Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
La Jolla |
Riquent |
Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA |
Lupus |
Is starting a trial in 45 patients to evaluate the effect of higher doses (1/11) |
Millennium |
MLN1202 |
Humanized monoclonal antibody designed to block CCR2 chemokine receptors |
Rheumatoid arthritis |
Development is ending in RA following a review of Phase IIa data (1/26) |
ZymoGenetics |
TACI-Ig |
Antagonist protein that binds to the TNF cytokines BLyS and APRIL |
Rheumatoid arthritis |
Phase Ib trial demonstrated safety and tolerability and biological responses (1/10) |
CANCER | ||||
Accentia Bio- |
BiovaxID |
Personalized vaccine; tumor antigen conjugated to KLH administered with GM-CSF |
Mantle cell lymphoma |
Follow-up data from Phase II trial, at a median of 3.8 years, showed a survival rate of 89% among the 23 treated patients (1/24) |
Accentia Bio- |
BiovaxID |
Personalized vaccine; tumor antigen conjugated to KLH administered with GM-CSF |
Follicular lymphoma |
Follow-up data from Phase II trial, at a median of 9.2 years, showed 45% of patients remained in continuous first clinical remission; the overall survival rate was 95% (1/10) |
Adherex |
Eniluracil |
Oral dihydropyrimidine dehydrogenase inhibitor |
Solid tumors |
Began Phase I trial to evaluate dosing in patients in combination with 5-fluorouracil (1/4) |
Allos |
Efaproxyn |
Efaproxiral; small molecule designed to sensitize hypoxic areas of tumors during radiation therapy |
Brain metastases |
New data from Phase III REACH trial showed improved responses and survival in patients with non- small-cell lung or breast cancer (1/3) |
Array |
ARRY-334543 |
Small-molecule tyrosine kinase inhibitor of ErbB-2 (Her-2/neu) and EGFR |
Advanced cancers |
Began Phase I trial to evaluate tolerability, pharmacokinetics and activity in patients (1/17) |
Avalon |
AVN944 |
Small-molecule inhibitor of the enzyme inosine monophosphate dehydrogenase |
Advanced hematological malignancies |
Began Phase I trial to evaluate safety, tolerability and dosing in up to 36 adult patients (1/9) |
AVAX |
AC Vaccine technology |
Vaccine composed of a patient's tumor cells modified with the hapten dinitrophenyl |
Non-small-cell lung cancer |
Began Phase I/II trial that will evaluate safety and immune responses of adjuvant treatment (1/17) |
Breakthrough |
VAX100 |
BCR-ABL peptide vaccine |
Chronic myeloid leukemia |
Phase II trial in patients on Gleevec showed immunological responses in 17 of 18 patients with a peptide-specific T-cell response (1/6) |
Celgene Corp. |
Thalomid (FDA-approved) |
Thalidomide |
Multiple myeloma |
Pivotal Phase III trial with dexamethasone vs. that drug alone demonstrated statistically significant improvements in time to disease progression and progression- free survival (1/9) |
EntreMed |
MKC-1 |
Small-molecule cell-cycle inhibitor |
Advanced breast cancer |
Began Phase II trial to evaluate the drug in advanced or metastatic patients (1/25) |
EntreMed |
Panzem |
2-methoxyestradiol; naturally occurring metabolite of endogenous estrogen |
Recurrent glioblastoma multiforme |
Began Phase II trial to evaluate safety, pharmacokinetics and efficacy in 32 relapsed/refractory patients (1/19) |
Erimos |
EM-1421 |
Small molecule derived from a desert plant designed to target tumor cells |
Advanced solid tumors |
Began Phase I trial to evaluate safety, pharmacokinetics and activity in 30 patients (1/24) |
Genentech |
-- |
Topical antagonist of the Hedgehog signaling pathway |
Basal cell carcinoma |
Interim data from Phase I trial showed less activity than expect- ed (1/23) |
Generex |
AE37 |
Second-generation peptide vaccine designed to stimulate responses against tumors expressing the HER-2/neuoncogene |
Breast cancer |
Initial data from trial indicated the vaccine was safe, well tolerated and exhibited dose-dependent immunologic responses (1/25) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Solid tumors |
Began trial to evaluate activity and safety of intermittent subcutaneous injection of a new formulation of the drug (1/24) |
GenVec Inc. |
