Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Isis Pharmaceuticals Inc. (ISIS)

Alicaforsen (ISIS 2302)

Antisense inhibitor of intercellular adhesion molecule-1

Crohn's disease

Company initiated a second Phase III trial with 150 patients at 35 sites in Europe (6/25)

CANCER

Advanced Viral Research Corp. (OTC BB:ADVR)

Product R

A nontoxic peptide-
nucleic acid-type immunomodulator that appears to stimulate the proinflammatory responses required to combat viral infections and to aberrant autoimmune-type inflammatory responses

Body wasting in patients with solid tumors

Company received approval to begin a Phase I study in Israel (6/18)

Amgen Inc.
(AMGN)

Aranesp/ Nespo; Neulasta/ Neupogen (FDA-approved)

Darbepoetin alfa; pegfilgrastim

Anemia in cancer patients; to reduce the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy

European Committee on Proprietary Medicinal Products recommended approval of darbepoetin alfa and pegfilgrastim (6/4)

BioVex Ltd.*
(UK)

OncoVEX GM-CSF

Herpes simplex virus engineered to replicate in and destroy cancer cells, and carrying the gene encoding the immune stimulator granulocyte macrophage-colony stimulating factor

Solid tumors

Company was granted approval in the UK to begin a Phase I trial (6/24)

Genzyme Canada (subsidiary of Genzyme Corp.; GENZ)

Thyrogen

Thyrotropin alfa for injection; a recombinant human thyroid stimulating hormone

Thyroid cancer

Genzyme received approval for Thyrogen in Canada (6/3)

Peregrine Pharmaceuticals Inc. (PPHM)

131i-chTNT

131 iodine-labeled chimeric tumor necrosis therapy antibody drug using a method of intratumoral injection

Lung cancer

Clinical data from a study in China show that 56% efficacy was achieved (6/19)

INFECTION

Advanced Viral Research Corp. (OTC BB:ADVR)

Product R

A nontoxic peptide-
nucleic acid-type immunomodulator that appears to stimulate the proinflammatory responses required to combat viral invections and to aberrant autoimmune-type inflammatory responses

AIDS-related wasting

The Israeli Ministry of Health approved Product R for Phase I/II trials (6/6)

CollaGenex Pharmaceuticals Inc. (CGPI)

Periostat (FDA-
approved)

Doxycycline 20 mg
tablets

Periodontitis

Company received final marketing authorization for Periostat in the Netherlands and Portugal (6/25)

Gilead Sciences Inc. (GILD) and
F. Hoffmann-La Roche Inc.

Tamiflu (FDA-
approved)

Oseltamivir phosphate

Influenza

Companies received approval to market Tamiflu in Europe (6/27)

ID Biomedical
Corp.
(Canada; TSE:IDB)

FluINsure

Intranasally delivered
vaccine

Influenza

Company received clearance from the Biologics and Genetic Therapies Directorate of the Health Products and Foods Branch of Health Canada to proceed with a Phase II trial (6/5)

MISCELLANEOUS

Modex Therapeutics
Ltd.
(Switzerland; SWX:MDXN)

Allox

An off-the-shelf
allogeneic cell-based
product

Skin wounds

Company completed a Phase I trial in Switzerland that demonstrated the product's safety (6/26**)

Procyon Biopharma Inc. (Canada; TSE:PBP)

Fibrostat

Topical cream

Hypertrophic scars

Results of a Canadian Phase II trial showed there were no serious or severe treatment reactions related to treatment (6/21)

Tanox Inc., (TNOX), Novartis Pharma AG and Genentech Inc. (NYSE:DNA)

Xolair

Omalizumab; anti-IgE therapy; a humanized monoclonal antibody

Moderate allergic asthma

Australian authorities approved Xolair (6/18)


Notes:

* Privately held.

** Denotes the date the item ran in BioWorld International.

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

NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange

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