Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: August 2004

Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

Biogen Idec
Inc. (BIIB) and
Elan Corp. plc
(Ireland)

Antegren (natalizumab)

Humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class

Multiple sclerosis

Companies submitted an application for approval in Canada and expect to submit applications in Australia and Switzerland in 4Q:04 (8/17)

CANCER

Amgen Inc.
(AMGN)

Aranesp (FDA-approved)

Darbepoetin alfa, a recombinant erythropoietic protein

Anemia from chemotherapy

European committee issued positive opinion on expanding the label to include extended dosing (8/5)

Aphton Corp.
(APHT)

Insegia
(G17DT)

Immunotherapy vaccine designed to induce antibodies to both gastrin 17 and glygastrin 17

Advanced pancreatic cancer

The company filed for approval of the drug in Canada for patients for whom chemotherapy is not indicated (8/26)

A.P. Pharma
Inc. (APPA)

APF530

The anti-emetic granisetron in a polymer- based drug delivery system

Chemotherapy-induced nausea and vomiting

Initial results from Phase I trial in the UK demonstrated measurable blood levels of granisetron over a four-day period (8/12)

Bioenvision
Inc. (BIVN)

Clofarabine

Second-generation purine nucleoside analogue

Acute leukemias in children

Filed for approval in Europe for treating refractory or relapsed leukemia in children (8/20)

Bioenvision
Inc. (BIVN)

Clofarabine

Second-generation purine nucleoside analogue

Adult acute leukemia

Began pivotal Phase II trial in the UK that will include 65 patients and last nine months (8/10)

Bioenvision
Inc. (BIVN)

Modrenal
(trilostane)

Drug designed to increase estrogen binding to ER beta and decrease binding to ER alpha

Breast cancer

Began two trials in the UK, a Phase II in pre-menopausal women and a Phase IV in post-menopausal women (8/9)

Onyx
Pharmaceuticals
Corp. (ONYX)
and Bayer
Pharmaceuticals Corp.

BAY 43-9006

RAF kinase and VEGF inhibitor

Renal-cell carcinoma

The drug was granted orphan designation in Europe in that indication (8/4)

OSI
Pharmaceuticals
Inc. (OSIP) and
Genentech Inc. (NYSE:DNA)

Tarceva

Erlotinib HCl; small-molecule HER1/EGFR inhibitor

Non-small-cell lung cancer

Partner F. Hoffmann-La Roche Ltd. submitted an application in Europe seeking approval as a mono-therapy in patients with advanced disease (8/26)

Viventia
Biotech Inc.
(Canada; TSE:VBI)

Proxinium

Product that uses tumor-seeking antibody fragments to deliver agents to cancer cells

Bladder cancer

Began Phase I trial in Canada to to assess safety and tolerability in 24 patients (8/19)

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

TheraCIM hR3

Humanized anti-epidermal growth factor receptor monoclonal antibody

Glioma

The product was granted orphan designation in Europe (8/10)

ZymoGenetics
Inc. (ZGEN) and
Serono SA
(Switzerland;
NYSE:SRA)

TACI-Ig

Soluble fusion protein linking the extracellular portion of the TACI receptor to the Fc portion of human immunoglobulin

Rheumatoid arthritis

Began Phase Ib study in Europe and Australia in 60 patients to evaluate safety and pharmacokinetics, while also monitoring biological effects (8/30)

CARDIOVASCULAR

Protemix Corp.*
(New Zealand)

Laszarin

Small molecule designed to remove excess copper from the body

Heart disease in diabetics

Phase II trial in Type II diabetics showed increased urinary output of copper vs. treated controls (8/31)

CENTRAL NERVOUS SYSTEM

Axaron
Bioscience AG*
(Germany)

AX200

Drug designed to prevent death of nerve cells and promote regeneration of damaged brain tissue

Stroke

Began Phase II trial in Germany (8/2)

DIABETES

Depomed Inc. (DEPO) and Biovail Corp. (Canada)

Glumetza

Once-daily, extended-release formulation of the approved drug metformin

Type II diabetes

Regulators in Canada accepted for review the new drug submission on the drug (8/10)

Generex
Biotechnology
Corp. (GNBT)

Oralin

Oral insulin spray formulation

Diabetes

Filed for approval of the product in Ecuador (8/31)

INFECTION

Immtech
International
Inc. (AMEX:IMM)

DB289

Oral, dicationic antiviral agent

Malaria

Began Phase I trial, designed to complement Phase II in Thailand, to evaluate pharmacokinetics in 74 healthy volunteers (8/9)

Viral Genetics Inc. (OTC BB:VRAL)

VGV-1

Thymus nuclear protein extracted from bovine thymus gland

HIV

Began 80-patient trial in South Africa that will assess viral load, as well as safety and immunological function (8/3)

MISCELLANEOUS

Discovery
Laboratories
Inc. (DSCO)

Surfaxin

Engineered version of natural human lung surfactant

Respiratory distress syndrome in premature neonates

European regulators designated Surfaxin an orphan product in that indication (8/12)

NexMed Inc.
(NXMD)

Femprox

Alprostadil cream

Female sexual arousal disorder

Pilot overseas study in eight patients showed a significant difference in the primary efficacy end- point vs. placebo cream (8/25)

Notes:

* Privately held.

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

AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange.