Company* |
Product | Description | Indication |
Status |
AUTOIMMUNE | ||||
Alba |
AT-1001 |
Oral zonulin receptor antagonist |
Celiac disease |
Phase Ib study met the primary endpoint of intestinal permeability (11/13) |
BioMS Medical |
MBP8298 |
Synthetic peptide |
Relapsing-remitting multiple sclerosis |
Enrolled the first patients in its Phase II trial; the 215-patient study will demonstrate the safety and efficacy over 15 months (11/27) |
Bioenvision |
Clofarabine |
Gel; next-generation purine nucleoside analogue |
Psoriasis |
Filed for authorization in Germany to start enrolling patients in two Phase I studies(11/10) |
Can-Fite |
CF101 |
Agent that targets the A3 adenosine receptor |
Rheumatoid arthritis |
Phase IIa data showed patients with a high expression of the A3 adenosine receptor achieved a significant response to CF101, while those with a low expression exhibited only a minor response (11/13) |
Centocor Inc. |
CNTO 148 |
Golimumab |
Rheumatoid arthritis |
Nearly 75% of patients with moderate to severe active disease receiving golimumab and methotrexate experienced at least a 20% improvement in arthritis symptoms at week 52 (11/13) |
CombinatoRx |
CRx-102 |
Agent containing a low dose of the steroid prednisolone with dipyridamole |
Rheumatoid arthritis |
Phase II data demonstrated statistically significant improvements on primary and secondary endpoints (11/6) |
Cytochroma |
CTA018 |
Cream; a vitamin D analogue designed as an activator of the vitamin D signaling pathway and an inhibitor of CYP24 |
Chronic plaque psoriasis |
Started recruitment in a Phase II trial (11/13) |
Genentech Inc. |
Rituxan |
Rituximab |
Rheumatoid arthritis |
Interim data from an open-label extension study in patients who had an inadequate response to previous treatment with at least one tumor necrosis factor antagonist therapy showed a large number of patients achieved ACR scores of 20, 50 or 70 after given an additional course of Rituxan in combination with methotrexate (11/13) |
Human Genome |
LymphoStat-B |
Belimumab |
Systemic lupus erythematosus |
Phase II data showed reduced disease activity, exhibited durable biological activity and appeared safe and well tolerated after 76 weeks (11/14) |
Phytomedics |
PMI-001 |
Oral, multi-mechanism botanical drug that inhibits IL-2, a-TNF, i-NOS and COX-2 gene transcription |
Rheumatoid arthritis |
Six-month Phase II trial showed a greater proportion of patients in the PMI-001 treatment group (53.3%) achieved an ACR20 response than in the sulfasalazine group (21.3%) (11/28) |
Pipex |
Coprexa |
Oral; tetrathiomolybdate; controls copper and binds to albumin |
Wilson's disease |
Phase III data showed a 26% incidence of neurological worsening in those given Syprine, compared with 4% in those given Coprexa (11/8) |
Sosei Group |
AD 452 |
N/A |
Rheumatoid arthritis |
Drug failed to meet its primary or secondary endpoints in a Phase IIb trial; company discontinued development (11/21) |
Targeted |
tgAAC94 |
Product using an adeno-associated viral vector to deliver a soluble TNF-alpha receptor protein |
Inflammatory arthritis |
Phase I/II interim data supported the safety and tolerability of intra-articular administration to affected joints in doses up to 1x10(13) DRP/mL of joint fluid (11/13) |
ZymoGenetics |
Atacicept |
Antagonist protein that binds to the TNF cytokines BLyS and APRIL |
Systemic lupus erythematosus |
Phase Ib data showed the drug was well tolerated across all dose levels and was associated with clear biologic activity as shown by dose-dependent reductions in several biologic markers (11/13) |
CANCER | ||||
Adherex |
Eniluracil |
Oral dihydropyrimidine dehydrogenase inhibitor |
Colorectal cancer |
Data showed that treatment with a single, oral dose of the drug resulted in inhibition of dihydropyrimidine dehydrogenase activity; Phase I data in solid tumors also showed that DHD was inhibited (11/8) |
Advaxis Inc. |
Lovaxin C |
Listeria-based cancer vaccine |
Advanced, recurrent or progressive cervical cancer |
Completed enrollment and dosing in a Phase I/II trial (11/7) |
AEterna |
Ozarelix |
Luteinizing hormone- releasing hormone antagonist |
Hormone- dependent inoperable prostate cancer |
Phase II demonstrated that ozarelix achieved its primary goal of determining that a dose of 130 mg administered intra-muscularly every four weeks over three months ensured continuous suppression of testosterone at castration level (11/13) |
AEterna |
AN-152 |
Cytotoxic conjugate |
