Company*
(Symbol)

Product

Description

Indication

Status
(Date)


CANCER

Abgenix Inc.
(ABGX)

ABX-EGF

Fully human monoclonal antibody

Non-small-cell lung cancer

Company initiated a Phase II trial, its second for ABX-EGF (7/31)

AltaRex Corp.
(Canada; OTC
BB: ALRXF;
TSE:AXO)

OvaRex

Modified murine monoclonal antibody that binds to CA125 cancer antigen

Ovarian cancer

Phase II results validated quality-of-life data associated with the administration of OvaRex MAb, as compared to placebo (7/27)

Atrix Laboratories Inc. (ATRX)

Leuprogel Three-Month Depot

Leuprolide acetate for subcutaneous depot for injection; leuprolide is a luteinizing hormone- releasing hormone agonist

Advanced prostate cancer

Phase III results showed 100% suppression of serum testosterone to very low levels (7/10)

BTG plc
(UK; LSE:BGC)

AQ4N

Lead compound selected from a series of hypoxic-cell cytotoxins designed to increase the effectiveness of several anticancer drugs, as well as radiotherapy

Cancer

Company started a Phase I trial (7/17)

Celgene
Corp.
(CELG)

Thalomid

Thalidomide; modulates levels of tumor necrosis factor-alpha

Multiple melanoma

Two-year event-free and overall survival rates of 20% and 48% were seen in a follow-up of a Phase II trial of 169 advanced and refractory patients (7/9)

EntreMed
Inc.
(ENMD)

Endostatin

Naturally occurring angiogenesis inhibitor

Cancer

Company enrolled the first patients in a Phase I/II trial (7/12)

Enzon Inc.
(ENZN)

Prothecan

PEG-camptothecin

Small-cell lung cancer

Company initiated patient dosing in a Phase II trial (7/24)

MedImmune Inc.

(MEDI)

Vitaxin

Antibody that has the potential to inhibit growth of new blood vessels by binding to a specific integrin

Colorectal cancer

Company began dosing colorectal cancer patients in a Phase I/II trial (7/16)

MetaPhore Pharma-
ceuticals
Inc.*

M40403

Enzyme mimetic drug

Advanced skin and end-stage kidney cancers

Company released initial results from its Phase I study that showed no dose side effects were observed or reported (7/12)

Ortho Biotech Products LP*

Doxil

Liposomal doxorubicin

Epithelial ovarian cancer

A study comparing Doxil with topotecan showed the median time to progression was 16.1 weeks for Doxil and 17 weeks for topotecan; the overall response rates were 19.7% and 17%, respectively (7/27)

OSI Pharma-
ceuticals
Inc. (OSIP)

OSI-774 (Tarceva)

Epidermal growth factor receptor tyrosine kinase

Non-small-cell lung cancer

Company initiated a Phase III trial in which Tarceva will be evaluated in combination with carboplatin and paclitaxel (7/25)

SafeScience
Inc.
(SAFS)

GBC-590

Carbohydrate compound derived from citrus pectin

Refractory pancreatic adenocarcinoma

Company completed patient enrollment in a Phase II trial (7/23)

Vion
Pharma-
ceuticals
Inc. (VION)

Triapine

Anticancer agent; inhibitor of the enzyme ribonucleotide reductase

Cancer

Company initiated the second Phase I combination trial designed to determine the safety and maximum dose of cisplatin when administered with Triapine (7/16); company initiated a Phase II trial in patients with acute and chronic leukemias (7/23)

CARDIOVASCULAR

Alteon Inc.
(AMEX:ALT)

ALT-711

A.G.E. crosslink breaker compound

Isolated systolic hypertension

Company started a Phase IIb trial (7/9)

Cardiome Pharma Corp. (Canada; OTC BB:COMTF; TSE:COM;)

RSD1235

Anti-arrhythmic drug

Acute atrial arrhythmia

Company completed a Phase I trial that showed the product to be safe and well tolerated (7/30)

Cyanotech
Corp.
(CYAN)

