Company* (Country; Symbol)




Status (Date)


Amgen Inc. (AMGN) and Genmab A/S (Denmark; CSE:GEN)

HuMax-IL15/ AMG 714

Human antibody against interleukin-15

Rheumatoid arthritis

Interim analysis on 115 patients in Phase II trial showed a significant difference between drug patients and those on placebo (3/22)

Astralis Ltd. (OTC BB: ASTR)


Protein-based immuno-stimulator


Company began 120-patient Phase II trial to evaluate safety and efficacy of repeated administrations in patients with moderate to severe plaque (3/29)

Celltech Group plc (UK; NYSE: CLL)


Product that uses pegylated antibody fragment technology to target TNF-alpha

Rheumatoid arthritis

The first Phase III trial of the drug in RA, Study 014, met its primary endpoint of ACR20 response at 24 weeks (3/31)

Enzo Biochem Inc. (NYSE:ENZ)


A complex of autologous colon-derived antigens administered orally

Crohn's disease

Interim Phase II results in 19 patients were encouraging and pointed to increasing the trial numbers (3/11)

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

Raptiva (FDA- approved)

Efalizumab; humanized antibody designed to block T cells implicated in psoriasis

Psoriatic arthritis

Preliminary results in a Phase II trial in 107 patients failed to demonstrate statistically significant responses at 12 weeks (3/20)

La Jolla Pharmaceutical Co. (LJPC)

Riquent (abetimus sodium)

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


One-year data from Phase III and Phase II/III trials showed a reduction of protein in urine in the drug group (3/11)

Protein Design Labs Inc. (PDLI)

Nuvion (visilizumab)

Humanized antibody directed at CD3 antigen on activated T cells

Ulcerative colitis

Data presented from Phase I trial in 32 patients with severe disease demonstrated positive clinical responses (3/22)

Protein Design Labs Inc. (PDLI)

HuZAF (fontolizumab)

Humanized anti-gamma interferon antibody

Crohn's disease

Drug demonstrated activity in Phase II trial with 133 patients but did not achieve statistical significance vs. placebo at day 28 (3/22)

Serono SA (Switzerland; NYSE:SRA)


Oral formulation of cladribine, a purine nucleoside analogue

Multiple sclerosis

Serono and IVAX Corp. said pharmacokinetic trials showed the drug met the targets for an orally delivered product (3/23)

Targeted Genetics Corp. (TGEN)


Product using an adeno- associated viral vector to deliver a soluble TNF- alpha receptor protein

Rheumatoid arthritis

Company began a Phase I trial in RA patients to test safety, as well as to monitor for symptoms of disease (3/17)


Antisoma plc (UK; LSE:ASM)


Vascular-targeting agent designed to disrupt tumor blood vessels


The third and final Phase I study provided the data needed to plan Phase II combination trials (3/22)

Antisoma plc (UK; LSE:ASM)

AS1405 (formerly AngioMab)

Radiolabeled antibody that binds to a protein found around new tumor blood vessels

Malignant brain cancer

Company started a Phase I trial in patients to get information on safety, dosing and distribution, as well as preliminary activity (3/22)

Array BioPharma Inc. (ARRY)

ARRY-142886 (AZD6244)

Small-molecule drug designed to interfere with MEK, a step in the cellular hyperproliferation pathway


Array plans to begin Phase I trials evaluating tolerability and pharmacokinetics in patients with advanced disease (3/5)

BioCryst Pharmaceuticals Inc. (BCRX)


Purine nucleoside phosphorylase inhibitor; blocks T-cell synthesis

T-cell cancers

Company began Phase IIa trial to evaluate response rate and duration in 20 patients with refractory T-cell leukemia (3/31)

Biomira Inc. (Canada; BIOM)


Vaccine combining mimic of cancer antigen sialyl-Tn and carrier molecule KLH

Colorectal cancer

Update from 20 patients in Phase II trial with chemotherapy showed a positive trend and no safety concerns (3/12)

CancerVax Corp. (CNVX)


Therapeutic whole-cell vaccine that expresses more than 20 antigens

Stage II melanoma

Retrospective analysis of Phase II trial showed a survival advantage for vaccine compared to historical controls (3/31)

CancerVax Corp. (CNVX)


Therapeutic whole-cell vaccine that expresses more than 20 antigens

Stage III melanoma

Monitoring board recommended Phase III trial of the immunotherapy continue, after second interim analysis; board also said Phase III Stage IV melanoma trial should continue (3/1)

Can-Fite BioPharma Ltd.* (Israel)


Oral version of agent that acts like a muscle-released molecule

Colorectal cancer

Interim data from Phase II trial in 56 patients showed disease stabilization in 20 of them who continued after eight weeks (3/30)

Cell Therapeutics Inc. (CTIC)


Anthracycline agent

Non-Hodgkin's lymphoma

CTI is initiating a pivotal study in about 320 patients with relapsed, aggressive disease (3/4)

Chiron Corp. (CHIR)


Next-generation nucleoside analogue

Gastroesophageal cancer

Phase II trial did not demonstrate sufficient antitumor activity to warrant further development (3/19)



Immunotherapy; vaccine that targets tumors expressing the HER-2/neu marker

HER-2/neu- positive cancers

Updated Phase I data showed continued clinical benefit and statistically significant T-cell immune responses in advanced breast cancer (3/29)

EntreMed Inc. (ENMD)


2-methoxyestradiol; naturally occurring metabolite of endogenous estrogen


Company started a Phase I trial to test the safety and pharmacokinetics of a new formulation of the drug (3/11)

Hybridon Inc. (AMEX:HBY)

IMOxine (HYB2055)

Immunomodulatory oligonucleotide; TLR9 agonist


Phase I trial in healthy volunteers showed the drug was safe and biologically active (3/31)

Introgen Therapeutics Inc. (INGN)


Adenoviral vector containing the p53 tumor- suppressor gene

Squamous-cell carcinoma of the head and neck

Phase II trials in 217 patients with recurrent disease showed an objective overall response rate of 10% with monotherapy; stable disease or better was achieved in 59% of all treated lesions (3/30)

Kosan Biosciences Inc. (KOSN)


Epothilone D

Advanced solid tumors

Kosan began a Phase Ib trial to evaluate KOS-862 in combination with gemcitabine (3/4)

Marshall Edwards Inc. (MSHL)


Designed to induce apoptosis by removing intracellular proteins (XIAP, c-FLIP)

Ovarian cancer

Phase II trial in 40 late-stage, unresponsive patients produced 10 responses (3/31)

NeoPharm Inc. (NEOL)

IL13- E38QQR

Tumor-targeting agent designed to deliver bacterial cytotoxic PE38

Glioblastoma multiforme

Company began enrollment in Phase III Precide trial comparing drug to Gliadel wafer in about 300 patients (3/8)

NeoRx Corp. (NERX)

Skeletal Targeted Radiotherapy

Bone-targeting molecule DOTMP with radioactive substance holmium-166

Multiple myeloma

NeoRx began a Phase III trial in the U.S. and Canada to test the drug in 240 patients with refractory disease; the primary endpoint is complete response (3/29)

OSI Pharmaceuticals Inc. (OSIP) and Genentech Inc. (NYSE:DNA)

Tarceva (erlotinib)

Small-molecule HER-1/EGFR inhibitor

Non-small-cell lung cancer

OSI began a Phase II trial comparing Tarceva monotherapy to standard chemotherapy in up to 102 poor-performance patients not previously treated (3/19)

Peplin Biotech Ltd. (Australia; ASX:PEP)


Topical formulation

Actinic keratosis and non-melanoma skin cancers

Peplin partner Allergan Inc. filed INDs for studies of the product in AK and in basal- ell carcinoma and squamous-cell carcinoma (3/23)

Pharmacyclics Inc. (PCYC)

Xcytrin (motexafin gadolinium)

Small-molecule, tumor- targeted agent from the texaphyrin class

Chronic lymphostatic leukemia

Company presented preliminary Phase II data showing antitumor activity in relapsed CLL, and said it was expanding trials in lymphomas (3/11)

Pharmacyclics Inc. (PCYC)

Xcytrin (motexafin gadolinium)

Small-molecule, tumor- targeted agent from the texaphyrin class

Head and neck cancer

Interim data from Phase I trial in combination with chemoradiation showed nine of 10 patients had a complete tumor response (3/1)

Pharmexa A/S (Denmark; CSE: PHARMX)

HER-2 Protein AutoVac

Therapeutic DNA vaccine designed to induce antibody responses against the HER-2 protein

Breast cancer

Phase I trial showed the vaccine was safe and that HER-2-specific antibody responses were seen in six of 10 patients in the trial (3/17)

Point Therapeutics Inc. (OTC BB:POTB)


Small molecule designed to stimulate the proliferation of hematopoietic progenitor cells

Non-small-cell lung cancer

Company began a Phase II trial in combination with Taxotere in up to 41 patients with Stage IIIb/IV disease (3/9)

Seattle Genetics Inc. (SGEN)


Humanized monoclonal antibody that targets the CD40 antigen

Multiple myeloma

Company began a Phase I trial to evaluate safety, pharmacokinetics and antitumor activity of a multidose regimen (3/25)

