Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

AltaRex Corp.
(Canada; TSE:AXO)

OvaRex

Oregovomab; a fully foreign monoclonal antibody that targets CA 125

Advanced ovarian cancer

Clinical data demonstrated a 41% reduced risk of relapse for OvaRex-treated patients compared to placebo, a result that is statistically significant; all studies to date demonstrate a benign safety profile (3/15); company saw positive primary results of its 20-patient chemo-immunotherapy study of OvaRex, showing T-cell responders demonstrated a statistically significant benefit over nonresponders in time to progression and survival (3/18)

AltaRex Corp. (Canada; TSE:AXO) CA 125

OvaRex

Oregovomab; a fully foreign monoclonal antibody that targets

Cancer

Company began a pharmacokinetic study with the treatment in the first three patients (3/5)

Coley Pharma-
ceutical
Group Inc.*

CpG 7909

Synthetic oligonucleotide sequences that activate different immunologic functions

Non-Hodgkin's lymphoma

Company initiated a Phase I study of its compound in combination with Rituxan (3/27)

CollaGenex Pharmaceuticals
Inc. (CGPI)

COL-3

Anti-angiogenesis compound

AIDS-related Kaposi's sarcoma

Phase I results showed eight of 18 patients responded to treatment with tumor regression (3/7)

Dynavax
Technologies
Corp.*

ISS and Rituxan (FDA-approved)

Immunostimulatory DNA sequence and monoclonal antibody therapy, rituximab

B-cell non-Hodgkin's lymphoma

Company initiated a Phase I study (3/25)

Hybridon Inc.
(HYBN)

GEM 231

Second-generation anti-sense product

Solid tumors

Company initiated a Phase I/II trial of GEM 231 and irinotecan (CPT-11, Camptosar) (3/4)

MGI Pharma
Inc.
(MOGN)

Irofulven

Anticancer compound; hydroxymethylacylfulvene

Cancer

Company initiated a Phase I trial of irofulven in combination with the antitumor agent cisplatin (3/19)

Northwest Biotherapeutics
Inc.
(NWBT)

DCVax-
Prostate

Dendritic cell-based immunotherapy

Prostate cancer

Phase I/II results showed overall stabilization of disease in 55% of patients (3/5)

SangStat
Medical Corp.
(SANG)

Thymoglobulin (FDA-
approved)

Anti-thymocyte globulin (rabbit)

Leukemia

Thymoglobulin improved both nonrelapse mortality and overall survival of leukemia patients undergoing unrelated donor bone marrow transplant (3/21)

Seattle Genetics
Inc.
(SGEN)

SGN-30

Monoclonal antibody

Hematologic malignancies

Company initiated its first Phase I trial of SGN-30 (3/21)

SuperGen Inc.
(SUPG)

Orathecin

Rubitecan; oral chemotherapy compound

Pancreatic cancer

Company completed a Phase III trial and gave the product the name Orathecin (3/7)

Viragen Inc.
(AMEX:VRA)

-

Natural interferon

Melanoma

Viragen said 158 patients in a Phase II/III trial showed no statistically significant increase in overall survival, but they tolerated the treatment well and the chance of relapse-free survival after five years was more than doubled in the treated patients (3/20)

Wilex AG
(Germany)*

WX-UK1

Small-molecule anti-metastatic drug; urokinase inhibitor

Cancer

Phase Ia data were positive, showing the drug was safe and well tolerated (3/20**)

Xcyte Thera-
peutics
Inc.*

Xcellerated T cells and are injected into the patient

Patient blood is collected and the T cells are stimulated to increase 100-fold cancer

Hormone-
refractory prostate

Company initiated a Phase I/II trial (3/29)

CARDIOVASCULAR

Collateral Therapeutics Inc. (CLTX), Schering AG (Germany) and Berlex Laboratories Inc.

