Company*
(Country;

Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

BioMS
Medical Corp.

(Canada; TSE:MS)

MBP8298

Synthetic peptide

Multiple sclerosis

Monitors reviewing pivotal Phase II/III trial in secondary progressive MS recommended continuation of the study (2/7)

GemacBio*
(France)

Agent comprising several molecules in the human body grafted together

Multiple sclerosis

Data from 22-patient Phase IIa trial showed a safety profile that could support long-term treatment (2/1)

CANCER

Advaxis Inc.
(OTC BB:ADXS)

Lovaxin C

Listeria-based cancer vaccine

Cervical cancer

Is starting Phase I/II trials at sites in Israel, Serbia and Mexico (2/21)

Algeta ASA*
(Norway)

Alpharadin

Radiopharmaceutical based on the alpha particle emitter radium-223

Bone metastases from prostate cancer

Follow-up data from Phase II trial in 64 patients in Europe showed a statistically significant decrease of bone-alkaline phosphatase vs. placebo (2/27)

Antisoma plc
(UK; LSE:ASM)

AS1411

Anti-nucleolin aptamer

Renal and pancreatic cancers

The product was granted orphan designation in Europe in both cancers (2/21)

Bioenvision
Inc.
(BIVN)

Evoltra (FDA- approved)

Clofarabine; second- generation purine nucleoside analogue

Acute lymphoblastic leukemia in pediatric patients

The European Medicines Agency issued a positive opinion on the marketing authorization application (2/23)

BioVex Inc.*

OncoVEX-GMCSF

Oncolytic virus designed to selectively kill tumor cells

Head and neck cancer

Began open-label trial in the UK to evaluate the product with chemo- radiotherapy in 16 patients (2/14)

Chemokine
Therapeutics

Corp.
(Canada;
OTC BB:CHKT)

CTCE-9908

Chemokine CXCR4
antagonist

Cancers

Is starting a Phase Ib/II trial in Canada to evaluate safety and early efficacy in up to 30 patients with late-stage cancers (2/6)

Ecopia
BioSciences

Inc.
(Canada;
TSE:EIA)

ECO-4601

Small-molecule agent derived from soil-dwelling microorganisms

Cancers

Began Phase I trial in Canada to evaluate safety and tolerability in up to 30 refractory patients (2/2)

Gastrotech
Pharma A/S*

(Denmark)

GTP-200

Product based on the naturally occurring peptide hormone, ghrelin

Cancer cachexia

Began Phase II trial in Sweden in 30 patients with end-stage cancer and significant weight loss (2/9)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Advanced metastatic melanoma

MAA filed in January in Europe was accepted for review (2/1)

Genentech
Inc.
(NYSE:DNA)

Herceptin (FDA-approved)

Trastuzumab; monoclonal antibody against the HER2/neu protein

Early stage breast cancer

Partner F. Hoffmann-La Roche Ltd. filed MAA seeking European approval for treating early stage, HER2-positive disease (2/15)

GPC Biotech
AG
(Germany;
GPCB)

1D09C3

Major histocompatibility complex class II monoclonal antibody

Multiple myeloma

The product was granted orphan designation in Europe in that indication (2/14)

ImClone
Systems Inc.

(IMCL)

Erbitux (FDA-approved)

Cetuximab; antibody that blocks the epidermal growth factor receptor

Head and neck cancer

Partner Merck KGaA received a positive opinion from the CHMP on marketing application to use drug with radiation in treating advanced disease (2/23)

ProMetic Life
Sciences Inc.

(Canada; TSE:PLI.SV)

PBI-1402

Orally active, low-molecular-weight synthetic compound

Anemia

Is starting a Phase Ib/II trial in Canada in up to 30 cancer patients undergoing chemotherapy (2/13)

TopoTarget
A/S
(Denmark;
CSE:TOPO)

Savicol

Histone deacetylase inhibitor

Colorectal polyps

Began pivotal Phase II trial in Germany and Russia in 60 patients with familial adenotmatous
polyposis (2/10)

Viragen Inc.
(AMEX:VRA)

Multiferon

Multisubtype, natural human alpha interferon

Malignant melanoma

The product was approved in Sweden for first-line adjuvant treatment of MM following dacarbazine after surgical removal of tumors (2/21)

CARDIOVASCULAR

Genzyme
Corp.
(GENZ)

Treatment with autologous skeletal myoblasts

Heart failure

Enrollment was stopped in Phase II trial in Europe after monitors concluded there was a low likeli- hood of improvements in heart function (2/23)

GTC
Biotherapeutics

Inc.
(GTCB)

ATryn

Recombinant form of human antithrombin

Hereditary antithrombin deficiency

Company said EMEA was issuing a negative opinion on marketing application; GTC intends to appeal that finding (2/23)

