Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Biogen Inc.
(BGEN) and Celltech Group plc (UK; LSE:CCH)

CDP 571

A humanized anti-TNF- alpha antibody

Crohn's disease

Product missed its primary endpoint in a Phase III trial (7/30)

Cell Pathways
Inc.
(CLPA)

CP461

Oral drug; selective apoptotic antineoplastic drug

Crohn's disease

Company initiated a Phase II trial (7/22)

Immunex Corp.
(IMNX)

Enbrel (FDA-
approved)

Etanercept; tumor necrosis factor inhibitor

Psoriasis

Company began a second Phase III trial (7/3)

La Jolla
Pharmaceutical

Co.
(LJPC)

LJP 394

Arrests the production
of antibodies to dsDNA without suppressing healthy functions of the immune system

Lupus

Phase II/III results showed that in 89% of patients with high-affinity antibodies for the drug, LJP 394 treatment prolonged time to and decreased the number of renal flares and delayed the need for high-dose corticosteroid and cyclophosphamide treatments when compared to placebo (7/1)

Regeneron Pharmaceuticals
Inc.
(REGN)

Interleukin-1 Trap

Designed to block inter- leukin-1 through a new mechanism of action

Rheumatoid arthritis

Company began a Phase II trial in about 200 patients (7/24)

CANCER

AnorMED
Inc.
(Canada; TSE:AOM)

AMD-3100

A potential agent in stem cell transplant by enhancing the effect of Neupogen

Cancer

Phase I results were positive; company intends to start a Phase II trial (7/9)

Antigenics Inc.
(AGEN)

Aroplatin

A liposomal formulation
of a third-generation platinum analogue

Metastatic colorectal cancer

Company enrolled the first patient in a Phase II study (7/18)

Aphton Corp.
(APHT)

G17DT

A targeted therapy designed to induce antibodies that bind to both gastrin 17 and glygastrin and remove them from circulation before they can bind to the cancer cell and initiate cell growth

Metastatic stomach cancer

Phase II results showed 37 of 72 evaluable patients had either a partial or complete tumor response for an overall response rate of 51.4% (7/31)

AVI BioPharma
Inc.
(AVII)

Avicine

Cancer vaccine that blocks human chorionic gonadotropin

Late-stage colorectal
cancer

Phase II results showed anti-hCG antibodies were detected in 56 patients out of 77 total (7/24)

Biomira Inc.
(Canada; BIOM; TSE:BRA)

BLP25

Synthetic MUC1 therapeutic vaccine consisting of the 25- amino-acid sequence of the MUC1 cancer mucin, encapsulated in liposomes

Non-small-cell lung cancer

An independent Data Safety Monitoring Board reviewed safety data in a Phase IIb trial and recommended the study continue as planned (7/22)

Bio-Technology General Corp. (BTGC)

Oxandrolone

Oral synthetic derivative
of testosterone

Cancer-related weight loss

Clinical results showed that 78% of patients were able to gain or stop losing weight (7/8)

British Biotech
plc
(UK; BBIOY; LSE:BBG)

E21R

A modified form of granulocyte macrophage- colony stimulating factor

Acute myeloid leukemia

Company stopped a Phase II study after new preclinical data failed to support the previous high incidence of apoptosis in AML (7/10**)

British Biotech
plc
(UK; BBIOY; LSE:BBG)

MG98

A second-generation antisense compound designed to inhibit the expression of DNA methyltransferase, an enzyme implicated in tumor growth

Head and neck cancer and renal carcinoma

Company closed recruitment in a Phase II study after patients failed to show a clinical response (7/10**)

Celgene Corp.
(CELG)

Actimid

Immunomodulatory
drug; orally available compound that is chemically linked, but functionally distinct from thalidomide

Multiple
myeloma

Phase I/II results showed eight people achieved stable disease, seven experienced a reduction in M-protein of between 25% and 50%, and three experienced a reduction in M-protein of greater than 50%; dose-limiting toxicities included neutropenia and thrombosis (7/8)

Cell Thera-
peutics
Inc.
(CTIC)

Xyotax

Links paclitaxel to a biodegradable polyglutamate polymer

Advanced
ovarian cancer

Company began its first Phase III trial (7/30)

EntreMed Inc.
(ENMD)

Angiostatin

Used in combination
with paclitaxel and carboplatin; subcutaneous antiangiogenic

Non-small-cell lung cancer

Company began a Phase II trial (7/17)

GenVec Inc.
(GNVC)

TNFerade

Delivers the human
tumor necrosis factor-alpha gene to tumors, using GenVec's adenovector gene delivery technology

Pancreatic
cancer

Company began a Phase IIb trial involving about 140 patients (7/17)

ILEX Oncology
Inc.
(ILXO)

Clofarex

Clofarabine; second- generation nucleoside analogue

Advanced solid tumors

Company began a Phase I trial (7/26)

KS Biomedix Holdings plc (UK; LSE:KSB)

TransMID

Delivers diphtheria toxin
to selectively kill tumor cells

Malignant brain tumors

Company received approval to start a Phase I trial in the U.S. in up to 30 children (7/10**)

MGI Pharma
Inc.
(MOGN)

Irofulven

Anticancer compound

Advanced gastrointestinal solid tumors

Company initiated a Phase II trial (7/15)

Oncolytics
Biotech Inc.
(Canada; TSE: ONC)

Reolysin

A human, reovirus-
based product

Brain cancer

Company began a Phase I/II trial (7/3)

Oxford Bio-
Medica plc*
(UK)

TroVax

Cancer gene therapy product

Cancer

Company is planning a Phase II trial (7/17**)

Sonus Pharma-
ceuticals
Inc.
(SNUS)

Tocosol Paclitaxel

Paclitaxel cancer product that uses the company's vitamin E-based Tocosol delivery technology

Cancer

Phase II data showed the maximum tolerated dose for the colorectal study to be 120 mg/m2; company also completed patient enrollment in the dose-escalation stage of its non-small-cell lung, ovarian and bladder studies (7/19)

TransMolecular
Inc.*

131I-TM-
601

A radiopharmaceutical containing chlorotoxin from scorpions

Glioma

Company started a Phase I/II trial (7/3)

Viventia Biotech
Inc.
(Canada; TSE:VBI)

VB2-011

"Totally Human" monoclonal antibody

Solid tumors

Company finished a Phase I/II safety and dose-escalation trial of VB2-011 (7/24)

CARDIOVASCULAR

Alteon Inc.
(AMEX:ALT)

ALT-711

A.G.E. crosslink
breaker

Diastolic heart failure

Company began a Phase IIa trial (7/16)

Cardiome Pharma
Corp.
(Canada; TSE:COM)

RSD1235

Atrial antiarrhythmic
drug candidate

Atrial fibrillation

Company completed dosing in a Phase II trial (7/10)

CV Therapeutics
Inc.
(CVTX)

CVT-510

Tecadenoson; a selective A1 adenosine receptor agonist

Paroxysmal supraventricular tachycardia

Company completed patient enrollment in a Phase III trial of CVT-510 (7/25)

Discovery Laboratories Inc. (DSCO)

Surfaxin

Humanized, synthesized peptide containing surfactant

Acute respiratory distress syndrome

Company completed the dose- ranging part of its Surfaxin Phase II trial (7/19)

Esperion Therapeutics
Inc.
(ESPR)

ETC-642

RLT peptide, which mimics the biological properties of apolipoprotein A-I to promote cholesterol removal from arterial walls and other tissues and to enhance reverse lipid transport

Artherosclerosis

Phase I results were positive (7/15)

Genzyme Biosurgery
(GZBX)

Gene therapy treatment; an engineered form of the HIF-1 alpha gene

Severe peripheral artery disease

Company completed enrollment in a Phase I trial (7/15)

Hyseq Pharma-
ceuticals
Inc.
(HYSQ)

Alfimeprase

A modified fibrolase
that directly degrades fibrin when delivered through a catheter at the site of a blood clot

Peripheral arterial occlusion

Company began a Phase I trial (7/1)

ICOS Corp.
(ICOS) and Texas Biotechnology Corp. (TXBI)

Sitaxsentan

Endothelin receptor antagonist

Pulmonary arterial hypertension

Companies stopped an extension of a Phase IIb/III trial due to liver abnormalities in patients (7/23)

CENTRAL NERVOUS SYSTEM

Durect Corp.
(DRRX)

Chronogesic

Sufentanil; pain therapy system

Pain

Company began patient dosing in a Phase III trial (7/9)

Forest
Laboratories
Inc. (NYSE:FRX) and Merz Pharma KgaA (Germany)

Memantine

Orally available neuroprotective agent that appears to restore damaged nerve cells and block excitatory signals by modulating the N- methyl D-aspartate receptor on cell membranes

Alzheimer's disease

Data showed that treatment with memantine seems to ease the economic burden and reduce care-giving time by more than 50 hours per month compared to placebo (7/22)

Neurobiological Technologies Inc. (NTII)

Memantine

N-methyl D-aspartate receptor antagonist

Alzheimer's disease

Phase III data showed sustained efficacy of Memantine over 52 weeks to treat Alzheimer's disease (7/25)

Pozen Inc.
(POZN)

MT 300

An injectable dihydro- ergotamine mesylate compound

Migraine

Phase III data showed MT 300 met its primary and secondary endpoints (7/22)

Titan Pharma-
ceuticals
Inc. (AMEX:TTP)

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

Company said a regulatory filing would be set back a year because of the need for addition- al trials (7/22)

DIABETES

Avanir Pharmaceuticals Inc. (AMEX:AVN)

Neurodex

Orally administered combination of dextromethorphan and an enzyme inhibitor

Diabetic neuropathy

Company began a Phase II trial (7/31)

ConjuChem Inc. (Canada; TSE:CJC)

DAC:
GLP-1

Subcutaneously injected; created with DAC technology to engineer an analogue of GLP-1 into a drug construct, CJC-1131, which bonds in vivo to albumin

Type II diabetes

Company began a Phase I trial (7/8)

INFECTION

Access Pharmaceuticals Inc. (AMEX:AKC)

OraDisc A

A mucoadhesive disc containing amlexanox

Canker sores

Company began a final Phase III trial (7/23)

Achillion Pharmaceuticals Inc.*

ACH-
126,443

An L-nucleoside
antiviral agent

HIV/AIDS

Company began a Phase II trial (7/17)

Amrad Corp.
(Australia; ASX:AMC)

AM365

Inhibitor of viral
replication

Hepatitis B

Company is stopping development of AM365 after poor results from a Phase IIa trial (7/17**)

Essential Therapeutics Inc. (ETRX) and Johnson & Johnson Pharmaceutical Research & Development LLC

Lead cephalosporin candidate

Antibiotic- resistant Gram-positive bacteria

Companies initiated Phase I trials (7/25)

Gilead Sciences
Inc.
(GILD)

Viread (FDA-
approved)

Tenofovir disoproxil fumarate

HIV

Phase III data showed 87% of patients in both the Viread arm and the stavudine arm achieved suppression of HIV RNA below 400 copies/mL following 48 weeks of treatment (7/8); Viread showed durable and sustained anti-HIV activity through 48 weeks, even in highly treatment-experienced patients with multiple thymidine analogue mutations (7/11)

Hemispherx Biopharma Inc. (AMEX:HEB)

AMP 719 (Ampligen)

Immunotherapeutic; double-stranded synthetic RNA compound poly 1; poly C124

AIDS

Phase IIb data showed that after a median of 4.5 months, Ampligen patients on HAART experienced a mean HIV-1 viral load decrease of 0.50 log using the Roche Amplicor assay (7/11)

NicOx SA
(France; Nouveau Marche:NICOX)

NCX 950

A nitric oxide-donating salbutamol salt; inhaled formulation

Respiratory infections

Company reported positive results from a Phase I/II trial (7/10**)

Oxxon
Pharmaccines
Ltd.* (UK)

Hepatitis B virus drug candidate

Hepatitis B

Company moved the product into Phase II trials after Phase I trials showed it was safe and well tolerated (7/1)

Progenics Pharmaceuticals Inc. (PGNX)

