Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

AEterna Laboratories Inc. (Canada; AELA)

Neovastat

Orally bioavailable; activates apoptosis of endothelial cells; also inhibits matrix metalloproteinases and vascular endothelial growth factor

Metastatic renal cell carcinoma

Phase I/II trial results showed a two fold increase in median survival time for patients treated with a higher dose of Neovastat (3/26)

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

OvaRex MAb

Modified murine monoclonal antibody that binds to CA125 cancer antigen

Ovarian cancer

Phase II results showed nearly half of patients treated survived 50 weeks or longer (3/6); company found a correlation between circulating levels of ovarian tumor marker CA125 and the efficacy of OvaRex (3/22)

AVAX Technologies Inc. (AVXT)

M-Vax

Haptenized autologous cell vaccine

Cancer

Data showed the timing of an induction dose of vaccine is critical to achieve maximum immunological and clinical response; patients who received M-Vax up to a week before receiving cyclophosphamide responded better than those who received them concurrently (3/27)

BioChem Pharma Inc. (Canada; BCHE)

Troxatyl

Troxacitabine; a DNA chain terminator and DNA polymerase inhibitor

Acute myelogenous leukemia

Troxatyl moved into a Phase III study (3/27)

Biomira Inc. (Canada; BIOM)

Theratope

Synthetic carbohydrate-based vaccine; mimic of cancer antigen si alyl-Tn plus carrier molecule KLH

Metastatic breast cancer

Company completed enrollment in its 950-patient trial (3/9); positive trial results showed the vaccine was well tolerated and had minimal side effects (3/29)

Cell Genesys Inc. (CEGE)

GVAX

Cancer vaccine; immuno-therapeutic comprised of irradiated and genetically modified tumor cells that secrete granulocyte macrophage-colony stimulating factor

Multiple myeloma

Company initiated a Phase I/II trial of GVAX (3/7)

Cell Pathways Inc. (CLPA)

Aptosyn

Small-molecule compound that augments apoptosis in precancerous cells; exisulind

Advanced non-small-cell lung cancer

Company initiated a Phase III study of Aptosyn in combination with Taxotere (3/2)

EntreMed Inc. (ENMD)

Endostatin

Naturally occurring angio-genesis inhibitor

Metastatic clear cell renal carcinoma

A study demonstrated that endostatin had detectable levels in serum from both healthy subjects and those with CCRC (3/22)

Genentech Inc. (NYSE:DNA)

Herceptin antibody

Trastuzumab; HER-2 neu

HER2-positive metastatic breast cancer

Pivotal trial results showed patients treated with Herceptin and chemotherapy experienced a significant survival benefit compared to chemotherapy treatment alone (3/15)

GLYCODesign Inc. (Canada; TSE:GD)

GD0039

Anticancer compound; orally administered and blocks the production of specific carbohydrates that are important for cancer spread

Metastatic renal cancer, advanced head and neck cancer, breast cancer and cutaneous T-cell lymphoma

Company added five Phase II trials in four cancer indications to its clinical program for GD0039 (3/29)

Inex Pharmaceuticals Corp. (Canada; INEX)

Onco TCS

Therapeutic consisting of vincristine encapsulated in Inex's transmembrane carrier systems drug delivery technology

Non-Hodgkin's lymphoma

Company began enrolling patients in a Phase II trial (3/26)

MedImmune Inc. (MEDI) and Applied Molecular Evolution Inc. (AMEV)

Vitaxin

Angiogenesis inhibitor optimized through AME's directed evolution technology platform, which targets the integrin alpha-v-beta-3

Cancer

MedImmune initiated a Phase I trial (3/13)

MGI Pharma Inc. (MOGN)

MGI 114

Irofulven; hydroxymethyl-acylfulvene

Refractory or recurrent advanced epithelial ovarian cancer

Company initiated a new Phase II trial (3/22)

Millennium Pharmaceuticals Inc. (MLNM)

LDP-341

Proteasome inhibitor small molecule that blocks proteasome function

Multiple myeloma

Company initiated a Phase II trial (3/1)

