Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Corixa Corp.
(CRXA) and Genesis Research and Development Corp. Ltd. (New Zealand; ASX:GEN)

PVAC

Immunotherapeutic based
on a process and formulation derived from heat-killed Mycobacterium vaccae

Psoriasis

Data from a Brazil trial showed clinical activity and safety but missed an endpoint of a 75% reduction in Psoriasis Area and Severity Index score at 12 weeks (11/7)

CANCER

Access Pharmaceuticals Inc. (AMEX:AKC)

AP5280

Novel platinum-polymer delivery system designed to deliver high concentrations of chemotherapeutic agents directly to solid tumors

Ovarian cancer

Company began enrolling patients in a Phase I/II ovarian cancer trial in Europe (11/26)

Australian Cancer Technology Ltd.* (Australia)

Pentrix

Vaccine designed around
the p53 peptide

Cancer

Phase Ib/IIa trial results showed a strong immune response in all five patients who had completed the multidose trial to date; trial is in Australia (11/12)

Guilford Pharmaceuticals
Inc.
(GLFD)

Gliadel Wafer
(FDA-
approved)

Biodegradable poly-
anhydride polymer wafer implant containing carmustine

Malignant
glioma

Company elected to withdraw its regulatory application in Europe seeking an expanded indication for use during initial surgery for malignant glioma (11/20)

Immuno-Designed Molecules SA* (France)

Eladem

Antitumor vaccine in which autologous dendritic cells loaded with recombinant PSA are injected into patients with recrudescent cancer after prostatectomy

Prostate
cancer

Phase I/II data showed that in six patients, the circulating prostate cancer cells that could be detected upon patient admission into the study had disappeared by six months; the trial was carried out in France (11/22)

Munich Biotech
AG*
(Germany)

LipoPac

Compound based on the tendency of new blood vessels to bind and take up highly charged cationic liposomes

Gastrointestinal cancer

Company began a Phase Ib trial in Germany (11/8)

Peregrine Pharmaceuticals Inc. (PPHM)

Cotara

A monoclonal antibody that carries the radioactive isotope iodine-131 to the necrotic core of solid tumor cancers

Glioma

European authorities granted orphan medicinal product designation to Cotara (11/25)

YM BioSciences
Inc.
(Canada; TSE:YM_PB)

Norelin

Vaccine targeting the gonadotropin-releasing hormone

Hormone-
dependent
prostate cancer

Company enrolled the first patient in a 12-patient safety study being held in Canada (11/8)

CARDIOVASCULAR

United Therapeutics
Corp. (UTHR)

Remodulin
(FDA-
approved)

Treprostinil sodium
injection

Pulmonary
arterial hypertension

The Israeli Ministry of Health approved Remodulin (11/4)

CENTRAL NERVOUS SYSTEM

Amarin Corp. plc
(UK; AMRN) and Tanabe Seiyaku Co. Ltd. (Japan)

--

Once-daily morphine sulfate formulation

Moderate to
severe pain

Companies submitted an NDA in Japan (11/12)

INFECTION

Advanced Viral Research Corp. (OTC BB: ADVR)

Product
R

A "switch-type" immunomodulator;
a peptide- nucleic acid

AIDS-related wasting
(cachexia)

Company initiated a Phase I trial in Israel (11/14)

MISCELLANEOUS

Aphton Corp.
(APHT)

G17DT

Antigastrin immunogen

Gastroesophageal reflux disease

Company plans to initiate a clinical trial in Europe (11/6)

ICOS Corp. (ICOS) and Eli Lilly and Co.

Cialis

Oral PDE5 inhibitor
tadalafil

Erectile
dysfunction

The European Commission granted marketing approval (11/14)

Inhale Therapeutic Systems Inc. (INHL)

Somavert

Uses Inhale's
PEGylation technology

Acromegaly

Somavert was approved in Europe (11/21)

Oxford
GlycoSciences
plc (UK; OGSI; LSE:OGS)

Zavesca

Oral capsule formulation of a glucosyltransferase inhibitor

Gaucher's
disease

Zavesca received marketing authorization in Europe (11/26)


Notes:

* Privately held

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

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange

NDA = New Drug Application