PRO 542

Viral entry inhibitor

HIV

Phase II data showed that PRO 542 produces an antiviral response in HIV-infected individuals for whom available antiretroviral medications have failed (7/8)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Thymalfasin, thymosin alpha 1

Hepatitis B

Clinical study demonstrated that Zadaxin helps clear the Hepatitis B virus in patients in the immune-tolerant phase of the infection (7/16)

Serono SA (Switzerland; NYSE:SRA)

Serostim (FDA-
approved)

Somatropin (rDNA
origin) for injection

AIDS-related metabolic complications

A Phase II/III study indicated that Serostim has a potential role in the treatment of body compo- sition issues associated with lipodystrophy; it also showed in a Phase IV study that it could restore lean body mass (7/9)

The Immune Response Corp. (IMNR)

Remune

HIV-1 immunogen

HIV

Data suggest that Remune induces helper T-cell immune responses aimed specifically at HIV in chronically infected HIV- positive individuals taking highly antiretroviral therapy (7/8); Phase II data showed treatment stimulated HIV-specific immune responses that correlated with control of virus in a three-year trial (7/11)

Triangle Pharmaceuticals Inc. (VIRS)

Coviracil

Emtricitabine; a
nucleoside reverse transcriptase inhibitor

HIV

Phase III results showed that 87% of patients on once-a-day Coviracil showed persistent virologic response through six months, compared to 80% of the twice- daily Zerit patients; Coviracil patients also had significant improvements in immunologic function (7/31)

Trimeris Inc.
(TRMS)

T-20

A fusion inhibitor

HIV

Clinical data showed patients receiving T-20 were less likely to experience virological failure or relapse over 24 weeks (7/8); Phase III data suggested subcutaneous delivery was well accepted by a majority of patients after the first eight weeks of treatment (7/9)

Trimeris Inc.
(TRMS) and F. Hoffmann- La Roche Inc.

T-1249

A second-generation fusion inhibitor candidate

HIV

Phase I/II results showed that T-1249 was well tolerated and exhibited antiviral activity (7/3)

MISCELLANEOUS

Dyax Corp.
(DYAX) and Debiopharm SA (Switzerland)

DX-890

A recombinant inhibitor
of human neutrophil elastase

Cystic fibrosis

Phase IIa results showed no ad- verse changes compared to base- line; patients had inhibition of sputum neutrophil elastase following the therapy (7/16)

ILEX Oncology
Inc.
(ILXO)

Apomine

A non-hormonal therapeutic agent known as bisphosphonate esters

Osteoporosis

Company began a Phase I/II trial (7/29)

Millennium Pharmaceuticals Inc. (MLNM)

MLN977

Second-generation compound in the class of asthma therapies known as 5-LO inhibitors, which block the production of leukotrienes

Asthma

Company is stopping development of MLN977 due to safety issues in a 193-patient Phase II trial; three patients experienced elevations in liver enzymes that were attributed to the drug (7/15)

Protein Design
Labs Inc.
(PDLI)

Nuvion

Visilizumab; humanized monoclonal antibody directed at the CD3- antigen

Ulcerative
colitis

Company initiated a Phase I trial (7/9)

Regeneron Pharmaceuticals Inc. (REGN)

Axokine

Genetically re-engineered version of a naturally occurring human protein known as ciliary neurotrophic factor

Obesity

Company completed enrollment in two additional studies in its Phase III program of Axokine in obesity (7/25)

SangStat
Medical Corp.
(SANG) and Abgenix Inc. (ABGX)

ABX-CBL

Anti-CD147
monoclonal antibody

Steroid-resistant graft-vs.-host disease in allogeneic bone marrow trans- plants

Companies completed enrollment in a Phase II/III study (7/16)

Vernalis Group
plc
(UK; LSE: VER) and F. Hoffmann- La Roche Ltd. (Switzerland)

VR1065

A 5-HT2c receptor agonist

Obesity

Companies decided not to continue with additional Phase I trials (7/30)

V.I. Technologies
Inc.
(VITX)

Inactine

Pathogen-reduction red blood cell system

Red blood cell transfusions

Company will initiate Phase III studies with 270 patients (7/1)


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; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange

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