Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
Genentech Inc. |
Rituxan (FDA-approved) |
Rituximab; antibody that targets and depletes CD20- positive B cells |
Multiple sclerosis |
Phase II trial in 104 relapsing- remitting MS patients showed a statistically significant reduction in gadolinium enhancing T1 lesions (8/28) |
Kemia Inc.* |
KC706 |
Anti-inflammatory agent; inhibitor of p38 MAP kinase |
Various indications |
Phase I trial demonstrated safety, tolerability and bioavailability in healthy volunteers (8/23) |
La Jolla |
Riquent |
Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA |
Lupus |
Began Phase III trial under FDA SPA that will evaluate time to renal flare in 600 patients from 10 countries (8/9) |
Millennium |
MLN0415 |
Selective, small-molecule inhibitor of IKK2 |
Various indications |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in up to 72 healthy volunteers (8/30) |
CANCER | ||||
Abeille |
AB-1001 |
Transdermal patch that delivers a commercially available 5HT3-antagonist |
Chemotherapy- induced nausea and vomiting |
Began Phase II irritation and sensitization study in 240 healthy volunteers (8/9) |
Allos |
PDX |
Pralatrexate; next- generation antifolate |
Advanced peripheral T-cell lymphoma |
Began pivotal Phase II trial under FDA SPA to evaluate responses and survival in 100 patients (8/29) |
Argos |
AGS-003 |
Second-generation, dendritic cell-based personalized immunotherapy |
Advanced kidney cancer |
Began Phase I/II trial to evaluate activity and safety in 26 patients with newly diagnosed, metastatic disease (8/17) |
Avantogen Oncology Inc. |
RP101 |
Antiviral drug marketed in Europe that downregulates the STAT3 and APEX genes |
Advanced pancreatic cancer |
Phase I trial with gemcitabine in patients established the dose for further testing (8/17) |
Celldex |
CDX-110 |
Epidermal growth factor receptor variant III peptide |
Ovarian and prostate cancers |
Phase I trial demonstrated tolerability and induction of specific immune responses in patients expressing the mutant receptor (8/23) |
Cell |
Xyotax |
Paclitaxel linked to a biodegradable polyglutamate polymer |
Esophageal and gastric cancers |
Four of 12 patients in Phase I trial with radiation had a complete response, and seven had a partial response (8/23) |
Cell |
Pixantrone |
Anthracycline agent designed to have improved properties |
Relapsed non- Hodgkin's lymphoma |
Phase III EXTEND trial will continue after encouraging response data were seen in a review of the first 40 patients (8/8) |
CuraGen |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Aggressive B-cell lymphoma |
Began Phase II trial to evaluate tolerability and responses in up to 40 refractory patients (8/24) |
CuraGen |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Advanced solid tumors |
Began Phase I trial to evaluate safety, tolerability and pharmacocokinetics, as well as antitumor activity (8/10) |
CuraGen |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Advanced hematologic malignancies |
Began Phase I trial to evaluate safety and tolerability in combination with azacitidine in up to 15 patients (8/8) |
Enzon |
Oncaspar (FDA-approved) |
PEG-enhanced version of the naturally occurring enzyme L-asparaginase |
Advanced solid tumors and lymphomas |
Began Phase I trial to evaluate safety and dosing in combination with Gemzar (8/1) |
Exelixis Inc. |
XL647 |
Small-molecule inhibitor of the HER2, EGF, VEGF and EphB4 receptor tyrosine kinases |
Metastatic non- small-cell lung cancer |
Began Phase II trial in advanced patients to evaluate safety and tolerability, as well as responses and survival (8/1) |
GPC Biotech |
Satraplatin |
Oral platinum compound |
Advanced non- small-cell lung cancer |
Began Phase II trial to evaluate drug with Tarceva as a first-line therapy in patients 70 years of age and older (8/2) |
Hana |
Marqibo |
Vincristine sulfate liposomes injection |