Gynecological and breast cancers |
Phase I data showed the compound has a good safety profile and established the maximum tolerated dose at 267 mg/m(2), which will be used in a Phase II trial (11/27) |
Allos |
Efaproxyn |
efaproxiral |
Unresectable non- small-cell lung cancer |
Phase II data showed that patients receiving Efaproxyn exhibited superior survival co pared to those in a Phase III radiation therapy oncology group study (11/6) Phase II data showed the drug produced superior survival of 20.6 months, compared to 13.3 months in a sequential chemo- radiotherapy arm (11/10) |
Amgen Inc. |
AMG 706 |
Oral, targeted VEGF receptor inhibitor |
Gastrointestinal stromal tumors |
Phase II data demonstrated a clinical benefit rate of 27%; the median progression-free survival was 16 weeks (11/6) |
AmpliMed Corp.* |
Amplimexon |
Imexon for injection |
Advanced solid tumors |
Phase I data showed the drug was well tolerated and showed evidence of antitumor activity (11/10) |
Antisoma plc |
AS1404 |
Small-molecule vascular disrupting agent that targets the blood vessels that nourish tumors |
Non-small-cell lung cancer |
Phase II data showed that those who received AS1404 in addition to standard chemotherapy had a median survival 5.2 months longer than that of patients who received standard chemotherapy alone (11/8) |
Ariad |
AP23573 |
An mTOR inhibitor |
Metastatic or unresectable bone and soft- tissue sarcomas |
Phase II data showed that 61 patients who had clinical-benefit response had a progression- free survival rate at six months of 70% (11/2) |
ArQule Inc. |
ARQ 501 |
Activated checkpoint therapy molecule designed to selectively kill cancer cells |
Advanced solid tumors |
Phase Ib data of ARQ 501 in combination with docetaxel support previously announced findings of clinical tolerability and antitumor activity in patients who have failed prior treatments (11/9) |
ArQule Inc. |
ARQ 197 |
C-MET receptor tyrosine kinase inhibitor |
Cancer |
Phase I interim data demonstrated the drug's clinical tolerability, favorable pharmacokinetics and promising signs of anti-tumor activity (11/10) |
AVAX |
M-Vax |
AC vaccine |
Metastatic melanoma |
FDA cleared the launch of a Phase III study, which will enroll 387 patients; primary endpoints are best overall antitumor response rate and survival after two years (11/29) |
Bioniche Life |
Urocidin |
Mycobacterial cell wall- DNA complex |
Refractory bladder cancer |
Began a Phase III trial to enroll 105 patients (11/8) |
Callisto |
Atiprimod |
Orally available small molecule shown to be antiangiogenic, inhibit secretion of VEGF and IL-6, elicit an apoptotic response and inhibit Phosphorylation of key kinases |
Neuroendocrine carcinomas |
Dosed first patients in a multi-center, open-label Phase II trial (11/7); began dosing in an open-label Phase II trial (11/9) |
Cellgate Inc.* |
CGC-11047 |
A polyamine analogue designed to halt cell growth and induce apoptosis |
Metastatic hormone refractory prostate cancer |
Began Phase II trial with 40 patients (11/1) |
Cell |
Xyotax |
Paclitaxel poliglumex |
Lung cancer |
Company temporarily suspended enrollment in the PIONEER trial after a data safety monitoring board recommended the stop- page to allow the data to mature and to assess differences in early cycle deaths (11/6) |
CuraGen Corp. |
PXD101 |
Intravenous; small molecule histone deacetylase inhibitor |
Cancer |
Phase Ib data showed PXD101 was well tolerated when administered in combination with standard doses of carboplatin and paclitaxel (11/10); began Phase II trial (11/16) |
Cyclacel |
CYC682 |
Sapacitabine; oral nucleoside analogue |
Refractory solid tumors or lymphomas |
Phase I data demonstrated that the product could be administered safely to patients (11/9) |
Cyclacel |
CYC682 |
Sapacitabine; oral nucleoside analogue |
Advanced leukemias or myelodysplastic syndromes |
Phase I interim results showed that one patient treated at 275 mg twice daily had a dose- limiting toxicity, unlike the re- maining five patients at that level (11/28) |
Cytokinetics |
Ispinesib |
Small-molecule inhibitor of kinesin spindle protein |
Advanced solid tumors |
Phase Ib data of ispinesib and capecitabine demonstrated an acceptable tolerability profile, with a maximum tolerated dose determined (11/10) |
Dendreon Corp. |
Provenge |
Sipuleucel-T |
Cancer |
Phase II data demonstrated a prolongation in prostate-specific antigen doubling time (11/8) Two Phase III studies showed a prolonged survival benefit for those initially treated with Provenge who then received docetaxel after disease progression (11/10) |
