Company* |
Product |
Description |
Indication |
Status |
| | ||||
AUTOIMMUNE | ||||
Active Biotech |
SAIK-MS |
Laquinimod |
Multiple sclerosis |
Phase II data showed that the trial met its primary endpoint, a statistically significant reduction in disease activity in patients treated with the oral compound during a six-month period (9/16) |
|
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Biogen Inc. |
Avonex (FDA-approved) |
Interferon beta-1a |
Multiple sclerosis |
Clinical data showed that Avonex could alter the long-term course of MS in patients who began treatment immediately after their initial MS attack, compared to initiation of treatment more than two years after onset of symptoms (9/22) |
|
||||
Human Genome |
LymphoStat-B |
Human antibody to B-lymphocyte stimulator |
Lupus |
Company initiated a Phase II trial designed to evaluate safety, dosing and preliminary efficacy in 300 patients (9/25) |
|
||||
Isis |
ISIS 104838 |
TNF-alpha inhibitor |
Rheumatoid rthritis |
Phase IIa data showed that ISIS 104838 reduced TNF-alpha mRNA levels in synovial tissue and stabilized levels of TNF-alpha in blood in rheumatoid arthritis patients who received 300 mg of the drug (9/18) |
|
||||
MedImmune |
Vitaxin |
Monoclonal antibody that targets alpha-v-beta-3 integrin |
Rheumatoid arthritis |
Company began a Phase II trial (9/9) |
|
||||
SkyePharma plc |
Psoraxine |
Injectable treatment |
Psoriasis |
Astralis initiated a Phase I trial in the U.S. (9/15) |
|
||||
ZymoGentics Inc. |
TACI-Ig |
Soluble-receptor protein |
Autoimmune disease |
Companies initiated a Phase I trial to assess safety and pharmacokinetics; effects on B lymphocytes also will be measured (9/29) |
|
||||
CANCER | ||||
AEterna |
Neovastat |
Anti-angiogenic drug |
Renal-cell carcinoma |
Drug failed to hit primary endpoint in 305-patient Phase III trial, but company said subgroup benefited (9/24) |
|
||||
Antigenics Inc. |
Oncophage |
Cancer vaccine |
Nonmetastatic pancreatic cancer |
Phase I data showed a median overall survival of 2.5 years, with one patient still alive and disease free after more than five years (9/22) |
|
||||
Antisense |
AP 12009 |
Combines precise selection of cancer target molecules and DNA-based phosphorothioate oligonucleotides |
High-grade glioma |
Phase I/II data were positive (9/4) |
|
||||
Aptamera Inc.* |
AGRO100 |
G-rich oligonucleotide that binds to nucleoin |
Cancer |
Company started Phase I trial testing safety and pharmacokinetics (9/24) |
|
||||
ArQule Inc. |
CO-501 |
Small-molecule drug that acts on cellular checkpoints |
Solid tumors |
Company started first trial, a dose-escalation safety study in cancer patients (9/30) |
|
||||
Bioenvision |
Modrenal |
Trilostane |
Breast cancer |
Company presented meta-analysis data from 700 postmenopausal patient with resistance showing clinical benefit rate of 55% (9/30) |
|
||||
Callisto |
Atiprimod |
Small-molecule drug with antiproliferative and anti- angiogenic activity |
Refractory or relapsed multiple myeloma |
Company filed IND for Phase I/IIa open-label safety and efficacy trial (9/24) |
|
||||
Celgene Corp. |
Thalomid (FDA-approved) |
Thalidomide |
Metastatic melanoma |
Clinical data showed an overall objective response rate of 32% when Thalomid was combined with temozolomide as an oral regimen (9/8) |
|
||||
Celgene Corp. |
Thalomid (FDA-approved) |
Thalidomide |
Androgen- independent prostat carcinoma |
Phase I/II data from 18 of 33 evaluable patients showed a 50%-79% decrease in PSA levels following combination therapy (9/25) |
|
||||
Cell Genesys |
GVAX |
Vaccine modified to secrete GM-CSF |
Melanoma |
Phase I data showed that 10 of 35 patients remained alive, with a minimum follow-up of 36 months, including four patients without evidence of recurrent disease following surgical resection of their tumor; the treatment was safe and well tolerated (9/2) |