NeoPharm Inc. (NEOL)

LE-AON

Electrostatic liposome encapsulated antisense cRaf oligonucleotide designed to block the expression of the cRaf protein

Cancer

Company initiated two Phase I/II trials (3/19)

Onyx Pharmaceuticals Inc. (ONXX) and Bayer AG (Germany)

BAY 43-9006

A selective agent designed to block the Ras signaling pathway in cells by inhibiting Raf kinase

Cancer

Phase I results demonstrated the compound's mechanism of action and potential applicability in multiple tumor types (3/26)

OSI Pharmaceuticals Inc. (OSIP)

OSI-774

A small-molecule anti-EGFR drug candidate used in combination with docetaxel (Taxotere)

Advanced cancer

Company began a Phase Ib trial (3/13)

Pharmacyclics Inc. (PCYC)

Xcytrin Injection

Motexafin gadolinium

Brain metastases

Company completed enrollment in a Phase III trial (3/14)

PhotoCure ASA (Norway; OSE:PHO)

Metvix

Photodynamic therapy involving a cream that is activated by light

Precancerous skin lesions

Company completed a Phase III trial, which showed Metvix completely removed 88% of the lesions (3/5)

Protarga Inc.*

Taxoprexin DHA-paclitaxel

Anticancer therapeutic; DHA-paclitaxel

Cancer

Company began Phase II studies (3/8)

SafeScience Inc. (SAFS)

GBC-590

Carbohydrate compound derived from citrus pectin

Colorectal cancer

Phase IIa trial data showed that five out of 23 patients had tumor stabilization from two to six months before disease state progression was observed (3/23)

SuperGen Inc. (SUPG)

Decitabine

Inhibits DNA methyltransferase activity

Advanced myelodysplastic syndrome

Company began enrollment in a Phase III trial (3/26)

Supratek Pharma Inc. (Canada)*

Vaccine

DNA vaccine formulated with SP1017

Melanoma

Company said the vaccine increased survival rates by more than 10-fold compared to the non-formulated DNA vaccine (3/6)

Telik Inc. (TELK)

TLK286

Small-molecule drug

Refractory colon cancer

Company began a Phase II trial (3/27)

Titan Pharmaceuticals Inc. (AMEX:TTP)

Pivanex

Small-molecule drug that attacks cancer cells by cellular differentiation

Liver tumors

Company initiated a Phase I/II study (3/28)

Vical Inc. (VICL)

Vaxid

Naked DNA vaccine

Low-grade, non-Hodgkin's B-cell lymphoma

Phase I/II data showed positive safety and immunogenicity results (3/27)

Vion Pharmaceuticals Inc. (VION)

Triapine

Small-molecule ribonucleotide reductase inhibitor

Cancer

Phase I data showed Triapine can be given safely daily for five days, every other week, and is well tolerated (3/28)

CARDIOVASCULAR

Alliance Pharmaceutical Corp. (ALLP)

Oxygent

Intravenous oxygen carrier comprised of liquid perfluorochemical core particles surrounded by a surfactant and suspended in a water-based solution

Patients undergoing cardiac surgery

Preliminary data showed no evidence to link Oxygent directly with an imbalance in certain adverse events, primarily stroke; enrollment of a Phase III study was halted in January due to the adverse events (3/13)

Alteon Inc. (AMEX:ALT)

ALT-711

Thiazolium-based compound; an advanced glycosylation end-product crosslink breaker

Cardiovascular disease

Phase IIa study results indicated ALT-711 improved arterial elasticity and reduced pulse pressure (3/19)

Biogen Inc. (BGEN) and CV Therapeutics Inc. (CVTX)

BG9719 (CVT-124)

A1 adenosine receptor antagonist

Moderate congestive heart failure

Phase II results showed treatment with BG9719, compared to placebo, resulted in renal function improvement, as well as an increase in renal output (3/20)

Collateral Therapeutics Inc. (CLTX)