EntreMed Inc. |
Panzem NCD |
2-methoxyestradiol |
Epithelial ovarian cancer |
Started Phase II trial (11/1) |
Epeius |
Rexin-G |
Gene therapy vector containing a gene that blocks the action of the cyclin G1 gene |
Chemo-resistant tumors |
Data showed an 83% progressive tumor reduction and/or necrosis in metastatic pancreatic cancer; and a 64% objective tumor response in metastatic breast, colon, uterine, muscle and vocal chord cancer (11/6) |
Exelixis Inc. |
XL999 |
Spectrum selective kinase inhibitor; targets multiple receptor tyrosine kinases |
Various cancers |
Suspended enrollment in a Phase II program due to cardio- vascular adverse events (11/1) Phase I data showed preliminary evidence of antitumor activity when administered weekly or every two weeks by intravenous infusion(11/8) |
Exelixis Inc. |
OX184 |
Small-molecule inhibitor of multiple receptor tyrosine kinases |
Advanced solid tumors |
Phase I data showed the drug was generally well tolerated, with no dose-limiting toxicities, and showed evidence of antitumor activity (11/9) |
Exelixis Inc. |
Becatecarin |
XL119; small-molecule |
Biliary tract |
Discontinued enrollment in a |
Favrille Inc. |
FavId |
Patient-specific vaccine designed to stimulate immune responses |
Follicular B-cell, non- Hodgkin's lymphoma |
Interim analysis showed the pivotal study failed to demonstrate statistical significance in response improvement, a secodary endpoint (11/13) |
|
Gamida Cell Ltd.* (Israel) |
StemEx |
Made of cord blood highly enriched with ex vivo- expanded stem cells |
leukemia and lymphoma |
Agreed on an SPA with the FDA for a Phase III study to begin in 2007 (11/2) |
Gemin X |
GX15-070 |
Small molecule designed to inhibit Bcl-2 |
Chronic lymphocytic leukemia, solid tumors, lymphomas, myelodysplastic syndrome and acute myelogenous leukemia |
Phase I data confirmed direct, dose- dependent biological activity of the drug (11/9) |
Genentech Inc. |
Herceptin |
Trastuzumab |
Breast cancer |
FDA granted a broader label allowing for its use in a treatment regimen containing doxo-rubicin, cyclophosphamide and paclitaxel (11/17) |
Genta Inc. |
Genasense |
Oblimersen sodium injection |
Relapsed or refractory chronic lymphocytic leukemia |
Phase III data showed that patients who were prospectively stratified as being non- efractory were four times more likely to achieve complete remission with Genasense as those treated with chemotherapy alone (11/8) |
Genta Inc. |
Genasense |
Oblimersen sodium |
Advanced melanoma |
Began study to evaluate Genasense in combination with Abraxane and Temodar; pilot trial will study the three-drug combination's safety, efficacy, pharmacokinetics and pharmaco- dynamics in chemotherapy- naive patients who have normal levels of serum lactate dehydro- genase (11/29) |
Genzyme Corp. |
Clolar (FDA-approved |
Clofarabine |
Acute myelogenous leukemia |
Started treating patients in a Phase II trial, a pivotal study aimed at expanding the label to include previously untreated, older adults with AML who are unlikely to benefit from standard induction therapy (11/27) |
Geron Corp. |
GRN163L |
Telomerase inhibitor |
Cancer |
Early data showed it was safe and well tolerated (11/10) |
Human Genome |
HGS-ETR1 |
Mapatumumab |
Solid tumors |
Interim Phase Ib data showed HGS-ETR1 with gemcitabine and cisplatin was well tolerated (11/8) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab |
Metastatic colorectal cancer |
Phase III data showed Erbitux met its primary endpoint of overall survival when added to best supportive care, but missed the endpoint when used with irinotecan in patients whose disease was not responding to first-line oxaliplatin-based chemotherapy(11/6) |
ImmunoGen |
huC242-DM4 |
Tumor-activated prodrug targeting the CanAg antigen |
Colorectal, pancreatic, gastric and other CanAg- expressing cancers |
Initial data from an ongoing Phase I study showed that 28 patients have received at least one dose of the compound, with no reports of clinically significant myelosuppresion (11/8) |
ImmunoGen |
huN901-DM1 |
Antibody designed to deliver DM1 to CD45- expressing cancer cells |
Relapsed small-cell lung cancer |
Phase I data showed evidence of anticancer activity; it was well tolerated (11/10) |
Infinity |
IPI-504 |
Heat shock protein 90 inhibitor |
Treatment-refractory, progressive gastrointestinal stromal tumors |