TNFerade |
Adenovector with TNF- alpha gene and a radiation- responsive promoter |
Advanced esophageal cancer |
Follow-up data from Phase II trial showed 88% of 24 patients were still alive after one year (1/27) |
GTx Inc. |
Acapodene |
Toremifene citrate; small- molecule non-steroidal selective estrogen receptor modulator |
Prostate cancer |
Monitors recommended continuation of two pivotal Phase III trials for treating and preventing prostate cancer, following an interim safety review (1/19) |
Hana |
Zensana |
Ondansetron oral spray; 5-HT3 antagonist |
Chemotherapy- induced nausea and vomiting |
Pivotal ZOOS 1 trial demonstrated bioequivalence to the commercially available 8-mg tablet, Zofran (1/9) |
Keryx Bio- |
KRX-0401 (perifosine) |
Oral agent that modulates AKT and other signal transduction pathways |
Relapsed multiple myeloma |
Began open-label Phase II trial to evaluate drug alone and with dexamethasone (1/3) |
Kosan |
KOS-1022 (DMAG) |
Oral formulation of a second-generation heat- shock protein 90 inhibitor |
Advanced solid tumors |
Began Phase I trial to evaluate safety, pharmacokinetics and preliminary antitumor activity (1/25) |
Millennium |
MLN2704 |
Monoclonal antibody (MLN591) directed at PSA conjugated to DM1 |
Prostate cancer |
Development was ended following unfavorable results from Phase I/II trial (1/26) |
ProlX |
PX-12 |
Small molecule designed to inhibit thioredoxin, a protein that stimulates cell growth |
Advanced gastrointestinal cancers |
Began Phase Ib trial to evaluate the safety, pharmacokinetics and activity of a new delivery schedule (1/20) |
Sunesis |
SNS-032 |
Small-molecule inhibitor of cyclin-dependent kinases 2, 7 and 9 |
Advanced solid tumors |
Began a Phase I trial to evaluate safety and preliminary antitumor activity in patients (1/4) |
Sunesis |
SNS-595 |
Small-molecule cell-cycle modulator designed to induce apoptosis |
Non-small-cell lung cancer |
Began Phase II trial to evaluate safety and efficacy as a second- line agent (1/4) |
Tapestry |
TPI 287 |
Third-generation taxane agent |
Advanced malignancies |
Began a second Phase I trial, to determine the maximum tolerated dose (1/10) |
Threshold |
Glufosfamide |
Small molecule targeting abnormal glucose metabolism |
Advanced cancers |
Phase I portion of Phase I/II trial showed drug with gemcitabine was well tolerated and warrants further investigation (1/11) |
Vion |
Cloretazine |
Sulfonylhydrazine DNA alkylating agent |
Acute myelogenous leukemia |
Is starting pivotal Phase II trial to evaluate the drug in 85 elderly patients with poor-risk acute AML (1/31) |
ZioPharm |
ZIO-101 |
Organic arsenic agent |
Advanced myeloma |
Began Phase I/II trial of the agent (1/31) |
CARDIOVASCULAR | ||||
Alexion |
Soliris (eculizumab) |
Humanized monoclonal antibody designed to block complement protein C5 |
Paroxysmal nocturnal hemoglobinuria |
Pivotal Phase III TRIUMPH trial in 87 patients met all primary and secondary endpoints with statistical significance (1/26) |
Arteriocyte |
-- |
Adult derived hemangio-blasts (stem cells) |
Chronic ischemia |
Began Phase I trial involving the delivery of stem cells through a catheter into the coronary arteries (1/19) |
Avanir |
AZD2479 |
Reverse cholesterol transport enhancer |
Dyslipidemia |
Began Phase I trial to evaluate safety, tolerability and pharmaco- kinetics in healthy volunteers (1/3) |
Corautus |
VEGF-2 |
Vascular endothelial growth factor-2 in the form of naked plasmid DNA |
Severe angina |
Monitors in Phase IIb GENASIS trial recommended continuation following the third and final interim analysis, in 240 patients (1/26) |
Encysive |
TBC3711 |
Next-generation, highly selective endothelin receptor antagonist |
Hypertension |
Began dose-ranging trial to evaluate the product in 150 patients with resistant hypertension (1/9) |
Icagen Inc. |
ICA-17043 |
Ion channel blocker |
Sickle cell anemia |
Monitors recommended continuation of pivotal Phase III ASSERT trial following planned safety review (1/30) |
NovaCardia |
KW-3902 |
A1 receptor antagonist |
Congestive heart failure |