Ad4-FGF4

Angiogenic gene therapy composed of an adenoviral gene therapy vector containing the human fibroblast growth factor-4 angiogenic gene; designed to stimulate blood vessel formulation

Stable exertional angina due to coronary artery disease

Drug appeared safe and well tolerated, as well as efficacious in a Phase I/II trial (3/19)

COR Therapeutics Inc. (CORR)

Integrilin and TNKase

Prevents reocclusion of the stented artery by blocking certain receptors, known as GP IIb-IIIa, on platelets responsible for thrombus development

ST-segment elevation myocardial infarction

Study results of Integrilin combined with a half dose of TNKase in patients showed the therapy fully restored blood flow through blocked arteries, supplying oxygen-starved heart muscle in 70% of patients within an hour of initiation of therapy (3/19)

Curis Inc. (CRIS)

Vascugel

Biodegradable implant containing human endothelial cells that will be wrapped at the junction of the bypassed and grafted coronary blood vessels at the time of the coronary artery bypass graft surgery and tissue perfusion

To prevent complications related to cardiovascular surgical procedures and to maintain long-lasting blood flow

Company initiated a Phase I trial (3/28)

Emisphere Technologies Inc. (EMIS)

Heparin

Oral heparin tablets formulated with Emisphere's delivery agent, Sodium N-[10-(2 hydroxybenzoyl)amino] decanoate

Prevention of deep vein thrombosis

Company began clinical testing (3/9)

Esperion Therapeutics Inc. (ESPR)

ETC-216

Comprised of ApoA-1 Milano and phospholipid (AIM); synthetic HDL

Cardiovascular disease

Company saw initial positive, results in a Phase I trial in which AIM was well tolerated with no serious side effects (3/29)

Genentech Inc. (NYSE:DNA) and Actelion Ltd. (Switzerland; SWX:ATLN)

Veletri

Tezosentan; intravenous dual endothelin receptor antagonist

Acute heart failure

Phase III results were positive demonstrating statistically significant blood circulation benefits (3/20)

NitroMed Inc.*

BiDil

Combination drug containing isosorbide dinitrate and hydralazine hydrochloride

Heart failure

Company initiated a study to confirm the efficacy of BiDil in treating African American heart failure patients (3/19)

Pharming Group NV (the Netherlands; EASDAQ:PHAR) and Baxter Healthcare Corp.

­

A recombinant human C1 inhibitor

Hereditary angioedema

Companies started a Phase I trial (3/9)

Scios Inc. (SCIO)

Natrecor

Recombinant form of B-type natriuretic peptide

Acute congestive heart failure

Company initiated a new study (3/19); an article published in the Journal of Cardiac Failure showed data in which Natrecor improves blood circulation and alleviates symptoms (3/20)

Texas Biotechnology Corp. (AMEX:TXB)

Argatroban

Anticoagulant; synthetic direct thrombin inhibitor that blocks the activity of thrombin

Acute ischemic stroke

Company began enrollment in a Phase II trial (3/14)

CENTRAL NERVOUS SYSTEM

Angiotech Pharmaceuticals Inc. (Canada; ANPI)

Micellar Paclitaxel

Intravenous therapy of FDA-approved paclitaxel

Multiple sclerosis

Company completed enrollment of a 189-patient Phase II study (3/1)

AtheroGenics Inc. (AGIX)

AGIX-4207

Orally administered treatment

Rheumatoid arthritis

Company began enrollment in a Phase I trial (3/27)

Boston Life Sciences Inc. (BLSI)

Atropine

Radio-imaging agent

Attention deficit hyper-activity disorder

Phase II results indicated the agent identified adults with ADHD (3/12)

Diacrin Inc. (DCRN) and Genzyme General (GENZ)

Neurocell-PD

Pig brain cells intended to function as replacement for brain cells lost to disease

Parkinson's disease

Early Phase II trial data showed no difference in improvement between those treated with Neurocell-PD and those in the control group (3/16)

Durect Corp. (DRRX)

Duros sufentanil

Uses the Duros osmotic delivery system to deliver sufentanil, an opioid

Chronic pain

Company completed patient enrollment in a Phase II trial (3/9)

Nastech Pharmaceutical Co. Inc. (NSTK)

Triptan

Nasally administered selective serotonergic agent

Migraine pain

Company began a Phase I trial in the U.S. (3/5)

NeoTherapeutics Inc. (NEOT)

Neotrofin

Leteprinim potassium

Parkinson's disease

Company began a Phase II trial (3/29)

Neurogen Corp. (NRGN) and Pfizer Inc.