Phase I data showed positive tumor responses (11/7) |
Kosan Biosciences Inc. (KOSN) |
KOS-1584 |
Epothilone drug candidate |
Cancer |
Phase I data showed antitumor activity in 17% of heavily pre- treated patients, and in 29.5% of patients in another study (11/10) |
MethylGene Inc. |
MGCD0103 |
Histone deaceytlase inhibitor |
Advanced solid tumors |
Phase I data showed that seven of 37 patients enrolled have had stable disease beyond two cycles (11/9) |
MGI Pharma |
Gliadel Wafer (FDA-approved) |
Polifeprosan 20 with carmustine implant |
Newly diagnosed resectable, high- grade malignant glioma |
Phase II interim results of 35 patients showed a median survival of 18.6 months when Gliadel Wafer and temozolomide are used in combination with surgery and radiotherapy (11/20) |
Neopharm Inc. |
Cintredekin besudotox |
Delivered via convection- enhanced delivery followed by external beam radiation with or without concurrent temozolomide following tumor resection |
Newly diagnosed malignant glioma |
Phase I results from 22 patients showed the drug appears to be safe and well tolerated (11/20) |
Novacea Inc. |
Vinorelbine |
Microtubule inhibitor |
Cancer |
Company dropped development of oral vinorelbine (11/1) |
Novacea Inc. |
AQ4N |
Banoxantrone |
Solid tumors |
Phase I data showed it was well tolerated when administered weekly for eight weeks to 16 patients with renal cell, ovarian and non-small-cell lung cancers (11/10) |
Novelos |
NOV-002 |
Oxidized glutathione-based compound; chemoprotectant and immunomodulator |
Advanced non-small-cell lung cancer |
Began pivotal Phase III trial under an SPA; will include 840 patients, and endpoint is overall survival (11/6) |
Oncolytics |
Reolysin |
A formulation of the human reovirus |
Colorectal, bladder, prostate pancreatic, endo metrial and non- small-cell lung cancers |
Phase I data showed activity of the drug when delivered systemically (11/9) |
Oxford BioMedica |
TroVax |
Immunotherapy vaccine that delivers an antigen (5T4) using a poxvirus vector |
Advanced or metastatic renal cell carcinoma |
Began a pivotal Phase III trial called TRIST; will recruit 700 patients and show whether TroVax added to standard of care prolongs survival (11/7) |
Oxford |
TroVax |
Immunotherapy vaccine that delivers an antigen (5T4) using a poxvirus |
Renal cell carcinoma vector |
Phase II data showed the drug was well tolerated and demonstrated antitumor activity (11/9) |
OxiGene Inc. |
CA4P |
Combretastatin A4P; vascular disrupting agent |
Advanced solid tumors |
Dosed the first patient in a Phase Ib trial of CA4P in combination with Avastin (11/8) |
Pharmacyclics |
Xcytrin |
Motexafin gadolium injection |
Brain metastases from solid tumors |
Phase II data suggested that Xcytrin might improve steriotactic radiosurgery treatment planning by enhancing magnetic resonance imaging (11/9) |
Pharmacyclics |
Xcytrin |
Motexafin gadolinium injection |
Non-small-cell lung cancer with brain metastases |
Phase III data showed Xcytrin and whole-train radiation therapy significantly prolonged time to neurologic progression; company plans to file an NDA by the end of the year (11/20) |
Poniard |
Picoplatin |
Intravenous platinum agent designed to overcome platinum resistance |
Small-cell lung cancer |
Phase II interim data showed a median overall survival of 26.7 weeks in the 72 evaluable patients treated (11/6) |
Praecis |
PPI-2458 |
Oral small molecule that targets methionine amino- peptidase-2 |
Cancer |
Interim Phase I data suggested that PPI- 458 is well tolerated at doses up to 8 mg(11/8) |
Pro- |
Davanat |
Carboydrate compound designed for targeted delivery |
Colorectal cancer |
Began dosing patients in its Phase II program evaluating Davanat with Avastin, 5-fluorour- acil and leucovorin in patients with locally advanced, unresectable or metastatic disease and are unable to tolerate intensive chemotherapy (11/27) |
PTC |
PTC299 |
Orally bioavailable drug designed to modulate RNA- mediated protein expression to inhibit production of VEGF |
Cancer |
Started a Phase I study (11/7) |
Reata |
RTA 744 |
Anthracycline derivative |
Advanced primary brain |
Phase I data showed positive |
Seattle Genetics |
SGN-35 |
Antibody conjugate using |
Hodgkin's |
Started a Phase I trial with 40 |
Sonus |
Tocosol |
Formulation of paclitaxel using Sonus' vitamin |
Metastatic breast cancer |
Completed enrollment in the pivotal Phase III (11/16) |
Threshold |
Glufosfamide |
