Company*
(Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

AtheroGenics Inc. (AGIX)

AGIX-4207

An intravenous compound derived from the v-protectant technology platform

Rheumatoid arthritis

Company completed a Phase I trial showing it was well tolerated (4/16)

Centocor Inc. (subsidiary of Johnson & Johnson)

Remicade
(FDA-
approved)

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

Ankylosing spondylitis

A study found that more than 80% of treated patients experienced clinical improvement, and more than 50% had their disease activity reduced by more than half (4/4)

Centocor Inc.
(subsidiary of
Johnson & Johnson)

Remicade
(FDA-
approved)

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

Rheumatoid arthritis

Study demonstrated that patients with RA may experience improvement in the pain and stiffness of the disease as early as 48 hours following their first in-office infusion of Remicade, in combination with methotrexate (4/5)

Genmab A/S
(Denmark; CSE:GEN)

HuMax-CD4

Monoclonal antibody

Psoriasis

Phase II results showed 19 of 64 patients achieved at least a 25% reduction of industry-recognized PASI scores at the trial endpoint at week seven (4/12)

Scil Biomedicals
GmbH*
(Germany)

Smart Anti-L-
selectin

Humanized antibody

Psoriasis

Company completed patient enrollment in a Phase Ib trial (4/4)

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

Xanelim

Efalizumab; humanized antibody

Rheumatoid arthritis

Company began enrollment in a Phase II trial (4/9)

CANCER

Antigenics
Inc.
(AGEN)

Oncophage

Vaccine; uses heat-shock proteins to activate cellular immune responses

Advanced melanoma and colorectal cancer

Phase II results showed that treatment with Oncophage can induce expansion of cancer-specific immune responses (4/8)

CancerVax
Corp.*

Canvaxin

Allogeneic; whole cell vaccine that expresses over 20 antigens

Melanoma

Phase II results showed median overall survival of Canvaxin was 58 months, compared to 28 months for patients not treated with the vaccine (4/22)

Cel-Sci Corp.
(AMEX:CVM)

Multikine

Immunotherapy drug; natural mixture of human cytokines, including interleukin-2

Head and neck cancer

Phase II results from a study in Hungary found that patients who received Multikine, in combination with surgery and radiation more than two years ago, have not had recurrences to date and remain alive (4/9)

Coley Pharma-
ceutical
Group Inc.*

CpG 7909

Synthetic oligonucleotide sequences that activate different immunologic functions

Metastatic renal-cell carcinoma

Company began a Phase I/II trial (4/30)

Genta Inc.
(GNTA)

Gallium

Low-dose gallium nitrate

Multiple myeloma

Clinical results showed median survival in the gallium-treated patients was 87-plus months, compared to the control group's 48 months; the trial compared 13 treated patients with 167 control patients (4/11)

GenVec Inc.
(GNVC)

TNFerade

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

Solid tumors

Company completed patient enrollment (4/10)

Genzyme Molecular Oncology (GZMO)

-

In vivo gene therapy vaccine that combines MelanA/ MARTI and gp100 into a vaccine that uses an adenovirus vector to deliver the antigens intradermally

Melanoma

Company enrolled 36 patients in its Phase I/II trial (4/9)

GlycoDesign Inc. (Canada; TSE:GD)

GD0039

Anticancer compound

Renal and colorectal cancer

Phase II data showed two renal cancer patients showed significant tumor shrinkage and three had stable disease; three patients with colorectal cancer showed stable disease; a total of 40 patients were evaluated (4/30)

GlycoGenesys
Inc.
(GLGS) and
Elan Corp. plc (Ireland)

GCS-100 (GBC-590)

Carbohydrate compound derived from citrus pectin

Solid tumors

Companies began a Phase I trial (4/8)

Human Genome
Sciences Inc.
(HGSI)

Mirostipen

Myeloid progenitor inhibitory factor

Chemotherapy-
induced neutropenia

Company is discontinuing development of Mirostipen as a single agent after the drug did not show enough activity in a Phase IIa trial to warrant further development (4/15)

Human Genome
Sciences Inc.
(HGSI)

Trail
Receptor-1

Human monoclonal
antibody

Advanced tumors

Company began a Phase I trial (4/30)

Introgen
Therapeutics
Inc.
(INGN)

Advexin

Gene therapy

Head and neck

cancer patients

Patients receiving higher doses of Advexin had significant survival advantages when compared to a group receiving a lower dose; the product is in Phase II (4/16)

