Company*
(Country;
Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Biogen Inc.
(BGEN)

Avonex (FDA-
approved)

Interferon beta-1a

Multiple sclerosis

Company said eight years of data showed Avonex produced lower levels of neutralizing antibodies than Serono's Rebif (5/30)

BioMs Medical
Corp.
(BIOM)

MBP8298

Intravenously injected peptide technology

Multiple sclerosis

Phase II data showed that a subset of patients had good results and the company is talking about starting a pivotal trial (5/23)

CellGate Inc.*

PsorBan

A topical cyclosporine conjugate

Mild to moderate plaque psoriasis

Phase IIa data showed a high dose exhibited benefits over placebo in both psoriasis severity score and physician treatment preference scores (5/2)

Enzo Biochem
Inc.
(NYSE:ENZ)

--

A complex of autologous colon-specific antigens administered orally

Crohn's disease

Phase I data showed that all 10 subjects had a clinical response to treatment, with seven achieving clinical remission (5/20)

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

Raptiva

Efalizumab; recombinant humanized monoclonal antibody

Moderate to severe rheumatoid arthritis

Companies stopped Phase II testing after anevaluation suggested there was no efficacy (5/12)

Genmab A/S
(Denmark; CSE:GEN)

HuMax-CD4

Antibody that targets the CD4 receptor on T lymphocytes

Psoriasis

Company completed accrual in a Phase IIb trial (5/15)

Medarex Inc. (MEDX) and Novartis Pharma AG (Switzerland)

--

Antibody created with Medarex's UltiMAb Human Antibody Development System

Autoimmune disease

Novartis began Phase I trials (5/6)

Serono SA
(Switzerland;
NYSE:SRA)

Rebif (FDA-approved)

Interferon beta-1a

Multiple sclerosis

Company released data showing Rebif was more effective in reducing the frequency of relapses over the course of a 63-week study when compared to Biogen's Avonex (5/30)

Vertex
Pharmaceuticals
Inc.
(VRTX)

VX-148

A second-generation IMPDH inhibitor

Moderate to severe psoriasis

Company completed enrollment in a Phase II trial (5/21)

CANCER

Agennix Inc.*

--

Recombinant human lactoferrin, a protein found naturally in milk and other exocrine secretions

Solid tumors

Company completed the safety portions of two Phase I/II cancer trials (5/23)

Allos Therapeutics
Inc.
(ALTH)

RSR13

Efaproxiral; synthetic small molecule

Breast cancer

Phase III data showed a statistically significant improvement in median survival; the company plans to file an NDA (5/29)

AnorMED Inc.
(Canada; TSE:AOM)

AMD-3100

Designed to block the CXCR4 chemokine receptor

Multiple
myeloma

Company began a second Phase II trial (5/23)

Ariad Pharmaceuticals
Inc. (ARIA)

AP23573

Cancer drug that inhibits the protein mTOR and shrinks tumors by cancer cell starvation through inhibition of growth factor stimulation

Cancer

Company began enrollment in two Phase I studies (5/7)

Celgene Corp.
(CELG)

Revimid

A small-molecule compound that modulates the immune system

Anemia in myelodysplastic syndrome

Phase I/II data showed patients were able to reduce or entirely eliminate red blood cell transfusions that previously were required to manage their condition (5/16)

Celgene Corp.
(CELG)

Thalomid

Thalidomide; modulates levels
of tumor necrosis factor alpha

Multiple
myeloma

Phase II data showed that the 17 patients who received Thalomid did not experience grade three or four neutropenia or thrombocytopenia, while 70% of patients receiving high-dose cyclophosphamide with VAD by continous infusion experienced thrombocytopenia, and all 50 of them experienced neutropenia (5/28)

Cell
Therapeutics
Inc.
(CTIC)

Trisenox (FDA-approved)

Arsenic trioxide
injection

Multiple
myeloma

Clinical data showed Trisenox produced objective responses in 31 of the 78 evaluable patients who were chemotherapy resistant (5/27)

Celsion Corp. (AMEX:CLN)

Thermodox

Microfocus BPH800 Urethroplasty System provides the heat required to trigger the release of the chemotherapeutic agent

Prostate cancer

Company treated the first patient in a Phase I trial (5/29)

