Company* |
Product |
Description | Indication |
Status (Date) |
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AUTOIMMUNE | ||||
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Abbott |
Humira (adalimumab; FDA-approved) |
Fully human antibody designed to block TNF-alpha |
Moderate to severe plaque psoriasis |
Phase II data showed a statistically significant reduction in disease activity at 12 weeks (2/9) |
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Abbott |
Humira (adalimumab; FDA-approved) |
Fully human antibody designed to block TNF-alpha |
Ankylosing spondylitis |
Abbott started a global Phase III trial in patients not responding to nonteroidal antinflammatory drugs (2/4) |
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Amgen |
Enbrel (FDA-approved) |
Etanercept; anti-TNF- alpha antibody |
Psoriasis |
Global Phase III trial showed a significant number of patients given initial loading doses rapidly achieved psoriasis clearing and then maintained the response with half the dose (2/7) |
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Biogen |
Amevive (FDA-approved) |
Alefacept; targets the CD45RO+ subset of T cells |
Moderate to severe chronic plaque psoriasis |
Preliminary results of a combination study showed Amevive improved treatment outcome compared to baseline (2/7) |
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Cambridge Antibody |
CAT-192 |
Human anti-TGF- eta-1 monoclonal antibody |
Diffuse systemic sclerosis |
Preliminary results from Phase I/II trial showed product generally was safe and well tolerated; no efficacy conclusions could be reached (2/9) |
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Isotechnika |
Trans-ISA247 |
Immuno- |
Psoriasis and renal transplantation |
Company is starting a dose ranging study in 46 subjects (2/25) |
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CANCER | ||||
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Allos |
RSR13 (efaproxiral) |
Radiation sensitizer; small molecule designed to decrease hemoglobin-oxygen binding affinity |
Brain metastases from breast cancer |
Allos started a Phase III trial of the drug as an adjunct to whole-brain radiation therapy; trial is designed to enroll 360 patients (2/12) |
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American |
Abraxane |
Nanoparticle albumin-bound taxane |
Non-small-cell lung cancer and metastatic melanoma |
ABI started a Phase I/II trial in NSCLC to study dosing, safety and activity, and a Phase II trial in melanoma to assess safety, tolerability and antitumor effect (2/25) |
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AnorMed |
AMD3100 |
Drug designed to block receptor-triggering movement of stem cells out of bone marrow |
Stem cell transplantation in cancer patients |
AnorMEd started its fourth Phase II trial, a study in 30 non-Hodgkin's lymphoma and multiple myeloma patients (2/6) |
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Aphton |
G17DT |
Immunotherapy designed to induce in patients antibodies that bind to both gastrin 17 and glygastrin 17 |
Advanced stomach cancer |
Final results from Phase II trial in combination with cisplatin and 5-FU produced encouraging data (2/5) |
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AVAX Technologies |
AC Vaccine |
Autologous cell vaccine |
Stage III melanoma |
Published follow-up results on 214 patients showed five- year surival rates of 44% (2/11) |
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Bioenvision Inc. (AMEX:BIV) |
Modrenal (trilostane) |
Drug designed to increase estrogen binding to ER beta and decrease binding to ER alpha |
Prostate cancer |
Bioenvision filed IND for Phase II trial in 18 patients with androgen-independent disease; it then would add 25 patients if a positive response is seen (2/18) |
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Cell Genesys |
GVAX |
Whole-cell vaccine com- prised of tumor cells irradiated and modified to secrete GM-CSF |
Lung cancer |
Baylor University researchers published data from Phase I/II trial showing previously released positive data (2/18) |
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Celsion Corp. (AMEX:CLN) |
ThermoDox |
Liposome- |
Prostate cancer |
Celsion got approval to expand Phase I trial to include patients with nonmetastatic disease (2/3) |
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Exelixis |
XL647 |
Spectrum-selective kinase inhibitor; inhibits EGFR, HER2, VEGFR and EphB4 |
Solid tumors |
Exelixis began a Phase I trial in patients to assess safety, tolerability, pharmacokinetics and biological activity (2/19) |
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GenVec |
TNFerade |
Adenovector with TNF- alpha gene and a radiation-responsive promoter |
Solid tumors |
Published data from Phase I trial in combination with radiation showed a 70% objective response rate across 12 different tumor types, as well as a positive safety profile (2/17) |
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Hudson Health |
PT-523 |
Multitargeted antifolate agent; water-soluble, type-B analogue of aminopterin |
Solid tumors |
Hudson began Phase I trial in 20 to 40 patients to assess safety, tolerability, pharmacokinetics and preliminary efficacy (2/20) |
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Human Genome |
Repifermin |
Keratinocyte growth factor-2 |
Cancer therapy- induced mucositis |
Phase II trial of product failed to meet primary endpoint of reducing mucositis in 92 patients with multiple myeloma (2/2) |
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Lorus Therapeutics |
GTI-2040 |
Antisense drug targeting the R2 component of ribonucleotide reductase |
Solid tumors |
Company initiated trial of drug in combination with gemcitabine to evaluate dosing, pharmacokinetics and cellular biomarkers (2/10) |
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Marshall Edwards |
Phenoxodiol |
Agent designed to inhibit anti-apoptotic proteins |
Cancer of the cervix |
Company began a Phase I neo-adjuvant study testing the drug as a monotherapy in early stage disease (2/23) |
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NeoPharm Inc. (NEOL) |
IL13-PE38QQR |
Tumor-targeting agent designed to deliver bacterial cytotoxic PE38 |
Glioblastoma multiforme |
Company reached special protocol agreement with FDA on pivotal Phase III trial called PRECISE comparing product to Gliadel (2/5) |
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Oncolytics Biotech Inc. (Canada; ONCY) |
Reolysin |
Formulation of the human reovirus |
T2 prostate cancer |
Final results from technical study showed Reolysin selectively infected and killed tumor cells, setting up future trials (2/27) |
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OSI Pharmaceuticals |
OSI-461 |
Second-generation molecule from class termed selective apoptotic anti-neoplastic drugs |
Advanced solid tumors |
OSI modified a Phase I trial to test administration of the drug with food, to increase drug exposure (2/25) |
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Peregrine |
Cotara |
Radiolabeled tumor necrosis therapy targeting monoclonal antibody |
Hepatic cancer metastases |
Published Phase I data of the drug with radiofrequency ablation suggested positive results (2/4) |
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SuperGen |
Dacogen |
Decitabine for injection |
Myelodysplastic syndrome |
Planned interim analysis on 45 patients in Phase III trial showed drug patients had a statistically significant increase in time to acute myelogenous leukemia or death (2/13) |
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Transgene SA |
MVA-Muc1- IL2 |
Uses MVA vaccinia virus vector to express Muc1 tumor-associated antigen and IL-2 to stimulate T-cell responses |
Cancers |
Interim Phase II trials of the vaccine in lung, prostate and kidney cancers showed good safety and tolerance and encouraging early-response data (2/9) |
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Vion |
Triapine |
Inhibitor of ribonucleotide reductase (inhibits a step in DNA synthesis) |
Prostate cancer and head and neck cancer |
Company stopped enrollment in single-agent Phase II trial in prostate cancer to focus on combination studies, and said nine of 32 patients with head and neck cancer had stable disease in single-agent Phase II trial (2/6) |
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CARDIOVASCULAR | ||||
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Alexion |
Eculizumab |
Humanized monoclonal antibody designed to block complement protein C5 |
Paroxysmal nocturnal hemoglobinuria |
Published three-month data on 11 patients showed reductions in red blood cell destruction, hemoglobinuria and blood transfusions (2/4) |
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Avant |
TP10 |
Soluble complement inhibitor |
Cardiac surgery |
Avant is starting a Phase II trial in 300 female patients to assess benefits on death and heart attack in surgery patients using cardiopulmonary bypass (2/17) |
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Alteon |
ALT-711 |
A.G.E. crosslink |
High blood pressure |
Post hoc analysis of Phase IIb trial showed lowering of systolic blood pressure in patients who started with high readings; product was safe and well tolerated (2/23) |
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Alteon |
ALT-711 |
A.G.E. crosslink |
Endothelial function |
Phase II trial was initiated at Johns Hopkins under an NIH grant to extend and confirm positive findings in diastolic dysfunction from Phase IIa trial (2/11) |
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Baxter Healthcare |
-- |
Adult stem cells for reimplantation |
Coronary artery disease |
Baxter is sponsoring a 24- patient Phase I trial that began at Caritas St. Elizabeth's Medical Center; the cells are injected into the heart (2/3) |
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Encysive |
Sitaxsentan |
Endothelin A receptor antagonist |
Pulmonary arterial hypertension |
Published data from Phase IIb/III STRIDE-1 trial showed improved walk distances in drug group at 12 weeks (2/17) |
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GTC |
ATryn |
Recombinant human antithrombin |
Hereditary antithrombin deficiency |
Data presented from 14-patient trial proved efficacy in preventing development of deep-vein thromboses and other thromboembolic complications in patients under- going high-risk surgery (2/27) |
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CENTRAL NERVOUS SYSTEM | ||||
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Cortex |
CX516 |
Ampakine compound that acts on AMPA receptors to increase strength of signals between neurons |
Mild cognitive impairment |
Phase IIb trial failed to meet its primary endpoint, although a subset of patients with the worst memory showed improvement (2/17) |
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Guilford |
GPI 1485 |
Small-molecule neuro- immunophilin ligand |
Parkinson's disease |
The NIH began a Phase II trial as part of its program investigating therapies for the disease (2/23) |
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Neurocrine |
Indiplon |
Immediate-release form of agent that acts on the GABA-A receptor |
Insomnia |
Phase III trial in 360 elderly patients with chronic insomnia demonstrated statistically significant benefit (2/18) |
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NeurogesX Inc.* |
NGX-4010 |
Trans-capsaicin dermal delivery system |
HIV-associated neuropathy |
Open-label study showed a mean 40% decrease in pain intensity that remained stable for 12 weeks from a single application (2/9) |
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Predix Pharmaceuticals |
PRX-00023 |
Serotonin 1A (5HT1A) receptor agonist/sigma-1 antagonist |
Neuropsychiatric disorders |
Predix began a Phase I trial in 40 volunteers to assess safety, tolerability and pharmacokinetics (2/18) |
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DIABETES | ||||
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Nobex Corp.* |
Hexyl-insulin monoconjugate 2 |
Orally delivered form of insulin |
Type I diabetes |
Published Phase I/II data suggest possible benefit on hyperglycemia when added to a basal insulin regimen (2/19) |
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INFECTION | ||||
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Anadys Pharmaceuticals |
ANA971 |
Oral prodrug of the company's nucleoside analogue isatoribine |
Hepatitis C |
Anadys began Phase I trial to assess safety and pharmacokinetics in healthy volunteers (2/19) |
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Barrier |
Hyphanox (formerly Sporamelt) |
Tablet formulation of the antifungal agent itraconazole |
Vaginal candidiasis |
Barrier began a Phase III trial comparing its product to fluconazole, a Pfizer Inc. drug; the trial will enroll 900 patients (2/17) |
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Cubist Pharmaceuticals |
CAB-175 |
Cephalosporin |
Bacterial infections |
Cubist stopped development of the product after seeing adverse events (2/26) |
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Gilead Sciences |
Viread (FDA-approved) |
Tenofovir disoproxil fumarate; nucleotide analogue reverse transcriptase inhibitor |
HIV |
144-week data from Phase III trial, Study 903, showed viral suppression and renal function similar to stavudine, and better triglyceride and cholesterol levels (2/4) |
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Incyte |
Reverset |
Nucleoside analogue reverse transcriptase inhibitor |
HIV |
Preliminary 10-day Phase II results showed drug was well tolerated and was active as a monotherapy in treatment-naive patients (2/11) |
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Indevus Pharmaceuticals |
Aminocandin |
Compound from echinocandin class |
Fungal infections |
Indevus started a Phase I trial to test the safety and tolerability of escalating intravenous doses (2/25) |
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Nabi Biopharma- |
Civacir |
Antibody-based hepatitis C immune globulin |
Hepatitis C |
Phase I/II trial showed product was well tolerated and showed trend toward reduction of ALT levels in patients who underwent liver transplants due to HCV- induced end-stage failure (2/23) |
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NanoBio Corp.* |
NanoHPX (NB001) |
Antimicrobial product made with NanoStat technology |
Herpes labialis (cold sores) |
Company plans to begin a Phase II trial testing safety, efficacy and dosing in 286 patients (2/24) |
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Panacos Pharmaceuticals |
PA-457 |
Drug from new class named maturation inhibitors |
HIV |
Company got approval to start a Phase I trial of the oral agent in noninfected volunteers (2/9) |
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SciClone Pharmaceuticals |
Zadaxin |
Synthetic preparation of thymosin alpha-1 |
Hepatitis C |
Pilot study in nonresponders showed better results when Zadaxin was added to treatment with pegylated interferon-alpha and ribavirin (2/18) |
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StressGen Biotechnologies |