|
||||
Corixa Corp. |
-- |
Vaccine containing a recombinant plasmid DNA and an adenovirus |
Non-small-cell lung cancer |
Company began a Phase I trial (9/18) |
|
||||
Corixa Corp. |
Bexxar (FDA-approved) |
Tositumomab and I-131 tositumomab |
Non-Hodgkin's lymphoma |
Phase II data showed that therapy with Bexxar following chemotherapy produced a high rate of response in patients with advanced follicular non-Hodgkin's lymphoma (9/22) |
|
||||
Dendreon |
Provenge |
Immunotherapy |
Prostate cancer |
Phase III data showed Provenge did not achieve the pre-specified endpoint (9/18) |
|
||||
Exelixis Inc. |
XL119 |
Small-molecule cancer compound |
Bile duct tumors and non-small-cell lung cancer |
Phase II data showed encouraging results relative to overall survival and progression-free survival in both indications (9/15) |
|
||||
Eximias |
Thymitaq |
Nolatrexed dihydrochloride |
Advanced solid tumors |
Company began a Phase I/II trial (9/16) |
|
||||
Genmab A/S |
HuMax-EGFr |
Human antibody |
Head and neck cancer |
Company began Phase I/II trial in up to 36 patients; the trial will test six doses (9/24) |
|
||||
Kosan Biosciences Inc. (KOSN) |
KOS-862 |
Epothilone D |
Cancer |
Company reported Phase I results in 10 patients with advanced solid tumors showing it was well tolerated and had preliminary activity (9/23) |
|
||||
Ligand |
Targretin |
Bexarotene capsules |
Advanced non-small-cell lung cancer |
Company exceeded its 600-patient enrollment goal in the second of two pivotal Phase III studies of Targretin capsules in front-line combination therapy (9/19) |
|
||||
Medarex |
MDX-010 |
A fully human anti-CTLA-4 antibody |
Metastatic breast cancer |
Company began a Phase II trial (9/8) |
MedImmune |
Vitaxin |
Monoclonal antibody that targets alpha-v-beta-3 integrin |
Metastatic melanoma |
Company began a Phase II trial (9/9) |
|
||||
Metabasis |
MB7133 |
Prodrug of cytarabine |
Inoperable primary liver cancer |
Company began clinical testing in trial to test safety and tolerability in patients (9/23) |
|
||||
Oxigene Inc. |
Combrestatin A4 Prodrug |
Vascular-targeting agent; combined with radio- |
Advanced colorectal cancer |
Company began Phase I/II trial of drug in combination with an iodine-labeled antibody (9/30) |
|
||||
Pharmacyclics |
Xcytrin |
Motexafin gadolinium injection |
Advanced solid tumors |
Company opened two new Phase I trials (9/4) |
|
||||
Salmedix Inc.* |
Bendamustine |
Alkylating agent |
Relapsed non-Hodgkin's lymphoma |
Company began Phase II/III trials as part of registrational program of drug that's been on market in Germany for decades (9/30) |
|
||||
Spectrum Pharmaceuticals Inc. (SPPI) and GPC Biotech Inc. (Germany; FSE:GPC) |
Satraplatin |
Orally available platinum compound |
Prostate cancer |
Companies initiated Phase III trial of drug in combination with prednisone vs. prednisone alone as second-line treatment (9/2) |
|
||||
Therion |
-- |
Prototype vaccine administered in combination with interleukin-2 |
Metastatic melanoma |
Clinical data showed objective tumor response in six of 12 treated patients (9/15) |
|
||||
Transgene SA |
MVA-FCU1 |
A virus-directed enzyme prodrug therapy |
Tumors |
Company began clinical development (9/18) |
|
||||
Xcyte Therapies |
Xcellerate |
Activated T cells and low doses of IL-2 |
Metastatic kidney cancer |
Some therapeutic effect was seen in Phase I trial in 25 patients; no adverse events reported (9/25) |
|
||||
CARDIOVASCULAR | ||||
Agenix Ltd. |
ThromboView |
Blood-clot detection technology |
Deep-vein thrombosis |
Company completed the first dose level in a group of six patients as part of a Phase Ib trial (9/16) |
|
||||
Alexion |
Pexelizumab |