ChemGenex
Therapeutics
Inc.*

Quinamed

Amonafide

Solid tumor cancers

Company completed patient enrollment in the first part of a Phase I/II trial (5/15)

Genentech Inc.
(NYSE:DNA)

Avastin

Bevacizumab, an antibody directed at vascular endothelial growth factor

Metastatic colorectal cancer

Phase III data showed the drug met its primary endpoint of improving overall survival and hit secondary endpoints of progression-free survival, response rates and duration of response (5/19)

Genta Inc.
(GNTA)

Genasense

Oblimersen sodium; antisense compound geared toward blocking the production Bcl-2

Multiple
myeloma

Phase I/II data of 15 evaluable patients showed three patients achieved a complete or near-complete response, and five patients achieved a partial response, for an overall response rate of 53% (5/27)

Hybridon Inc.
(OTC BB:HYBN)

HYB2055

Second-generation immunomodulatory oligonucleotide

Malignant
solid tumors

Company initiated a Phase I trial (5/19)

Milkhaus
Laboratory
Inc.*

ML-04

Human chorionic gonadotropin

Benign prostatic hyperplasia

Company completed enrollment in a Phase IIb trial (5/1)

Onyvax Ltd.*
(UK)

Onyvax-P

Cancer vaccine consisting of three inactivated cell lines that target a range of prostate cancer-associated antigens

Prostate cancer

Phase IIa data demonstrated an immune response with a statistically significant decrease in the rate of prostate-specific antigen release (5/6)

Oxford
BioMedica plc*

(UK)

TroVax

Targets the tumor antigen 5T4; gene therapy

Renal cancer

Company started a Phase II trial in the U.S. (5/28**)

PharmaMar* (Spain; division of the Zeltia Group)

Kahalalide F

An antitumor agent derived from the sea slug, Elysia rufescens

Liver cancer

Company entered Phase II trials (5/29)

Pharmexa A/S
(Denmark; Pink Sheets:PMXAY)

HER-2 Protein AutoVac

Product that uses the AutoVac technology, which aims to induce a strong but controlled antibody response against harmful self-antigens to reduce their levels

Breast cancer

Company will begin a Phase I trial (5/14**)

Point
Therapeutics
Inc.
(OTC BB:POTP)

PT-100

Orally active small molecule, which stimulates the proliferation of hematopoietic progenitor cells and the differentiation of neutrophils

Severe neutropenia associated with chemotherapy

Clinical results showed an improvement in severe neutropenia, and the therapy was well tolerated (5/28)

Pro-
Pharmaceuticals
Inc.
(OTC BB:PROH)

Davant

Glyco-upgrade drug that targets sugar-specific binding sites found on cancer cells using carbohydrate technology

Advanced solid tumors

Company began dosing patients in a Phase I trial (5/14)

QLT Inc. (Canada; QLTI) and Xenova Group plc (UK; XNVA)

Tariquidar

P-glycoprotein membrane inhibitor

Non-small-cell lung cancer

Companies halted Phase III trials after an independent safety committee brought up toxicity issues (5/13)

Vion Pharmaceuticals
Inc.
(VION)

Triapine

Inhibitor of ribonucleotide reductase

Non-small-cell lung cancer

Company began a Phase II trial (5/21)

Vion Pharmaceuticals
Inc.
(VION)

Triapine

Inhibitor of ribonucleotide reductase

Pancreatic
cancer

Company initiated a Phase II trial (5/28)

CARDIOVASCULAR

Actelion Ltd. (Switzerland; SWX:ATLN)

Tracleer (FDA-approved)

Oral dual endothelin receptor antagonist

Pulmonary hypertension

Clinical data suggested that the use of Tracleer is associated with improved survival (5/20)

Centocor Inc. (unit of Johnson & Johnson)
and Eli Lilly and Co.

ReoPro (FDA-approved)

Abciximab, an anticlotting agent

Acute ischemic stroke

Phase IIb results showed ReoPro improves the recovery of patients when administered up to six hours after stroke onset (5/23)

Encysive Pharmaceuticals (ENCY; formerly Texas Biotechnology Corp.)

