Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Novogen
Ltd.
(Australia;
NVGN)

NV-52

Synthetic analogue based on the phenolic structure of naturally occurring isoflavones

Inflammatory bowel disease

Began Phase I trial in Australia to evaluate safety and inflammatory markers in 12 volunteers (8/7)

CANCER

Epeius
Biotechnologies
Corp.*

Rexin-G

Gene therapy vector containing a gene that blocks the action of the cyclin G1 gene

Solid tumors

The product was granted accelerated approval in the Philippines for treating all solid tumors (8/10)

Immutep SA*
(France)

ImmuFact IMP321

T-cell immunostimulatory factor designed to amplify T- cell responses

Metastatic breast cancer

Began Phase I trial in France to evaluate use of the drug after paclitaxel treatment (8/3)

Generex
Biotechnology
Corp.
(Canada;
GNBT)

AE37

Synthetic peptide vaccine designed to stimulate response against tumors expressing the HER-2/neu oncogene

Prostate cancer

Began Phase II trial in Greece to evaluate the vaccine in 30 patients; the product comes from Generex subsidiary Antigen Express (8/8)

MGI Pharma
Inc.
(MOGN)

Dacogen (FDA-approved)

Decitabine for injection; a hypomethylating agent

Acute myeloid leukemia

The EMEA granted orphan designation to the product in Europe in that indication (8/1)

Pharmexa
A/S
(Denmark;
SSE:PHARMX)

HER-2 Protein AutoVac

Vaccine designed to generate an antibody response against the HER-2 protein

Stage IV breast cancer

Data from the first 10 patients in Phase II trial testing drug with the adjuvant QS-21 did not show efficacy; further recruitment was stopped (8/14)

Spectrum
Pharmaceuticals
Inc.
(SPPI) and AEterna
Zentaris Inc.
(Canada; AEZS)

Ozarelix

Fourth-generation luteinizing hormone- releasing hormone

Hormone- dependent prostate cancer

Phase II trial in 64 patients in Europe showed encouraging safety and efficacy results (8/2)

CARDIOVASCULAR

Encysive
Pharmaceuticals
Inc.
(ENCY)

Thelin

Sitaxsentan; small molecule designed to block endothelin

Pulmonary arterial hypertension

The company was notified that the product is being approved in Europe (8/10)

GTC
Biotherapeutics
Inc.
(GTCB)

ATryn

Recombinant form of human antithrombin

Venous thrombo- embolism

The product was approved in Europe for the prophylaxis of VT in surgery of patients with congenital antithrombin deficiency (8/2)

CENTRAL NERVOUS SYSTEM

Addex
Pharmaceuticals
SA*
(Switzerland)

ADX10059

Selective modulator of the metabotropic glutamate receptor

Migraine

Began Phase IIa trial in Europe to evaluate efficacy, safety and toler- ability (8/30)

Evotec AG
(Germany;
FSE:EVT)

EVT 101

NR2B subtype selective NMDA receptor antagonist

Alzheimer's disease

Phase I trial in healthy volunteers demonstrated favorable tolerability and pharmacokinetics (8/9)

GW
Pharmaceuticals
plc
(UK; LSE:GWP)

Sativex

Spray formulation of cannabis extract

Central neuropathic pain

Began Phase III trial in Europe and Canada to evaluate pain relief in 218 patients with multiple sclerosis (8/9)

Labopharm
Inc.
(Canada;
TSE:DDS)

--

Once-daily formulation of the analgesic tramadol

Pain

Canadian regulators accepted marketing application for review; the targeted review period is 300 days (8/28)

Transition
Therapeutics Inc.
(Canada;
TSE:TTI)

AZD-103

Scyllo-cyclohexanehexol; oral agent that acts on beta amyloid

Alzheimer's disease

Phase I trial in Canada demon- favorable safety, tolerability and pharmacokinetics (8/8)

Vectura Group
plc
(UK; LSE:VEC)

VR040

Inhaled formulation of apomorphine

Parkinson's disease

Phase II trial demonstrated safety, tolerability and recovery from an induced "off" episode of PD (8/8)

DIABETES

Diamyd
Medical AB
(Sweden; SSE:DIAM)

Diamyd

Agent containing GAD65, the dominating autoantigen in autoimmune diabetes

Type I diabetes

Phase II trial in 70 young people in Sweden demonstrated statistically significant preservation of insulin production (8/25)

