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

Phase I trial in 30 volunteers in
Sweden showed tolerability and
suitability of oral usage (7/18)

Advitech Inc.
(Canada; TSE:AVI)

XP-828L

Oral growth factor
complex derived from
milk proteins

Psoriasis

84-patient trial demonstrated efficacy vs. placebo on a physician's global assessment scale, the primary endpoint (7/5)

York Pharma
plc
(UK; AIM:YRK)

YP003

Agent designed to inhibit an enzyme that regulates cellular proliferation

Psoriasis

Began Phase II trial in Australia to compare drug to calcipotriol or placebo (7/1)

CANCER

Amgen Inc.
(AMGN)

Kepivance (FDA- approved)

Palifermin; recombinant human keratinocyte growth factor

Oral mucositis in cancer patients

Regulatory committee in Europe recommended approval of the product (7/28)

AVAX
Technologies
Inc.
(OTC BB:
AVXT)

M-Vax

Autologous, hapten-modified melanoma vaccine

Metastatic peritoneal cancer

Began a trial in France that will evaluate safety and vaccine activity (7/13)

GammaCan
International
Inc.
(Israel;
OTC BB:GCAN)

GCAN 101

Therapy based on intravenous immuno-globulin

Cancers

Began Phase II trial in up to 30 patients with various cancers (7/26)

KuDOS
Pharmaceuticals
Ltd.*
(UK)

--

Oral polyADP ribose polymerase inhibitor

Breast and ovarian cancers

Began Phase I study in the UK to evaluate safety and tolerability in patients (7/25)

Oncolytics
Biotech Inc.
(Canada; ONCY)

Reolysin

Formulation of the human reovirus

Advanced solid tumors

Began Phase I trial in the UK to test safety, tolerability, dosing and actvitity with radiation therapy in up to 45 patients (7/26)

OSI
Pharmaceuticals
Inc.
(OSIP) and
Genentech
Inc.
(NYSE:DNA)

Tarceva
(FDA-approved)

Erlotinib HCl; small-molecule HER1/EGFR inhibitor

Advanced non-small-cell lung cancer

The product was approved in Canada for treating NSCLC following failure of first- or second- line chemotherapy (7/13)

Provectus
Pharmaceuticals
Inc.
(OTC BB:PVCT)

PV-10

Agent designed to be retained in tumor cells while leaving normal tissue unharmed

Stage III metastatic melanoma

Began Phase I trial to evaluate safety and preliminary efficacy in 20 subjects in Australia (7/21)

Wilex AG*
(Germany)

WX-671

Oral, second-generation serine protease inhibitor targeting the uPA system

Solid tumors

Phase I trial in 16 healthy volunteers demonstrated safety, tolerability and oral bioavailablity (7/27)

CARDIOVASCULAR

Encysive
Pharmaceuticals
Inc.
(ENCY)

Thelin

Sitaxsentan; small molecule designed to block endothelin

Pulmonary arterial hypertension

Completed submission of MAA with the EMEA, seeking approval of the product in Europe (7/28)

CENTRAL NERVOUS SYSTEM

Durect Corp.
(DRRX)

SABER-Bupivacaine

Sustained-release formulation of bupivacaine delivered by SABER system

Post-operative pain

Began third and final cohort of Phase II trial, in 60 hernia patients in Australia (7/11)

Intrac Inc.
(OTC BB: ITRD)

Dyloject

The analgesic diclofenac sodium for injection

Pain

Pivotal European Phase II/III trial met its primary endpoint of superior pain relief over 4 hours vs. placebo and therapeutic non-inferiority to Voltarol (7/12)

DIABETES

Generex
Biotechnology
Corp.
(Canada;
GNBT)

Oral-lyn

Oral insulin buccal spray formulation

Type I diabetes

Phase I trial demonstrated comparable blood glucose levels to injectable regular insulin (7/6)

INFECTION

Avant
Immuno-therapeutics
Inc.
(AVAN)

CholeraGarde

Vaccine based on the Peru-15 attenuated strain of cholera

Cholera

Phase II trial in infants and children in India showed a single dose to be well tolerated and highly immunogenic (7/27)

Paratek
Pharmaceuticals
Inc.*

PTK 0796

Broad-spectrum antibiotic from the aminomethylcycline class

Infections

Began Phase I trial in the UK to evaluate safety and tolerability in healthy subjects (7/28)

The Immune
Response Corp.
(IMNR)

Remune

Immune-based therapy comprising a whole-killed virus and an adjuvant

HIV

Phase II data from trials in Spain showed drug delayed virologic failure during treatment interruption; and that treatment induced allo-specific responses (7/27)

The Immune
Response Corp.
(IMNR)

IR103

Combination of HIV-1 Immunogen and Amplivax, an immunostimulatory oligonucleotide adjuvant

HIV

Preliminary data from trial indicates the product is safe, induces HIV-specific immune responses and enhances IFN-gamma and RANTES mRNA (7/26)

Sinovac
Biotech Ltd.
(China; AMEX:SVA)

Anflu

Influenza vaccine

Influenza
virus

Chinese regulators issued a production license, which authorizes Sinovac to begin vaccine production (7/27)

York Pharma
plc
(UK; AIM:YRK)

Abasol (abafungin)

Broad-spectrum anti- fungal and antibacterial agent

Dermatomycoses

Filed for approval in the UK as the first step for seeking approval throughout Europe (7/29)

MISCELLANEOUS

BioXell SpA*
(Italy)

BXL628

Inhibitor of growth factor phosphorylation and bcl-2

Benign prostatic hyperplasia

Began Phase IIb trial in Italy that will evalaute the effect on prostate volume in more than 500 patients (7/7)

Corgentech
Inc.
(CGTK)

NF-kB Decoy

Inhibitor of the NF-kB transcription factor

Atopic dermatitis (eczema)

Began Phase I/II trial in Switzerland and Australia to evaluate safety and tolerability in 120 patients (7/21)

Diurnal Ltd.*
(UK)

--

Modified-release hydrocortisone tablet

Congenital adrenal hyperplasia

The product was granted orphan designation in Europe in that indication (7/26)

NicOx SA
(France; Eurolist:
NICOX)

HCT 1026

Nitric oxide-donating derivative of flurbiprofen

Osteopenia (low bone density)

Pilot Phase II trial showed a significant reduction in bone resorption markers (7/11)

Novogen Ltd.
(Australia; ASX:
NRT)

Glucoprime

Gel formulation of a carbohydrate extracted from yeast cell walls

Venous stasis ulcers

Phase II trial in 60 patients in Australia showed the drug promoted wound healing significantly faster than placebo (7/12)

PTC
Therapeutics
Inc.*

PTC124

Oral agent that targets nonsense mutations

Duchenne's muscular dystrophy and cystic fibrosis

The EMEA granted orphan designation to the product in Europe in both indications (7/7)

7TM Pharma
A/S*
(Denmark)

TM30338

Peptide that targets two types of Y receptors

Obesity

Began Phase I/II trials of the product (7/7)


Notes:

* Privately held.

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

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

AIM = Alternative Investment Market; AMEX = American Stock Exchange; ASX = Australian Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange.

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