Antibody fragment |
Acute myocardial infarction |
Phase II data showed pexelizumab did not significantly reduce infarct size, the primary endpoint, but it significantly reduced all-cause mortality at 90 days by 70% (9/2) |
|
||||
Alteon Inc. |
ALT-711 |
A.G.E. crosslink breaker |
Heart failure |
Phase IIa data showed a statistically significant reduction in left ventricular mass and a marked improvement in left ventricular diastolic filling, as well as statistically significant improvements in multiple quality-of-life measurements (9/3) |
|
||||
Avant |
TP10 |
Complement inhibitor |
Women undergoing cardiopulmonary surgery |
Company reinstated development with plans for Phase II trial in 200 patients by year's end (9/23) |
|
||||
AVI BioPharma |
Resten-NG |
Antisense drug |
Restenosis |
Phase II data showed that use of Resten-NG resulted in a statistically significant, 75% reduction in the rate of restenosis (9/18) |
|
||||
BioMarin |
Neutralase |
Carbohydrate-modifying enzyme that cleaves heparin |
Coronary artery bypass graft surgery |
Company stopped its Phase IIIa study and terminated further development after a Data Safety Monitoring Board recommended stopping enrollment due to an increasing frequency of adverse events (9/22) |
|
||||
Cardiome Pharma |
Oxypurinol |
Designed to improve oxygen-use efficiency |
Heart disease |
Clinical data showed it met its primary endpoint (9/22) |
|
||||
Corgentech Inc.* |
CGT003 |
Oligonucleotide that binds and blocks E2F |
To prevent graft failure following coronary artery bypass graft surgery |
Company completed patient enrollment in a pivotal Phase III trial (9/18) |
|
||||
Icagen Inc.* |
ICA-17043 |
Ion channel |
Sickle-cell anemia |
Company completed enrollment of 90 patients in a Phase II trial (9/3) |
|
||||
Medicure Inc. |
MC-1 |
Oral therapeutic |
Heart damage |
Phase II MEND-1 trial showed reduced damage to heart caused by ischemia in 60 high-risk cardiovascular patients undergoing angioplasty (9/26) |
|
||||
NicOx SA |
NCX 4016 |
Cardiovascular |
Peripheral arterial obstructive disease |
Clinical data showed NCX 4016 showed greater activity in the inhibition of inflammatory markers compared to aspirin (9/9) |
|
||||
Octagen Corp.* |
OBI-1 |
Recombinant porcine coagulation Factor VIII |
Hemophilia A |
Companies began a Phase I trial (9/3) |
|
||||
Pharmacyclics |
Antrin Injection |
Motexafin lutetium; water-soluble photoactive agent that accumulates in vascular plaque and is cleared from the rest of the body |
Atherosclerotic plaque |
Clinical data showed no deleterious effects on treated arterial segments and no significant systemic toxicities (9/19) |
|
||||
Scios Inc. |
Natrecor (FDA-approved) |
Nesiritide; recombinant B- type natriuretic peptide |
Advanced chronic congestive heart failure |
Company reported positive results from pilot study named FUSION I (9/23) |
|
||||
CENTRAL NERVOUS SYSTEM | ||||
Aradigm |
AERx Pain Management System |
Delivers morphine via inhalation |
Pain |
Clinical data showed it was safe, well tolerated and produced comparable pain relief to intravenous morphine (9/8) |
|
||||
Axonyx Inc. |
Phenserine |
Acetylcholinesterase beta amyloid precursor protein inhibitor |
Alzheimer's disease |
Company is providing Phenserine treatment to Alzheimer's disease patients in an ongoing Phase IIb and Phase III trial through a formal six-month extension study (9/18) |
|
||||
DOV |
Bicifadine |
Non-narcotic analgesic |
Post-surgical dental pain |
Phase III data showed bicifadine was an effective analgesic, compared to placebo, with efficacy at least equivalent to tramadol (9/10) |
|
||||
Labopharm |
Tramadol |
Analgesic |
Pain |
Company completed the treatment stage for two pivotal Phase III trials (9/15) |
|
||||
Neurocrine |
Indiplon |
