Company* |
Product |
Description |
Indication |
Status |
AUTOIMMUNE | ||||
Abbott |
Humira |
Adalimumab; fully human antibody designed to block TNF-alpha |
Plaque psoriasis |
Phase II trial showed 64% of patients dosed every other week achieved at least a 75% improvement in disease extent and severity after 24 weeks (7/29) |
Genentech |
Raptiva (FDA-approved) |
Efalizumab; humanized antibody designed to block T cells implicated in psoriasis |
Chronic plaque |
Preliminary 30-month results from open-label study showed 75% or greater improvement on PASI scores in 78% (124/159) of patients (7/29) |
Hemispherx |
Alferon N |
Purified mixture of natural alpha interferons |
Multiple sclerosis |
Got FDA authorization for open-label Phase IIb trial to test safety and efficacy in patients with relapsing-remitting MS who stopped interferon-beta therapy (7/20) |
Isotechnika |
TAFA-93 |
Prodrug of the mTOR inhibitor rapamycin |
Various conditions |
Got approval for a Phase Ib trial that is expected to start after completion of a Phase Ia trial in Canada (7/7) |
Isotechnika |
Trans-ISA247 |
Immunosuppressive agent |
Psoriasis and renal transplantation |
SAD trial in healthy volunteers confirmed new formulation was more potent than original mixture, without adverse events (7/6) |
The Immune |
NeuroVax |
T-cell receptor peptide vaccine; combines three TCR peptides with an adjuvant |
Multiple sclerosis |
Presented early Phase II data showing immunological activity and potential inducement of regulatory T cells (7/1) |
ZymoGentics |
TACI-Ig |
Soluble fusion protein linking the extracellular portion of the TACI receptor to the Fc portion of human immunoglobulin |
Lupus |
Began Phase Ib trial in 32 patients to assess systemic and local tolerability, as well as to test pharmacokinetics and effects on biological markers (7/27) |
CANCER | ||||
Adherex |
Exherin |
Cadherin antagonist; small-peptide, tumor-vascular-targeting agent |
Cancers |
Began Phase I trial to test tolerability and pharmacokinetics, as well as activity, in up to 20 patients (7/6) |
Celgene Corp. |
Thalomid |
Thalidomide |
Prostate |
Published Phase II results in 75 patients showed combination vs. docetaxel alone improved PSA levels and overall survival (7/1) |
Cell Genesys |
GVAX |
Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF |
Prostate cancer |
Began Phase III VITAL-1 trial to test GVAX vs. docetaxel in 600 patients with metastatic hormone-refractory disease (7/15) |
GTx Inc. |
Acapodene |
Toremifene citrate; small-molecule non-steroidal selective estrogen receptor modulator |
Prostate cancer |
Presented new data from Phase IIa trial in 514 men with high-grade prostatic intraepithelial neoplasia; data suggest drug may be effective in preventing prostate cancer (7/15) |
Kosan |
DMAG |
17-allylamino-17-demethoxy-geldanamycin; second-generation |
Advanced solid tumors |
Began first Phase I trial to assess safety, pharmacokinetics and pharmacodynamics of escalating doses (7/21) |
Kosan |
KOS-862 |
Epothilone D, a polyketide |
Advanced solid tumors |
Began Phase Ib trial to evaluate KOS-862 in combination with carboplatin to assess safety, dosing and potential benefit (7/19) |
Kosan |
KOS-953 |
17-allylamino-17-demethoxy |
Multiple |
Began Phase I trial to evaluate a |
NeoRx Corp. |
Skeletal |
Bone-targeting molecule |
Metastases to the bone |
Filed IND for Phase II trial in breast cancer that has spread, and reported encouraging data from a small study in Stage IV disease (7/6) |
Onconova |
ON 01910.Na |
Non-ATP competitive kinase inhibitor that targets specific checkpoints in the cell cycle |
Advanced cancers |
Began Phase I trial to evaluate safety in up to 28 patients with advanced or metastatic disease (7/26) |
Pharmacyclics |
Xcytrin (motexafin gadolinium) |
Small-molecule, tumor-targeted agent from the texaphyrin class |
Renal-cell carcinoma |
Began Phase II trial to evaluate single-agent efficacy and safety in about 40 patients with metastatic disease (7/8) |
Prima BioMed |
-- |
MUC1-based immunotherapy |
Progressive |
Prima subsidiary CancerVac began a Phase II trial in up to 20 patients who will be treated for one year; CA-125 levels will be measured to assess effect (7/29) |
Seattle Genetics |
SGN-15 |
Antibody-drug conjugate that provides targeting to doxorubicin |
Non-small-cell lung cancer |
Began Phase II trial in 30 patients that will use a biomarker to help evaluate dosing in combination with Taxotere (7/23) |
Xenova |
TransMID |
Modified diphtheria toxin |
Glioblastoma multiforme |
Began Phase III trial in up to 323 patients with nonresectable or progressive disease (7/7) |
CARDIOVASCULAR | ||||
Alexion |
Pexelizumab |
Monoclonal antibody; terminal complement inhibitor |
Coronary artery bypass graft surgery and acute myocardial infarction |
Began pivotal Phase III PRIMO- CABG-2 trial in 4,000 patients in Europe and North America; also began pivotal APEX-AMI Phase III trial in AMI in 8,500 patients worldwide (7/20) |
Cardiome |
Oxypurinol |
Xanthine oxidase inhibitor that is the active metabolite of allopurinol |
Congestive heart failure |
Monitors recommended the Phase II trial evaluating the product as an add-on therapy continue, after completing a safety analysis (7/9) |
Cardiome Pharma |
RSD1235 |
Intravenous agent designed to selectively block ion channels |
Atrial fibrillation |
Partner Fujisawa Healthcare Inc. began ACT 3, the third Phase III trial of the drug, to test safety and efficacy in recent-onset patients (7/7) |
Corautus |
-- |
Vascular endothelial growth factor-2 |
Severe cardiovascular disease |
Got FDA OK for Phase IIa trial of drug delivered via Boston Scientific Corp.'s Stiletto catheter in up to 404 patients with Class III or IV angina (7/15) |
Endovasc |
Liprostin |
Liposome-encapsulated form of prostaglandin E1 |
Peripheral vascular disease |
Initial assessment from Phase II trial showed improvement in walking distance and pain-free walking (7/19) |
Guilford |
Aggrastat (FDA-approved) |
Glycoprotein IIb/IIIa receptor antagonist; tirofiban |
Acute coronary conditions |
Published data from ADVANCE trial showing significantly reduced primary composite endpoint with heparin vs. heparin and placebo in patients undergoing percutaneous coronary intervention; published data from separate 100- patient trial suggested high-dose tirofiban may be as effective as abciximab for 30-day recovery of left ventricular function in patients undergoing primary coronary angioplasty for STEMI (7/29) |
Myogen |
Darusentan |
Type-A selective endothelin receptor antagonist and inhibitor of endothelin- induced vasoconstriction |
Resistant systolic hypertension |
Began Phase IIb trial in 105 patients to assess effectiveness of reducing systolic blood pressure (7/15) |
NitroMed |
BiDil oral agent |
Nitric oxide-enhancing |
Heart failure |
Phase III A-HeFT trial in African-Americans was stopped after a statistically significant survival benefit was seen with the drug (7/19) |
Northfield |
PolyHeme |
Oxygen-carrying blood substitute derived from human blood |
Blood loss |
Monitors recommended Phase III suburban ambulance trial continue without modification, after an initial review of data (7/21) |
Nuvelo |
Alfimeprase |
Modified fibrolase delivered via catheter; thrombolytic agent |
Occluded central venous catheters |
Closed Phase II trial early, with 56 patients, after preliminary efficacy and no safety concerns were seen (7/12) |
TargeGen Inc.* |
TG100-115 |
Selective kinase inhibitor |
Heart attack |
Got FDA OK for Phase I/II trial in 100 patients (7/19) |
Titan |
DITPA |
3,5-diiodothyropropionic acid; thyroid hormone analogue |
Congestive heart failure |
The U.S. Department of Veterans Affairs began a 150- patient Phase II trial vs. placebo (7/26) |
CENTRAL NERVOUS SYSTEM | ||||
Aderis |
Rotigotine |
Dopamine receptor agonist delivered transdermally via a patch |
Restless legs syndrome |
Partner Schwarz Pharma AG said Phase IIb trial in 310 patients demonstrated a statistically significant reduction in symptoms (7/12) |
Boston Life |
Axosine |
Small-molecule axonal growth factor |
Motor function recovery after a stroke |
Filed IND for 27-patient Phase I trial that would test three dose levels (7/26) |
Cobalis Corp. |
PreHistin |
Product believed to mediate IgE synthesis |
Migraine |
Planning Phase II trial to test the product's ability to mitigate the onset of migraine (7/26) |
Endo |
Oxymorphone |
Extended-release formulation of oxymorphone |
Pain |
Reached agreement with FDA on trial to assess safety and efficacy as called for in 2003 approvable letter (7/7) |
KetoCytonyx |
KTX 0101 |
Sodium beta-hydroxybuty-rate; a ketone used as an alternative energy system |
Cognitive impairment in CABG surgery |
Began Phase I trial to evaluate tolerability and pharmacokinetics in up to 20 volunteers (7/7) |
Metaphore |
M40403 |
Small molecule that mimics the activity of superoxide dismutase |
Post-operative pain |
Began Phase II trial in combination with morphine in 300 patients following first metatarsal bunion-ectomy surgery (7/8) |
Myriad |
Flurizan (MPC-7869) |
R-flurbiprofen; acts on NFkB, a transcriptional activator |
Alzheimer's disease |
Presented 21-day Phase I data from 48 healthy older persons showing the drug was safe and well tolerated (7/20) |
Neurochem |
Alzhemed |
Small molecule designed to interfere with association between glycosaminoglycans and A-beta protein |
Alzheimer's disease |
Presented interim data from open-label Phase II trial showing stabilized or improved cognitive function even after 20 months (7/18) |
Vernalis plc |
Frova |
Frovatriptan; 5HT 1B/1D agonist |
Menstrually associated migraine |
Published Phase III results demonstrated the drug significantly reduced the incidence of MAM in women who took it preventively (7/28) |
Xenome Ltd.* |
Xen2174 |
Agent from the chi cono-peptide class, derived from the venom of the coneshell, that selectively inhibits the norepinephrine transporter |
Nueropathic pain |
Began Phase I trial in Australia to evaluate safety and tolerability in up to 20 healthy males (7/20) |
XenoPort |
XP13512 |
Transported produg of the approved agent gabapentin (Pfizer Inc.'s Neurontin) |
Restless legs syndrome and post-herpetic neuralgia |
Began Phase IIa trial to assess safety, tolerability, pharmacokinetics and preliminary efficacy in each indication (7/14) |
Xenova Group |
TA-NIC |
Therapeutic vaccine |
Nicotine addiction |
Phase I trial in 60 smokers showed dose-dependent anti-nicotine antibody responses, as well as increased quit rates; a dose was selected for further trials (4/14) |
DIABETES | ||||
Amylin |
Exenatide |
Incretin mimetic; synthetic exendin-4 |
Type II diabetes |
Six-month study comparing exenatide and insulin glargine showed similar glycemic control, and weight- loss benefits in the exenatide group (7/26) |
ConjuChem |
DAC:GLP-1 |
Insulinotropic hormone GLP-1 created with firm's DAC technology |
Type II diabetes |
Phase II monotherapy trial met endpoints related to glucose control, but nausea was seen as a dose-limiting factor (7/15) |
Cytomedix |
AutoloGel |
Autologous platelet gel composed of growth factors and fibrin matrix |
Diabetic foot ulcers |
Began treatment phase of a trial comparing product to standard of care (7/14) |
Ligand Pharmaceuticals |
Naveglitazar (LY818; formerly LY519818) |
Oral peroxisome proliferator-activated receptor modulator; gamma dominant, alpha-gamma dual agonist |
Type II diabetes |
FDA guidance calling for data on two-year rodent studies before long-term trials of PPAR drugs will delay development 18-24 months; Ligand also said Phase II trial produced statistically significant results in primary and secondary endpoints (7/8) |
INFECTION | ||||
AnorMED Inc. |
AMD070 |
Agent targeting CXCR4 chemokine receptor to prevent HIV from entering and infecting healthy cells |
HIV |
Phase Ia trial in 30 healthy volunteers showed drug generally was safe and well absorbed; Phase Ib/II trial is being planned (7/9) |
Epimmune |
EP HIV-1090 |
DNA vaccine encoding 21 CTL epitopes from conserved regions of multiple HIV proteins |
HIV |
