Company*

Product

Description

Indication

Status

(Symbol)

(Date)

CANCER

Ark Therapeutics Ltd. (UK)*

EG009

Combination of a herpes simplex virus thymidine kinase gene in a modified adenoviral delivery vector, and ganciclovir

Malignant glioma

Phase I/IIa trial showed the therapy doubled patient survival time (4/4)

Bavarian Nordic Research Institute A/S (Denmark; CSE:BAVA)

MVA-BN tyr vaccine

Orthopox vaccine

Late-stage melanoma

Company said primary data of its first clinical study showed the vaccine activates patients' immune systems to fight cancer cells; study was conducted in Italy (4/18)

Cell Therapeutics Inc. (CTIC)

Trisenox

Aresenic trioxide injection

Multiple myeloma and myelodysplatic syndrome

European Commission granted orphan medicinal product designation (4/4)

Ligand Pharmaceuticals Inc. (LGND)

Targretin

Capsules; bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors

Cancer

Company was granted marketing approval in Europe; company also submitted an application to market Targretin 1% gel in Europe (4/3)

MGI Pharma Inc. (MOGN)

MGI-114

Irofulven; hydroxymethylacylfulvene

Cancer

Company initiated an additional Phase II trial in Europe testing irofulven as a single agent and in combination with prednisone (4/12)

PhotoCure ASA (Norway; OSE:PHO)

Metvix PDT

Photodynamic therapy involving a cream that is activated by light

Basal cell carcinoma and actinic keratosis

Company submitted a marketing authorization application in New Zealand (4/26)

Progen Industries Ltd. (Australia; PGLAF) and Medigen Biotechnology Corp. (Taiwan)*

PI-88

Anticancer agent; sulfated oligosaccharide

Cancer

Medigen received approval to begin a Phase Ib trial (4/11)

Vasogen Inc. (Canada; AMEX:MEW; TSE:VAS)

Immune modulation therapy

Chronic lymphocytic leukemia

Company received approval from Health Canada to proceed with a clinical trial (4/5)

CARDIOVASCULAR

Hemosol Inc. (Canada; HMSL; TSE:HML)

Hemolink

Human hemoglobin-based oxygen carrier use to avoid or reduce the use of donor red blood cells

Patients undergoing coronary artery bypass surgery

Health Canada completed its first review of the company's new drug submission (4/26)

Medicure Inc. (Canada; CDNX: MPH)

MC-1

Cardiovascular drug

Heart attack and patients undergoing coronary bypass surgery

Company completed a Phase I trial (4/19)

Nortran Pharmaceuticals Inc. (Canada; OTC BB:NTRDF; TSE:NRT)

RSD1235

Anti-arrhythmic drug

Acute arterial fibrillation

Company began a Phase I trial (4/12)

ThromboGenics Ltd. (Ireland)*

SY162

Clot-dissolving agent

Central venous catheter occlusion and acute peripheral arterial occlusive disease

Company initiated two Phase II trials (4/19)

DIABETES

Organogenesis Inc. (AMEX:ORG)

Apligraf

Living human skin equivalent, composed of living human keratinocytes and fibroblasts

Diabetic foot ulcers and venous leg ulcers

Company submitted a European marketing application for Apligraf (4/17)

Senetek plc (SNTKY)

Invicorp

Combination of vasoactive intestinal peptide with 1 to 2 mg of phentolamine mesylate

Erectile dysfunction associated with diabetes

Company said a study in England showed a 77% response rate in 23 patients who took Invicorp, compared to a 19% rate in the placebo group (4/23)

INFECTION

Biovector Therapeutics SA (France)*

VAC12

Anti-HIV vaccine; mixture of four new-generation lipopeptides with HIV epitopes, co-linearly linked to a tetanic toxoid epitope

HIV

Company began a Phase I study in France (4/26)

Chiron Corp. (CHIR)

Menjugate

A conjugate vaccine against Neisseria meningitidis sero group C

Meningococcal disease

Company gained approval for Menjugate in Canada (4/25)

SkyePharma plc (UK; SKYE; LSE:SKP)

DepoCyte

Injectable, sustained-release form of the chemotherapeutic cytarabine

Lymphomatous meningitis

Company was granted pan-European marketing approval (4/4**)

MISCELLANEOUS

Biopure Corp. (BPUR)

Hemopure

An oxygen therapeutic; hemoglobin glutamer-250 (bovine)

Acute anemia and avoidance of the need for donor red blood cells in adult surgery patients

South Africa's Medicines Control Council approved Hemopure (4/10)

DUSA Pharmaceuticals Inc. (DUSA)

Levulan

Aminolevulinic acid HCl photodynamic therapy

Dysplastic Barrett's esophagus

Independent investigators in the UK initiated a new study to determine the effect of varying drug concentrations on the ability of Levulan to treat the condition (4/6)

Imagenetix Inc. (OTC BB:IAGX)

CMC

Fatty acid ester complex capsules

Osteoarthritis

Data from a trial in India indicated CMC statistically significantly reduced pain, improved flexibility and enhanced quality of life (4/2)

International Wex Technologies Inc. (Canada; CDNX:WXI)

Tetrodin

Non-narcotic pharmaceutical developed from a naturally occurring organic substance

Opiate withdrawal and pain management

Company received a "no objection" letter allowing the company to proceed with Phase Ib and Ic trials (4/6)

MedImmune Inc. (MEDI)

MEDI-507

Humanized monoclonal antibody against CD2 antigen receptor found on T cells and natural killer cells

Psoriasis

Company initiated a Phase II trial in Europe (4/2)

NicOx SA (France; Nouveau Marche:NICOX)

HCT-1026

Nitric oxide-releasing derivative of the nonsteroidal anti-inflammatory drug flurbiprofen

Drug-induced prolonged contact urticaria

Phase I/II results were positive with potent anti-inflammatory activity (4/24)

Senetek plc (SNTKY)

Invicorp

Combination of vasoactive intestinal peptide with 1 or 2 mg of phentolamine mesylate

Erectile dysfunction

Company said a European study of 21 patients showed the product is well tolerated in patients with high blood pressure (4/20)

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.

AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; OSE = Norwegian Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange

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