Non-U.S. Clinical Trials And Regulatory Actions: November 2006

Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)

AUTOIMMUNE

Abbott
Laboratories
(NYSE:ABT)

Humira

Adalimumab

Ankylosing spondylitis

Health Canada granted marketing approval (11/6)

KaloBios
Pharmaceuticals
Inc.*

KB002

Engineered human monoclonal antibody that targets and neutralizes GM-CSF, the granulocyte macrophage colony- stimulating factor

Rheumatoid arthritis

Started Phase I trial of drug;
it will enroll 30 patients in
Australia (11/9)

CANCER

BioCryst
Pharmaceuticals
Inc. (BCRX)

Fodosine

Purine nucleoside phosphorylase inhibitor

T-cell acute
lymphoblastic
leukemia

European Medicines Agency granted orphan designation (11/17) Forodesine; transition state

IDM Pharma
Inc. (IDMI)

Mepact

Mifamurtide for injection

Osteosarcoma

Submitted marketing authorization application in Europe for its use in newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with postoperative multiagent chemotherapy (11/7)

Peregrine
Pharmaceuticals
Inc. (PPHM)

Bavituximab

Anti-phospholipid immunotherapy agent

Cancer

Started patient treatment in its Phase Ib trial of 12 patients at three sites in India (11/17)

SkyePharma plc
(UK; SKYE;
LSE:SKP)

Solaraze

Diclofenac; topical gel

Actinic keratosis

Australian regulators approved the product (11/28)

CARDIOVASCULAR

Angiotech
Pharmaceuticals
Inc. (Canada; ANPI;
TSX:ANP)

Vascular Wrap

Paclitaxel-eluting product

Peripheral arterial disease

Data produced evidence of a reduced overall incidence of leg amputation and prolonged limb retention vs. the control group (11/9)

Argenta
Discovery Ltd.
(UK; OTC BB:AGTA)

ADC4022

Inhaled therapy

Chronic obstructive pulmonary disease and severe asthma

Started a Phase I trial with 36 volunteers (11/8)

EPIX
Pharmaceuticals
Inc. (EPIX)

Vasovist

Gadofosveset trisodium injection; blood pool imaging agent

Vascular disease

Health Canada approved Vasovist (11/6)

INFECTION

AMDL Inc.
(AMEX:ADL)

Levoflocaxin

Antibiotic; fluoroquinolone

Pneumonia, urinary tract infections, kidney and skin infections

Approved by Chinese regulatory authorities (11/17)

Arrow
Therapeutics
Ltd.* (UK)

A-831

Small-molecule antiviral inhibitor designed to target the NS5a protein

Hepatitis C virus

Started a Phase I study in the UK (11/27)

Generex
Biotechnology
Corp. (Canada;
GNBT)

Antigen Express

Synthetic vaccine based on simple peptide-synthesis technology

Avian influenza

Will conduct first clinical trial at the Lebanese-Canadian Hospital in Beirut (11/6)

Protherics
plc (UK;
LSE:PTI)
and
AstraZeneca plc
(UK)

CytoFab

Anti-TNF-alpha polyclonal antibody fragment

Severe sepsis

Expanded development with the addition of a 48-patient Phase II program (11/3)

MISCELLANEOUS

DOR BioPharma
Inc. (OTC
BB:DORB)

orBec

Oral beclomethasone dipropionate

Gastrointestinal graft-vs.- host disease

Submitted marketing authorization to the European Medicines Agency (11/7); European regulators accepted the application (11/28)

Kamada Ltd.
(Israel;
TASE:KMDA)

API

Alpha 1-proteinase inhibitor

Congenital emphysema and cystic fibrosis

Started Phase I trials of an inhaled formulation (11/27)

Notes:

* Privately held.

CHMP = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.

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

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TASE = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange.