Company*
(Symbol)

Product

Description

Indication

Status (Date)


CANCER

Abgenix Inc.
(ABGX)

ABX-EGF

Fully human monoclonal antibody against the epidermal growth factor receptor

Colorectal cancer

Company began a Phase II trial (1/8)

Alfacell Corp.
(OTC BB:ACEL)

Onconase

Cytotoxic ribonuclease; member of the super-
family of pancreatic ribonucleases

Inoperable malignant mesothelioma

Phase II data showed the one- and two-year survival rates overall were 34.3% and 21.6%, respectively, for the 105 patients treated with Onconase (1/22)

AltaRex Corp.
(Canada; TSE:
AXO)

OvaRex
MAb

Oregovomab; a fully foreign monoclonal antibody that targets CA125

Ovarian cancer

Phase IIb trial results were mixed with time before relapse being up to seven months in the U.S. trial, and up to two months in the Canadian trial (1/25); the combined results were positive and statistically significant overall (1/31)

Aphton Corp.
(APHT)

G17DT

Anti-G17 immunogen

Metastatic gastric cancer

Company completed patient recruitment in a trial of a combination therapy of G17DT and 5-FU plus cisplatin (1/23)

Dendreon
Corp.
(DNDN)

Provenge
(APC8015)

Therapeutic vaccine

Prostate cancer

Phase III data indicate that Provenge will not meet its primary endpoint of time to disease progression (1/11)

Human Genome
Sciences Inc.
(HGSI)

Albuleukin

A novel recombinant human protein

Cancer

The company will begin a Phase I trial in patients with solid tumors (1/7)

IDEC Pharma-
ceuticals
Corp.
(IDPH)

Zevalin

Radiolabeled mouse monoclonal antibody targeted against the CD20 antigen; ibritumomab tiuxetan

Non-Hodgkin's lymphoma

FDA told the company Zevalin is approvable pending resolution of certain manufacturing compliance issues at the company's fill/finish provider, Catalytica Pharmaceuticals Inc. (1/9)

Interferon
Sciences Inc.
(OTC BB:IFSC)

Alferon N

Natural-source, multispecies alpha interferon

To prevent metastatic recurrences of cancer after surgical removal of tumors

Company began a clinical study (1/8)

Isis Pharma-
ceuticals
Inc.
(ISIP)

LY900003
(ISIS 3521)

Antisense agent that uses the genetic code to prevent the production of disease-causing proteins

Non-small-cell lung cancer

Company completed enrollment of 600 patients in a Phase III trial (1/16)

Maxim Pharma-
ceuticals
Inc.
(MAXM)

Ceplene

Histamine
dihydrochloride

Advanced metastatic
melanoma

Phase III results showed that use of Ceplene as an adjunct to IL-2 is safe, well tolerated and associated with a statistically significant prolongation of survival compared with IL-2 alone (1/9); company initiated a Phase III trial with Ceplene and IL-2 in patients with liver metastases (1/17)

MGI Pharma
Inc.
(MOGN)
and Helsinn
Healthcare SA
(Switzerland)

Palonosetron

A 5-HT antagonist

Chemotherapy- induced nausea and vomiting

Company reported that patient treatment is completed in the pivotal Phase III trials (1/16)

MGI Pharma
Inc.
(MOGN)
and MethylGene
Inc.
(Canada)*

MG98

A second-generation antisense inhibitor of DNA methyltransferase

Advanced myelodysplasia and relapsed or refractory acute myeloid leukemia

Companies began a clinical trial of MG98 (1/29)

Millennium
Pharmaceu-
ticals
Inc.
(MLNM)

MLN341
(LDP-341
or PS-341)

Anticancer agent designed to specifically block the proteasome

Solid tumors

Company began multiple Phase I trials of MLN341 in combination with taxotere (1/7)

NeoRx Corp.
(NERX)

Pretarget
Lymphoma

Targeted therapeutic that deliver intense doses of anticancer agents to tumor cells while sparing healthy tissue

Non-Hodgkin's lymphoma and gastrointestinal adenocarcinoma

Company completed enrollment in a Phase Ia trial in lymphoma, and initiated enrollment in a Phase Ia trial in gastrointestinal adenocarcinoma (1/2)

NeoTherapeu-
tics Inc.
(NEOT)

Neotrofin

Nerve regeneration drug

Chemotherapy- induced neuropathy

Company started two Phase II trials (1/9)

NewBiotics
Inc.*

NB1011

Derived from NewBiotics' Enzyme Catalyzed Therapeutic Activation technology

Colon cancer

Company began a Phase I/II trial (1/7)