Modified-release formulation of indiplon |
Insomnia |
Preliminary top-line results from first Phase III study showed statistically significant improvements (9/24) |
|
||||
Pozen Inc. |
MT 100 |
Tablet formulation |
Migraine |
Phase III data showed MT100 was more effective in providing pain relief at two hours than a single tablet of Imitrex 50 mg in migraine patients with severe pain or nausea at baseline (9/16); Phase IIIb data showed superior pain relief compared to placebo (9/24) |
|
||||
Proneuron Biotechnologies Inc.* |
ProCord |
Autologous activated macrophage therapy |
Spinal cord injury |
Company began enrollment in 61-patient, controlled Phase II trial (9/23) |
|
||||
DIABETES | ||||
Isis |
ISIS 113715 |
Transports glucose into cells; an antisense inhibitor of protein tyrosine phosphatase |
Type II diabetes |
Clinical data showed increased insulin sensitivity; less insulin was required to normalize glucose, without causing hypoglycemia (9/16) |
|
||||
Metabasis Therapeutics Inc.* and Sankyo Co. Ltd. (Japan) |
-- |
Oral gluconeogenesis inhibitor |
Type II diabetes |
Companies completed a Phase IIa trial; results showed class of drug demonstrated potential in reducing glucose levels (9/26) |
|
||||
INFECTION | ||||
Agouron Pharmaceuticals Inc. (unit of Pfizer Inc.) |
Viracept (FDA-approved) |
Nelfinavir mesylate |
HIV and hepatitis C virus |
Clinical results were positive, showing CD4 cell-count changes and viral load changes (9/15) |
|
||||
AnorMED Inc. (Canada; TSE:AOM) |
AMD070 |
CXCR4 inhibitor |
HIV |
Company began enrolling healthy volunteers in a Phase I trial to evaluate the safety of AMD070 (9/3) |
|
||||
Avant Immunotherapeutics |
CholeraGarde |
Oral vaccine candidate |
Cholera |
Clinical data showed the vaccine's ability to elicit vibriocidal antibodies without an increased incidence of adverse effects compared to placebo in healthy volunteers who took part in the study (9/16) |
|
||||
AVI BioPharma Inc. (AVII) |
AVI-4020 |
Neugene antisense drug |
West Nile virus |
Company began dosing patients in a Phase Ib trial (9/10) |
|
||||
Biosyn Inc.* |
UC-781 |
Microbicide; a non-nucleo- side reverse transcriptase inhibitor |
HIV |
Company initiated enrollment in a Phase I trial (9/4) |
|
||||
Depomed Inc. (AMEX:DMI) |
Ciprofloxacin GR |
Formulation using Gastric Retention technology |
Urinary tract infections |
Phase III data showed that the once-daily Ciprofloxacin GR product was as effective as Cipro, which is given twice daily (9/4) |
|
||||
ID Biomedical Corp. (Canada; IDBE) |
FluINsure |
Vaccine |
Influenza |
Clinical data showed significant reductions in clinical illness across all vaccine regimens tested when compared with placebo (9/18) |
|
||||
Inhibitex Inc.* |
Aurexis |
Humanized monoclonal antibody |
Staphylococcus aureus infections |
Company completed a Phase I study showing all dose levels were well tolerated (9/8) |
|
||||
InterMune Inc. (ITMN) |
Oritavancin |
Intravenous antibiotic |
Skin/skin- structure infections |
Phase III data showed oritavancin achieved its primary efficacy endpoint, demonstrating that the drug was as effective as the comparator regimen of vancomycin followed by cephalexin (9/16) |
|
||||
IntraBiotics Pharmaceuticals Inc. (IBPI) |
Iseganan hydrochloride |
Oral rinse product |
To prevent ventilator- associated pneumonia |
Company will begin two pivotal trials enrolling 900 patients each (9/19) |
|
||||
Nabi Biopharmaceuticals Inc. (NABI) |
StaphVAX |
S. aureus polysaccharide conjugate vaccine |
To prevent S. aureus infections in end-stage renal disease |
Company started second Phase III study that will include 3,000 pat-ients on hemodialysis (9/29) |
|
||||
SciClone Pharmaceuticals Inc. (SCLN) |
Zadaxin |
Synthetic thymosin alpha-1 |
Hepatitis C |