Small molecule containing a glucose molecule and an alkylator |
Pancreatic cancer |
Results are delayed in a Phase III evaluating it as a second-line treatment because the 258th death has not occurred yet (11/29) |
Vion |
Cloretazine |
Sulfonylhydrazine DNA alkylating agent |
Relapsed acute myelogenous leukemia |
Accrued 210 patients in the Phase III trial of cloretazine in combination with cytarabine (11/13) |
Ziopharm |
ZIO-201 |
A form of the active metabolite of ifosfamide |
Sarcoma |
Phase I data demonstrated evidence of clinical activity (11/3) |
Ziopharm |
ZIO-101 |
Organic arsenic agent |
Hematological cancers and solid tumors |
Phase I data showed ZIO-101 produced clinical activity over a range of doses(11/10) |
CARDIOVASCULAR | ||||
Aegerion |
AEGR-733 |
Microsomal tryglyceride transfer protein inhibitors |
Cholesterol management |
Phase II interim results of AEGR-733 with Zeltia show that patients receiving both achieved an LDL reduction of 35% after four weeks (11/15) |
Bioheart Inc.* |
MyoCell |
Adult myogenic stem cell composition and needle injection catheter |
Heart failure |
Company is expanding U.S. and European trials (11/16) |
Biopure Corp. |
Hemopure |
Hemoglobin glutamer 250 [bovine] |
Trauma |
An independent data and safety monitoring board recommended the Phase II trial continue (11/7) |
Corautus |
VEGF-2 |
Vascular endothelial growth factor in the form of naked plasmid DNA |
Cardiovascular and peripheral vascular disease |
Company does not plan to continue development after it missed its endpoint in the GENASIS trial (11/6) |
Dyax Corp. |
DX-88 |
Ecallantide |
Hereditary angioedema |
Findings from a 77-patient study demonstrated clinical response at or before four hours for all dose levels of the drug (11/14); completed the double-blind portion of its pivotal Phase III trial, EDEMA3(11/21) |
EPIX |
EP-2104R |
Fibrin-binding thrombus imaging agent |
To detect blood clots |
Phase IIa data showed the product was able to detect blood clots not previously seen on magnetic resonance imaging (11/29) |
Karo Bio AB |
KB2115 |
Compound that stimulates the thyroid hormone receptor |
Dyslipidemia |
Began a Phase II study with 100 patients (11/1) |
Ligand |
LGD 4665 |
Oral, small-molecule drug designed to mimic the activity of thrombopoietin |
Idiopathic thrombocytopenia purpura and other indications |
Started Phase I trials (11/30) |
Medicure Inc. |
MC-1 |
Cardioprotectant |
Heart attack patients under- going coronary artery bypass graft surgery |
Began enrolling patients in a pivotal Phase III study (11/17) |
MediQuest |
Vascana |
Non-systemic topical application |
Raynaud's disease |
Phase IIIa data showed that two different doses produced a significant improvement in blood flow compared to placebo (11/14) |
NovaCardia |
KW-3902 |
An adenosine A1 receptor antagonist |
Congestive heart failure |
Phase II data showed the drug provided an increase in glomerular filtration rate of 32.1% over baseline compared to an 8.3% increase with placebo over an eight-hour period (11/14) |
Pervasis |
Vascugel |
An allogeneic cell therapy |
To maintain vascular patency |
Reported successful safety re- sults of two Phase I trials evalu- ating Vascugel in patients with arteriovenous access fistulas and arteriovenous access grafts for dialysis treatment of end- stage renal disease (11/15) |
Surface Logix |
SLx-4090 |
Enterocyte-specific microsomal triglyceride transfer protein inhibitor |
Dyslipidemia |
Phase I data were positive (11/14) |
CENTRAL NERVOUS SYSTEM | ||||
Anesiva Inc. |
Zingo |
Needle-free system that delivers lidocaine powder into the epidermis of the skin and provides analgesia in one to three minutes after administration |
Pain from venous access procedures in children |
Filed an NDA; will begin a follow-on trial in adults in early 2007 (11/27) |
Antipodean |
MitoQ |
Mitoquinone |
Parkinson's disease |
Completed enrollment in a Phase II study (11/27) |
AVI BioPharma |
Neugene |
Antisense drugs |
Central nervous system disorders |
Data of three drugs entered the cerebral spinal fluid of healthy male volunteers following a single 100-mg dose via intra- venous or subcutaneous injections (11/10) |
BioAxone |
Cethrin |
Agent targeting Rho GTPase signaling; believed to have neuroprotective properties |
Acute spinal cord injury |
Phase I/IIa data showed the treatment is safe and well tolerated when administered at four dose levels 0.3 mg, 1 mg, 3 mg and 6 mg and that the functional benefit might be dose dependent (11/27) |