Pharmacyclics
Inc.
(PCYC)

Xyctrin

Motexafin gadolinium

Brain cancer metastasis

Xcytrin missed its co-primary endpoints in a Phase III trial (1/8)

Telik Inc.
(TELK)

TLK286

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

Breast cancer

Company completed a Phase I trial (1/8)

CARDIOVASCULAR

Alexion Pharma-
ceuticals
Inc.
(ALXN)

Pexelizumab
(5G1.1-SC)

An anti-inflammatory C5 inhibitor monoclonal antibody fragment

Myocardial infarction

The drug entered a 3,000-patient Phase III study (1/7); company completed enrollment in a 900-patient Phase II study (1/15)

Cardiome
Pharma Corp.
(Canada; OTC BB:COMTF; TSE:COM)

RSD1235

Anti-arrhythmic drug

Atrial fibrillation

Company began patient dosing in a Phase II study (1/17)

Emisphere
Technologies
Inc.
(EMIS)

An oral heparin solution formulation; sodium-N- [8-(2-hydroxybenzoyl) amino] caprylate delivery agent

Deep-vein thrombosis following total hip replacement surgery

Enrollment of the PROTECT trial with 2,292 patients was completed (1/7)

Genaissance
Pharmaceuticals
Inc.
(GNSC)

Lovastatin

Cholesterol-lowering
drug

High cholesterol

Company completed enrollment of its second clinical trial (1/15)

Scios Inc.
(SCIO)

Natrecor

Nesiritide

Chronic advanced congestive heart failure

Company began enrolling patients in a pilot study (1/4)

CENTRAL NERVOUS SYSTEM

Amarin Corp.
plc
(UK; AMRN)

LAX-101

Compound that inhibits certain harmful enzymes including phospholipases and caspases

Huntington's
disease

Phase II data showed a mean 34% improvement for patients receiving LAX-101 vs. a mean 23% decline for the patients receiving placebo (1/23)

DIABETES

Amylin Pharma-
ceuticals
Inc.
(AMLN)

AC2993

Synthetic exendin-4

Type II diabetes

Study results showed that sustained, continuous, subcutaneous infusion lowered both pre-meal and post-meal glucose concentrations throughout the day (1/3); company started the second of three Phase III trials (1/30)

Insmed Inc.
(INSM)

SomatoKine

Recombinant protein being developed as an insulin sensitizer

Type II diabetes

Company reported positive results in a Phase II trial, showing improvements in insulin sensitivity and fasting blood glucose (1/8)

ISTA Pharma-
ceuticals
Inc.
(ISTA)

Vitrase

Injectable enzyme; hyaluronidase

Diabetic
retinopathy

Phase IIa results showed that complete posterior vitreous detachments were documented in 60% of eyes treated with a single dose of Vitrase, compared with only 6% of patients in the saline control group (1/7)

Neurocrine
Biosciences Inc.
(NBIX) and Taisho
Pharmaceutical
Co. Ltd. (Japan)

NBI-6024

Vaccine with potential to stop the destruction of insulin-secreting beta islet cells

Type I diabetes

Companies began a Phase IIb trial (1/3)

Peptor Ltd.
(Israel)*

DiaPep277

Synthetic version of P277, a peptide derived from hsp60, a 60kDa heat-shock protein

Type I diabetes

Company plans to begin a Phase II trial in the U.S. (1/14)

INFECTION

Amerimmune
Pharmaceuticals
Inc.
(OTC BB:
AMUN)

Cytolin

Monoclonal antibody that blocks certain adhesion molecules

HIV

Company reported that a Phase Ib trial is in progress (1/14)

BioCryst Pharm-
aceuticals Inc.
(BCRX)

Peramivir
(RWJ-
270201)

Orally active small molecule

Flu

Company began Phase III enrollment in the U.S. (1/3)

Corixa Corp.
(CRXA) and
Rhein
Biotech NV (the Netherlands)

RC-529

Synthetic adjuvant used in combination with Rhein's yeast Hansenula polymorpha- based recombinant hepatitis B antigen

Hepatitis B

Companies reported statistically significant results of a Phase III trial (1/9)

Cubist Pharma-
ceuticals
Inc.
(CBST)

Cidecin

Daptomycin for injection

Community-
acquired
pneumonia

Cidecin failed to meet its primary endpoint in the first of two Phase III trials (1/16)

InterMune
Inc.
(ITMN)

Actimmune

Interferon gamma-1b injection

Severe liver fibrosis, or cirrhosis, caused by hepatitis C virus

Company began enrolling patients in a Phase II trial (1/8)

Triangle Pharma-
ceuticals
Inc.
(VIRS)

