Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Active Biotech
AB
(Sweden;
SSE:ACTI)

57-57

Product derived from the company's linomide chemistry platform

Lupus

Began a Phase I trial in Sweden to test increasing doses in healthy volunteers (11/2)

Antisense
Therapeutics
Ltd.
(Australia;
ASX:ANP)

ATL1101

Antisense drug designed to block the synthesis of the IGF-1 receptor

Psoriasis

Began a trial in Australia to test the product against a placebo cream and against reference cream products (11/18)

Cytochroma
Inc.*
(Canada)

CTA018

Vitamin D signal amplifier

Psoriasis

Began a Phase Ia trial in Canada to test various doses of the topical formulation in patients (11/23)

Isotechnika
Inc.
(Canada
TSE:ISA)

Trans-ISA247

Immunosuppressive agent; calcineurin inhibitor

Psoriasis

Ascending-dose study in healthy volunteers in Canada achieved all safety endpoints (11/3)

CANCER

AnorMED Inc.
(Canada; TSE:AOM)

AMD3100

Agent designed to block receptor that triggers movement of stem cells out of bone marrow

Stem cell transplantation in cancer patients

Began a Phase II trial in Canada and Europe with G-CSF in up to 50 non-Hodgkin's lymphoma and multiple myeloma patients (11/4)

BioAlliance
Pharma SA*
(France)

Doxorubicin Transdrug

Nanoparticle formulation of the cancer drug

Hepatocellular carcinoma

The European Commission granted orphan designation to the product, which is in Phase I/II trials (11/16)

Chroma
Therapeutics
Ltd.*
(UK)

CHR-2797

Metalloenzyme designed to inhibit intracellular aminopeptidases

Cancer

Began Phase I trial in the UK to evaluate safety, tolerability, dosing and preliminary activity in up to 40 patients with advanced disease (11/16)

Dragon
Pharmaceutical
Inc.
(Canada;
TSE:DDD)

--

Recombinant erythropoietin product

Anemia

The product was approved in the Dominican Republic and Trinidad and Tobago; a license application was accepted in Kosovo (11/15)

Igeneon AG*
(Austria)

IGN101

Vaccine designed to trigger an immune response to epithelial cell-adhesion molecule

Cancers

A Phase II trial in 239 patients did not demonstrate statistical significance on surival overall, but did in the subgroup of 53 patients with metastatic rectal cancer (11/8)

ImClone
Systems Inc.
(IMCL)

IMC-11F8

Fully human monoclonal antibody targeting the epidermal growth factor receptor

Solid tumors

Began Phase I trial in the Netherlands to evaluate safety and pharmacology in up to 40 patients (11/30)

ImClone
Systems Inc.
(IMCL)

Erbitux
(FDA-approved)

Cetuximab; antibody that blocks the epidermal growth factor receptor

Colorectal cancer

Merck KGaA presented data showing the drug might be safe and effective in combination with standard chemotherapies (11/1)

Inex
Pharmaceuticals
Corp.
(Canada;
TSE:IEX) and Enzon
Pharmaceuticals
Inc.
(ENZN)

Marqibo (formerly Onco TCS)

Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology

Non-Hodgkin's lymphoma

They filed in Canada for approval as a single-agent treatment for relapsed, aggressive NHL previously treated with at least two combination chemotherapy regimens (11/5)

Lorus
Therapeutics
Inc.
(Canada;
TSE:LOR)

GTI-2040

Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase

Hormone- refractory prostate cancer

Began a National Cancer Institute- sponsored Phase trial in Canada to test the agent in combination with docetaxel and prednisone (11/18)

Marshall
Edwards Inc.
(MSHL)

Phenoxodiol

Apoptotic agent designed to block sphingosine-1- phosphate

Prostate cancer

Study in Australia in 19 patients with hormone-refractory disease showed a dose-response effect in terms of disease progression and PSA levels (11/22)

PharmaMar
SA
(Spain;
subsidiary of
Zeltia Group)

Aplidin

Antitumor agent derived from the marine tunicate Aplidium albicans

Hematological malignancies

Began various Phase II trials in multiple myeloma, non-Hodgkin's lymphoma and adult acute lymphoblastic leukemia (11/25)

PharmaMar
SA
(Spain;
subsidiary of
Zeltia Group)

Aplidin

Antitumor agent derived from the marine tunicate Aplidium albicans

Multiple myeloma

The product was granted orphan drug status by the European Commission (11/19)

Pharmexa
A/S
(Denmark;
CSE:PHARMX)

HER-2 Protein AutoVac

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

Breast cancer

Began a Phase II trial that will include up to 50 patients in Hungary and Poland (11/11)

Transgene SA
(France; TRGNY)

MVA-HPV-IL2

Product using the MVA virus to carry and express two HPV antigens found in HPV 16

Precancerous lesions of the cervix

Began Phase II trial in France to test the product in 16 women (11/30)

Viragen Inc.
(AMEX:VRA)

Multiferon

Multisubtype, natural human alpha interferon

Various diseases

Partner Arriani Pharmaceuticals SA gained approval in Bulgaria for use as a second-line treatment in recombinant interferon failures (11/22)

YM BioSciences
Inc.
(Canada;
TSE:YM) and
Oncoscience
AG*
(Germany)

Theraloc (TheraCIM hR3)