SuperGen Inc. (SUPG)


Decitabine for injection

Myelodysplastic syndrome

Analysis of first 45 events in a Phase III trial showed Dacogen patients had an increased time to acute myelogenous leukemia or death (3/10); final data showed different results depending on which of two measures of statistical significance was used (3/31)

SuperGen Inc. (SUPG)


Decitabine for injection

Hematological malignancies

Published data from Phase I trial studying low-dose outpatient treatment showed encouraging activity (3/2)

Telik Inc. (TELK)


Small-molecule tumor-activated drug designed to induce apoptosis

Non-small-cell lung cancer

Telik began Phase III ASSIST-2 trial in 520 patients to assess the reduction in the risk of death vs. Iressa (3/30)

Telik Inc. (TELK)


Small-molecule tumor- activated drug designed to induce apoptosis

Non-small-cell lung cancer

Telik initiated a Phase I/IIa trial in combination with cisplatin in the front-line treatment of Stage IIIb or IV disease (3/9)

Threshold Pharmaceuticals Inc.*

2-deoxy- D-glucose

Compound designed to target cells in hypoxic regions in solid tumors

Solid tumors

Company began a Phase I trial to test safety and pharmacokinetics and establish dosing (3/8)

Vion Pharmaceuticals Inc. (VION)

Cloretazine (VNP40101M)

Sulfonyl hydrazine alkylating agent

Acute myeloid leukemia or myelodysplastic syndromes

Company began a Phase II trial in up to 80 patients in the U.S. and Europe to assess responses from single-agent treatment (3/29)


Adenosine Therapeutics LLC* and Bristol-Myers Squibb Co.


Selective A2a adenosine receptor agonist

Cardiac perfusion imaging

Companies started a Phase II trial testing the product as a pharmacologic stress agent in cardiac perfusion imaging studies (3/24)

Alexion Pharmaceuticals Inc. (ALXN) and Procter & Gamble Co.


Monoclonal antibody; terminal complement inhibitor

Acute cardiovascular disease

Meta-analysis presentation of results from various trials showed significantly reduced 30-day mortality (3/8)

Alteon Inc. (AMEX:ALT)


Alagebrium chloride; A.G.E. crosslink breaker

Systolic hypertension

Company started Phase IIb trial named SPECTRA to evaluate drug's ability to lower systolic blood pressure (3/10)

Cardiome Pharma Corp. (Canada; TSE:COM)


Atrial anti-arrhythmic drug candidate

Atrial fibrillation

Company started Act 2 study that will include 210 patients; it is the second of three planned Phase III trials of the drug (3/30)

GenVec Inc. (GNVC)


Myoblast cell transplantation

Congestive heart failure

Data presented from Phase I trial showed no adverse events and the survival of human myoblasts (3/9)

Guilford Pharmaceuticals Inc. (GLFD)

Aggrastat (FDA-approved)

Glycoprotein IIb/IIIa receptor antagonist

Acute coronary syndrome

Published data showed use of Aggrastat, along with aspirin, heparin and coronary stenting, with early intervention provided statistically significant benefit compared to early intervention alone (3/2)

Human Genome Sciences Inc. (HGSI)


Small-molecule inhibitor of lipoprotein-associated phospholipase A2

Cardiovascular disease

Partner GlaxoSmithKline plc initiated a Phase I trial of the drug (3/30)

Myogen Inc. (MYOG)


Small-molecule inhibitor of Type-III phospho- diesterase

Chronic heart failure

Phase III EMOTE study failed to reach statistical significance in weaning patients off inotrope therapy; secondary endpoints were reached (3/25)

NitroMed Inc. (NTMD)


Nitric oxide-enhancing oral agent

Heart failure

Monitoring board conducted third interim analysis and found no safety concerns, recommending Phase III trial in African-Americans continue (3/16)


Neurocrine Biosciences Inc. (NBIX)


Modified-release form of agent that acts on the GABA-A receptor


Long-term data from Phase III SLEEP and RESTFUL trials demonstrated statistical significance in primary and secondary endpoints; an NDA is being planned (3/24)

Neurocrine Biosciences Inc. (NBIX)


Modified-release form of agent that acts on the GABA-A receptor


Phase III trial in elderly patients with chronic insomnia achieved statistically significant total sleep time vs. placebo (3/2)

Neurocrine Biosciences Inc. (NBIX)


Modified-release form of agent that acts on the GABA-A receptor


Phase III trial in 325 healthy adults with transient insomnia demonstrated statistically significant benefit vs. placebo (3/1)

NeuroMed Technologies Inc.* (Canada)


Calcium-channel blocker

Chronic pain

Company began a Phase I trial to evaluate the safety, tolerability and pharmacokinetics in healthy individuals (3/11)

Pain Therapeutics Inc. (PTIE)


Oral agent designed to inhibit an excitatory effect of opioid receptors


Company began a second Phase III trial; it will be compared to placebo and oxycodone in 700 patients with moderate to severe osteoarthritic pain (3/30)


Amylin Pharmaceuticals Inc. (AMLN)

Exenatide LAR

Long-acting formulation of synthetic exendin-4

Type II diabetes

Company began a Phase II trial to assess dosing in up to 60 patients; the product is being developed with Alkermes Inc. and Eli Lilly and Co. (3/30)

Generex Biotechnology Corp. (GNBT)


Oral insulin spray formulation

Type II diabetes

Published data on trial with 21 patients showed agent could be used as an add-on therapy (3/8)

Ligand Pharmaceuticals Inc. (LGND) and Eli Lilly and Co.


Oral, once-daily peroxi- some proliferator- activated receptor modulator

Type II diabetes

Lilly decided to move product into registrational Phase III trials (3/2)

Metabolex Inc.*


Insulin sensitizer

Type II diabetes

Company began a Phase II study in about 200 patients in the U.S. and Mexico, who are using insulin but who have poor fasting blood-glucose levels (3/2)


Adventrx Pharmaceuticals Inc.*


Peptide-based drug designed to block viral entry


Company filed IND to begin its clinical program for the product (3/4)

Basilea Pharmaceutica AG (Switzerland; SWX:BSLN)


Broad-spectrum cephalosporin antibiotic

Skin and skin- structure infections

Phase II trial showed no failures among 35 evaluable patients (3/3)

CytRx Corp. (CYTR) and Advanced BioScience Laboratories*


Polyvalent HIV vaccine based on five strains of HIV


The University of Massachusetts Medical School is starting a Phase I trial in 36 patients; the vaccine was created by UMMS and ABL (3/23)

Depomed Inc. (DEPO)

Ciprofloxacin GR

Extended-release form- ulation of ciprofloxacin

Urinary tract infections

Phase III data showed product eliminated the organisms responsible for infections as effectively as twice-daily Cipro with fewer gastrointestinal side effects (3/18)

Hemispherx Biopharma Inc. (AMEX:HEB)

Alferon LDO

Low-dose, oral natural alpha interferon


Company began a Phase II trial in asymtomatic patients to evaluate safety and activity (3/2)

Human Genome Sciences Inc. (HGSI)


Human monoclonal anti- body to Bacillus anthracis protective antigen

Anthrax infection

Phase I data showed the product was safe and well tolerated in healthy volunteers, and that desired blood levels were achieved (3/9)

Immtech International Inc. (AMEX:IMM)


Oral antiviral agent

African sleeping sickness

Immtech filed an IND for a trial testing oral administration of the drug in Stage I disease (3/23)

Inhibitex Inc.*


Human monoclonal antibody

Staphylococcus aureus infections

Company began enrollment in a Phase II trial testing drug in first- line treatment with standard-of-care antibiotics

Medinox Inc.*

Norathiol (NOX-100)

Nitric oxide neutralizer

Septic shock

Data presented from Phase I/II trial indicated a beneficial effect and a good safety profile (3/8)

Panacos Pharmaceuticals Inc.*


Small-molecule drug from new class named maturation inhibitors


Panacos began a Phase I trial in healthy volunteers to assess safety and pharmacokinetics (3/16)

Peninsula Pharmaceuticals Inc.*

Doripenem (S-4661)

Agent from the carbapenem class of beta-lactam antibiotics

Complicated intra- abdominal infections

Company began two Phase III trials to evaluate intravenous form of drug (3/30)

PharmAthene, Inc.*


Mutated anthrax protective antigen designed to prevent release of anthrax toxins into the cell

Anthrax infection

Company submitted an IND for a Phase I trial to test the product in healthy volunteers (3/31)

Serono SA (Switzerland; NYSE:SRA)

Serostim (FDA- approved)

Somatropin for injection

AIDS wasting

Published results showed drug approved superior to placebo in international trial with 757 patients (3/31)

VaxGen Inc. (VXGN)


Recombinant protective antigen anthrax vaccine

Anthrax infection

Phase I trial demonstrated comparable immune responses to Anthrax Vaccine Adsorbed, a licensed anthrax vaccine (3/2)

Vical Inc. (VICL)


Gene-based immunotherapeutic vaccine encoding two immunogens


Vical began a Phase I trial to test safety and immune responses in healthy volunteers (3/31)