Phosphagenics
Ltd.
(Australia;
ASX:POH)

TPM-02/ Insulin

Insulin delivered by transdermal carrier

Diabetes

Phase I trial in healthy volunteers demonstrated delivery of insulin through the skin (8/23)

INFECTION

ACE
BioSciences
A/S*
(Denmark)

ACE393

Injectable vaccine against Campylobacter jejuni

Travelers' diarrhea

Began Phase I trial in France to evaluate safety, tolerability and immunogenicity in up to 72 healthy subjects (8/31)

Arpida Ltd.
(Switzerland;
SWX:ARPN)

AR-709

Bactericidal antibiotic agent

Infections

Is starting a microdose study in healthy volunteers in the UK to evaluate pharmacokinetics (8/3)

Biota Holdings Ltd.
(Australia; ASX:
SmithKline plc (UK)

Relenza

Zanamivir for inhalation; neuraminidase inhibitor

Influenza

GSK gained marketing approval of the drug in Europe for preventing flu in those 5 years old and BTA) and Glaxoolder, and for treating children who are 5 or older (8/25)

Biota
Holdings Ltd.
(Australia; ASX:
BTA)

BTA-798

Agent targeting the human rhinovirus

The common cold

Phase Ia trial in the UK demonstrated safety and tolerability (8/2); began Phase Ib trial in the UK in 32 healthy volunteers (8/17)

Cellegy
Pharmaceuticals
Inc.
(CLGY)

Savvy

C31G vaginal gel

HIV prevention

Monitors said trial in Nigeria was unlikely to provide evidence of efficacy, based on interim data; the trial was being stopped (8/28)

Oscient
Pharmaceuticals
Corp.
(OSCI)
and Pfizer
SA de CV

Factive (FDA-approved)

Gemifloxacin mesylate; a fluoroquinolone antibiotic

Multiple indications

The product was approved in Mexico for community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis (8/1)

Sinovac
Biotech Ltd.
(China; AMEX:SVA)

--

Vaccine against H5N1 influenza virus

Influenza

Preliminary data from Phase I trial showed different doses induced immune responses (8/28)

Transave Inc.*

SLIT Amikacin

Inhaled, sustained-release liposome formulation of amikacin

Pseudomonas aeruginosa infections

The product was granted orphan designation in Europe for treating P. aeruginosa lung infections in cystic fibrosis patients (8/2)

MISCELLANEOUS

Athersys
Inc.*

ATHX- 105

Selective agonist of the serotonin receptor 5HT2c

Obesity

Is starting a Phase I trial in the UK to evaluate safety, tolerability and pharmacokinetics in healthy volunteers (8/10)

BioBalance
Corp.
(OTC BB:
BBAL)

Probactrix

Single strain of non- pathogenic E. coli M-17

Gastro- esophageal reflux disease

Began open-label trial in Israel to evaluate the product in 30 GERD patients (8/16)

IDEA AG*
(Germany)

IDEA-033

Analgesic agent keptoprofen delivered by ultradeformable carriers

Osteoarthritis of the knee

Phase III trial in 866 patients in Europe demonstrated statistical significance at the highest dose levels (8/2)

Genzyme
Corp.
(GENZ)

Synvisc (FDA-approved)

Hylan G-F20; an elastoviscous hylan therapeutic

Osteoarthritis

Filed for expanded approval in Europe to include treatment of pain due to osteoarthritis of the ankle and shoulder (8/11)

NeuroSearch
A/S
(Denmark;
CSE:NEUS)

Tesofensine (NS2330)

Agent designed to inhibit reuptake of serotonin, noradrenaline and dopamine

Obesity

Is starting Phase IIb TIPO-1 trial to evaluate the product in 200 patients (8/18)

TopoTarget
A/S
(Denmark;
CSE:TOPO)

Savene (Totect)

Dexrazoxane; inhibitor of topoisomerase II

Antidote to anthracyline extravasation

The product was approved in Europe for protecting tissue from accidental exposure to cancer agents during chemotherapy (8/2)


Notes:

* Privately held.

MAA = Marketing authorization application; MRP = Mutual Recognition Procedure; EMEA = European Medicines Agency.

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

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange.

No Comments