NGD 97-1

GABA (gamma aminobutyric acid receptor agonist)

Alzheimer's disease

Companies initiated Phase II studies (3/15)

Teva Neuroscience (division of Teva Pharmaceutical Industries Ltd.; TEVA)

Copaxone

Glatiramer acetate for injection

Relapsing-remitting multiple sclerosis

A study found Copaxone produced a 29% reduction in enhancing lesions compared to placebo and reduced the number of relapses in RRMS patients by 33% compared to placebo (3/6)

DIABETES

Amylin Pharmacueticals Inc. (AMLN) and Alkermes Inc. (ALKS)

AC2993 LAR

A long-acting-release formulation of AC2993 (synthetic exendin-4), based on Alkermes' Medisorb injectable sustained-release delivery technology

Type II diabetes

Companies initiated a Phase I trial (3/26)

Calyx Therapeutics Inc.*

CLX-0901

Water-soluble, orally active small molecule shown to bind to the insulin receptor

Diabetes

Company began a Phase II trial (3/22)

Insmed Inc. (INSM)

SomatoKine

Recombinant protein being developed as an insulin sensitizer

Diabetes

Phase II data indicated Somato-Kine produced reductions in patients' average daily insulin requirements and average daily fasting glucose levels (3/22)

INFECTION

AnorMED Inc. (Canada; TSE:AOM)

AMD-3100

Inhibitor of the CXCR4 chemokine receptor

HIV

Company initiated a Phase I trial to study the white blood cell-increasing effects of AMD-3100 (3/19)

Cubist Pharmaceuticals Inc. (CBST)

Cidecin

Daptomycin, a novel cyclic lipopeptide antibiotic derived from a fermentation product of Streptomyces roseosporous

Skin and soft tissue infections

Pivotal Phase III results showed Cidecin achieved its primary endpoint of demonstrating equivalency to comparator agents (3/14)

Human Genome Sciences Inc. (HGSI)

Albuferon

Created by fusing interferon alpha to albumin

Hepatitis C

Company began a Phase I trial (3/23)

Inhibitex Inc.*

SA-IGIV

Staphylococcus aureus immune globulin intravenous

Infectious endocarditis

Company began patient enrollment for a Phase II trial (3/8)

IntraBiotics Pharmaceuticals Inc. (IBPI)

Protegrin IB-367

A rinse; synthetically derived analogue of naturally occurring protegrins

Ventilator-associated pneumonia

Phase IIa data indicate the compound was well tolerated and demonstrated antimicrobial activity (3/9)

IntraBiotics Pharmaceuticals Inc. (IBPI)

Ramoplanin Oral

Naturally occurring antibiotic

Bloodstream infections due to vancomycin-resistant enterococci

Company said its Phase III trials will be delayed a year or more due to difficulties enrolling 950 patients (3/12)

The Immune Response Corp. (IMNR)

Remune

HIV-1 Immunogen used in addition to HAART (highly active antiretroviral therapy)

HIV

Preliminary data from an open-label study suggests treatment may help HIV-positive individuals maintain control of the virus during structured treatment interruptions of the HAART regimen (3/13)

Versicor Inc. (VERS)

V-Echinocandin

Anidulafungin; intravenous antifungal agent

Esophageal candidiasis

Company entered a pivotal Phase III trial (3/22)

ViroPharma Inc. (VPHM)