Ad5FGF-4

Angiogenic gene therapy product

Angina

Phase II results demonstrated that Ad5FGF-4 showed improvement in myocardial perfusion (3/20)

CENTRAL NERVOUS SYSTEM

Amrad Corp-
oration
Ltd.
(Australia;
ASX:AMC)

Emfilermin by certain human cells

Leukemia inhibitory factor; a protein growth factor naturally produced

To reduce nerve damage

Company is abandoning development due to poor Phase II results (3/27**)

Boston Life Sciences Inc. (BLSI)

Altropane

Radioimaging agent that targets the dopamine transporter

Attention deficit hyperactivity disorder

Company initiated a Phase II study (3/18)

Celltech Pharma-
ceuticals
Inc. (subsidiary of Celltech Group plc; UK; LSE:CCH)

Metadate CD (FDA-
approved)

Methylphenidate HCl, USP; extended-release capsules

Attention deficit hyperactivity disorder

Phase III results demonstrated that Metadate, when administered daily before school, controlled ADHD during the school day without the need for a second dose (3/6)

Nastech Pharma-
ceutical
Co.
(NSTK)

Interferon beta-1a

Nasally delivered

Multiple sclerosis

Phase I interim results demonstrated the successful nasal delivery of interferon beta-1a (3/21)

NeoTherapeutics
Inc.
(NEOT)

Neotrofin

Small-molecule compound designed to cross blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors

Alzheimer's disease

Company completed patient dosing in its pivotal trial (3/15)

ReGen Thera-
peutics
plc (UK; LSE:RGT)

Colostrinin

Proline-rich polypeptide complex isolated from ovine colostrum

Alzheimer's disease

Phase IIa data showed the rate of deterioration was slower than in the placebo group, but it did not achieve statistical significance (3/27**)

DIABETES

Amylin Pharma-
ceuticals Inc.
(AMLN)

AC2993

Synthetic exendin-4

Type II diabetes

Company began the third of three Phase III pivotal trials (3/14)

INFECTION

Advanced Viral Research Corp. (OTC BB:ADVR)

Product R

Nontoxic peptide nucleic acid-type immuno-modulator

Genital warts caused by infection

Phase I results showed the product was safe and well tolerated (3/11)

Atrix Laboratories Inc. (ATRX)

-

Oral interferon-alpha product

Oral warts caused by human papillomavirus in HIV-infected patients

Company began Phase II trials (3/20)

BioCryst Pharmaceuticals Inc. (BCRX)

Peramivir (RWJ-270201)

Orally administered; neuraminidase inhibitor

Influenza

Company completed patient enrollment in the first Phase III trial (3/25)

Crucell NV (CRXL; the Netherlands) and Merck & Co. Inc.

-

Vaccine based on a recombinant adenovirus; it is produced on Crucell's PER.C6 cell technology platform

HIV

Phase I data showed the vaccine was generally well tolerated and generated a substantial and prolonged specific T-cell response (3/5)

DepoMed Inc.
(AMEX:DMI)

Ciprofloxacin GR

Once-daily extended-release dosage form

Urinary tract infection

Company completed enrollment in a Phase II trial comparing the extended-release form with the immediate-release ciprofloxacin HCl formulation, Cipro (3/5)

Hemispherx
Biopharma Inc.
(AMEX:HEB)

Ampligen

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

HIV

Clinical results showed no patients relapsed while on Ampligen within the first 30 days, compared to 86% of a control group of 21 patients, resulting in a statistically significant difference (3/18)

HepaSense Ltd. (joint venture of Isis Pharmaceuticals Inc., ISIP; and Elan Corp. plc, Ireland)

ISIS 14803

Antisense drug; 20-base phosphorothioate oligonucleotide

Chronic hepatitis C

Company initiated a Phase II trial (3/21)

ID Biomedical Corp. (Canada; TSE:IDB)

StreptAVAX

A multivalent alum-adjuvanted vaccine containing recombinant proteins representing coverage for 26 significant serotypes of group A streptococci

To prevent diseases caused by group A streptococci

Phase I results showed the desired immune response endpoints were achieved and no safety concerns were apparent (3/20)

Keryx Bio-
pharmaceuticals
Inc. (KERX)

KRX-101

Sulodexide

HIV-associated nephropathy in AIDS patients

Company began initial dosing of patients in a Phase II trial (3/14)