Phase II trial met primary end- points related to fluid elimination and renal function (1/3) |
Valentis Inc. |
VLTS 934 |
Non-ionic, block copolymer (poloxamer) |
Peripheral arterial disease |
Company reported favorable interim data from Phase IIb trial; the trial will continue as planned (1/10) |
CENTRAL NERVOUS SYSTEM | ||||
Axonyx |
Posiphen |
Positive isomer of Phenserine, an inhibitor of acetylcholine |
Alzheimer's disease |
Phase I trial established well- tolerated doses; no adverse events were reported (1/24) |
Avicena |
HD-02 |
Agent that incorporates a formulation of creatine |
Huntington's disease |
Phase I/II trial demonstrated safety and tolerability, and increased levels of creatine (1/24) |
Clinical Data |
Vilazodone |
Selective serotonin reuptake inhibitor and a 5HT1A partial agonist |
Depression |
Began pivotal Phase III trial to evaluate safety and efficacy and to discover biomarkers in 400 patients with major depressive disorder (1/26) |
Depomed |
Gabapentin GR |
Extended-release formulation of the approved agent |
Postherpetic neuralgia |
Phase II trial in 158 patients demonstrated statistically significant benefits vs. placebo (1/4) |
Elite |
OxyQD |
Once-daily, sustained- release oxycodone product |
Pain |
Is starting Phase I trial to evaluate the extent of oxycodone absorption (1/31) |
Javelin |
Dyloject |
Diclofenac injection; nonsteroidal anti-inflammatory agent |
Post-operative pain |
Phase II trial showed drug was superior to placebo and demonstrated superior onset of pain relief vs. Ketorolac (1/23) |
Nabi Bio- |
NicVAX |
Nicotine conjugate vaccine |
Nicotine addiction |
Phase II trial showed product was well tolerated; further Phase II testing is being planned (1/25) |
Pharmos |
Cannabinor |
CB2-selective synthetic cannabinoid agent |
Pain |
Phase I trial in 48 volunteers showed agent was safe and well tolerated (1/26) |
DIABETES | ||||
MannKind |
Technosphere Insulin |
Insulin formulation delivered via the company's inhaler |
Type II diabetes |
Phase IIb trial showed improved glycemic control with no negative effects on pulmonary function and no weight gain (1/17) |
INFECTION | ||||
Advanced Life |
Cethromycin |
Ketolide antibiotic agent |
Pneumonia |
Began pivotal trial that will evaluate non-inferiority vs. clarithromycin in 500 patients with community-acquired disease (1/5) |
Avant Immuno-therapeutics Inc. (AVAN) |
Rotarix |
Oral, two-dose, live attenuated vaccine developed from a single human strain |
Rotavirus infection |
Phase III trial demonstrated the safety and efficacy of the vaccine (1/5) |
AVI |
AVI-4065 |
Neugene antisense compound |
Hepatitis C |
First phase of trial demonstrated positive safety and pharmacokinetic data in 30 healthy volunteers (1/10) |
DOR BioPharma |
RiVax |
Recombinant vaccine against ricin toxin |
Ricin infection |
Phase I trial in 15 volunteers demonstrated tolerability and the induction of antibodies that neutralize ricin toxin (1/30) |
Enanta |
EDP-420 |
Bridged bicyclic macrolide antibiotic |
Community- acquired pneumonia |
Began Phase II trial to evaluate safety, tolerability and efficacy (1/19) |
Gilead |
Viread and Emtriva (FDA-approved as Truvada) |
Nucleotide and nucleoside reverse transcriptase inhibitors, respectively |
HIV |
48-week data from Study 934 showed combination with Sustiva was superior to Combivir and Sustiva combination (1/18) |
Gilead |
Truvada and Sustiva (both FDA-approved) |
Fixed-dose combination of HIV drugs from Gilead and BMS |
HIV |
Trial demonstrated bioequiva- lence of the combination vs. the (GILD) and individual components; NDA filing planned for 2Q:06 (1/9) |
Gilead |
JTK-303 (GS 9137) |
Oral HIV integrase inhibitor |
HIV |
Phase I/II trial with ritonavir showed significant viral load reductions (1/9) |
Idenix |
Valopicitabine |
HCV polymerase inhibitor |
Hepatitis C |
Partial 4-week data from Phase IIb trial with pegylated interferon showed rapid and marked reductions in virus levels (1/9) |
Salix |
Xifaxan (FDA-approved) |
Rifaximin tablets; gut-selective oral antibiotic |
Travelers' diarrhea |
Phase III trial in 210 patients who had traveled to Mexico showed statistically significant prevention of the condition (1/4) |