BioAstin

Formulation of the microalgae Haematococcus pluvialis, which contains high levels of astaxanthin

For the reduction of LDL cholesterol, while increasing HDL cholesterol

Cyanotech initiated a new trial to measure BioAstin's effectiveness in reducing LDL cholesterol while increasing HDL cholesterol (7/6)

CENTRAL NERVOUS SYSTEM

Guilford Pharmaceuticals
Inc.
(GLFD) and
Amgen Inc. (AMGN)

NIL-A

Neuroimmunophilin ligand

Parkinson's disease

Company completed a Phase II trial, which showed the product did not reach statistical significance in any of its endpoints (7/26)

Protein Therapeutics
Inc.*

¿

Oral human gammaglobulin

Juvenile rheumatoid arthritis

Company started enrollment for a Phase II trial (7/9)

Repligen
Corp.
(RGEN)

¿

Human synthetic secretin

Autism

Phase II data showed patients had an improvement in symptoms over the eight-week period of the trial (7/20)

Titan Pharma-
ceuticals
Inc. (AMEX:TTP)

Spheramine

Cell therapy product that uses human retinal pigmented epithelial cells that secrete dopamine

Parkinson's disease

Phase I/II data demonstrated improvement in motor function and quality of life for Parkinson's patients treated with Spheramine (7/31)

Titan Pharma-
ceuticals
Inc. (AMEX:TTP) and Novartis Pharma AG (Switzerland)

Zomaril

Iloperidone; antipsychotic that has an antagonistic activity on brain receptors for dopamine and serotonin, with preferential affinity for 5HT2A serotonin receptors in humans

Schizophrenia

Companies said they will initiate additional dose-related trials, delaying regulatory filing, in order to demonstrate a favorable safety profile when switching from other antipsychotic agents to Zomaril (7/24)

DIABETES

DepoMed
Inc.
(AMEX:DMI)

Metformin GR

Once-daily treatment that uses DepoMed's gastric retention technology

Diabetes

Phase II data confirmed findings indicating the safety and efficacy and relative tolerability; it showed that the GR formulation was as effective as the IR formulation and the differences among the treatments were not significant (7/31)

Restoragen
Inc.*

Betatropin

Recombinant glucagon-like peptide-1

Type II diabetes

Phase II and Phase I/II results indicated the therapy produced a statistically significant reduction in glycated hemoglobin (7/5)

INFECTION

Achillion
Pharma-
ceuticals
Inc.*

ACH-126,443

Beta-LFd4C

Chronic hepatitis B

Company began a Phase Ib/II study of the compound (7/24)

Cangene
Corp.
(Canada;
TSE:CNJ)

¿

Anti-hepatitis C hyperimmune product

Hepatitis C

Company stopped its Phase II trial in liver transplant recipients after an independent monitoring board found no statistical difference between patients receiving the drug and those receiving placebo (7/12)

Cubist Pharma-
ceuticals
Inc. (CBST)

Cidecin

Daptomycin for injection; a novel cyclic lipopeptide antibiotic derived from a fermentation product of streptomyces roseosporous

Skin and soft tissue infection

Company completed enrollment in the second of its Phase III trials (7/16)

Medinox Inc.*

NOX-100

Small-molecule, nitric oxide-blocking agent designed to bind and inactivate excessive amounts of NO

Sepsis

Company started a Phase I/IIa trial (7/9)

Micrologix
Biotech Inc.
(Canada; TSE:MBI)

MBI 853NL

Anti-infective; intranasally delivered

Hospital-acquired Staphylococcus aureus

Company suspended its plans for a Phase II efficacy study due to Phase Ib results that showed further studies would involve greater risk, time and costs than could be justified (7/16)

Trinity Medical
Group USA Inc.
(OTC BB:TMGU) and The Immune Response Corp. (IMNR)

Remune

HIV-1 immunogen

HIV

Clinical studies showed there was no mutation of the virus (7/11)

XTL Biopharma-
ceuticals Ltd.
(Israel; LSE:XTL)

XTL-002

Human monoclonal antibody shown to reduce viral levels of HCV

Hepatitis C

Company began Phase I studies (7/3)

