Company*
(Country;
Symbol)

Product

Description

Indication

Status
(Date)


AUTOIMMUNE

Advitech Inc.
(Canada; TSE:AVI)

XP-828L

Oral bioactive complex derived from milk proteins

Psoriasis

Four of seven patients in open-label extension study had further improvements in PASI scores; seven of 11 patients improved in initial eight-week study (8/31)

Astralis Ltd.
(OTC BB:ASTR)

Psoraxine

Protein-based immuno-
stimulator

Plaque psoriasis

Phase I trial showed drug generally was well tolerated; some signs of efficacy were seen (8/5)

La Jolla
Pharmaceutical
Co.
(LJPC)

Riquent (abetimus sodium)

B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA

Lupus

Reached agreement with FDA on Phase IV trial to assess time to renal flare over 12 months in 500 to 600 patients (8/2)

MedImmune
Inc.
(MEDI)

Vitaxin

Monoclonal antibody that targets the alpha-v beta-3 integrin

Rheumatoid arthritis and psoriasis

Terminated Phase II testing based on preliminary data suggesting lack of clinical benefit; no safety concerns were noted, and trials in cancer continue (8/30)

Protein Design
Labs Inc.
(PDLI)

Nuvion
(visilizumab)

Humanized antibody directed at CD3 antigen on activated T cells

Ulcerative colitis

Resumed enrollment in optional re-reatment arm of Phase I/II trial in patients with severe disease that is refractory to intravenous steroids (8/9)

TolerRx Inc.*

TRX4

Humanized monoclonal antibody that binds to the CD3 receptor found on all mature T cells

Psoriasis

Began Phase I trial in 30 psoriasis patients to assess safety, pharmacokinetics and pharmacodynamics (8/2)

CANCER

Cell Genesys
Inc.
(CEGE)

CG7870

Oncolytic virus therapy

Prostate cancer

Began Phase I/II trial in combination with Taxotere in up to 70 patients with metastatic, hormone-refractory disease who have not had prior chemotherapy (8/18)

Celsion Corp.
(AMEX:CLN)

ThermoDox

Liposome-encapsulated
formulation of doxorubicin

Liver cancer

The National Institutes of Health began a Phase I trial to test the product in combination with radiofrequency ablation (8/31)

Conforma
Therapeutics
Corp.*

CNF1010

Small-molecule inhibitor of heat-shock protein 90 containing a form of the geldanamycin derivative 17-AAG

Advanced solid tumors/chronic myelogenous leukemia

Began Phase I trials in each indication to assess safety, tolerability, pharmacokinetics and pharmaco-dynamics (8/2)

Cytogen Corp.
(CYTO)

Quadramet (FDA-approved)

Samarium-153 bound to a small-molecule, bone-seeking phosphonate

Hormone-refractory prostate cancer

Began trial to evaluate safety, tolerability and efficacy in combination with docetaxel in patients whose cancer progressed after hormonal therapy (8/5)

Erimos
Pharmaceuticals
LLC*

EM-1421

Small molecule designed to temporarily prevent cell division and to induce cell death in tumor cells

Refractory head and neck cancer

Phase I trial produced tumor necrosis in five of six patients and appeared to be well tolerated (8/12)

Genmab A/S
(Denmark; CSE:GEN)

HuMax-CD4

Human antibody that targets the CD4 receptor on T lymphocytes

Non-cutaneous T-cell lymphoma

Began Phase II trial in 20 patients with relapsed or refractory disease that will measure tumor response at 18 weeks (8/13)

Genmab A/S
(Denmark;
CSE:GEN)

HuMax-CD4

Human antibody that targets the CD4 receptor on T lymphocytes

Cutaneous T-cell lymphoma

Presented Phase II data on 38 CTCL patients with mycosis fungoides, 42% of whom achieved at least a partial response (8/11)

Human
Genome Sciences
Inc.
(HGSI)

HGS-TR2J

Agonistic human monoclonal antibody to TRAIL Receptor 2

Advanced solid tumors

Began Phase I trial in Canada in up to 48 patients to assess safety and tolerability, as well as pharmacokinetics and disease response (8/24)

Introgen
Therapeutics
Inc.
(INGN)

Advexin

Adenoviral vector containing the p53 tumor-suppressor gene

Head and neck cancer

Investigator presented data from Phase II trial showing clinical activity and a positive safety profile (8/10)

Keryx
Biopharmaceuticals
Inc.
(KERX)

KRX-0401 (perifosine)

Oral AKT inhibitor

Solid tumors

Began trial to evaluate safety and tolerability of the drug in combination with gemcitabine in patients who failed gemcitabine treatment (8/4)

Lorus
Therapeutics
Inc.
(Canada;
TSE:LOR)