Advanced acute lymphoblastic leukemia |
Began Phase II trial with pulse dexamethasone to evaluate efficacy in up to 44 patients (8/17) |
Hana |
Sphingosome Encapsulated Vinorelbine |
Targeted liposomal formulation of the microtubule inhibitor vinorelbine |
Advanced solid tumors |
Began Phase I trial to evaluate safety, tolerability and preliminary efficacy in patients (8/3) |
Medarex Inc. |
MDX-1106 (ONO-4538) |
Fully human anti-PD-1 antibody |
Cancer |
Starting Phase I trial to evaluate pharmacokinetics and safety in up to 39 patients (8/1) |
MethylGene |
MGCD0103 |
Oral histone deacetylase inhibitor |
Advanced Hodgkin's lymphoma |
Began single-agent Phase II trial to evaluate responses and other endpoints in up to 35 patients who failed other therapies (8/22) |
Oncolys |
Telomelysin |
Adenovirus carrying human telomerase gene promoter sequence |
Solid tumors |
Is starting Phase I trial in patients resistant to other treatments (8/28) |
Raven |
RAV12 |
High-affinity IgG1 chimeric antibody |
Adeno- carcinomas |
Interim Phase I data from 15 patients showed a partial remission in one patient and stable disease in three patients (8/15) |
SGX |
Troxatyl |
Troxacitabine; nucleoside analogue |
Acute myelogenous leukemia |
Monitors in Phase II/III trial evaluating drug in third-line setting said drug was unlikely to show efficacy; the trial was discontinued (8/28) |
YM BioSciences |
Tesmilifene |
Small molecule designed to augment the activity of chemotherapy agents |
Advanced breast cancer |
Monitors in pivotal Phase III trial of drug with chemotherapy recommended continuation of study, following their second safety and efficacy review(8/22) |
CARDIOVASCULAR | ||||
Cytokinetics |
CK-1827452 |
Oral formulation; direct cardiac myosin activator |
Heart failure |
Began Phase I trial to evaluate pharmacokinetics in healthy volunteers (8/23) |
Decode |
DG051 |
Small-molecule inhibitor of leukotriene A4 hydrolase |
Prevention of heart attack |
Began Phase I trial to evaluate safety, tolerability and pharmacokinetics (8/14) |
Icagen Inc. |
ICA-17043 |
Small-molecule ion channel inhibitor |
Sickle cell disease |
Monitors recommended ending enrollment in Phase III trial for those not on concurrent hydroxyurea therapy, about half the patients, due to lack of efficacy (8/4) |
Inspire |
INS50589 Antiplatelet |
Inhibitor of the platelet P2Y12 adenosine diphosphate receptor |
For use in cardiac surgery |
Phase II trial was terminated after interim analysis showed bleeding complications (8/7) |
Predix |
PRX-08066 |
Small-molecule serotonin 5-HT2B antagonist |
Pulmonary hypertension |
Began Phase II trial to evaluate efficacy and safety in 72 patients with PH associated with chronic obstructive pulmonary disease (8/7) |
CENTRAL NERVOUS SYSTEM | ||||
Accera Inc.* |
Ketasyn (AC-1202) |
Neuronal cell-targeting agent that acts to increase mitochondrial activity |
Age-associated memory impairment |
Began Phase IIa trial to evaluate safety and efficacy in patients ages 50 to 85 (8/23) |
Adolor |
ADL5859 |
Oral Delta opioid receptor agonist |
Pain |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in healthy volunteers (8/30) |
BioDelivery |
BEMA LA |
Long-acting formulation of an undisclosed analgesic |
Pain |
Proof-of-concept study in normal volunteers produced positive pharmacokinetic results (8/16) |
Corcept |
Corlux |
Mifepristone; oral GR-II antagonist with potential mitigating effects on cortisol |
Psychotic major depression |
First of three Phase III trials failed to demonstrate efficacy vs. placebo for both primary and secondary endpoints (8/25) |
NovaDel |
Zolpidem oral spray |
Formulation of the active ingredient in Ambien |
Insomnia |
Began bioequivalance trial to evaluate pharmacokinetic profile vs. Ambien in healthy volunteers (8/8) |
Pain |
PTI-202 |
Long-acting, abuse- resistant opioid agent |
Pain |
Began Phase I trial to evaluate the agent in humans (8/2) |
Pharmos |