Samaritan |
SP-01A |
Oral entry inhibitor |
HIV |
Began Phase IIb monotherapy trial to evaluate safety and effect on viral load in 60 treatment-experienced patients (1/3) |
Vertex |
VX-950 |
Oral hepatitis C virus protease inhibitor |
Hepatitis C |
Phase Ib trial with pegylated interferon showed rapid and large reductions in viral levels (1/9) |
MISCELLANEOUS | ||||
CombinatoRx |
CRx-102 |
Oral agent containing a low dose of prednisolone and dipyridamole |
Hand osteoarthritis |
Phase II trial demonstrated a statistically significant reduction in pain vs. placebo (1/30) |
DOR BioPharma |
orBec |
Oral formulation of beclomethasone dipropionate; a corticosteroid |
Gastrointestinal graft-vs.-host disease |
New analysis from Phase II and III trials showed positive survival results (1/20) |
Dynavax |
Tolamba |
Dynavax's ISS molecule linked to Amb a 1, the major allergen of ragweed |
Ragweed allergy |
Phase II/III trial showed statistically significant reductions in nasal symptoms vs. placebo in the second year of the trial; secondary endpoints also were met (1/18) |
Insmed Inc. |
iPlex (FDA-approved) |
Composition of insulin-like growth factor-1 and its primary binding protein, BP3 |
Myotonic muscular dystrophy |
Began Phase II trial to evaluate dosing, tolerability, safety and efficacy in 30 patients (1/4) |
Isotechnika |
ISA247 |
Immunosuppressive agent |
For use in kidney transplantation |
Began Phase IIb trial to compare acute rejection episodes vs. tacrolimus in 332 newly trans-planted patients (1/5) |
Genentech Inc.(NYSE:DNA) |
Lucentis |
Ranibizumab; humanized antibody fragment designed to bind and inhibit VEGF-A |
Wet age-related macular degeneration |
One-year data from pivotal Phase III ANCHOR trial showed improved vision vs. Visudyne photodynamic therapy (1/14) |
Genentech |
Xolair (FDA-approved) |
Omalizumab; humanized monoclonal antibody to IgE |
Reactions to peanut allergy |
Testing was halted due to safety concerns in trials involving volunteers (1/17) |
Inspire |
INS37217 Ophthalmic |
Denufosol tetrasodium; P2Y2 receptor agonist |
Macular edema |
Discontinued two Phase II pilot trials after data from the first failed to show improvement; development was ended in retinal diseases (1/20) |
Neurotech SA* |
NT-501 |
Encapsulated cell technology used to deliver ciliary neurotrophic factor |
Dry age-related macular degeneration |
Began Phase II trial to evaluate the efficacy and safety of the CNTF implant (1/5) |
Nuvo |
Pennsaid |
Topical non-steroidal anti-inflammatory agent |
Osteoarthritis |
Phase III trial in 775 patients demonstrated statistically significant improvement in pain, physical function and overall health (1/16) |
Nymox |
NX-1207 |
Investigational agent for BPH |
Benign prostatic hyperplasia |
Monitors recommended continuation of pivotal trial after reviewing safety and efficacy data (1/23) |
PTC |
PTC124 |
Oral agent that targets nonsense mutations |
Duchenne |
Began Phase II trial to evaluate the drug in patients who have DMD due to a nonsense mutation in the dystrophin gene (1/27) |
Serono SA |
-- |
Recombinant human growth hormone |
HIV-associated adipose redistribution syndrome |
Pivotal Phase III trial in more than 300 patients met all primary and major secondary end points (1/9) |
Tranzyme |
TZP-101 |
Selective ghrelin receptor agonist |
Post-operative ileus |
Began Phase I trial to evaluate safety, tolerability and pharmaco- kinetics (1/10) |
XenoPort |
XP19986 |
Transported prodrug of R-baclofen |
Gastro- esophageal reflux disease |
Phase I trial demonstrated positive tolerability and pharmacokinetic results (1/5) |
Zonagen Inc.(ZONA) |
Androxal |
Oral antagonist designed to induce production of endogenous testosterone |
Hypogonadism |
Began Phase III trial to evaluate safety and efficacy in 200 men who are hypogonadal due to secondary hypogonadism (1/9) |
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; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; | ||||
TSE = Toronto Stock Exchange. | ||||
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