Progenics
Pharmaceuticals
Inc.
(PGNX)

PRO 542

Fusion protein that incorporates HIV binding region of human cell surface receptor (CD4) into a human antibody molecule that binds to GP120

HIV

Company said the drug produced an antiviral response in HIV-infected individuals who were no longer responding to currently available antiretroviral medications (3/18)

The Medicines
Co.
(MDCO)

CTV-05

A strain of human Lactobacillus

Bacterial
vaginosis

Company said a Phase II trial of CTV-05, as an adjunct to antibiotic treatment, did not improve clinical cure rates at 30 days, the primary endpoint of the trial (3/27)

Versicor Inc.
(VERS)

Dalbavancin

Antibiotic; a novel second-generation glycopeptide agent

Bloodstream infections that are catheter-related

Company started a Phase II trial (3/12)

INFLAMMATION

Isis Pharma-
ceuticals
Inc. (ISIP)

ISIS 104838

Antisense inhibitor of tumor necrosis factor-alpha

Rheumatoid arthritis

Company initiated a Phase II trial (3/13)

MISCELLANEOUS

Actelion Ltd.
(Switzerland; SWX:ATLN)

Tracleer
(FDA-
approved)

Orally available dual endothelin receptor antagonist

Digital ulcers

Company initiated a clinical trials program to expand the use of Tracleer (3/27)

Amrad
Corporation
Ltd.
(Australia; ASX:AMC)

AM336

Synthetic version of the molecule CVID, originally isolated from the venom of a fish-eating species of cone snail from Australia's Great Barrier Reef

Chronic severe pain

Phase I/II results were positive (3/6**)

Aradigm Corp.
(ARDM)

AERx

Pain management system; aerosolized morphine delivered via the AERx pulmonary drug delivery technology

Pain

Phase IIb results showed faster onset of pain relief when compared to immediate-release oral morphine solution and intravenous morphine (3/18)

AtheroGenics
Inc.
(AGIX)

AG1-1096

Oral treatment; an antioxidant and selective anti-inflammatory agent derived from AtheroGenics' v-protectant technology platform

To prevent organ transplant rejection

Company began a Phase I trial (3/5)

Atrix Labora-
tories Inc.
(ATRX)

Atrisone

Dapsone topical gel in SMP technology

Acne

Phase III results showed Atrisone was statistically superior to vehicle on all four primary efficacy endpoints (3/28)

Biopure Corp.
(BPUR)

Hemopure

Blood oxygenator; hemoglobin glutamer-250 (bovine)

Orthopedic surgery

Phase III results showed an avoidance of red blood cell transfusion in 59.4% of the Hemopure-treated patients at 42 days post-surgery, 70.3% at one week following surgery and 96.3% on the day of surgery itself (3/20)

Biovitrum AB
(Sweden)*

BVT.933

Appetite suppressant

Obesity

Phase IIa results were positive with subjects achieving a statistically significant and clinically relevant weight reduction compared to placebo (3/6**)

Cellegy Pharma-
ceuticals Inc.
(CLGY)

Tostrelle

Testosterone gel

Sexual dysfunction

Company began a Phase II/III trial (3/26)

Celltech Group
plc (UK; LSE:CCH)

CDP 870

Antibody drug administered by monthly injection

Crohn's disease

Phase II results demonstrated the drug was effective and safe, but the study did not reach statistical significance because of a very high placebo response rate (3/6**)

Centocor Inc.
(unit of Johnson
and Johnson)

Remicade
(FDA-
approved)

Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood

Spondylo-
arthropathies

Clinical results found that patients treated with Remicade monotherapy experienced median improvements in disease activity of 73% and 78% as determined by validated patient and physician global assessment measuring tools (3/11)

Durect Corp. (DRRX)

Chronogesic

Pain therapy system; a three-month continuous infusion subcutaneous implant

Chronic pain

Phase III results showed no evidence of patient overdose at any point; the median reduction in opioid consumption other than from the Chronogesic product was 72%; 78% of patients reported either an improvement or no change in their pain scores (3/18)