GTI-2040

Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase

Metastatic kidney cancer

Phase II trial demonstrated that GTI- 040 was well tolerated in combination with capecitabine (8/13)

NeoPharm
Inc.
(NEOL)

IL13-PE38QQR

Tumor-targeting agent designed to deliver bacterial cytotoxic PE38

Malignant glioma

Began Phase I trial to include 24 patients; delivery will follow tumor resection after initial diagnosis (8/4)

Novacea Inc.*

DN-101

Contains calcitriol, a naturally occurring hormone and the biologically active form of vitamin D

Androgen-independent prostate cancer

Will continue Phase II/III trial with Taxotere after reviewing six-month data from all 250 patients (8/4)

Peplin Biotech
Ltd.
(Australia;
ASX:PEP)

PEP005

Topical formulation

Actinic keratosis and non-melanoma skin cancers

Partner Allergan Inc. began Phase I/II testing of the product (8/27)

Point
Therapeutics
Inc.
(POTP)

Talabostat (PT-100)

Small molecule designed to stimulate proliferation of hematopoietic progenitor cells

B-cell malignancies

Data from ongoing Phase I trial showed drug could be safely administered in combination with rituximab; some activity also was seen (8/3)

Spectrum
Pharmaceuticals
Inc.
(SPPI)

Elsamitrucin

Antibiotic designed to inhibit topoisomerase I and II

Non-Hodgkin's lymphoma

Presented preliminary Phase II data showing evidence of anti-tumor activity in advanced patients, as well as tolerability (8/11)

CARDIOVASCULAR

Archemix Corp.*
and Nuvelo Inc.
(NUVO)

ARC183

Anti-thrombin aptamer

Anticoagulant

Began Phase I trial in 16 healthy volunteers to test safety, tolerability and anticoagulation activity, to be followed by testing in patients with coronary artery disease (8/9)

CV
Therapeutics
Inc.
(CVTX)

Ranexa
(ranolazine)

Partial inhibitor of fatty-acid oxidation

Chronic angina

Began trial under FDA SPA in 500 patients with chronic angina who remain symptomatic despite treatment with amlodipine (8/2)

Encysive
Pharmaceuticals
Inc.
(ENCY)

Thelin (sitaxsentan)

Small molecule designed to block endothelin

Pulmonary arterial hypertension

12-patient study in combination with Viagra showed a minor pharmacokinetic drug-drug interaction (8/27); presented extension data from pivotal Phase IIb/III STRIDE-1 trial showing positive long-term data (8/31)

Endovasc Inc.
(OTC BB:EVSC)

Liprostin

Liposome-encapsulated
form of prostaglandin E1

Peripheral vascular disease

Phase II trial in 73 patients demonstrated significant improvements in mean walking distance and painfree walking distance, the primary endpoints; patients monitored at one center had improved transcutaneous oxygen pressure (8/24)

Guilford
Pharmaceuticals
Inc.
(GLFD)

Aggrastat
(FDA-approved)

Glycoprotein IIb/IIIa receptor antagonist; tirofiban hydrochloride

Acute coronary conditions

Plans to begin two Phase III trials to determine the optimal regimen at the time of percutaneous coronary intervention; a 2,000-patient trial will compare drug to placebo in high-risk patients undergoing PCI with coronary stent placement; the TENACITY study in 8,000 patients will determine whether the 30-day efficacy is non-inferior to abciximab (8/12)

Isis
Pharmaceuticals
Inc.
(ISIS)

ISIS 301012

Second-generation antisense inhibitor of ApoB-100

Cardiovascular disease

Preliminary Phase I data showed reductions of apoB-100 by up to 55%, and lowered cholesterol levels (8/11)

Sangamo
BioSciences
Inc.
(SGMO)
and Edwards
Lifesciences Corp.

EW-A-401

Agent encoding a zinc finger DNA-binding protein transcription factor designed to activate all isoforms of the VEGF-A gene

Intermittent claudication

Edwards began a Phase I/II trial in 36 patients to test safety, as well as gather preliminary efficacy data (8/30)

The Medicines
Co.
(MDCO)

Angiomax
(FDA-approved)

Bivalirudin; direct
thrombin inhibitor

Anti-clotting agent

Published data from REPLACE-2 angioplasty trial showed lowered one-year mortality in high-risk Angiomax patients vs. those treated with heparin plus GP IIb/IIIa blockade (8/10)

CENTRAL NERVOUS SYSTEM

Amarin Corp.
plc
(UK; AMRN)

Miraxion (LAX-101)

Compound that inhibits certain enzymes, including phospholipases and caspases

Huntington's disease

Gene-variant analysis from failed Phase III trial identified a group of patients with a specific variant that responded to treatment; the initial trial was conducted by Laxdale Ltd. (8/24)

