Company* (Country; Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

4SC AG* (Germany)

SC12267

Small molecule designed to inhibit pyrimidine synthesis

Rheumatoid arthritis

Company began Phase I trial in Germany in 56 volunteers to test safety, tolerability and pharmaco-kinetics in increasing doses (12/10)

Advanced Viral Research Corp. (OTC BB:ADVR)

AVR118

Immunomodulator

Rheumatoid arthritis

Open-label study in 27 patients in Argentina showed improvements in quality of life (12/3)

CANCER

Active Biotech AB* (Sweden)

CD2

A TTS, or tumor-targeted superantigen

Renal cancer

Final analysis of Phase IIa open- label study confirmed previous positive data; company is moving ahead with improved compound, TTS CD3 (12/18)

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

Alizyme got approval for Phase IIa trial in UK to compare drug to placebo in patients undergoing ablative therapy prior to autologous bone marrow transplantation for leukemia or lymphoma (12/19)

Aphton Corp. (APHT)

G17DT

Immunotherapy designed to induce in patients antibodies that bind to both gastrin 17 and gly-gastrin

Advanced pancreatic cancer

Aphton began filing process in Australia seeking approval as a monotherapy in patients not taking chemotherapy (12/30)

Atrix Laboratories Inc. (ATRX)

Eligard 7.5 mg (Leuprogel)

Leuprolide acetate; lutenizing hormone- releasing hormone agonist

Prostate cancer

Atrix licensee MediGene AG received approval of Eligard in Germany (12/2)

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

Pentrix

Vaccine designed to trigger immune response against cancer cells with mutated p53 gene

Hormone- refractory prostate cancer

Company got approval for Phase II trial in Australia to evaluate safety of new formulation in 40 patients (12/19)

Bionevision Inc. (AMEX:BIV)

Clofarabine

Second-generation purine nucleoside antimetabolite

Acute lymphoblastic leukemia

The first patient has been treated in a pivotal European Phase II pediatric study expected to include 65 patients (12/4)

ImClone Systems Inc. (IMCL)

Erbitux

Cetuximab; antibody designed to block EGFR

Irinotecan- refractory colorectal cancer

ImClone partner Merck KGaA received approval of Erbitux in Switzerland (12/1)

Lorus Therapeutics Inc. (Canada; TSE:LOR)

GTI-2501

Antisense drug that targets the R1 component of ribonucleotide reductase

Hormone- refractory prostate cancer

Company started a Phase I trial in Toronto to assess safety and efficacy of drug in combination with docetaxel (12/23)

ML Laboratories plc (UK; LSE:MLB)

--

Vaccine using patient's dendritic cells with CL22 antigen-delivery system

Advanced melanoma

Company began a Phase I trial in 10 patients in the UK that will assess immune response (12/19)

Munich Biotech AG* (Germany)

MBT-0312

Camptothecin-based drug in a lipid complex

Advanced solid tumors

Company started a Phase I trial to assess safety and tolerability, and preliminary efficacy of escalating doses (12/12)

Munich Biotech AG* (Germany)

MBT-0206

Anti-neovascular cancer agent containing paclitaxel and a lipid-based carrier

Metastatic breast cancer and pancreatic cancer

Preliminary Phase I data showed clinical benefit and no safety concerns; also, Phase I trial with 5-FU showed combination was well tolerated (12/8)

Munich Biotech AG* (Germany)

MBT-0206

Anti-neovascular cancer agent containing paclitaxel and a lipid-based carrier

Pancreatic cancer

Company started a first-line Phase I study in combination with gemcitabine (12/8)

Pharmion Corp. (PHRM)

Thalidomide Pharmion

Thalidomide; modulates levels of tumor necrosis factor-alpha

Multiple myeloma

New Zealand officials approved the drug for treating refractory disease, and for treating a severe complication of leprosy (12/18)

Solbec Pharmaceuticals Ltd. (Australia; ASX:SBC)

SBP002

Combination of two glycoalkaloids isolated from the fruit of Solanum linnaeanum

Cancers

Soltec began Phase I/IIa trial in up to 25 patients in Australia to evaluate product in patients with advanced solid tumors (12/16)