HspE7 |
Fusion product consisting of heat-shock protein fused to HPV antigen |
Recurrent respiratory pappilomatosis and anal dysplasia |
A Phase II trial in RRP demonstrated statistical significance in lengthening the interval between surgeries; a Phase III trial in anal dysplasia failed to demonstrate statistical significance (2/24) |
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Tanox |
TNX-355 |
Humanized anti-CD4 monoclonal antibody |
HIV |
Phase Ib trial in 22 patients showed clinically meaningful viral reductions from baseline (2/11) |
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ViroPharma Inc. (VPHM) and Wyeth |
HCV-086 |
Antiviral compound from new chemical series |
Hepatitis C |
Companies began Phase I trial to assess safety, tolerability and pharmacokinetics in healthy vol- unteers (2/24) |
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ViroPharma |
Maribavir patients |
Benzimidazole compound; oral inhibitor of cytomegalovirus |
Prevention of CMV infection in transplant |
ViroPharma initiated a Phase I drug-drug interaction and safety study in healthy volunteers (2/5) |
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MISCELLANEOUS | ||||
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Abgenix |
ABX-PTH |
Fully human monoclonal antibody designed to target and neutralize the action of parathyroid hormone |
Secondary hyperpara- thyroidism |
Company started a Phase I trial (2/3) |
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BioBalance Corp. (subsidiary of New |
Probactrix |
Nonpathogenic E. coli M- 17 in a liquid suspension |
Irritable bowel syndrome |
Company began enrollment in 210-patient trial to test the agent when incorporated into dietary management (2/5) |
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BioMarin Pharmaceuticals |
Phenoptin |
Form of the enzyme cofactor 6R-BH4 |
Phenylketonuria |
BioMarin began a clinical program in the enzyme deficiency disorder, starting with a screening program to identify the best potential responders (2/23) |
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CollaGenex Pharmaceuticals |
Periostat (FDA- approved) |
Doxycycline hyclate tablets |
Rosacea |
Phase III study in 134 patients showed statistically significant improvement for those taking the drug vs. those on placebo (2/17) |
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Dynavax Technologies |
AIC |
Anti-allergy immunotherapy |
Ragweed allergy |
Company started a two-year Phase II/III trial in 462 subjects, in collaboration with UCB Pharma (2/25) |
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Isolagen Inc. (AMEX:ILE) |
-- |
Autologous cellular therapy |
Periodontal disease |
Phase I trial in 21 patients showed product reversed gingival recession and improved pocketing (3/3) |
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Nabi Biopharma-ceuticals (NABI) |
NicVax |
Nicotine conjugate vaccine |
Nicotine addiction |
Phase I/II trial demonstrated safety and production of nicotine-specific antibodies |
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Nastech Pharmaceutical |
PYY3-36 Nasal Spray |
High-affinity Y2 receptor agonist |
Obesity |
Company began a Phase Ic trial to assess proper dosing regimens (2/24) |
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Ortec International Inc. (OTC BB:ORTN) |
OrCel |
Collagen sponge seeded with allogeneic epidermal and dermal cells |
Venous leg ulcers |
Data presented from pivotal trial showed frozen version of product proved beneficial in wound closure, healing and other endpoints; PMA filing is under way (2/9) |
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Palatin Technologies |
PT-141 |
Intranasally delivered melanocortin agonist |
Erectile dysfunction |
Published results from study of drug showed positive results (2/20) |
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Serono SA (Switzerland; NYSE:SRA) |
Serostim (FDA- approved) |
Somatropin for injeciton |
Visceral-fat accumulation |
Extension study showed benefit of drug in sustaining reductions of excess visceral-fat accumulation in those with HIV-associated adipose redistribution syndrome (2/12) |
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Sucampo Pharmaceuticals Inc.* |
SPI-0211 |
Chloride channel activator |
Constipation |
Second of three Phase III trials, in 299 patients over 48 weeks, duplicated positive results of first study (2/18) |
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Targeted Genetics Corp. (TGEN) |
tgAAVCF |
Gene therapy that uses an adeno-associated virus vector to deliver the CFTR gene directly into the lungs |
Cystic fibrosis |
Published Phase II data in 37 patients with mild CF showed statistically significant improvements in lung function and a clean safety profile (2/10) |
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Vivus Inc. (VVUS) |
TA-1790 |
Oral phosphodiesterase type-5 inhibitor |
Erectile dysfunction |
Phase II study against Viagra showed the products had comparable onset of action (2/6) |
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