A.P. Pharma
Inc.
(APPA)

APF112

The anesthetic mepivacaine in a polymer-based drug delivery
system

Pain following inguinal hernia repair

Phase II trial in 90 patients produced no significant difference in efficacy between two formulations of APF112 and bupivacaine (8/12)

Avanir
Pharmaceuticals
Inc.
(AMEX:AVN)

Neurodex

Oral combination of dextromethorphan and an enzyme inhibitor, quinidine

Pseudobulbar affect

Pivotal Phase III trial in 150 PBA patients with multiple sclerosis demonstrated a statistically significant benefit for the drug vs. placebo on primary and secondary endpoints (8/24)

Avigen Inc.
(AVGN)

AV201

Delivers gene for aromatic L-mino acid decarboxylase to allow lower doses of levodopa

Parkinson's disease

Got FDA authorization to begin Phase I/II trial (8/12)

Cephalon Inc. (CEPH)

Modafinil (FDA-approved as Provigil)

Once-daily dosage form of the drug

Attention deficit hyperactivity disorder

Three nine-week trials involving a total of 600 children each showed a statistically significant improvement vs. placebo on the primary endpoint of teacher ratings; an NDA filing is planned for 4Q:04 (8/19)

DarPharma Inc.*

DAR-0100

Dopamine D1 receptor agonist

Schizophrenia

Began Phase I trial in patients to evaluate the effect on brain activation (8/24)

NeuroSearch
A/S
(Denmark;
CSE:NEUR) and
Abbott Laboratories

ABT-894

Nicotinic acetylcholine modulator

Neuropathic pain

Abbott began Phase I trials of the product candidate (8/5)

INFECTION

AVI BioPharma
Inc.
(AVII)

AVI-4020

Neugene antisense drug; designed to block function of the target gene or virus

West Nile virus

Began trial in 50 patients with presumptive acute WNV neuroinvasive disease to test safety and disease progression and resolution (8/31)

BioPort Corp.*

BioThrax (FDA-approved)

FDA-licensed anthrax vaccine

Anthrax infection

Got FDA OK for proof-of-concept studies in humans in which an immune-stimulating molecule will be added to the vaccine (8/18)

Cubist
Pharmaceuticals
Inc.
(CBST)

Cubicin (FDA-approved)

Daptomycin for injection

Infective endocarditis and bacteremia caused by S. aureus

Monitors recommended Phase III trial continue, following a third safety review involving more than 100 patients (8/4)

Enanta Pharmaceuticals Inc.*

EP-013420

A bridged bicyclic ketolide

Infections

Began Phase I trial to evaluate pharmacokinetics, safety and tol- erability in healthy volunteers (8/31)

ID Biomedical
Corp.
(Canada; IDBE)

StreptAvax

Vaccine that targets 26 serotypes of group A streptococci with a mixture of four proteins

Group A streptococci

Preliminary data from expanded Phase II trial showed the vaccine induced high titers of antibodies to all 26 serotypes and was well tolerated (8/10)

Gilead
Sciences Inc.
(GILD)

Viread and Emtriva (FDA- approved as Truvada)

Nucleotide and nucleoside reverse transcriptase inhibitors, respectively

HIV

24-week data from Phase III Study 934 in 500 treatment-naive patients showed a statistically significant benefit for drugs plus efavirenz vs. Combivir and efavirenz (8/26)

Metabasis
Therapeutics
Inc.
(MBRX) and
Valeant Pharma-ceuticals Inc.

Remofovir mesylate

Prodrug of the approved HBV drug adefovir (Gilead Sciences Inc.'s Hepsera)

Hepatitis B

Began 48-week Phase II trial in 220 patients with compensated HBV, at sites in the U.S. and Asia (8/3)

Oscient
Pharmaceuticals
Corp.
(OSCI)

Factive (FDA-approved)

Gemifloxacin mesylate; a fluoroquinolone antibiotic

Community-acquired pneumonia

Published data in CAP and in acute bacterial exacerbations of chronic bronchitis showed positive data in both indications (8/11)

Oscient
Pharmaceuticals
Corp.
(OSCI)

Ramoplanin

Naturally occurring antibiotic

Clostridium difficile-associated diarrhea

Phase II trial failed to show non-inferiority due to lower response rates than expected; company still plans to move into Phase III (8/10)

Vicuron Pharmaceuticals Inc. (MICU)

Dalbavancin

Glycopeptide agent from the same class as vancomycin

Skin and soft-tissue infections

Three pivotal Phase III trials in more than 1,500 patients all met the primary endpoint of non-inferiority; company said an NDA filing is planned in 2004 (8/12)