Picovir

Antiviral drug; pleconaril; inhibits the function of the picornavirus capsid

Common cold

Preliminary analyses of two Phase III studies showed that Picovir reached the primary endpoints of reduction in time to eliminate a runny nose and reduction or elimination of all other disease symptoms (3/15)

MISCELLANEOUS

Abgenix Inc. (ABGX)

ABX-IL8

Fully human monoclonal antibody directed against interleukin-8

Moderate to severe psoriasis

Phase IIa results presented at the American Academy of Dermatology meeting showed the drug was associated with a statistically significant improvement in plaque psoriasis (3/5)

Adolor Corp. (ADLR)

ADL 8-2698

Small-molecule therapeutic that blocks opioid-induced bowel paralysis without blocking post-operative analgesic performance

Post-operative ileus

Company began enrollment in a Phase III trial of 180 patients (3/19)

AeroGen Inc. (AEGN)

AeroDose

Ipratropium inhaler; a small portable hand-held device that uses AeroGen's aerosol generator technology to aerosolize liquids

Respiratory disorders

Company entered Phase II trials with AeroDose (3/13)

Applied Genetics Inc. Dermatics*

T4N5 Liposomes Lotion

Uses liposomes to deliver DNA repair enzymes into the skin

Xeroderma pigmentosum

Study results show the drug uses liposomes to deliver DNA repair enzymes into the skin that reverse DNA damage caused by sunlight (3/15)

Atrix Laboratories Inc. (ATRX)

Atrisone dapsone

Topical gel in SMP technology

Moderate to severe acne

Phase I/II trial results indicated Atrisone reduced lesions by about one-half over the 28-day study (3/6)

Biogen Inc. (BGEN)

Amevive

Alefacept; human LFA-3 IgG1 fusion protein

Moderate to severe chronic plaque psoriasis

Results presented at the American Academy of Dermatology meeting showed the retreatment with Amevive displayed responses within four weeks that tended to be more rapid with the second course of treatment; the retreatment study followed an initial Phase II study (3/5)

BioMarin Pharmaceutical Inc. (BMRN) and Genzyme General (GENZ)

Aldurazyme

Recombinant human alpha-L-iduronidase; enzyme replacement therapy

MPS-1

Companies completed patient enrollment of a pivotal Phase III trial of Aldurazyme (3/2)

BioMarin Pharmaceutical Inc. (BMRN)

rhASB

Recombinant human arylsulfatase B; enzyme replacement therapy

MPS-VI

BioMarin completed patient enrollment of a Phase I trial (3/2)

Centocor Inc.*

Remicade (FDA-approved)

Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha

Moderate to severe psoriasis

Phase II results indicated infliximab could benefit patients with moderate to severe psoriasis (3/7)

Claragen Inc.*

CC10

Recombinant human protein

Chronic lung disease

Company began a multicenter clinical study of CC10 in chronic lung disease in premature infants (3/8)

CollaGenex Pharmaceuticals Inc. (CGPI)

Periostat

Doxycycline hyclate

Osteoporosis, osteopenia and periodontitis

Studies indicated that the therapy can reduce bone loss in the jaws of postmenopausal women; the studies were presented at the American Association for Dental Research meeting (3/9)

Curis Inc. (CRIS)

Chondrogel

Minimally invasive tissue augmentation product

Stress urinary incontinence

A pilot study published in the February issue of Neurology and Urodynamics indicated patients with stress urinary incontinence experienced significant improvement in their conditions (3/9)

DrugAbuse Sciences Inc.*

Naltrexone depot

Injectable sustained-release formulation of naltrexone

Alcohol dependence

Company completed patient enrollment in a Phase III trial (3/5)

Dynavax Technologies Corp.*

AIC anti-allergy vaccine

Short-course form of immunotherapy

Ragweed allergy

Phase II results showed the injections were well tolerated, with the exception of self-limited local reactions (3/20)

Genzyme General (GENZ) and Pharming Group NV (the Netherlands; EASDAQ:PHAR)

