Company* |
Product |
Description |
Indication |
Status |
AUTOIMMUNE | ||||
Active |
ABR- 224050 |
Oral inhibitor of dihydroorotate dehydrogenase |
Rheumatoid arthritis |
Completed microdosing study in human volunteers; they plan to conduct further preclinical testing before additional Phase I trials, which are expected to begin in 2008 (3/13) |
Alba |
AT-1001 |
Orally administered zonulin receptor antagonist |
Celiac disease |
Completed enrollment and dosing of patients in its Phase IIa trial(3/8) |
Cytochroma Inc.* |
CTA018 |
Cream; vitamin D analogue |
Chronic plaque psoriasis |
Completed enrollment in a Phase II trial with 147 subjects (3/6) |
La Jolla |
Riquent |
Abetimus sodium; B-cell toleragen |
Systemic lupus erythematosus |
Phase III data indicated patients treated with 900 mg or 300 mg of Riquent per week had greater reductions in antibodies to double-stranded DNA than patients treated with 100 mg per week or placebo (3/8) |
Medarex Inc. |
MEDI-545 |
A fully human monoclonal antibody targeting interferon-alpha |
Psoriasis |
Started a Phase I trial (3/23) |
Ocera |
AST-120 |
Oral spherical adsorptive carbon |
Crohn's disease |
Met the 50% enrollment target in a 240-patient pivotal trial (3/26) |
| CANCER | ||||
Abraxis |
ABI-008 |
An albumin-bound chemotherapeutic; nabdocetaxel |
Hormone-refractory prostate and metastatic breast cancer |
Will begin enrollment in two Phase I/II trials in the second quarter (3/21) |
Adherex |
ADH-1 |
Cadherin antagonist; small peptide, tumor/vascular- targeting agent |
Melanoma |
Started a Phase I trial of systemic ADH-1 plus isolated limb infusion melphalan (3/27) |
Aeolus |
AEOL 10150 |
Small-molecule catalytic antioxidant |
To protect healthy cells in radiation therapy |
Phase I data showed it was safe and well tolerated at doses up to 2 mg/kg/day (3/22) |
Amgen Inc. |
Vectibix (FDA- |
Panitumumab; fully human monoclonal antibody directed against the epidermal growth factor receptor |
Colorectal cancer |
Company stopped a Phase III trial of Vectibix as a first-line treatment due to a lack of efficacy and toxicity concerns (3/23) |
Antisoma plc |
AS1404 |
Small molecule derived from xanthenone acetic acid; vascular disrupting agent |
Non-small-cell lung cancer |
A second, confirmatory Phase II trial of AS1404 in combination with carboplatin and paclitaxel chemotherapy showed a response rate of 50% in 30 patients; 43% of patients had disease stabilization, while only 7% had progressive disease (3/8) |
BioCryst |
Fodosine |
Forodesine; ; blocks an enzyme called purine nucleoside phosphorylase |
T-cell acute lymphoblastic leukemia/ lymphoma |
Company is backing off development for an intravenous formulation due to lack of benefits; also, a stability problem prompted the company to suspend a Phase IIb study (3/27) |
Celldex |
|
Vaccine targeting an epidermal growth factor receptor variant, or EGFRvIII |
Glioblastoma |
Company is sponsoring a Phase II trial that will enroll 81 patients whose tumors produce the altered protein(3/22) |
Chemokine |
CTCE-9908 |
Chemokine CXCR4 antagonist |
Ovarian cancer |
Phase Ib/II data showed no dose-limiting toxicities and two of three patients responded positively and exhibited stable disease (3/12) |
Chroma |
CHR-2798 |
Oral inhibitor of aminopeptidases |
Refractory acute myeloid leukemia |
Entered its first Phase II trial in elderly patients (3/26) |
Ciphergen |
Ovarian triage test |
Diagnostic |
To detect ovarian cancer |
Data demonstrated it correctly identified 84% of the ovarian cancer cases, compared to only 33% identified using standard diagnosis methods (3/5) |
CuraGen Corp. |
PDX101 |
Belinostat, a small- molecule histone deacetylase inhibitor |
Multiple myeloma |
Began patient dosing in a Phase II trial of PDX101 in combination with Velcade; the study is expected to enroll up to 35 patients (3/27) |
Cytogen Corp. |
Quadramet |
Samarium Sm-153 lexidronam injection |
Hormone-refractory prostate cancer |
Started a Phase II trial of Quadramet in combination with the NIH's targeted therapeutic vaccine PSA-TRICOM (3/1) |
EntreMed Inc. |
Panzem |
2-methoxyestradiol or 2ME2 |
Metastatic renal cell carcinoma |
Began a Phase II trial of Panzem alone and in combination with Sutent (3/6) |
Enzon |
EZN-2968 |
A Hypoxia-inducible factor-1 alpha or HIF-1 alpha antagonist |
Advanced solid tumors or lymphoma |
First patient was enrolled in an open-label, non- andomized study (3/29) |
Erimos |