Celtic |
Xerecept |
Corticorelin acetate injection |
Peritumoral brain edema |
An open-label extension study of a Phase III program showed that, of 20 subjects, 11 had reduced their dexamethasone dosage during the four-week study, and two took no concomitant dexamethasone (11/17) |
Corcept |
Corlux |
Mifepristone |
Psychotic major depression |
Completed patient enrollment of 441 patients, the third of three Phase III trials (11/13) |
Evotec AG |
EVT 201 |
Agent that acts on GABA-A receptors |
Chronic primary insomnia and daytime sleepiness |
Started a second Phase II study in 135 elderly patients (11/17) |
Genzyme Corp. |
Synvisc |
Hylan G-F 20 |
Osteoarthritis of the knee |
Preliminary results indicate that Synvisc-treated patients achieved a statistically significant improvement in pain over 26 weeks compared to placebo (11/30) |
Memory |
MEM 1003 |
Neuronal L-type calcium channel modulator |
Acute mania in bipolar disorder |
Completed enrollment in its Phase IIa trial with 80 subjects (11/27) |
Metabolic |
ACV1 |
Inhibitor of neuronal nicotinic acetylcholine receptors; dervied from Australian cone snail |
Neuropathic sciatic pain |
First group of patients started treatment in the Phase IIa trial (11/29) |
Neurochem |
Alzhemed |
Tramiprosate, or 3- amino-1-propanesulfonic acid |
Alzheimer's disease |
Phase II data showed the drug had no significant impact on vital signs and laboratory test values (11/3); data safety monitoring boards recommended Phase III trials continued in Europe and North America (11/6) |
Neurogen |
MK-2295 |
Part of the vanilloid receptor-1 program |
Postoperative dental pain |
Began a Phase II trial (11/1) |
Ovation |
Clobazam |
N/A |
Lennox-Gastaut syndrome |
Phase II data from 68 patients showed a significant difference between the treatment groups in the percent reduction in weekly seizures from baseline to maintenance period, and more than 83% of patients in the high-dose group had a 50% or greater reduction in weekly drop seizures rate from baseline (11/13) |
Pain |
PTI-202 |
Oral; long-acting, abuse- resistant opioid agent |
Chronic pain |
Phase I data showed a single, oral dose was safe and well tolerated in healthy volunteers (11/29) |
Pharmos Corp. |
NanoEmulsion |
Topical drug delivery technology formulated with diclofenac |
Inflammation |
Phase I data showed the drug was well tolerated with no severe or serious adverse events (11/14) |
Santhera |
SNT-MC17 |
Idebenone; small molecule optimized to facilitate the transport of electrons within mitochondria |
Friedreich's ataxia |
Data in 48 subjects supported the safety and tolerability of the drug at doses up to 2,250 mg per day (11/13) |
Somaxon |
Silenor |
Dexepin HCl |
Insomnia |
Data from its third Phase III trial showed the drug demonstrated a statistically significant improvement compared to placebo in subjective total sleep time, as measured at one week (11/20) |
Targacept Inc. |
|
Mecamylamine hydrochloride |
Major depression |
Phase II data showed patients receiving mecamylamine in combination with citalopram demonstrated greater improvement on symptoms of depression over citalopram alone (11/9) |
TorreyPines |
NGX426 |
Oral prodrug of tezampanel |
Acute migraine and chronic pain |
Phase I data showed the drug was well tolerated and rapidly converted to tezampanel at all doses tested (11/2) |
Valera |
VP004 |
Subcutaneous implant that uses its Hydron technology to deliver naltrexone |
Opioid addiction |
Began an open-label clinical study with 12 healthy volunteers (11/6) |
Vanda |
VEC-162 |
Melatonin receptor agonist |
Transient insomnia |
Drug hit statistical significance at all three doses in the primary endpoint of latency to persistent sleep in a Phase III trial (11/15) |
DIABETES | ||||
Amylin |
Byetta |
Exenatide |
Type II diabetes |
European commission granted marketing authorization for Byetta as adjunctive therapy to improve blood sugar control (11/21) |
Avanir |
Zenvia |
Oral combination of dextro- methorphan and an enzyme inhibitor, quinidine |
Diabetic neuropathy |
Enrolled targeted number of patients, 380, in a Phase III trial (11/15) |
Emisphere |
|
Oral insulin product that employs Emisphere's oral delivery technology |
Diabetes |
Phase II results showed the high dose of oral insulin, 10 mg QID, had the most profound effect on HbA1c reduction (11/8) |
FibroGen Inc.* |
FG-3019 |
Fully human monoclonal antibody against connective tissue growth factor |
Type I and II diabetes and and microal- buminuria |