Dynavax Technologies Corp.*

AIC

Anti-allergy immunotherapy made of ragweed allergen, Amb a 1, linked to Dynavax's 1018 immunostimulatory DNA sequence

Allergies

Company announced positive preliminary results from a Phase II trial (3/4)

GenStar Therapeutics
Corp. (AMEX: GNT)

MAX AD Factor VIII

Factor VIII gene therapy

Hemophilia A

Phase I results showed that after eight months patients sustained an expression level of Factor VIII of 1% (3/27)

Hemosol Inc. (Canada; HMSL; TSE:HML)

Hemolink

Oxygen therapeutic

Chemotherapy-induced anemia

Company began a Phase II trial (3/26)

InSite Vision Inc. (AMEX:ISV)

ISV-205

Uses the DuraSite drug delivery technology; intended to block steroid-induced intraocular pressure elevation

Glaucoma

Phase II results showed ISV-205 prevented maximum elevation of the intraocular pressure compared with placebo; it also significantly lowered intraocular pressure compared to the control vehicle (3/12)

Inspire Pharma-
ceuticals
Inc. (ISPH)

INS37217

Intranasal spray; second-generation P2Y(2) agonist

Upper respiratory disorders

Company completed a Phase I trial (3/6)

Interneuron
Pharmaceuticals
Inc.
(IPIC)

Dersalazine

Orally administered; combines activity against TNF-alpha and other inflammatory cytokines with 4-ASA

Inflammatory bowel disease

Company began a Phase I trial (3/7)

ISTA Pharma-
ceuticals
Inc. (ISTA)

Vitrase

Injectable enzyme; hyaluronidase

Vitreous hemorrhage

Vitrase failed to meet its primary endpoint in a Phase III trial (3/26)

Karo Bio AB (Sweden; SSE:KARO) and Bristol-Myers Squibb Co.

-

A thyroid hormone receptor modulator

Obesity

Companies dropped development following toxic metabolites found in animals from a preclinical study; the compound was in Phase I development (3/27)

Neurocrine Biosciences Inc. (NBIX)

NBI-34060

Modified-release tablets

Insomnia

Company began a Phase III trial that will include 3,500 patients (3/19)

Neurogen Corp. (NRGN) and Pfizer Inc.

NGD 96-3

Modulates receptors of the GABAA neurotransmitter system

Insomnia

Companies began Phase I trials (3/11)

NeuroSearch A/S (Denmark)* and Glaxo-SmithKline plc (UK)

NS2389

Neurotransmitter reuptake inhibitor of serotonin, noradrenaline and dopamine

Depression

Companies decided to discontinue development of NS2389, which had been in Phase II trials (3/13**)

NeuroSearch
A/S
(Denmark)*
and Grupo Ferrer Internnacional SA (Spain)

NS2710

A modulator of gamma amino buytric acid

Anxiety disorder

Companies are stopping development due to skin rashes that occurred in the Phase II trials (3/22)

Novavax Inc.
(NVAX)

Estrasorb

Estradiol topical emulsion

Menopause

Phase III data showed patients experienced an 85% reduction in the total number of hot flashes during the trial (3/22)

NPS Pharma-
ceuticals
Inc. (NPSP)

Preos

A full-length human parathyroid hormone

Osteoporosis

Company completed patient enrollment in a Phase III study (3/27)

Protein Design
Labs Inc.
(PDLI)

Nuvion

Visilizumab; humanized monoclonal antibody directed at the CD3 antigen

Steroid-resistant, acute graft-vs.-host disease

Company initiated a Phase II study (3/11)

Protein Design
Labs Inc.
(PDLI)

Zenapax
(FDA-
approved)

Humanized antibody

Psoriasis

Zenapax did not prolong the time to recurrence in a Phase II trial, prompting the company to discontinue further development (3/21)

Vasogen Inc.
(Canada; AMEX:MEW; TSE:VAS)

-

Immune modulation therapy

Psoriasis

Company said its open-label clinical trial in moderate to severe psoriasis achieved its objective of identifying an optimal treatment schedule (3/14)


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.

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