Isis Pharmaceu-
ticals
Inc. (ISIP)

ISIS 2503

Antisense inhibitor of H-ras

Pancreatic cancer

Phase II data of ISIS 2503 in combination with gemcitabine showed patients survived six months or longer, surpassing the primary endpoint of the study (4/10)

Kosan
Biosciences
Inc.
(KOSN)

KOS-862

Epothilone D; polyketide natural product that inhibits cancer cells by the same mechanism as paclitaxel

Advanced solid tumors

Company initiated a Phase I study (4/9)

Ligand Pharma-
ceuticals
Inc.
(LGND)

Ontak (FDA-
approved)

Denileukin diftitox

T-cell lymphoma

Phase III results showed patients who responded to Ontak also experienced significant quality-of-life improvements (4/18)

Meditech
Research Ltd.*
(Australia)

HyACTTM

Drug delivery technology formulated with 5-fluorouracil

Colorectal cancer

Company completed a Phase I trial (4/5)

MGI Pharma
Inc.
(MOGN)

Irofulven

Hydroxymethylacylfulvene; anticancer compound

Pancreatic cancer

Company stopped development when Phase III results showed the comparator agent, 5-fluorouracil, demonstrated a greater than expected survival benefit (4/17)

MGI Pharma
Inc.
(MOGN)

Palonosetron

A 5-HT antagonist

Chemotherapy-
induced nausea

Phase III results showed it met its endpoint of acute complete response (4/17)

Mojave
Therapeutics
Inc.*

-

Therapeutic vaccine using Mojave's Javelin antigen delivery system

Melanoma

Phase I/IIa results showed the vaccine was safe and well tolerated by all patients at each dose level (4/8)

Northwest
Biotherapeutics
Inc.
(NWBT)

DCVax-Brain

Dendritic cell-based immunotherapy

Glioblastoma multiforme

Phase I results were favorable (4/2)

Northwest
Biotherapeutics
Inc.
(NWBT)

DCVax-
Prostate

Dendritic cell-based immunotherapy

Prostate cancer

Phase I/II results were favorable (4/3)

Novogen Ltd.
(Australia; NVGN)

Phenoxodiol

Targets the underlying control mechanism in cells that determines whether a cell will live or die

Cancer

Trial results indicated the drug slowed cancer progression in six of 10 patients (4/8)

Novuspharma
SpA
(Italy; Nuovo
Mercato:NOV)

BBR 2778

Administered as a one-hour intravenous infusion

Non-Hodgkin's lymphoma

Company began a Phase III trial in Europe, the U.S. and Canada (4/4)

Oncolytics
Biotech Inc.
(Canada; ONCY;
TSE:ONC)

Reolysin

A human reovirus-based product

Prostate cancer

Company began patient treatment in its clinical study to evaluate the efficacy of Reolysin (4/16)

Pharmacyclics
Inc.
(PCYC)

Xcytrin

Motexafin gadolinium

Lung cancer metastasized to the brain

Company is planning a new Phase III trial focusing on the sector of patients for whom the drug seems to do the most good; even though it missed its co-primary endpoints in earlier trials, it showed promise in 251 lung cancer patients (4/16)

Ribozyme
Pharmaceuticals
Inc.
(RZYM)

Angiozyme

Ribozyme that targets the high-affinity receptor for vascular endothelial growth factor, designed as an angiogenesis inhibitor

Metastatic breast cancer

Phase II results showed the drug failed to achieve a clinically significant response rate (4/30)

Sonus Pharma-
ceuticals
Inc.
(SNUS)

Tocosol
Paclitaxel

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

Tumors

Company began a Phase II trial (4/4); Phase I results indicated that 12 of 33 evaluable patients showed a tumor response (4/8)

SuperGen Inc.
(SUPG)

Decitabine

Inhibits DNA methyl-
transferase activity

Solid tumors

Phase I results showed it was well tolerated and resulted in specific changes in gene promotor methylation (4/11)

SuperGen Inc.
(SUPG)

Orathecin

Rubitecan; oral chemotherapy compound

Pancreatic cancer

Phase II results confirmed the drug's activity (4/3)

Telik Inc.
(TELK)

TLK286

Small-molecule drug candidate in development for cancers that are refractory to standard treatments

Breast cancer

Company began a Phase II trial (4/11)

Tragen Pharma-
ceuticals
Inc.*

ISF154

Designed to activate dormant leukemia B cells and rally T cells to selectively attack blood- and tissue-based leukemia cells

Chronic lymphocytic leukemia

Company began a Phase II trial (4/30)

Transgene SA
(France; TRGNY)

MVA-Muc
1-IL2

Uses the highly attenuated MVA vaccinia virus vector to express the Muc1 tumor- associated antigen and the cytokine interleukin-2 (IL-2) in order to stimulate specific T-cell responses.