Cannabinor (PRS-211,375) |
CB2-selective synthetic cannabinoid agent |
Pain |
Began second Phase IIa trial to evaluate analgesic activity and safety in healthy subjects with capsaicin-induced pain (8/10) |
TorreyPines |
NGX426 |
Oral prodrug of tezampanel, an AMPA/ kainate receptor antagonist |
Migraine and neuropathic pain |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in 30 healthy volunteers (8/7) |
Transition |
AZD-103 |
Scyllo-cyclohexanehexol; oral agent that acts on beta amyloid |
Alzheimer's disease |
Is starting Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in healthy volunteers (8/1) |
DIABETES | ||||
Advanced Viral |
AVR118 |
Peptide-nucleic acid complex with immuno-modulatory properties |
Type II diabetes |
Interim Phase I data demonstrated safety; no effects were seen on blood glucose levels in those receiving oral hypoglycemic therapies (8/10) |
Alantos |
ALS 2-0426 |
Small-molecule inhibitor of dipeptidyl peptidase IV |
Type II diabetes |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in 50 healthy volunteers (8/16) |
INFECTION | ||||
Advancis |
Amoxicillin Pulsys |
Amoxicillin formulation delivered with once-daily pulsatile Pulsys technology |
Pharyngitis/ tonsillitis |
Phase III trial in patients with strep throat achieved its desired microbiological and clinical end-points (8/10) |
Ambrilia |
PPL-100 |
HIV protease inhibitor |
HIV |
Phase I trial demonstrated safety, tolerability and a favorable pharmacokinetic profile (8/17) |
Anacor |
AN2690 |
Small-molecule, boron-based topical agent |
Onychomycosis |
No drug was detected in the bloodstream of 15 patients in a Phase I trial (8/9) |
Cerexa Inc.* |
Ceftaroline |
Next-generation, broad- spectrum, injectable cephalosporin agent |
Complicated skin and skin structure infections |
Phase II trial in 100 patients showed a clinical cure rate of 96.8% vs. 88.9% for those treated with vancomycin (8/2) |
Cubist |
Cubicin (FDA-approved) |
Daptomycin for injection; a bactericidal antibiotic |
S. aureus bacteremia and endocarditis |
Phase III trial vs. dual-therapy standard of care demonstrated non-inferiority (8/16) |
Enzo |
StealthVector HGTV43 |
Retrovirus-based vector used to transfer three antisense genes |
HIV |
Data from Phase I trial showed long- erm presence of the engineered CD34+ stem cells and engineered CD4+ immune cells; Phase I/II trial is under way (8/15) |
GenVec Inc. |
-- |
HIV vaccine using GenVec's adenoviral vector technology with a DNA prime vaccine |
HIV |
The Vaccine Research Center began the first human studies, which will evaluate safety and immunogenicity in 15 patients (8/22); data from Phase I trials showed favorable safety and immunogenicity results (8/31) |
Genzyme |
Tolevamer |
Non-antibiotic polymer therapy |
C. difficile- associated diarrhea |
Phase II trial demonstrated a similar treatment outcome as vancomycin in time to resolution of diarrhea, and a trend toward reduced recurrence (8/15) |
Iomai Corp. |
-- |
Vaccine patch |
Travelers' diarrhea |
Began Phase II trial to evaluate safety and frequency of E. coli infection in volunteers traveling to Mexico and Guatemala (8/15) |
Tanox Inc. |
TNX-355 |
Humanized anti-CD4 monoclonal antibody; viral entry inhibitor |
HIV |
Phase II trial with optimized background regimen produced a sustained virologic response through 48 weeks (8/17) |
Theravance |
Telavancin |
Lipoglycopeptide; bactericidal injectable antibiotic |
Complicated skin and skin structure infections |
Phase III ATLAS I and ATLAS II trials in 1,867 patients demonstrated better rates of cure and microbio- logical eradication than vancomycin (8/22) |
VaxGen Inc.(PK:VXGN) |
rPA102 |
Recombinant protective antigen anthrax vaccine |
Anthrax infection |
Phase I trial showed a relationship between the dose and the immune response; no toxicity was seen (8/14) |
Vical Inc. |
-- |
Vaccine based on Vical's DNA delivery technology, boosted by an adenoviral vector vaccine |