Coactinon

Emivirine; non-nucleoside reverse transcriptase inhibitor

HIV infection

Company terminated further development because Coactinon was not performing as well as its comparator drug, abacavir, across the full study population (1/18)

Versicor Inc.
(VERS)

Anidula-
fungin

Intravenous infusion

Aspergillosis

Company began a Phase III trial in aspergillosis, a life-threatening fungal infection (1/7)

XTL Biopharm-
aceuticals Ltd.
(Israel; LSE:XTL)

XTL-002

A fully human, high-affinity monoclonal antibody

Hepatitis C

Company reported positive results, with eight out of 15 patients experiencing reduction of HCV viral load (1/14)

INFLAMMATION AND PAIN

aaiPharma Inc.
(AAII)

ProSorb-D

Diclofenac pain product

Pain

Company enrolled and dosed the first group of patients in a Phase II/III trial (1/9)

Abgenix Inc.
(ABGX)

ABX-IL8

Moncolonal antibody generated with Abgenix's XenoMouse technology; it blocks interleukin-8, a chemokine

Rheumatoid
arthritis

The Phase IIa study failed to meet its endpoints; the company has abandoned development plans in the RA indication (1/4)

Alexion Pharm-
aceuticals
Inc.
(ALXN)

5G1.1

Humanized monoclonal antibody C5 complement inhibitor

Rheumatoid
arthritis

Company began its first Phase IIb trial (1/29)

A.P. Pharma
Inc.
(APPA)

APF 112

Incorporates mepivacaine and the Biochronomer bioerodible drug delivery system

Post-surgical pain

Company completed its initial Phase I trial; results indicated the drug caused no adverse events in 16 subjects (1/29)

Pozen Inc.
(POZN)

MT 300

An injectable dihydro-
ergotamine mesylate compound

Severe migraine

Pozen began the final Phase III pivotal trial of MT 300 (1/31)

Regeneron
Pharmaceuticals
Inc.
(REGN)

Interleukin-
1 Trap

Highly potent blocker of interleukin-1

Rheumatoid
arthritis

Phase Ib results showed dose-dependent improvements in tender and swollen joints and C-reactive protein levels (1/7)

MISCELLANEOUS

Connetics
Corp.
(CNCT)

Olux

Clobetasol propionate
foam

Mild-to-moderate non-scalp psoriasis

Phase IV results showed 71% of treated patients had complete or almost complete clearance of disease, compared with 22% treated with placebo (1/29)

Genaera
Corp.
(GENR)

Squalamine

Anti-angiogenic agent with a multifaceted mechanism of action that blocks the action of a number of angiogenic growth factors, including vascular endothelial growth factor

Fibrodysplasia
ossificans
progressiva

Company began a clinical trial of squalamine (1/16)

Human
Genome
Sciences Inc.
(HGSI)

Repifermin

Keratinocyte growth
factor-2

Chronic venous ulcers

Phase IIa results showed patients achieved 75% wound closure within a 12-week duration; repifermin was well tolerated (1/29)

Idun Pharma-
ceuticals Inc.*

IDN-6556

Small-molecule caspase protease inhibitors

Liver disease

Phase I results showed it was safe and well tolerated (1/31)

Inspire Pharma-
ceuticals
Inc.
(ISPH)

INS365 Ophthalmic

An eye drop that works by activating the P2Y receptor

Dry eye

Phase III results indicate the eye drop did not meet the primary efficacy endpoint (1/16)

La Jolla Pharm-
aceutical Co.
(LJPC)

LJP 394

Arrests the production of antibodies to dsDNA without suppressing the healthy functions of the immune system

Lupus renal
disease

Phase II/III data showed improved or sustained health-related quality of life in patients with lupus renal disease (1/10)

Miravant
Medical
Technologies
Inc.
(MRVT)

PhotoPoint

Photodynamic therapy

Plaque psoriasis

Company began treating patients in a Phase II trial (1/9)

Miravant Medical
Technologies
Inc.
(MRVT)

SnET2

Tin ethyl etiopurpurin; photodynamic therapy

Subfoveal choroidal neovascularization

Phase III data showed it did not meet its primary efficacy endpoint (1/14)

Neurocrine
Biosciences
Inc.
(NBIX)

NBI-
34060

Modified-release tablets

Insomnia

Company saw positive efficacy results in a Phase II study; the tablets demonstrated a statistically significant improvement in sleep efficiency (1/18)

Regeneron
Pharmaceu-
ticals
Inc. (REGN)

Axokine

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

Obesity

Company completed enrollment in a Phase III trial (1/10)


Notes:

* Privately held

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

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