Prostate cancer

Company began a Phase II trial (4/9)

Zycos Inc.*

ZYC300

Designed to stimulate the body's own immune system against cells expressing CYP1B1

Cancer

Company began treating patients in a Phase I/IIa trial (4/16)

CARDIOVASCULAR

Alexion Pharma-
ceuticals
Inc. (ALXN)

Pexelizumab

An anti-inflammatory C5 inhibitor monoclonal antibody fragment

Acute myocardial infarction

Company completed enrollment of about 900 patients in a Phase II trial (4/8); Phase IIb results demonstrated a significant statistical link between increasing severity of postoperative myocardial damage and mortality in patients undergoing coronary artery bypass graft surgery (4/23)

Corvas
International
Inc. (CVAS)

UK-279,276

A neutrophil inhibitory factor

Ischemic stroke

Phase IIb results showed it failed to meet its primary endpoints (4/24)

La Jolla Pharma-
ceutical
Co. (LJPC)

LJP 1082

Composed of four copies of a recombinant protein attached to a synthetic organic platform designed to reduce disease-causing antibodies

Antibody- mediated thrombosis

Phase I/II results supported the drug as a potential treatment (4/25)

Medicure Inc.
(Canada; CDNX:
MPH)

MC-1

Cardiovascular drug

Ischemia and ischemia reperfusion

Company began patient enrollment for a Phase II trial in the U.S. and Canada (4/4)

NeuroSearch
A/S*
(Denmark)

NS3728

A compound developed to treat sickle cell anemia

Sickle cell anemia

Company said it will not proceed with a Phase II program after a Phase I study indicated the candidate cannot be used to treat all stages of the disease (4/25)

NicOx SA
(France; Nouveau
Marche:NICOX)

NCX 4016

Nitric oxide-donating derivative of aspirin

Symptomatic peripheral arterial disease

Phase I/IIa results were positive; the company is initiating a Phase II trial (4/16)

Protherics plc
(UK; LSE:PTI)

-

Angiotensin vaccine

Hypertension

Company will start a Phase II trial involving 360 patients (5/1**)

CENTRAL NERVOUS SYSTEM

Active Biotech
AB
(Sweden; ACTIB)

SAIK-MS

Orally active immune response regulatory

Multiple sclerosis

Company began a Phase II study (4/11)

Adolor Corp.
(ADLR)

ADL 10-0101

Stimulant of peripherally restricted kappa opioid analgesic

Visceral or inflammatory pain

Phase II studies had negative results, causing the company to move the compound back to Phase I to work on dosing (4/1)

Biogen Inc.
(BGEN) and
Serono SA
(Switzerland;
NYSE:SRA)

Avonex and Rebif (FDA-
approved)

Interferon beta-1a and recombinant interferon beta-1a

Multiple sclerosis

Biogen is launching a study to determine the long-term safety, tolerability and efficacy of Avonex, compared to Serono's Rebif (4/16); Serono said 48-week data showed 62% of patients treated with Rebif did not experience a relapse, compared to 52% of patients treated with Avonex (4/17)

Chiron Corp.
(CHIR)

Betaseron
(FDA-approved)

Interferon beta-1b

Relapsing-remitting multiple sclerosis

Study results showed patients taking Betaseron had significantly fewer exacerbations and less disease activity than patients who reduced their dose from interferon beta-1b to interferon beta-1a (4/19)

Guilford Pharma-
ceuticals
Inc. (GLFD)

GPI 1485

Drug that belongs to a class of compounds called neuroimmunophilin ligands

Parkinson's disease

Phase II results suggest GPI 1485 may retard the loss of dopamine transporters in patients with Parkinson's disease (4/17)

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

Neotrofin failed to meet its primary 12-week endpoints in a pivotal Phase III trial; company plans to out-license the drug (4/29)

Neurochem Inc.
(Canada; TSE:NRM)

Alzhemed

A small sulfonated molecule that has been specifically designed to interfere with the association of glycosaminoglycans with the amyloid beta amyloidogenic protein

Alzheimer's disease

Phase I results showed the drug is orally bioavailable with a good safety and pharmacokinetic profile (4/4)