MISCELLANEOUS

Acuity
Pharmaceuticals
Inc.*

Cand5

Small interfering RNA therapeutic designed to shut down VEGF

Wet age-related macular degeneration

Filed IND to begin a Phase I trial (8/10)

Amgen Inc.
(AMGN)

AMG 162

Fully human monoclonal antibody that binds to and inhibits RANK ligand

Postmenopausal osteoporosis and treatment-induced bone loss

Began two pivotal Phase III trials to test the effect of the drug on protecting against bone loss (8/10)

Amicus
Therapeutics Inc.*

AT1001

Small molecule designed to enhance alpha-galactosidase A activity

Fabry's disease

Began Phase I trial in healthy volunteers to evaluate safety and pharmacokinetics (8/5)

BioMarin Pharmaceutical Inc. (BMRN)

Vibrilase

Topical agent containing the enzyme vibriolysin, which preferentially digests burned skin

Serious burns

Phase Ib trial in 19 patients suggested the product generally was safe and well tolerated, and effectively debrided partial-thickness burns (8/25)

Columbia
Laboratories
Inc.
(CBRX)

Striant

Testosterone buccal system

Testosterone replacement

Published Phase III data showed Striant was a safe and effective treatment in hypogonadal men (8/3)

Genetronics
Biomedical
Corp.
(AMEX:GEB)

Medpulser DNA Delivery System

Electroporation-mediated method for delivering DNA- ased therapies

Various conditions

Pilot study in healthy volunteers showed the delivery method was safe and tolerable (8/2)

Indevus
Pharmaceuticals
Inc.
(IDEV)

Sanctura
(FDA-
approved)

Trospium chloride; anti-cholinergic compound; muscarinic receptor antagonist

Overactive bladder

Trial data showed drug reduced micturitions and urge urinary incontinence episodes; separate trial showed safety and tolerability in hepatically impaired patients; presented data showing drug did not produce daytime sleepiness (8/26)

InKine
Pharmaceutical
Co. Inc.
(INKP)

Visicol (FDA- approved)

Tablet form of sodium phosphate

Constipation

Phase IV study supported additional trials to seek an expansion of the label to include constipation (8/23)

Jerini AG*
(Germany)

Icatibant

Bradykinin B2 receptor antagonist

Hereditary angioedema

Phase II proof-of-concept study had positive results, with no efficacy difference between intravenous and subcutaneous formulations (8/26)

MacroChem
Corp.
(MCHM)

Opterone

Testosterone in cream form delivered with SEPA technology

Testosterone
replacement

Pharmacokinetics study in 32 patients demonstrated estosterone delivery to the bloodstream (8/3)

MedImmune
Inc.
(MEDI) and
Genaera Corp
(GENR)

--

Anti-interleukin-9 monoclonal antibody

Asthma

Began Phase I trial in 24 healthy adult volunteers to evaluate safety, tolerability, pharmacokinetics and immunogenicity (8/18)

Miravant
Medical
Technologies
Inc.
(OTC BB:MRVT)

SnET2

Photodynamic therapy that uses a light-activated drug to destroy abnormal blood vessels

Macular degeneration

Presented subgroup analyses from Phase III trial showing stat- istically significant vision benefit in both predominantly occult and pure occult AMD lesions (8/17)

Peptimmune Inc.*

GT389-255

Lipase inhibitor conjugated to a fat-binding polymer, designed to prevent fat digestion

Obesity

Began Phase I trial to evaluate the safety, tolerability and pharmacokinetics in 48 healthy male volunteers (8/9)

Rigel
Pharmaceuticals
Inc.
(RIGL)

R112

Intranasal agent designed to interrupt the signal from the IgE receptor

Allergic rhinitis

Phase II “Park“ study in 319 patients demonstrated statistical significance in reducing symptoms (8/2)

Santarus Inc.
(SNTS)

Zegerid

Immediate-release capsule formulation of the proton pump inhibitor omeprazole

Gastrointestinal conditions

Began pivotal trial to evaluate pharmacokinetics; a powder form of the drug is approved as Rapimnex (8/25)

Theratechnologies Inc. (Canada; TSE:TH)

ThGRF

Analogue of growth hormone-releasing factor

HIV-associated lipodystrophy

Said it will present Phase II data, first reported in April, showing agent is safe and could represent a new treatment option (8/26)

XOMA Ltd.
(XOMA)

XMP.629

Gel formulation of synthetic
peptide derived from bactericidal/permeability-
increasing protein

Acne

Phase II trial in 253 patients did not demonstrate efficacy vs. vehicle gel; there was no discernable dose response, and the vehicle response was higher than anticipated (8/16)


Notes:

* Privately held

BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment.

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

AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange.

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