Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Biomira Inc. (BIOM)

BLP25

Synthetic MUC-1 therapeutic vaccine; consists of 25-amino-acid sequence of the MUC-1 cancer mucin, encapsulated in liposomes; suppresses tumor angiogenesis

Advanced non-small-cell lung cancer

Initiated a multicenter Phase IIb trial expected to involve 166 patients at 10 Canadian sites (8/9)

Cel-Sci Corp. (AMEX:CVM)

Multikine

Natural mixture of human cytokines, including interleukin-2

Head and neck cancer

Company received permission to start a Phase II trial in the Czech Republic in conjunction with clinical centers in Poland (8/21)

Elan Corp. (Ireland; NYSE:ELN)

Myocet

Liposomal formulation of doxorubicin

Metastatic breast cancer

European Commission granted the company marketing authorization (8/1)

LifeTime Pharmaceuticals*

Beta LT

Beta-alanyl cysteamine disulfide; synthetic small- molecule immune stimulator

Cancer

Announced results of a Phase I/II trial at McGill University in Mon- treal; data were presented at the International Society of Hematology meeting in Toronto (8/28)

Ligand Pharmaceuticals Inc. (LGND)

Targretin Capsules and Gel (FDA- approved)

Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors; oral formulation

Cutaneous T-cell lymphoma

Reported results from Phase II/III trials in Australia for Targretin capsules and gel at the 28th World Congress of the Intern- ational Society of Hematology; has plans for a Phase I/II study in Tufts New England Medical Center (8/29)

Novogen Ltd. (Australia; NVGN)

NV-06

Anticancer product administered via once weekly via injection

Solid metastatic cancers

Received clearance to begin Phase I/II trial in Australia (8/29)

Theratechnologies (TSE:TH)

Theralux

Ex vivo photodynamic cell therapy system that treats patient's blood with photosensitive molecule TH 9402 and a light source to eradicate cancer cells and preserve healthy ones

Non-Hodgkin's lymphoma

Company filed an application with the Health Protection Branch in Ottawa to begin the clinical validation of Theralux (8/9)

CARDIOVASCULAR

Aventis Behring LLC (unit of Aventis SA [France; NYSE: AVE])

Helixate NexGen

Recombinant, non-plasma- derived Factor VIII product

Hemophilia A

The European Commission approved Helixate NexGen in a new formulation that does not include human albumin and has added solvent detergent treatment (8/10)

BioTime Inc. (AMEX:BTX)

Hextend

Physiologically-balanced plasma volume expander

To replace blood volume

Company submitted application to sell Hextend in Sweden (8/29)

Cerus Corp. (CERS) and Baxter Healthcare Corp. (NYSE:BAX)

Intercept Platelet System

Pathogen inactivation system that targets and inactivates bloodborne pathogens, while leaving the therapeutic properties of platelets intact; process uses light-activated psoralen compound, S-59, which disables nucleic acid

To protect against the transmission of disease through blood transfusions

Announced results of the European Phase III trial; data supports a regulatory submission in Europe (8/22)

D-Pharm Ltd.* (Israel)

DP-b99

Membrane-activated chelator designed to control apoptotic processes by regulating intracellular homeostasis divalent metal ions; intravenously delivered

Acute stroke

Completed first stage of a Phase I placebo-controlled, randomized safety study, conducted in Germany (8/1)

CENTRAL NERVOUS SYSTEM

Cyberonics Inc. (CYBX)

The Neuro- Cybernetic Prosthesis

Stimulates left cervical vagus nerve to improve memory

Alzheimer's disease

Company said the first patient in pilot study was implanted with the NeuroCybernetic Prosthesis System at the Sahlgrenska University Hospital in Gothenburg, Sweden (8/3)

NeuroSearch A/S (Denmark) and Glaxo Wellcome plc (UK; NYSE:GLX)

NS2389 (GW650 250A)

Monoamine reuptake inhibitor; combines inhibi- tion of noradrenalen and serotonin reuptake with stimulation of dopaminergic system

Depression

Companies temporarily suspend ed the Phase II studies due to animal-based toxicology results that are inconsistent with previous results (8/17)

NeuroSearch A/S (Denmark)

NS2359

Synthetic small-molecule compound that acts as mixed monoamine reuptake inhibitor

Cocaine addiction

Company said the National Institute of Drug Abuse agreed to fund the next stage of development; Phase II trials will begin in October (8/28)

INFECTION

Chiron Corp. (CHIR)

Menjugate

Conjugate vaccine against Neisseria meningitidis serogroup C

Prevention of meningococcal C disease

Cleared for marketing in Ireland (8/8)

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

Tamiflu (FDA- approved)

Oseltamivir phosphate; oral neruaminidase inhibitor

Treatment and prophylaxis of influenza A and B infection in adults

Roche submitted the product for regulatory approval in Japan (8/2)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Thymosin alpha 1; synthetic version of naturally occurring peptide hormone thymosin (immunomodulator)