Pozen Inc.
(POZN)

MT 100

Formulation of two approved drugs, a fast-release metoclopramide and naproxen sodium

Migraine

Company completed a second Phase III trial showing the product is as efficacious as Imitrex (4/11)

Titan Pharma-
ceuticals
Inc. (AMEX:TTP)

Spheramine

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

Parkinson's disease

Spheramine produced a nearly 50% improvement in motor function in patients with advanced Parkinson's disease in a Phase I/II trial (4/18)

DIABETES

Amylin Pharma-
ceuticals Inc.
(AMLN)

Symlin

Pramlintide acetate

Type I diabetes

Company began a dose-titration study of Symlin (4/15)

INFECTION

Advanced Viral
Research Corp.
(OTC BB:ADVR)

Product R

A nontoxic peptide-nucleic acid-type immunomodulator that appears to stimulate the proinflammatory responses required to combat viral invections and to aberrant autoimmune-type inflammatory responses

Genital warts

Phase I results indicated the product was safe and well tolerated dermatologically in all of the doses studied (4/12)

BioMarin
Pharmaceutical
Inc.
(BMRN)

Aryplase

Recombinant human N-acetylgalactosamine 4-sulfatase or arylsulfatase B; an enzyme replacement therapy

Mucopolysac-
charidosis VI (also called Maroteaux- Lamy syndrome)

Company began dosing patients in a Phase II trial (4/22)

BioMedicines
Inc.*

Omega interferon

Naturally occurring omega interferon

Hepatitis C

Company completed enrollment in a Phase II trial (4/18)

Cubist Pharma-
ceuticals
Inc. (CBST)

Cidecin

Daptomycin for injection

Vancomycin-
resistant Enterococci faecium

Phase II results showed the survival rate with Cidecin was 50%, compared to 22% with placebo; cure rates were 55% vs. 33%, respectively (4/26)

Cytovax Bio-
technologies Inc.
(Canada; TSE:CXB)

Cytovaxine

A peptide vaccine

Infections caused by Pseudomonas aeruginosa

Company began a Phase I trial (4/3)

DynPort Vaccine
Co.*
(joint venture between DynCorp and Porton International plc; UK)

-

Smallpox vaccine developed through large-scale cell culture technology

Smallpox

Joint venture is beginning a 150-patient Phase I trial (4/26)

Gilead Sciences
Inc.
(GILD)

Adefovir dipivoxil

Nucleotide analogue that works by blocking the hepatitis B virus DNA polymerase

Hepatitis B

Phase III data from a 48-week analysis showed that treatment was associated with improved liver histology and reduced serum hepatitis B virus DNA concentrations (4/18)

Hemispherx Biopharma Inc. (AMEX:HEB)

Ampligen

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

HIV/AIDS

Company initiated clinical trials to assess the application of Ampligen to the treatment of HIV/AIDS (4/18)

Hollis-Eden Pharmaceuticals Inc. (HEPH)

HE2200

Subcutaneously administered; immune- regulating hormone drug candidate

Hepatitis B

Company initiated a Phase I/II trial (4/10)

ID Biomedical
Corp.
(Canada; TSE:IDB)

FluINsure

A non-living, subunit vaccine administered by a nasal spray

Influenza

Phase I results displayed no safety concerns (4/2)

Immtech
International
Inc. (IMMT)

DB289

Oral anti-infective

Pneumocystis carinii pneumonia in HIV/AIDS patients

Company began a Phase II trial (4/3)

Nabi Biopharma-
ceuticals
(NABI)

Civacir

Hepatitis C immune globulin (human)

Hepatitis C

Company initiated a Phase I/II trial (4/17)

Ribozyme Pharmaceuticals Inc. (RZYM) of HCV

Heptazyme

A direct antiviral therapeutic specifically engineered to prevent replication

Hepatitis C

Company stopped dosing in a Phase II trial after an animal in a study lost its vision (4/30)

SciClone Pharmaceuticals Inc. (SCLN)

Zadaxin

Monotherapy treatment; synthetic immunostimulant peptide

Hepatitis C

Company has enrolled the first patients in its U.S. Phase III trial (4/15)

Trimeris Inc.
(TRMS) and Hoffmann-La Roche Ltd. (Switzerland)

T-20

Injected subcutaneously; inhibits fusion of HIV with host cells before the virus enters the cell and starts the replication process