Sitaxsentan

Endothelin receptor antagonist

Pulmonary arterial hypertension

A Phase IIb/III trial found that sitaxsentan 100-mg and 300 mg provided clinical benefit in those patients, while the 100-mg dose was better tolerated (5/20)

InterMune Inc.
(ITMN)

Actimmune (FDA-approved)

Interferon gamma-1b

Idiopathic pulmonary
fibrosis

Phase III data failed to show a significant treatment effect on the primary endpoint, but did suggest a survival benefit in the intent-to-treat population (5/19)

InterMune
Inc.
(ITMN)

Pirfenidone

Orally active small molecule drug that appears to inhibit collagen synthesis, downregulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines

Idiopathic pulmonary fibrosis

Phase II data suggests the drug may be more efficacious than prednisone in patients with idiopathic pulmonary fibrosis (5/9)

NicOx SA
(France; Nouveau
Marche:NICOX)

NCX 4016

Nitric oxide-donating derivative of aspirin

Cardiovascular diseases

Clinical data showed gastro protection of NCX 4016 even when it was co-administered with celecoxib (5/21)

United Therapeutics Corp. (UTHR)

Remodulin (FDA-approved)

Treprostinil sodium injection

Pulmonary arterial hypertension

Clinical data showed statistically significant reductions in pulmonary vascular resistance, and patients experienced other clinically significant improvements in their hemodynamic measurements and exercise capacity (5/21)

ThromboGenics
Ltd.*
(Ireland)

Microplasmin

A thrombolytic agent

Thromboembolic diseases

Company completed a Phase I trial showing it was safe and well tolerated (5/23)

CENTRAL NERVOUS SYSTEM

Cephalon Inc.
(CEPH)

Provigil (FDA-approved)

Modafinil tablets; oral formulation of the synthetic compound

Attention deficit hyperactivity disorder

Phase II data showed that Provigil improves attention deficit hyper-activity disorder symptoms in children in both school and home settings and is well tolerated (5/21)

Cypress
Bioscience
Inc.
(CYPB)

Milnacipran

The first of a new class of agents known as NSRIs, or norepinephrine serotonin reuptake inhibitors

Fibromyalgia syndrome

Phase II data demonstrated the safety and efficacy of milnacipran (5/29)

Neurocrine
Biosciences
Inc.
(NBIX)

Indiplon

Capsules; acts on the GABA-A receptor

Insomnia

The drug showed no evidence of rebound insomnia or withdrawal in a Phase III trial with two doses (5/19); Phase II data showed the primary endpoint of latency to persistent sleep was met (5/22)

NicOx SA
(France; Nouveau Marche:NICOX)

HCT 1026

Nitric oxide-donating derivative of flurbiprofen

Alzheimer's disease

Phase I data showed penetration of the blood-brain barrier and the presence of effective drug concentrations in the cerebrospinal fluid after repeated oral dosing (5/13)

Phytopharm plc
(UK; LSE:PYM)

PYM50028

Orally active synthetic neuroprotective and neuroregenerative
product

Parkinson's disease

Company completed a Phase I trial that showed a good safety profile (5/28**)

Repligen
Corp.
(RGEN)

RG1068

Synthetic human secretin

Schizophrenia

Company began a Phase II trial (5/14)

DIABETES

Altea Therapeutics Corp.*

ATI391

A daily insulin patch

Diabetes

Company began Phase I trials (5/28)

Amylin Pharmaceuticals Inc. (AMLN)

Symlin

Pramlintide acetate; an analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas

Diabetes

Clinical data in a 296-patient study showed Symlin-treated subjects used 12% less insulin overall compared to control (5/19)

ConjuChem Inc.
(Canada; TSE:CJC)

DAC:GLP-1

Derived from the human hormone glucagon-like peptide 1 (7-36)-amide; it is engineered into a drug construct using DAC technology

Type II diabetes

Company plans to begin a Phase I/II trial in the U.S. (5/9)

Emisphere Technologies Inc. (EMIS)

--

Oral insulin formulation that uses Emisphere's eligen oral drug delivery technology to deliver the insulin in a capsule

Type II diabetes

Company began a 12-patient trial (5/8)

Forest Laboratories
Inc.
(NYSE:FRX)
and Neurobiological Technologies Inc.
(NTII)

Memantine

A moderate-affinity, uncompetitive N-methyl D-aspartate receptor antagonist that modulates glutamate levels