HIV |
A Phase I trial sponsored by the National Institutes of Health was initiated (8/22); Phase I trial in 40 patients demonstrated safety, tolerability and induction of T-cell immune responses (8/31) |
ViRexx |
HepaVaxx B Vaccine |
Vaccine containing a a hepatitis B viral antigen and part of a murine monoclonal antibody |
Hepatitis B |
No significant adverse events were seen in a Phase I trial in 15 healthy volunteers (8/9) |
ViroPharma |
HCV-796 |
Oral hepatitis C virus polymerase inhibitor |
Hepatitis C |
Preliminary data from Phase Ib trial with pegylated interferon showed encouraging activity (8/28) |
MISCELLANEOUS | ||||
Athernagen |
ATG003 |
Eye-drop formulation of the anti-angiogenic agent mecamylamine |
Age-related macular degeneration |
Began a Phase I trial to evaluate ocular tolerability and safety (8/21) |
Critical |
Zileuton I.V. |
Intravenous formulation of zileuton (Zyflo), a 5-lipoxygenase inhibitor |
Asthma |
Phase I/II trial demonstrated tolerability and improvements in lung function vs. placebo (8/23) |
Halozyme |
Enhanze |
Delivery platform based on recombinant human PH20 hyaluronidase |
Agent designed to enhance absorption of large molecules |
Began trial to evaluate pharmaco-kinetics, safety and tolerability of a protein drug injected both with and without rHuPH20 (8/8) |
Isotechnika |
TAFA93 |
Small-molecule mTOR inhibitor; prodrug of rapamycin |
Various indications |
Phase I trials demonstrated safety and tolerability in healthy volunteers (8/21) |
MAP |
MAP0010 |
Nebulized formulation of budesonide for inhalation |
Asthma |
Began Phase II trial to evaluate asthma control in 225 pediatric and adolescent patients (8/2) |
Nastech |
PYY(3-36) |
Nasal spray formulation of the Y2 receptor agonist |
Obesity |
Began study in 12 obese subjects to evaluate pharmacokinetics, safety and efficacy measures (8/14) |
Omrix Bio- |
Omr-IgG-am |
Intravenous immunoglobulin |
Primary immune deficiency |
Partner FFE Enterprises Inc. is starting a Phase III trial (8/17) |
OrthoLogic |
Chrysalin (TP508) |
Synthetic peptide that mimics certain attributes of the thrombin molecule |
Wrist fractures |
Interim data from 240 patients in Phase IIb trial did not show benefit vs. placebo; secondary end- points also were missed; the trial was discontinued (8/29) |
Palatin |
Bremelanotide |
Melanocortin receptor agonist |
Female sexual arousal disorder |
Phase IIa pilot study in post- menopausal women showed 73% of drug patients reported an increased level of genital arousal vs. 23% for placebo (8/3) |
PDL |
Terlipressin |
Peptide derived from the natural hormone lysine-vasopressin |
Type 1 hepatorenal syndrome |
Phase III trial showed a trend toward improvement but did not achieve statistical significance for primary endpoint of treatment success (8/3) |
Progenics |
Oral methylnaltrexone |
Peripheral mu opioid receptor antagonist |
Opioid-induced constipation |
Began Phase II trial to evaluate efficacy and dosing in 200 to 400 patients (8/22) |
Serono SA |
-- |
Recombinant human growth hormone |
HIV-associated adipose redistribution syndrome |
Phase III HARS trial met all primary and major secondary efficacy endpoints; a supplemental NDA is on file with the FDA (8/17) |
Sirna |
Sirna-027 |
Chemically modified short interfering RNA targeting vascular endothelial growth factor receptor-1 |
Age-related macular degeneration |
Phase I trial demonstrated safety and tolerability, and all 26 patients showed visual acuity stabilization eight weeks after a single injection (8/10) |
Vyteris |
Actyve |
Transdermal drug delivery technology |
Infertility |
Phase I trials demonstrated the delivery of therapeutic levels of a peptide used to treat infertility (8/10) |
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; | ||||
NDA = New drug application; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; TSE = Toronto Stock Exchange. |