HIV

Phase III results showed it met the primary endpoint of decreasing the amount of virus in the blood compared to an individualized treatment regimen alone (4/18)

VaxGen Inc.
(VXGN)

AIDSVax

AIDS vaccine made from a synthetic protein

HIV/AIDS

A review of Phase III trials resulted in an independent Data and Safety Monitoring Board finding that the vaccine candidates continue to exhibit a strong safety profile (4/24)

Versicor Inc.
(VERS)

Anidulafungin

Intravenous infusion

Fungus infection

Phase I results showed the drug was well tolerated when used in combination with cyclosporine (4/30)

MISCELLANEOUS

Alkermes Inc.
(ALKS)

Vivitrex

Injectable extended-release formulation of naltrexone

Alcohol dependence

Company started a Phase III trial (4/1)

Amgen Inc.
(AMGN)

Aranesp
(FDA-approved)

Darbepoetin alfa

Anemia

Clinical results showed Aranesp maintained hemoglobin in 83% of dialysis patients receiving it once a month; 91% receiving it every three weeks maintained hemoglobin levels (4/18)

AnorMED Inc.
(Canada; TSE:AOM)

AMD-3100

Inhibitor of CXCR4, a chemokine receptor

Stem cell transplant

Company initiated a Phase I trial (4/15)

Avanir Pharma-
ceuticals
Inc. (AMEX:AVN)

Neurodex

Orally administered combination of dextromethorphan and an enzyme inhibitor

Emotional lability

Company completed enrollment in a Phase II/III trial (4/11)

Cortex Pharma-
ceuticals
Inc. (AMEX:COR)

Ampakine

Acts to increase the strength of signals at connection between brain cells

Fragile X syndrome and autism

A Phase II study is beginning enrollment (4/30)

Genaissance Pharmaceuticals
Inc.
(GNSC)

HAP-
Clozapine

Uses Genaissance's HAP technology with the approved drug Clozapine

To discover patients at risk of clozapine-induced agranulocytosis

Company said the first patient was enrolled in its Caring study (4/17)

Guilford Pharma-
ceuticals
Inc. (GLFD)

Aquavan Injection

Water-soluble prodrug of propofol

To induce sedation and anesthesia

Phase I data showed it can induce sedation and anesthesia without serious side effects (4/9)

Inflazyme Pharmaceuticals Ltd. (Canada; TSE: IZP) and Aventis Pharmaceuticals (unit of Aventis Pharma AG; Germany)

IPL576,092

Leukocyte-suppressing anti-inflammatory drug

Asthma

Phase II results indicated the drug showed a favorable difference to placebo, but did not reach a statistically significant result (4/23)

Inspire Pharma-
ceuticals
Inc.
(ISPH)

INS365 Ophthalmic receptor

An eye drop that works by activating the P2Y

Dry eye syndrome

Company started enrollment of a third Phase III trial (4/3)

NicOx SA (France; Nouveau Marche: NICOX)

HCT 1026

Nitric oxide-donating derivative of flurbiprofen

Overactive bladder

Phase IIa results showed statistically significant improvement with HCT 1026 as compared with placebo (4/2)

Nobex Corp.*
and Elan Corp. plc (Ireland)

Oratonin

Oral calcitonin

Osteoporosis

Companies began dosing in a Phase I trial (4/9)

Proneuron Biotechnologies Inc.*

-

Activated autologous macrophage therapy

Acute complete spinal cord injury

Company dosed its targeted eight patients for its Phase I trial (4/10)

Regeneron Pharmaceuticals Inc. (REGN)

Axokine

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

Obesity

Company began two additional Phase III studies (4/9)

SangStat Medical Corp. (SANG)

Thymoglobulin (FDA-approved)

Anti-thymocyte globulin

Kidney transplant

Clincial results showed patients treated with Thymoglobulin were two-and-a-half times less likely to experience an acute kidney rejection than those treated with Novartis AG's Simulect (4/29)

Telik Inc.
(TELK)

TLK199

Small-molecule drug

Myelodysplatic syndrome

Company began a Phase I/IIa trial (4/23)

Vivus Inc.
(VVUS)

TA-1790

An oral phosphodiesterase type 5 inhibitor

Erectile dysfunction

Company began treating patients in a clinical study (4/4)

Xenova Group
plc
(UK; XNVA)

TA-CD

Anti-cocaine addiction vaccine

Cocaine addiction

Company began patient dosing in a Phase IIa dose-escalation trial (4/2)


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; CSE= Copenhagen 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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