Phase Ib data demonstrated that the drug was well tolerated, with no dose-limiting toxicities observed (11/17) |
Generex |
Oral-lyn |
Oral insulin spray |
Type I diabetes |
Data showed that Oral-lyn and mealtime injections of regular insulin achieved near normalization of metabolic control parameters as reflected by continous improvement in fructosamine and HbA1c concentrations (11/28) |
Sangamo |
SB-509 |
Injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor |
Diabetes |
Started a 100-patient trial to test the safety and efficacy in patients with mild to moderate diabetic peripheral sensory motor neuropathy in the legs (11/29) |
INFECTION | ||||
Accentia |
SinuNase |
Intranasal lavage of 0.01% amphotericin B |
Severe chronic sinusitis refractory to sinus surgery |
Began patient enrollment for the Phase III; will include 300 patients (11/6) |
Alnylam |
ALN-RSV01 |
RNAi therapeutic |
Respiratory syncytial virus |
Started a human study to establish a safe and reliable RSV infection of the upper respiratory tract; will then begin a trial of ALN- RSV01 (11/28) |
Arpida Ltd.* |
Iclaprim |
Capsule formulation of broad- pectrum antibiotic |
Skin and skin structure infections |
Phase III data showed clinical cure rates of 85.5% for iclaprim and 91.9% for Pfizer Inc.'s Zyvox, indicating statistical nonin- feriority (11/30) |
Debiopharm |
Debio-025 |
Cyclophilin inhibitor |
HIV/HCV |
Phase Ib data in treatment-naive, co- nfected patients demonstrated that the product was absorbed rapidly, with peak plasma levels reached after two hours and a terminal life of 100 hours (11/2) |
Dynavax |
Heplisav |
Vaccine based on the company's immunostimulatory sequence that specifically targets Toll-like receptor 9 |
Hepatitis B virus |
Phase III data showed a statistically significant difference in the primary endpoint, seroprotection four weeks after the third immunization; the analysis showed that 100 percent of Heplisav- treated subjects achieved sero-protection compared to 73.1% of those vaccinated with Engerix-B (11/29) |
Enzon |
rhMBL |
Recombinant human man- nose-binding lectin |
Severe infections in patients with low levels of MBL |
Trials in patients with multiple myeloma and those undergoing liver transplant treatment will begin later this year (11/2) |
Helix |
|
Topical interferon-alpha-2b |
Human papillomavirus infection |
Completed enrollment in a Phase II trial in women with low-grade squamous intraepithelial lesions (11/15) |
InSite Vision |
AzaSite Plus |
ISV-502; a combination of azithromycin and dexamethasone in DuraSite |
Ocular treatment in which inflammation and bacterial infection are present |
Started a Phase I safety trial (11/8) |
Lux |
LX211 |
Next-generation calcineurin inhbitor |
Uveitis |
A 30-day waiting period for its IND application has elapsed, and the company will begin pivotal clinical trials early in 2007; trials will enroll more than 500 patients (11/28) |
Maxygen Inc. |
Maxy-alpha |
PEGylated interferon alpha variant created through the use of Maxygen's MolecularBreeding directed molecular evolution technologies |
Hepatitis C virus |
Started a Phase Ia trial (11/7) |
MedImmune |
Numax |
Motavizumab; third- generation variant of the anti-RSV antibody Synagis |
Respiratory syncytial virus |
Phase III data showed it met its primary endpoint of non-inferiority by reducing the incidence of hospitalizations caused by RSV in infants by 26% compared to Synagis, the company's marketed drug (11/6) |
Migenix Inc. |
MX-3253 |
Oral alpha-glucosidase inhibitor, celgosivir |
Chronic hepatitis C virus |
Top-line Phase II data demonstrated proof of concept and evidence of clinical benefit when used in combination with pegylated interferon and ribavirin (11/6) |
Transgene SA |
TG 4001 |
Therapeutic vaccine |
Cervical intraepithelial neoplasia (CIN2/3) |
Phase II data showed that 10 of 21 patients had no more CIN2/3 or any human papillomavirus 16 mRNA detected (11/14) |
MISCELLANEOUS | ||||
AEterna |
Cetrorelix |
Luteinizing hormone- releasing hormone antagonist |
Benign prostatic hyperplasia |
Plans to begin a Phase III program before the end of the year; two studies will involve 600 and 300 patients, respectively (11/29) |
Altus |
ALTU-238 |
Long-acting, crystalline formulation of recombinant human growth hormone |
Growth- hormone deficiency |
Phase II data supported a once- a-week dosing regimen (11/13) |
Altus |
ALTU-135 |
Oral enzyme replacement therapy |
Cystic fibrosis |