Presented preliminary Phase I data showing drug appeared to be safe and well tolerated in HIV patients (7/13) |
ID |
FluINsure |
Nonliving, subunit vaccine for intranasal administration |
Influenza |
Field study in 1,349 healthy subjects in Canada demonstrated encouraging results (7/20) |
GenVec Inc. |
-- |
HIV vaccine candidate that uses GenVec's gene delivery technology |
HIV |
An NIH unit began a Phase I trial to assess safety and immune response (7/28) |
Gilead Sciences |
Viread and Emtriva (both FDA-approved) |
Nucleotide and nucleoside reverse transcriptase inhibitors, respectively |
HIV |
Published data from Study 903 showed comparable success in suppressing HIV for Viread and stavudine at 144 weeks; Study 301a showed a regimen with Emtriva was superior to one containing stavudine (d4T) (7/11) |
Idun |
IDN-6556 |
Inhibitor of caspase enzymes that mediate apoptosis |
Hepatitis C-induced liver damage |
Began Phase II trial in up to 200 HCV patients to test if the drug can decrease liver damage (7/29) |
Incyte Corp. |
Reverset |
Nucleoside analogue reverse transcriptase inhibitor |
HIV |
Phase II Study 202 trial in 40 patients showed drug was tolerted and resulted in reduced viral load; company is enrolling 180 patients in Phase II Study 203 (7/12) |
InSite Vision |
AzaSite (ISV-401) |
Formulation of azithromycin formulated with DuraSite delivery vehicle |
Bacterial conjunctivitis |
Began two pivotal Phase III trials, one with 550 patients and the other with 775 patients (7/21) |
Oscient Pharmaceuticals |
Ramoplanin |
Naturally occurring |
Vancomycin-resistant enterococci infections |
Ended enrollment in the RAVE trial, which was designed to enroll 950 patients but was only two-thirds complete after four years (7/19) |
Osel Inc.* |
Lactin-V |
Product exploiting naturally occurringmucosal bacteria |
Bacterial vaginosis |
Began Phase I trial of the product (7/19) |
Panacos |
PA-457 |
Small-molecule maturation inhibitor designed to block a step in processing of the HIV Gag protein |
HIV |
Presented Phase I data showing the drug was well tolerated at all doses, with good oral bioavailability and favorable pharmacokinetics (7/14) |
Peninsula |
Doripenem |
Agent from the carbapenem class of beta-lactam antibiotics |
Ventilator-associated pneumonia |
Began sixth and final pivotal Phase III trial, which will compare doripenem with imipenem in patients with VAP (7/13) |
Trimeris Inc. |
Fuzeon |
Enfuvirtide; HIV fusion inhibitor |
HIV |
Presented data from analysis of 1,000 patients showing suppression of HIV and continuous increases in immune cells over 96 weeks (7/12) |
Vertex Pharmaceuticals Inc. (VRTX) |
Lexiva |
Fosamprenavir calcium; |
HIV |
48-week SOLO trial showed drug with ritonavir once daily provided comparable antiviral suppression to twice-daily nelfinavir (7/8); 48-week Phase III CONTEXT trial showed effective viral suppression using that combination or with lopinavir and ritonavir in patients who had failed prior PI- containing regimens (7/12); drug with abacavir and lamivudine demonstrated sustained efficacy and safety after 96 weeks of treatment (7/13) |
Vical |
-- |
Prophylactic, cationic lipid- formulated, bivalent plasmid DNA vaccine |
Anthrax infection |
Began Phase I trial in up to 52 healthy adult volunteers to assess safety and immune responses (7/21) |
ViroPharma Inc. (VPHM) |
Maribavir |
Benzimidazole compound; oral inhibitor of cytomega-lovirus |
Prevention of CMV infection |
Began Phase II program in 108 CMV-seropositive subjects who have undergone allogeneic stem cell transplantation (7/27) |
MISCELLANEOUS | ||||
Arena |
APD356 |
Small-molecule, selective 5HT2C serotonin receptor agonist |
Obesity |
Phase Ia trial showed a pharmacological effect and positive tolerability data (7/14); began Phase Ib trial to evaluate safety over 14-day dosing period in otherwise healthy overweight volunteers (7/26) |
BioMarin |
6R-BH4 |
Enzyme co-factor; the active ingredient in the company's investigational agent |
Phenylketonuria |
Pilot study in 20 patients showed positive effect on phenylalanine blood levels (7/20) |