Company completed enrollment of 500 patients in first of two Phase III trials (9/24) |
|
||||
Stressgen Biotechnologies Corp. (Canada; TSE:SSB) |
HspE7 |
Heat-shock protein |
Recurrent respiratory papillomatosis |
Phase II data showed HspE7 hit its primary endpoint (9/16) |
|
||||
The Immune Response Corp. (IMNR) |
Remune |
Immune-based therapeutic vaccine |
HIV |
Company began Phase II trial of Remune in drug-naïve patients (9-29) |
|
||||
Vertex Pharmaceuticals Inc. (VRTX) and GlaxoSmithKline plc (UK) |
433908 |
HIV protease inhibitor |
HIV |
Clinical data showed the compound can be co-administered with the antacids Maalox TC or Zantac as well as the cholesterol-lowering Lipitor (9/16) |
|
||||
MISCELLANEOUS | ||||
Adolor Corp. |
Entereg (alvimopan) |
Muopiod antagonist |
Postoperative ileus |
Phase II study showed statistically significant improvement in time to recovery of gastrointestinal function (9/23) |
|
||||
Auxilium Pharmaceuticals |
Testim |
Testosterone gel |
Hypogonadism |
Clinical data showed treatment with Testim can significantly increase bone mineral density and improve body composition in aging hypogonadal men (9/22) |
|
||||
Cerus Corp. (CERS) and Baxter Healthcare Corp. |
Intercept Blood System |
Pathogen-inactivation system for red blood cells that uses the compound S-303 |
Blood transfusions |
Companies stopped a Phase III trial after two study patients developed antibodies to red blood cells treated with S-303 (9/4) |
|
||||
Helix BioMedix Inc. (OTC BB:HXBM) |
HB64 |
Peptides |
Acne |
Clinical data showed 75% of patients had clinical improvement, while 85% reported the gel helped their complexion (9/8) |
|
||||
Human Genome Sciences Inc. (HGSI) |
Repifermin |
Keratinocyte growth factor-2 |
Chronic venous ulcers |
Company ended development in that indication following failed Phase II trial, which measured wound closure (9/25) |
|
||||
Nobex Corp.* |
Apaza |
Combines marketed drugs 5-ASA and 4-APAA |
Inflammatory bowel disease |
Completed Phase I trial exploring tolerance, safety and pharmacokinetics (9/30) |
|
||||
NPS |
PTH |
Parathyroid hormone |
Osteoporosis |
Clinical data suggest that PTH might be more effective than the combination of PTH and alendronate, and alendronate alone, in promoting bone formation in postmenopausal osteoporotic women (9/22) |
|
||||
Regeneron Pharmaceuticals Inc. (REGN) |
Axokine |
A modified form of ciliary neutrophic factor |
Obesity |
Company began a confirmatory Phase III trial (9/10) |
|
||||
Rigel Pharmaceuticals Inc. (RIGL) |
R112 |
Interrupts IgE receptor signal |
Allergic rhinitis |
Company initiated a trial of R112 (9/11) |
|
||||
Sucampo Pharmaceuticals Inc.* |
SPI-0211 |
Chloride channel activator |
Constipation |
Company completed enrollment for the second of two Phase III studies (9/8) |
|
||||
Titan Pharmaceuticals Inc. (AMEX:TTP) |
-- |
Oral gallium maltolate |
Paget's disease |
Clinical data showed serum gallium concentrations increased in a linear fashion with increasing doses (9/22) |
|
||||
Titan Pharmaceuticals Inc. (AMEX:TTP) |
Probuphine |
Incorporates buprenorphine in Titan's delivery system |
Opiate addiction |
Company reported positive preliminary results from first cohort in a pilot safety and efficacy study (9/26) |
|
||||
Transkaryotic Therapies Inc. |
Iduronate-2- sulfatase |
Enzyme replacement therapy |
Hunter syndrome |
Phase I/II data demonstrated the ability of the enzyme replacement therapy in treating Hunter syndrome (9/4); company began dosing in a Phase III pivotal trial (9/19) |
|
||||
XOMA |
XMP.629 |
Topical synthetic peptide derived from human host- defense protein |
Acne |
Company began Phase I safety study in healthy volunteers (9/29) |
|
||||
|
| ||||
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSE = Toronto Stock Exchange. | ||||
