Company
(Country; Symbol)

Product

Description

Indication

Status (Date)

AUTOIMMUNE

Genzyme Bio-
surgery (division
of Genzyme Corp.; GENZ)

Synvisc (FDA-
approved)

Hylan G-F20; an elastoviscous hylan therapeutic

Osteoarthritis

European Union granted approval to market Synvisc (7/2)

CANCER

AltaRex Corp.
(Canada; TSE:AXO)

OvaRex

Oregovomab; a fully foreign monoclonal antibody that targets CA125

Ovarian cancer

European committee adopted a positive opinion recommending the granting of orphan medicinal product designation (7/9)

CARDIOVASCULAR

Genzyme Bio-
surgery (subsidiary of Genzyme Corp.; GENZ) and Myosix SA* (France)

A therapy designed to improve a patient's heart function after a heart attack through the introduction of muscle cells from another part of the body into the damaged areas of the heart

Heart failure

Companies plan to start a large- scale Phase II trial of the cell therapy in Europe (7/30)

Guilford
Pharmaceuticals Inc. (GLFD)

Aquavan

A sedative/hypnotic; a water soluble prodrug of propofol

Coronary artery surgery patients

Company began a Phase II trial in Europe (7/15)

Pharmos Corp.
(PARS)

Dexanabinol

Non-psychotropic, synthetic analogue of marijuana

Mild cognitive impairment that follows coronary surgery with cardiopulmonary bypass operations

Company received approval for a Phase II trial in Israel (7/25)

CENTRAL NERVOUS SYSTEM

ReGen Thera-
peutics plc (UK; LSE:RGT)

Colostrinin

Proline-rich polypeptide complex isolated from ovine colostrum

Alzheimer's disease

In a clinical trial, about 40% of patients were stabilized or improved after 15 weeks, and 33% continued to show stabilization or improvement at 30 weeks; the trial is being conducted in Poland (7/10**)

INFECTION

Hollis-Eden Pharmaceuticals Inc. (HEPH)

HE2000

Immune-regulating
hormone

HIV

Data from a Phase II South African trial showed a downward slope in viral load in the 50-mg and 100-mg dose groups (7/8)

MISCELLANEOUS

ICOS Corp.
(ICOS) and
Eli Lilly and Co.

Cialis

Tadalafil; oral PDE5
inhibitor

Erectile dysfunction

The European Committee for Proprietary Medicinal Products issued a positive opinion for Cialis, recommending that approval should be granted (7/25)

Insmed Inc.
(INSM)

Somato-
Kine

Recombinant protein being developed as an insulin sensitizer

Growth hormone insensitivity syndrome

Company initiated a Phase II trial with SomatoKine in children in the UK (7/18)

Oxford Glyco-
Sciences plc (UK; OGSI; LSE:OGS)

Vevesca (Zavesca)

Oral capsule formulation
of a glucosyltransferase inhibitor

Gaucher's disease

Israeli authorities have lifted their temporary suspension of Oxford's Vevesca trials (7/24); company received approval in Europe for Vevesca (7/26)

Notes:

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

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