Neuropathic pain in diabetes patients

A pivotal trial failed, showing the drug did not demonstrate a significant difference vs. placebo relative to the trial's primary endpoints (5/7)

Isis
Pharmaceuticals
Inc. (ISIS)

ISIS 113715

Second-generation antisense drug designed to improve defective insulin signaling by targeting PTP-1B

Type II diabetes

Company initiated a Phase I trial (5/14)

INFECTION

Access Pharmaceuticals Inc. (AMEX:AKC)

OraDisc A

A mucoadhesive disc containing amlexanox

Canker sores

Phase III data showed OraDisc A achieved its primary endpoint (5/27)

AM-Pharma Holding BV* (the Netherlands)

--

Alkaline phosphatase

Sepsis

Company completed a Phase I trial and a Phase IIa trial (5/8)

Cubist
Pharmaceuticals
Inc. (CBST)

CAB-175

Cephalosporin
antibiotic

Streptococcus pneumoniae and Staphylococcus aureus infection

Phase I data showed that a single dose up to 1,000 mg was tolerated by normal, healthy male subjects (5/13)

ID Biomedical
Corp.
(Canada; IDBE; TSE:IDB)

FluINsure

Intranasal influenza
vaccine

Influenza

Clinical results showed positive results for both safety and the potential endpoints of the study (5/1)

ID Biomedical
Corp.
(Canada; IDBE; TSE:IDB)

StreptAvax

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

Group A streptococci

Phase II data showed that StreptAvax vaccine's immunogenicity was significant and generated antibody responses (5/6)

Immtech International Inc. (OTC BB:IMMT)

DB289

Oral anti-infective; dicationic pharmaceutical compound

Penumocystis carinii pneumonia

Company began a Phase IIb trial (5/27)

Inhibitex Inc.*

Veronate

Antibody-based product that belongs to a class of drugs referred to as immune globulins

To prevent staphylococcal infections in low-birth-weight infants

Phase I data showed it was well tolerated at lower dose levels (5/6)

InterMune Inc.
(ITMN)

Infergen (FDA-approved)

Interferon alfacon-1

Chronic hepatitis C

Clinical data showed that more than half of patients who didn't respond to pegylated interferon and ribavirin responded to Infergen (5/20)

Isis Pharmaceuticals Inc. (ISIS)

ISIS 14803

Antisense drug; 20-base phosphorothioate oligo- nucleotide

Hepatitis C

Company initiated a Phase II trial (5/29)

Ribapharm Inc. (NYSE:RNA)

Hepavir B

A nucleoside analogue

Hepatitis B

Company began a Phase I trial (5/2)

Sunol Molecular
Corp.*

--

An antibody designed to neutralize one of the two Shiga toxins released by E. coli strains during infection

E. coli infection

Company began a Phase I trial (5/6)

The Immune
Response Corp.
(IMNR)

Remune

HIV-1 immunogen

HIV

Clinical results showed that vaccination with Remune increased HIV-1-specific immune response in chronic HIV patients receiving suppressive antiretroviral therapy (5/19)

Theratechnologies
Inc. (Canada; TSE:TH)

ThGRF

Growth hormone-releasing factor analogue

HIV-related lipodystrophy

Company enrolled the first patient in a Phase II trial (5/22)

Vicuron Pharmaceuticals Inc. (MICU)

Anidulafungin

Antifungal agent; member of the echinocandin class

Candidiasis/candidemia

Phase II data showed efficacy and that anidulafungin was well tolerated (5/13)

MISCELLANEOUS

Altus
Biologics Inc.*

TheraCLEC

Enzyme replacement therapy

Malabsorption as a result of pancreatic insufficiency

Phase I data showed it was safe and well tolerated (5/14)

BioBalance
Corp.*

--

A non-pathogenic strain of E. coli Probiotic oral suspension

Inflammatory bowel disease

The strain appeared to relieve the major clinical symptoms of inflammatory bowel disease in a pilot trial (5/20)

BioSante Pharmaceuticals Inc. (OTC BB:BISP)

Bio-E-Gel

Estradiol topical gel

Moderate to severe hot flashes in menopausal women

Phase II/III data pointed to an effective dose of Bio-E-Gel (5/7)