Recombinant human alpha-glucosidase

Enzyme replacement therapy

Pompe disease

Phase I/II results indicate the therapy may be able to reduce heart size and improve cardiac function (3/20); companies began a Phase II/III trial in infants (3/30)

IDEC Pharmaceuticals Corp. (IDPH)

IDEC-114

Primatized anti-CD80 moncolonal antibody

Moderate to severe psoriasis

Phase I/II results presented at the American Academy of Dermatology meeting showed that 40% of patients achieved the clinical endpoint (3/5)

IDEC Pharmaceuticals Corp. (IDPH)

IDEC-152

A primatized anti-CD23 monoclonal antibody

Allergic asthma

Phase I data showed reductions in IgE levels and an encouraging safety profile (3/19)

Immunex Corp. (IMNX)

Enbrel (FDA-approved)

Tumor necrosis factor receptor

Psoriatic arthritis

The company said a Phase III trial has produced positive data (3/22)

Immunex Corp. (IMNX)

Nuvance

A recombinant human version of a naturally occurring protein thought to act by binding to interleukin-4, a protein present in asthmatic lungs

Asthma

Phase II data show that Nuvance did not meet efficacy endpoints (3/22)

InterMune Pharmaceuticals Inc. (ITMN)

Actimmune

A gamma interferon therapy

Cystic fibrosis

Phase II results showed that inhaled gamma interferon could reduce chronic airway inflammation in cystic fibrosis patients (3/13)

La Jolla Pharmaceutical Co. (LJPC)

LJP 394

Molecule (toleragen) that binds to the surface of B cells and shuts off production of antibodies to double-stranded DNA

Lupus

Phase II/III data showed that as the dose of LJP 394 increased, the number of renal flares decreased in drug-treated patients relative to placebo patients; a Phase III trial is under way (3/28)

Ligand Pharmaceuticals Inc. (LGND)

Ontak

Denileukin diftitox

Moderate to severe psoriasis

Pilot study data showed all six patients achieved at least a 30% decrease in Psoriasis Area and Severity Index (3/6)

NeoTherapeutics Inc. (NEOT)

Neotrofin

Leteprinim potassium

Spinal cord injury

Company initiated a 12-week, open-label study (3/26)

Neurocrine Biosciences Inc. (NBIX)

CRF1 receptor

Corticotrophin-releasing factor receptor antagonist

Depression and anxiety

Company completed a Phase I trial (3/8)

NexMed Inc. (NEXM)

Alprox-TD

Topical treatment

Severe erectile dysfunction

Company completed testing in a Phase II efficacy and safety study (3/12)

Phytopharm plc (UK; LSE:PYM)

P57

Orally administered appetite suppressant derived from an extract of a South American plant

Obesity

Company started a Phase IIa trial (3/14**)

Protein Design Labs Inc. (PDLI)

SB240683

Humanized anti-IL-4 antibody

Mild to moderate asthma

Phase I results showed the antibody was well tolerated and had a half-life of 18 to 21 days (3/22)

Regeneron Pharmaceuticals Inc. (REGN)

Axokine

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

Obesity

Phase II results showed patients maintained their average weight loss for three months (3/1)

SR Pharma plc (UK; LSE:SPA)

SRL 172

Immune potentiator

Atopic dermatitis

Phase II results showed a mean 48% reduction in surface area and 68% reduction in severity of the dermatitis, compared with 4% and 18% in the placebo group (3/21**)

Symbollon Corp.

IoGen (SYMBA)

Molecular iodine

Fibrocystic breast disease

Phase II data indicated an overall reduction of about 50% of breast pain and tenderness, compared to a 10% increase in patients receiving placebo (3/14)

XOMA Ltd. (XOMA)

Xanelim delivered

Efalizumab subcutaneously

Moderate to severe plaque psoriasis

Phase I/II and Phase III data presented at the American Academy of Dermatology's annual meeting showed 75% of patients given Xanelim achieved 50% or better PASI (Psoriasis Area and Severity Index) improvement (3/5)

Notes:

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

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