Hepatitis B and C infection

Received expanded marketing approval in Argentina; company plans Phase III trial in the U.S. by year's end (8/7)

Tularik Inc. (TLRK)

T902611

Oral inhibitor of cytomegalo- virus enzyme essential for for initiating synthesis of viral DNA as part of the repli- cation process

Cytomegalovirus

Initiated a Phase I study in the UK (8/14)

VaxGen Inc. (VXGN)

AIDSVAX

Bivalent vaccine composed of recombinant gp120 (envelope protein) from two strains of HIV-1 that are prevalent in Southeast Asia and the Pacific Rim

Prevention of HIV infection

Completed enrollment of the preventive HIV vaccine trial held in Bangkok, Thailand; Phase III trial enrolled 2,500 patients (8/31)

Viragen Inc. (AMEX:VRA)

Omniferon

Natural, multi-subtype alpha interferon

Hepatitis C

Company expects to enroll an additional 100 patients in Phase II European trials; it will file an IND with the FDA by year's end (8/10)

Virax Holdings Ltd. (Australia; ASX:VHL)

VIR201

Recombinant avipox virus designed to co- express genes for immunogenic but highly conserved parts of the HIV virus in conjunction with a human cytokine (interferon gamma)

HIV/AIDS

Company received approval to conduct clinical trials in Australia to test the vaccine; the Phase I/IIa trial will be conducted at Melbourne's Alfred Hospital (8/31)

MISCELLANEOUS

Atlantic Technology Ventures Inc. (ATLC)

CT-3

Ajulemic acid; synthetic derivative of trahydrocannabinol (THC-11-oic acid)

Inflammation

Completed a Phase I trial of CT-3 at the Aster Clinical Research Center in Paris (8/28)

BioTransplant Inc. (BTRN)

BTI-322

Murine monoclonal antibody that binds to CD2 antigen receptor on T cells and natural killer cells

Liver transplant rejection

Company said Phase I/II study results showed BTI-322, in con- junction with Prograf (tacrolimus) immuno-suppressive therapy, reduces the incidence of rejection in the immediate post-operative period by 70% as compared to Prograf alone; data were pre- sented at teh International Con- gress of The Transplantation Society in Rome (8/30)

Hemispherx Biopharma Inc. (AMEX:HEB)

Ampligen

Double-stranded synthetic RNA compound poly I; poly C12U

Severe chronic fatigue syndrome

Company said its European subsidiary filed for orphan drug designation in Europe (8/1)

Isotechnika Inc. (Canada; VSE:ISA)

ISAtx247

Immunosuppressive therapy based on cyclosporine

Prevention of organ rejection following transplantation (8/28)

Presented preclinical and Phase I results of trial held in Canada at the International Congress of the Transplant Society in Rome

SangStat Medical Corp. (SANG)

Thymoglobuline

Anti-thymocyte globulin; polyclonal antibody produced in rabbits

Prophylaxis of transplant rejection and therapy for acute kidney rejection

Cleared for marketing in Italy (8/31)

Serono SA (Switzerland; SWX:SEO)

Luveris

Recombinant human luteinizing hormone, lutropin alfa

Female infertility

The committee for Proprietary Medicinal Products recommended approval in Europe (8/15)

Teva Pharmaceutical Industries Ltd. (TEVA)

Copaxone (FDA- approved)

Glatiramer acetate for injection; four-amino-acid peptide derived from myelin basic protein

Relapsing- remitting multiple sclerosis

Cleared for marketing in the UK, allowing Teva to file for approval throughout the Euro- pean Union, under the mutual recognition procedure (8/13)

Theratechnologies Inc. (Canada; MSE:TH)

ThGRF 1-44

Analogue of growth hormone releasing factor

Chronic obstructive pulmonary disease

Company filed an IND with the Health Protection Branch in Ottawa to begin a Phase II, double-blind, randomized and placebo-controlled study to be conducted on 90 patients (8/22)

Transkaryotic Therapies Inc. and Aventis Pharma AG (unit of Avents SA [France; NYSE:AVE])

Dynepo (formerly GA-EPO)

Gene-activated erythro- poietin; gene in human cells is activated in situ to produce EPO

Anemia in patients with chronic renal failure

Aventis filed in the U.S. and Europe for marketing approval (8/3)

Unigene Laboratories Inc. (OTCBB: UGNE)

Forcaltonin

Injectable recombinant calcitonin

Osteoporosis, Paget's disease and hypercalcemia

Company received a pre-approval letter to market the product in Switzerland (8/15)

Zonagen Inc. (ZONA) and Schering-Plough Corp. (NYSE:SGP)

Vasomax

Immediate-release, oral formulation of phentolamine mesylate

Erectile dysfunction

The UK's Medicines Control Agency sent Schering-Plough a letter saying the product poses no carcinogenic threat to humans; the findings lifted the suspension of clinical testing (imposed in 1999 based on a rat study)

Notes:

* Privately held

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