Plans to start a Phase III trial in CF patients with pancreatic insufficiency in the second quarter (11/15) |
Anacor |
ANO128 |
Topical anti-inflammatory |
Atopic dermatitis |
Started dosing patients in a Phase IIb study; will enroll 200 patients (11/9) |
Aradigm Corp. |
HCQ |
Inhaled hydroxychloroquine |
Moderate- persistent asthma |
A Phase IIa trial did not meet the efficacy endpoints (11/20) |
Auxilium |
AA4500 |
Injectable enzyme product |
Dupuytren's contracture |
First patients were dosed in the second Phase III pivotal trial and the first Phase III study outside the U.S. (11/20) |
BioMimetic |
GEM OS1 |
For bone grafts |
Foot and ankle fusions |
Interim results of the orthopedic trial in Canada showed that 85% of patients had some degree of fusion by 12 weeks, and 67% achieved greater than 50% osseous bridging (11/6) |
Cellgate Inc.* |
CGC-11047 |
A polyamine analogue that targets the hyper-proliferating blood vessel growth |
Age-related macular degeneration |
Began a Phase I study (11/8) |
Cytos |
CYT009- rQb |
Therapeutic vaccine designed to produce a specific anti-ghrelin response |
Obesity |
Failed to meet primary endpoint of weight loss in a Phase I/II study; company will not develop it further for obesity (11/7) |
Dynavax |
Tolamba |
ISS molecule linked to Amb a- 1, the major allergen of ragweed |
Ragweed allergy |
Phase IIb data showed Tolamba reaped benefit regardless of the severity of a patient's disease (11/13) |
Genzyme Corp. |
Thymo- globulin |
Anti-thymocyte globulin |
Kidney transplant |
Patients undergoing induction therapy showed a significantly reduced risk of acute rejection, acute rejection requiring anti- body therapy and delayed graft function, graft loss and death when treated with Thymoglobulin compared with patients receiving basiliximab (11/9) |
Halozyme |
Enhanze molecules |
Enzyme-based drug delivery platform based on recombinant human |
To enhance absorption of large PH20 hyaluronidase |
Completed enrollment of a clinical trial(11/27) |
Inflazyme |
IPL512,602 |
Leukocyte-selective anti- inflammatory agent |
Moderate to severe asthma (11/9) |
Completed patient enrollment in its Phase IIb trial of 218 patients |
Inspire |
Denufosol |
Inhalation solution |
Cystic fibrosis |
Phase II data showed that both the 20-mg and 60-mg doses given three times daily were well tolerated with a safety profile similar to placebo (11/3) |
Isotechnika Inc. |
ISA247 |
Immunosuppressive drug |
Kidney transplant |
Phase IIb data showed an 8% rate of acute rejection with ISA247 compared to a 14% rate in the tacrolimus group (11/16) |
Manhattan |
Oleoylestrone |
Oral, synthetic form |
Obesity |
Company is adding sites for its Phase IIa trial with about 100 obese adults (11/8) |
MediciNova Inc. |
MN-001 |
Oral; small-molecule inhibitor of inflammatory mechanisms involved in asthma |
Bronchial asthma |
Started Phase III program with a 12-week trial of 700 patients (11/16) |
Neurogen Corp. |
NGD-4715 |
Antagonist of the melanin- concentrating hormone receptor-1 |
Obesity |
Started Phase I trials (11/13) |
Osiris |
Prochymal |
Adult stem cell therapy |
Graft-vs.-host disease |
Phase II data showed that 94% of evaluable patients responded after two intravenous infusions, and 74% had a complete response (11/9) |
Palatin |
Bremelanotide |
Melanocortin receptor agonist |
Erectile dysfunction |
Phase IIb data showed that four of the five doses evaluated had clinically and statistically significant changes in the primary efficacy endpoint (11/6) |
PTC |
PTC124 |
Oral agent that targets nonsense mutations |
Cystic fibrosis |
Phase II data suggested that PTC124 can restore function of the cystic fibrosis transmembrane conductance regulator protein in airway cells and significantly reduce blood neutrophil counts (11/3) |
Sepracor Inc. |
Xopenex HFA |
Levalbuterol tartrate inhalation aerosol |
Data demonstrated that both albuterol systemic exposure and consequent beta- mediated adverse events were reduced following cumulative dosing of the drug compared to cumulative dosing with racemic albuterol HFA MDI (11/13) |
|
TargeGen |
TG100801 |
Small-molecule topically applied multi-targeted kinase inhibitor |
Macular degeneration |
Started a Phase I trial with 45 subjects (11/1) |
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; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TEL = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange. | ||||
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