CARDIOVASCULAR

Alexion Pharmaceuticals Inc. (ALXN)

Eculizumab

A humanized monoclonal antibody C5 complement inhibitor

Paroxysmal nocturnal hemoglobinuria

European regulators granted orphan status to the product in that indication (12/8)

Biopure Corp. (BPUR)

Hemopure (HBOC-201)

Oxygen therapeutic consisting of bovine hemoglobin

Oxygen therapeutic

Company started a pilot Phase II trial in Europe testing safety in patients with coronary artery disease (12/22)

Trigen Ltd.* (UK)

TGN 167

Oral direct thrombin inhibitor

Thrombosis

Phase I study in 20 volunteers showed agent was well tolerated (12/16)

Trigen Ltd.* (UK)

TGN 255

Intravenous direct thrombin inhibitor

Thrombosis

Phase I study showed increase in thrombin clotting time (12/3)

United Therapeutics Corp. (UTHR)

Remodulin (FDA-approved)

Treprostinil sodium injection

Pulmonary arterial hypertension

Swiss officials issued notice of approval in that indication and primary pulmonary hypertension pending labeling and an interactive study; the drug also was recommended for approval in Austria for PAH (12/17)

CENTRAL NERVOUS SYSTEM

Arakis Ltd.* (UK)

ED 1612

Opioid and an opioid potentiator in a modified- release formulation

Pain

Company started a study in 36 volunteers using an established pain model (12/2)

GB Therapeutics Ltd.* (Canada)

GT 1061

Mimetic of nitric oxide

Alzheimer's disease

GB received approval for a Phase I trial in Canada in healthy aged volunteers (12/4)

Nutra Pharma Inc. (OTC BB:NPHC)

Immunokine

Oral agent

Adrenomyelo- neuropathy

Company said published results from placebo-controlled Phase IIa trial in the UK showed the drug was safe and well tolerated (12/5)

Phytopharm plc (UK; LSE:PYM)

PYM50028

Product based on Asian plant extract believed to have neuroprotective effects

Alzheimer's disease

Company got approval for Phase II trial in the UK to test the drug against placebo in 200 patients (12/9)

Prana Biotechnology Ltd. (Australia; PRAN)

PBT-1 (clioquinol)

Chemical that binds zinc and copper

Alzheimer's disease

Pilot Phase II trial showed drug slowed progression of cognitive decline in patients with moderate to severe disease vs. placebo; study conducted in Australia (12/16)

INFECTION

Arpida Ltd.* (Switzerland)

Iclaprim (AR-100)

Diaminopyrimidine; anti- infective

Skin and soft-tissue infections

Company completed a Phase II trial in 92 patients that showed clinical cure rates similar to that seen with vancomycin (12/17)**

Immtech International Inc. (AMEX:IMM)

DB289

Oral antiviral agent

Malaria

Phase II study in 32 patients in Thailand showed all cleared the parasite; the drug was well tolerated (12/8)

Targeted Genetics Corp. (TGEN)

tgAAC09

Gene therapy using AAV vector to elicit immune system responses

HIV

Company and nonprofit partners began Phase I trial in Belgium to test safety and immune responses in up to 50 volunteers (12/9)

Vicuron Pharmaceuticals Inc. (MICU)

Anidulafungin

Broad-spectrum agent from the echinocandin class

Esophageal candidiasis

Company filed approval application in Europe (12/18)

MISCELLANEOUS

Discovery Laboratories Inc. (DSCO)

--

Humanized lung surfactant delivered as inhaled aerosol

Asthma

Company started a Phase Ib trial in the UK in up to 12 patients to assess preliminary safety and tol- erability (12/22)

Pharmagene plc (UK: LSE:PGN)

PGN0052

Synthetic version of human secretin

Cystic fibrosis

Company began Phase II trial in 18 patients in the UK to establish proof of principle (12/17)

Notes:

* Privately held.

** Denotes the date item ran in BioWorld International.

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; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange.