV-2

Vaccine using recombinant strain of herpes in which an oncogene has been deleted

Prevention of recurrence of genital herpes

Received authorization from the Mexican Ministry of Health to conduct Phase I/II trial (4/30)

BioChem Pharma Inc. (Canada; BCHE)

Epivir-HBV (FDA-approved)

Lamivudine

Hepatitis B infection

Presented interim review of long-term follow-up study in Chinese patients at the 10th International Symposium on Viral Hepatitis and Liver Diseases (4/11)

Hemispherx Biopharma Europe NV/SA (AMEX:HEB)

­

Product ND

Chronic fatigue syndrome

Withdrew treatment application in order to take advantage of new European orphan products regulations (4/13)

Hemispherx Biopharma Inc. (AMEX:HEB)

Ampligen

Double-stranded synthetic RNA compound poly I:poly C12U

HIV

FDA authorized emergency treatment for patients developing resistance to currently approved regimens (4/12)

Hollis-Eden Pharmaceuticals Inc. (HEPH)

HE2000

Compound thought to act by a mechanism of action that affects energy regulation in the host cell

HIV infection

Presented preliminary clinical data from South African Phase I/II trial (4/10)

Maxim Pharmaceuticals (MAXM)

Maxamine

Histamine dihydrochloride; H2 receptor agonist

Chronic hepatitis C infection

Initiated trial of Maxamine in combination with interferon-alpha and Ribavirin in Israel (4/3)

SciClone Pharmaceuticals

Zadaxin

Thymosin alpha 1; synthetic version of naturally occurring peptide hormone thymosin (immunomodulator)

Influenza vaccine adjuvant for individuals with weakened immune systems

Cleared for marketing in South Korea (4/13)

MISCELLANEOUS

Karo Bio AB (Sweden)

­

Ointment containing a substance that activates the thyroid hormone receptor

Skin atrophy caused by repeated steroid treatment of skin diseases

Swedish Medical Products Agency approved application to start Phase II trials (4/18)

NicOx SA (France; Nouveau Marche: NICOX)

HCT-1026

Nitro-flubiprofen; prostaglandin inhibitor

Urinary frequency and urgency, with or without urinary incontinence

UK Medicines Control Agency approved Clinical Trials Exemption (4/20)

Oxford GlycoSciences plc (UK; LSE:OGS)

OGT 918

Orally active small molecule that inhibits glycolipid formation

Gaucher disease

The Lancet published results of trial in the UK, Netherlands, the Czech Republic and Israel (4/28)

QLT PhotoTherapeutics Inc. (Canada; QLTI)

Visudyne

Verteporfin for injection; photodynamic therapy is activated through use of specially designed laser that produces low-level, non-thermal 689 nm light

Wet form of age-related macular degeneration

Committee for Proprietary Medicinal Products recommeded approval in the European Union (4/14)

Notes:

* Privately held.

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

AMEX = American Stock Exchange; BSX = Berlin Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange

ND = Not disclosed