CollaGenex |
Periostat (FDA-approved) |
Doxycycline hyclate |
Periodontitis |
180-patient trial showed a statistically significant benefit for drug, Atridox and scaling and root planning vs. SRP alone (7/6) |
ConjuChem Inc. (Canada; TSE:CJC) |
DAC:GRF |
Growth-releasing hormone modified with company's DAC technology |
Growth hormone deficiency |
Data from 30 volunteers in Phase I trial showed safety and tolerability, and increases in growth hormone and insulin-like growth factor-1 plasma levels (7/19) |
Critical Therapeutics |
CTI-01 |
Ethyl pyruvate; small molecule believed to inhibit release of cytokines |
Inflammatory conditions |
Began second Phase I trial to further assess safety and tolerability in 60 healthy subjects (7/20) |
Dynavax Technologies |
-- |
Inhaled immunostimulatory sequences |
Asthma |
Phase IIa challenge study demonstrated safety, and showed statistically significant pharmacological activity (7/28) |
Indevus |
Sanctura (FDA-approved) |
Trospium chloride; anti-cholinergic compound; muscarinic receptor antagonist |
Overactive bladder |
Presented 12-month data showing long-term efficacy and that the product was well tolerated (7/29) |
InKine |
INKP-102 |
New-generation sodium phosphate purgative tablet |
Bowel cleansing prior to colonoscopy |
Phase II study in 214 adults appeared to support move into Phase III trial vs. InKine's approved product, Visicol (7/15) |
Insmed |
SomatoKine |
Composition of insulin-like growth factor-1 and its primary binding protein, BP3 |
Severe short stature due to growth hormone insensitivity syndrome |
Six-month analysis from pivotal Phase III trial showed a statistically significant increase in height velocity in children receiving the drug (7/21) |
Isolagen Inc. (AMEX:ILE) |
Isolagen Process |
Autologous cellular therapy |
Facial contour deformities |
Six-month data from Phase III trial in 146 patients showed a positive response in 82% of those treated with Isolagen (7/28) |
Isolagen Inc. |
Isolagen Process |
Autologous cellular therapy |
Facial wrinkles |
Began two identical pivotal Phase III trials, each with 100 patients split between drug and placebo groups (7/21) |
Nymox |
NX-1207 |
Investigational drug for BPH |
Benign prostatic hyperplasia |
Said it is moving into Phase II trial following FDA approval of the protocol (7/14); data from 20 men in Phase I/II trial showed a statistically significant improvement in symptoms (7/28) |
PTC |
PTC124 |
Oral agent that targets nonsense mutations (single-point alterations in DNA that stop translation) |
Cystic fibrosis and Duchenne muscular dystrophy |
Began Phase I trial to evaluate safety, tolerability, and pharmaco-kinetics in healthy volunteers (7/13) |
Santarus Inc. (SNTS) |
Rapinex (FDA-approved) |
Immediate-release powder formulation of the proton pump inhibitor omeprazole |
Heartburn |
Began pivotal trial comparing 20-mg dose to delayed-release ome-prazole capsules in about 36 healthy subjects (7/15) |
Tanox Inc. |
Xolair (FDA-approved) |
Omalizumab; humanized monoclonal antibody to IgE |
Peanut allergy |
Began Phase II trial to evaluate safety and efficacy in about 150 patients (7/7) |
Vivus Inc. |
Alista |
Topical formulation of alprostadil |
Female sexual arousal disorder |
Phase II trial in 36 premenopausal women showed a significant increase in satisfying sexual events vs. placebo (7/14) |
XOMA Ltd. (XOMA) |
XMP.629 |
Synthetic peptide derived from bactericidal/permeability-increasing protein; gel formulation |
Acne |
Presented data from Phase I trials showing no problems with skin irritation or systemic absorption, and a reduction in lesion counts in as few as two weeks (7/29) |
Zonagen Inc. |
Androxal |
Oral antagonist designed to induce production ofendogenous testosterone |
Hypogonadism |
Phase I/II study in 70 patients produced no side effects and statistically significant changes in testosterone levels (7/1) |
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; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