Neose
Technologies

Inc.
(NTEC0

NE-180

Long-acting, GlycoPEG-ylated erythropoietin

Anemia

Began Phase I trial in Europe to evaluate safety and pharmaco- kinetics in 40 volunteers (2/13)

CENTRAL NERVOUS SYSTEM

Cytos
Biotechnology

AG
(Switzerland;
SWX:CYGN)

CYT002- NicQb

Therapeutic vaccine that induces nicotine-specific antibodies that bind nicotine

Smoking cessation

Study designed to induce high enough antibody levels was succesfully completed (2/2)

Evotec AG
FSE:EVT)

EVT 101

NR2B subtype selective NMDA receptor antagonist

Alzheimer's disease

Phase I trial in 48 young, healthy (Germany; subjects showed agent was well tolerated and had a good pharmacokinetic profile (2/3)

Memory
Pharmaceuticals

Corp.
(MEMY)

MEM 3454

Nicotinic alpha-7 agonist

Central nervous system disorders

Phase I trial in Canada in 48 healthy volunteers demonstrated improved memory scores (2/21)

Neurogen
Corp.
(NRGN)

NGD-8243

Agent targeting the type 1 vanilloid receptor

Pain

Partner Merck & Co. Inc. began a Phase I trial in Europe to evaluate safety and pharmacokinetics in healthy volunteers (2/16)

Pain
Therapeutics

Inc.
(PTIE) and
King Pharma-
ceuticals Inc.

Remoxy

Abuse-resistant form of long-acting oxycodone

Pain

Began Phase III trial under FDA SPA to evaluate the drug in 400 patients with moderate to severe osteoarthritic pain (2/16)

Prana
Biotechnology

Ltd.
(Australia;
PRAN)

PBT2

Small molecule that binds metal ions

Alzheimer's disease

Phase I trial in the Netherlands demonstrated suitable safety and pharmacokinetic profiles for continued development (2/7)

INFECTION

Avant Immuno-
therapeutics

Inc.
(AVAN)

Rotarix

Oral, two-dose, live attenuated vaccine developed from a single human strain

Rotavirus infection

Partner GlaxoSmithKline plc received approval to market the product in Europe to prevent gas- troenteritis caused by rotavirus (2/27)

Biota
Holdings Ltd.

(Australia; ASX:BTA)

BTA-798

Agent targeting the
human rhinovirus

The common cold

Began Phase I trial in the UK that will include up to 48 volunteers (2/16)

Debiopharm
SA*
(Switzerland)

Debio-025

Synthetic, non-immuno-suppressive cyclosporin

HIV

Data from trial in 36 patients
demonstrated tolerability and
safety (2/9)

Idenix
Pharmaceuticals

Inc.
(IDIX)

Telbivudine

Selective, oral nucleoside analogue

Hepatitis B

Partner Novartis AG submitted an MAA seeking approval of the product in Europe (2/7)

Targeted
Genetics Corp.

(TGEN)

tgAAC09

Gene therapy using AAV vector to elicit immune system responses

HIV

Began Phase II trial in Uganda to evaluate the safety and immuno- genicity of the preventive vaccine (2/6)

MISCELLANEOUS

Allergy
Therapeutics

plc*
(UK)

MPL103

Monophosphoryl lipid A; TLR-4 agonist used as an adjuvant

Allergies

Began Phase I/II trial in Germany that will evaluate product with sublingual vaccines in 80 patients allergic to grass pollens (2/10)

BioPartners
GmbH*

(Switzerland)

Valtropin

Recombinant human growth hormone

Growth hormone deficiency

The CHMP recommended approval of the product in Europe (2/24)

Bone Medical
Ltd.
(Australia;
ASX:BNE)

Oral parathyroid hormone

Osteoporosis

Phase I trial demonstrated safety and evidence of biological activity (2/14)

CollaGenex
Pharmaceuticals

Inc.
(CGPI)

Oracea

Non-antimicrobial tetracycline derivative

Rosacea

Filed MAA seeking approval in the UK, which will serve as the reference state for Europe (2/27)

NPS
Pharmaceuticals

Inc.
(NPSP)

Preotact (Preos)

Recombinant human parathyroid hormone

Osteoporosis

The CHMP recommended approval of the product in Europe, where Nycomed Group has rights (2/23)

OSI
Pharmaceuticals

Inc.
(OSIP)

Macugen(FDA-approved)

Pegaptanib sodium; injection; pegylated anti- VEGF-aptamer

Age-related macular degeneration

Partner Pfizer Inc. gained approval of the product in Europe (2/2)

Scil
Technology

GmbH*
(Germany)

MD05

Recombinant growth and differentiation factor with a synthetic inorganic carrier

For use in bone augmentation

Began Phase II trial in patients requiring bone augmentation prior to implant insertion (2/14)


Notes:

* Privately held.

CHMP = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.

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

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