Biovitrum AB* (Sweden) and laxoSmithKline plc (UK)

BVT.933

A 5-HT2c receptor agonist

Obesity

Companies agreed to halt a Phase IIb study in order to focus on more highly selective compounds (5/22)

Cell Therapeutics Inc. (CTIC)

Trisenox
(FDA-approved)

Arsenic trioxide injection

Myelodysplasia

Clinical data suggest Trisenox could be active and well tolerated against the disease (5/19)

DrugAbuse
Sciences Inc.*

Naltrexone Depot

A once-per-month injection of naltrexone

Alcoholism

Phase III data showed that by 12 months patients experienced 73% more drink-free days than the placebo-group counterparts (5/5)

Genaera Corp.
(GENR)

Squalamine

Angiogenesis inhibitor that blocks a number of angiogenic growth factors, including vascular endothelial growth factor

Age-related macular degeneration

Phase I/II data showed evidence of activity such as shrinkage of the size of the choroidal neovascularization lesions associated with age-related macular degeneration (5/9)

Genzyme General (GENZ)

Myozyme

Recombinant human acid alpha-glucosidase enzyme

Pompe disease

Genzyme treated the first patient in a pivotal clinical trial (5/29)

Inspire
Pharmaceuticals
Inc. (ISPH)

INS37217

A non-preserved nasal spray formulation

Allergic rhinitis

Phase III data failed to meet the primary endpoint as the product did not significantly reduce the total nasal symptom score over the 28-day treatment period against placebo (5/20)

Isis Pharmaceuticals Inc. (ISIS)

ISIS 2302

Antisense inhibitor of the inflammatory target intercellular adhesion molecule-1

Inflammatory bowel disease

Phase II data showed improvements in endoscopic scores, suggesting a long-term benefit of ICAM-1 inhibition (5/21)

Millennium Pharmaceuticals Inc. (MLNM)

MLN02

Monoclonal antibody

Ulcerative colitis

Phase II data showed statistically significant improvements in the clinical remission rates of patients treated with MLN02, compared to placebo (5/22)

Nastech Pharmaceutical Co. Inc. (NSTK)

Apomorphine

Intranasal formulation; a potent dopamine agonist

Female sexual dysfunction

Phase II data showed that 55% of women treated had improvement in satisfaction with sexual activity (5/29)

Oculex
Pharmaceuticals
Inc.*

Posurdex

Biodegradable microsized drug delivery system designed to provide continuous drug therapy for about one month inside the eye

Persistent macular edema

Phase II data suggested that Posurdex improves vision in patients with persistent macular edema (5/8)

Pain Therapeutics Inc. (PTIE)

PTI-901

Opioid antagonist

Irritable bowel syndrome

Clinical data showed the drug significantly improved all of the common symptoms associated with irritable bowel syndrome (5/29)

Palatin Technologies Inc. (AMEX:PTN)

PT-141

Peptide analogue of (alpha)-MSH ([alpha]-melanocyte-
stimulating hormone)

Erectile
dysfunction

Company began enrolling patients in a Phase IIb study (5/13)

Progenics Pharmaceuticals Inc. (PGNX)

MNTX

Methylnaltrexone; designed to reverse the side effects of opioids without interfering with pain relief

Post-operative ileus

Company began a Phase II trial (5/13)

Protein Design Labs Inc. (PDLI)

Nuvance

Anti-interleukin-4 antibody

Asthma

Product failed to show clinical benefit in a Phase IIa trial; the company is stopping development (5/8)

Regeneron Pharmaceuticals Inc. (REGN)

Axokine

A genetically re-engineered version of ciliary neurotrophic factor

Obesity

Phase III data showed certain obese patients lost up to 7% of their body weight after a year (5/19)

Repligen Corp. (RGEN)

SecreFlo (FDA-approved)

A synthetic porcine secretin for injection

Pancreatitis

Trial results demonstrated that SecreFlo reduced the incidence of pancreatitis following endoscopic retrograde cholangiopan- creatography (5/22)

Sucampo Pharmaceuticals Inc.*

SPI-0211

A chloride channel activator

Constipation

Phase III data demonstrated SPI-0211 performed significantly better than placebo for all constipation variables tested (5/20)


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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