Humanized anti-epidermal growth factor receptor monoclonal antibody

Metastatic pancreatic cancer

Began a Phase I/II trial in Germany in 30 patients; depending on response rates, another 30 patients could be enrolled (11/18)

CARDIOVASCULAR

Acelion Ltd.
(Switzerland;
SWX:ATLN)

Veletri

Tezosentan; intravenous dual endothelin receptor antagonist

Acute heart failure

Stopped Phase III VERITAS study after an interim analysis indicated that it would not attain primary efficacy endpoints (11/7)

DIABETES

Generex
Biotechnology
Corp.
(GNBT)

Orallyn (Oralin)

Oral insulin spray formulation

Type II diabetes

Study in Ecuador showed the product can be used in place of mealtime insulin injections to regulate postprandial glucose levels (11/30)

INFECTION

Gilead Sciences
Inc.
(GILD)

Truvada (FDA-approved)

Fixed-dose combination of the company's Viread and Emtriva drugs

HIV

The scientific comittee of the EMEA recommended approval of the product for use with other antiretroviral agents (11/18)

Helix
BioPharma
Corp.*
(Canada)

Interferon alpha

Cream formulation of interferon-alpha 2b

Human pappiloma-virus

Began a Phase II trial in Germany to evaluate the product in women with low-grade squamous intraepithelial lesions that are positive for HPV infection (11/1)

Hemispherx
Biopharma
Inc.
(AMEX:HEB)

Alferon LDO

Low-dose, oral alpha- interferon cocktail

Severe acute respiratoy syndrome

Hong Kong officials approved a trial in normal volunteers and/or asymtomatic subjects possibly exposed to SARS (11/22)

Immtech
International
Inc.
(AMEX:IMM)

DB289

Oral, dicationic antiviral agent

African sleeping sickness

All 30 patients in extended-dose regimen of Phase IIb trial in the Congo cleared the parasite within treatment period;no significant adverse results were seen (11/9)

Microscience
Ltd.*
(UK)

spi-VECTM

Vaccine consisting of a Salmonella bacterium modified to carry the hepatitis B core antigen

Hepatitis B

Phase I trial in 30 healthy volunteers demonstrated safety and immunogenicity (11/3)

PowderMed
Ltd.*
(UK)

--

Powdered DNA vaccine

Influenza

Phase I trial in 36 volunteers supported continued development (11/18)

SciClone
Pharmaceuticals
Inc.
(SCLN)

Zadaxin

Synthetic preparation of thymosin alpha-1

Hepatitis C

Triple therapy with pegylated interferon and ribavirin in a pilot trial in Mexico sustained virologic response in 19% of previous non-responders (11/1)

The Immune
Response Corp.
(IMNR)

Remune

Immune-based therapy comprised of a whole-killed virus and an adjuvant

HIV

Phase II data on 37 patients from a trial in Italy showed positive trends in disease markers over the 28-day treatment period (11/17)

Viral Genetics
Inc.
(OTC BB:VRAL)

VGV-1

Thymus nuclear protein extracted from bovine thymus gland

HIV

Five of 10 patients in a trial in Mexico who had failed other therapies had undetectable viral loads within three months of treatment (11/29)

MISCELLANEOUS

Angiotech
Pharmaceuticals
Inc.
(Canada;
ANPI)

Adhibit

Adhesion prevention gel

Reduction of post-surgical adhesions

Eight-week follow-up data on 20 patients from pivotal European trial in patients undergoing myoectomy suggested the product prevented adhesions (11/12)

BioPartners
GmbH*
(Switzerland)

Valtropin

Somatropin; recombinant human growth hormone

Growth hormone deficiency

Filed with the EMEA seeking approval in Europe for treating adult and pediatric GHD and other growth disorders (11/29)

BioXell SpA*
(Italy)

BXL628

Inhibitor of growth factor phosphorylation and bcl-2

Overactive bladder

Began Phase IIa trial in Italy in 120 patients to evaluate urination levels and related endpoints (11/29)

Cambridge
Antibody Technology
Group plc
(UK; CATG)

Trabio (CAT-152)

Lerdelimumab; fully human monoclonal antibody that neutralizes transforming growth factor beta-2

Glaucoma

Phase III trial in 344 patients in Europe failed to meet the primary endpoint of improving the outcome of surgery for glaucoma compared to placebo (11/9)

LifeCycle
Pharma A/S*
(Denmark)

--

Tablet formulation of the marketed immunosuppressant drug tacrolimus (Prograf)

For use in organ transplantations and other indications

Began clinical trials to test multiple tablet formulations (11/10)

Nabi Biopharmaceuticals
(NABI)

PhosLo (FDA-approved)

Calcium acetate

Control of blood phosphorus in end-stage renal disease

The company filed for approval in Europe (11/4)

SR Pharma
plc
(UK; LSE:SPA)

SRP299

Immunomodulator

Atopic dermatitis

Company stopped development in that indication following Phase II trial that failed to demonstrate efficacy (11/19)

Zonagen Inc.
(ZONA)

Progenta

Agent designed to block progesterone without blocking adrenal hormones

Uterine fibroids

One-month data from trial in Poland showed a statistically significant reduction of fibroid size in the highest dose, but not in the other doses or in the positive control (11/8)


Notes:

* Privately held.

EMEA = European Medicines Agency; MAA = Marketing authorization application.

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; LSE = London Stock Exchange; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange.

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