MISCELLANEOUS

Adolor Corp.
(ADLR)

ADL 8-2698

Oral nonabsorbed small- molecule opioid receptor antagonist

Opioid bowel dysfunction

Company started enrollment in a Phase III trial (7/9)

Amarillo
Biosciences Inc.
(OTC BB:AMAR)

Lozenges

The lozenges contain 50 international units of natural human interferon alpha

Fibromyalgia syndrome

Phase II study in which patients did not have an injury that contributed to the syndrome showed the therapy was statistically significant (7/17)

BioMarin
Pharmaceutical
Inc.
(BMRN) replacement therapy

¿

Recombinant human N- acetylgalactosamine 4- sulfatase, an enzyme

Maroteaux-Lamy syndrome

Company completed the 24-week treatment stage of its Phase I trial (7/25)

Discovery
Laboratories
Inc.
(DSCO)

Surfaxin

Humanized, peptide- containing surfactant designed to lower surface tension at the air-water interface in the rings

Idiopathic respiratory distress syndrome

Company began patient enrollment in a Phase III trial in premature infants (7/9)

Genentech Inc. (NYSE:DNA) and XOMA Ltd. (XOMA)

Xanelim

Efalizumab

Psoriasis

Phase III data showed that all endpoints were met, indicating the ability of Xanelim to provide long-term control of psoriasis symptoms in patients with moderate to severe forms of the disease (7/31)

GenStar Therapeutics (AMEX:GNT)

Maximum AD

Factor VIII gene therapy

Hemophilia A

Phase I data demonstrated an increase in Factor VIII clotting factor levels from less than 1% up to 3% (7/12)

ICOS Corp.
(ICOS)

IC747

Orally active, small-molecule LFA-1 antagonist

Inflammatory conditions

Phase I trial began (7/2)

ISTA
Pharma-
ceuticals
Inc. (ISTA)

Vitrase

Injectable enzyme; hyaluronidase

Severe vitreous hemorrhage

ISTA completed patient enrollment in the second of its Phase III trials (7/5)

Metabolex
Inc.*

MBX-102

Single isomer of racemic drug

Lowering lipids (glucose, cholesterol and triglycerides)

Company began a Phase I trial (7/9)

MedImmune
Inc.
(MEDI)

Siplizumab

Humanized monoclonal antibody that has the potential to suppress the immune system

Psoriasis

Company began dosing patients in a Phase I trial (7/26)

Neurochem
Inc.
(Canada; TSE:NRM)

Fibrillex

Anti-amyloid drug

Secondary amyloidosis

Company saw positive Phase I safety data (7/17)

Neurocrine
Biosciences
Inc.
(NBIX)

NBI-34060

Type 1 GABA-a, a receptor agonist; chemically distinct from benzodiazepines

Chronic insomnia

Company received positive efficacy results in all four doses of NBI-34060 in a Phase II study (7/17)

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

Vevesca

Oral capsule formulation of a glucosyltransferase inhibitor

Type I Gaucher disease

Company initiated a clinical study in the U.S. (7/13)

Phytopharm
plc
(UK; LSE:
PYM)

P57

Appetite suppressant derived from a South African plant

Obesity

Company completed the second stage of its Phase II study and no serious side effects were experienced by any of the 18 patients (7/18**)

Regeneron
Pharma-
ceuticals
Inc. (REGN)

Axokine

Genetically reengineered version of a naturally occurring human protein known as ciliary neurotrophic factor

Obesity

Company initiated a Phase III trial (7/31)

Targeted
Genetics Corp.
(TGEN)

tgAAV-CF

Gene therapy product that uses an adeno- associated virus vector delivery system

Cystic fibrosis

Phase II data showed no serious adverse events (7/10)

XOMA Ltd.
(XOMA)

Neuprex

Recombinant bactericidal/ permability increasing protein

Crohn's disease

Company initiated a Phase II trial (7/26)


Notes:

* Privately held

** Denotes the date the item ran in BioWorld International.

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

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange

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