Vicuron Pharmaceuticals Inc. (MICU)


Broad-spectrum agent from the echinocandin class

Invasive aspergillosis

Phase III results showed product could be combined with liposomal amphotericin B without increased side effects (3/24)


Alkermes Inc. (ALKS)

AIR Epinephrine

Inhaled formulation of epinephrine


The product demonstrated rapid systemic delivery in a Phase I trial in normal volunteers, with no safety problems (3/22)

Amylin Pharmaceuticals Inc. (AMLN)

AC162352 (PYY 3-36)

Y2 receptor agonist


Amylin began a Phase I study to assess safety in up to 80 healthy volunteers (3/30)

BioGentech Corp. (OTC BB: BGTH)


Sublingual lozenge designed to modulate IgE

Seasonal allergic rhinitis

Company began a Phase III trial to evaluate the drug in up to 1,000 allergy sufferers (3/29)

Discovery Laboratories Inc. (DSCO)


Aerosol formualtion of humanized lung surfactant


Phase Ib trial showed product was safe, well tolerated, did not induce bronchospasm, and was deposited to the lungs (3/9)

Eyetech Pharmaceuticals Inc. (EYET)


Pegaptanib sodium; vascular endothelial growth factor inhibitor

Wet age-related macular degeneration

Additional data presented from pivotal trials showed efficacy was independent of lesion size and patient age (3/4)

InKine Pharmaceutical Co. Inc. (INKP)


New-generation sodium phosphate purgative tablet

Colon-cleansing agent

Company began dosing in Phase II trial to compare several doses to its marketed Visicol tablets in adults scheduled for colonoscopy (3/22)

InterMune Inc. (ITMN)


Interferon gamma-1b

Idiopathic pulmonary fibrosis

Phase II trial provided evidence of altered expression of biomarkers involved in IPF (3/30)

ISTA Pharmaceuticals Inc. (ISTA)


Topical non-steroidal anti-inflammatory solution

Ocular inflammation following cataract surgery

Two Phase III trials demonstrated statistical significance in the pri- mary endpoint of proportion of patients with complete absence of ocular inflammation (3/9)

Maxim Pharmaceuticals Inc. (MAXM)


Oral histamine dihydro- chloride drug candidate

Chronic liver diseases

Company completed a Phase Ia pharmacokinetic trial to deter- mine dosing and set the stage for further trials (3/23)

Nastech Pharmaceutical Co. Inc. (NSTK)


Nasal formulation of apomorphine

Sexual dysfunction

A Phase II trial in 102 men showed the product was safe, and established dosing information (3/10)

Nastech Pharmaceutical Co. Inc. (NSTK)

PYY 3-36

Nasal spray formulation of high-affinity Y2 receptor agonist


Phase Ib study in 11 overweight subjects showed a reduced aver- age calorie intake and reduced appetite (3/10)

NexMed Inc. (NEXM)


Product combining ingredients for treating premature ejaculation with NexACT delivery technology

Premature ejaculation

Pilot study in 89 patients showed it met endpoints of extending the ejaculatory latency time and improving overall satisfaction (3/22)

NPS Pharmaceuticals Inc. (NPSP)


Recombinant human parathyroid hormone


Phase III trial met the primary endpoint of reducing new or worsened vertebral fractures in postmenopausal women with mild to moderate osteoporosis; an NDA filing is planned (3/30)

Protein Design Labs Inc. (PDLI)

Daclizumab (FDA-approved as Zenapax)

Humanized monoclonal antibody; interleukin-2 receptor antagonist


Phase II study in patients with chronic, persistent disease demonstrated statistical significance in percent change in FEV1 from baseline to 12 weeks (3/15)

Regeneron Pharmaceuticals Inc. (REGN) and Aventis SA (France)


Intravenous product designed to block vascular endothelial growth factor

Wet age-related macular degeneration

Companies began Phase I trial to assess safety and tolerability and preliminary effects on visual acuity (3/9)

Rigel Pharmaceuticals Inc. (RIGL)


Agent designed to interrupt the signal from the IgE receptor

Allergic rhinitis

Data from Phase I/II trial were presented showing R112 was well tolerated and produced favorable biological effects (3/18)

Serono SA (Switzerland; NYSE:SRA)


Somatropin (rDNA origin) for injection

HIV-associated adipose redistribution syndrome

Published study on 239 patients showed statistically significant decrease in visceral adipose tissue; product also met secondary end- points (3/1)

Zelos Therapeutics Inc.*


Parathyroid hormone analogue


Zelos began a Phase Ia trial of the product (3/9)


* Privately held

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