EM-1421 |
Terameprocol; a small molecule designed to prevent the production and activation of survivin |
Recurrent high-grade glioma brain tumors |
Began dosing patients in a Phase I/II study (3/26) |
GPC Biotech AG |
Satraplatin |
Oral platinum compound |
Refractory cancer |
Phase III data showed that pain response rates for patients treated with satraplatin plus prednisone (24.2%) were statistically superior compared to the pain response rates for patientsin the placebo arm (13.8%) (3/22) |
Hana Biosciences |
Talvesta |
Talotrexin for injection; nonclassical antifolate; analogue of aminopterin |
Solid tumors |
Discontinued a Phase I trial due to toxicity issues, specifically leukoencephalopathy (3/23) |
MAT Biopharma* |
Ferritarg P |
A 90 Yttrium radio-labeled rabbit polyclonal antibody |
Relapsed or refractory Hodgkin's disease |
Began an escalating-dose Phase I/II study (3/7) |
Maxygen |
MAXY-G34 |
Pegylated form of granulocyte- olony stimulating factor |
Chemotherapy-induced anemia |
Phase I trial in 40 healthy volunteers showed dose-responsive potency in neutrophil generation as measured by neutrophil count and CD34+ stem cells (3/14) |
Myriad Genetics |
Azixa (MPC-6827) |
Believed to have a dual mode of action as a cytotoxin and a vascular disrupting agent |
Brain cancer |
Started the first Phase II trial (3/8) |
Myriad Genetics |
Azixa (MPC-6827) |
Believed to have a dual mode of action as cytotoxin and a vascular disrupting agent |
Metastatic brain cancer |
Started a Phase II trial in patients with melanoma that has spread to the brain (3/27) |
Neoprobe Corp. |
Lymphoseek |
A radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure called intraoperative lymphatic mapping |
For use in melanoma or breast cancer |
Company is moving into the second stage of a Phase II trial, which will involve an additional 40 patients with melanoma or breast cancer (3/5) |
Neose |
NE-180 |
Pegylated form oferythropoietin |
Anemia in cancer patients |
Got an OK from the FDA to begin clinical trials in the U.S. (3/15) |
Neose |
GlycoPEG-GCSF |
Long-acting granulocyte colony stimulating factor |
Neutropenia associated with cancer chemo-therapy |
Started the second Phase I trial (3/21) |
Nektar |
NKTR-102 |
Pegylated, small-molecule formulation of the cancer drug irinotecan |
Refractory solid tumors |
Began Phase I trial to evaluate safety, tolerability and pharma- cokinetics in up to 30 patients (3/13) |
Peregrine |
Bavituximab |
A monoclonal antibody designed to target and bind to phosphatidylserine |
Advanced cancer |
Completed enrollment of the planned 12 evaluable patients in its Phase Ib trial of bavituximab in combination with common chemotherapy (3/22) |
Point |
Talabostat |
A pan-inhibitor of dipeptidyl peptidase enzymes |
Non-small-cell lung cancer; pancreatic cancer |
Phase III trial of talabostat plus Taxotere is behind schedule; Phase II data of talabostat plus Gemzar in pancreatic cancer patients will not meet its primary endpoint (3/1) |
Protherics plc |
OncoGel |
A formulation of paclitaxel for local administration |
For surgical removal of tumors in patients with recurrent glioblastoma multiforme |
Enrolled the first patient in a study that will enroll 36 total (3/27) |
Semafore |
SF1126 |
P13 kinase inhibitor |
Solid tumors |
Started a Phase I trial (3/26) |
Sunesis |
SNS-032 |
A selective, small-molecule inhibitor of cyclin-dependent kinases 2, 7 and 9 |
Advanced B-cell malignancies |
Began dosing in a Phase I trial (3/6) |
Transgene |
TG 1042 |
Adenoviral vector containing the human interferon gamma gene |
Relapsing cutaneous B-cell lymphoma |
Began first stage of Phase II trial that will evaluate regression, disappearance of lesions, safety and quality of life in 13 patients in the U.S. and Europe (2/14) |
Xanthus |
Clomet |
DMPEN, 4-demethylpen- clomedine |
Solid tumors |
Began a Phase I dose-escalation study (3/22) |
CARDIOVASCULAR | ||||
AtheroGenics |
AGI-1067 |
Oral agent designed to inhibit the production of VCAM-1 and other molecules in the inflammatory process |
Atherosclerosis |
Phase III ARISE trial in more than 6,100 patients failed to show significance vs. placebo in reducing a composite of major adverse cardiovascular events; it did meet secondary endpoints (3/19) |
CV |
Ranexa (FDA- approved) |
Ranolazine; partial inhibitor of fatty-acid oxidation |
Angina |
After missing its primary endpoint, the company believes positive safety data will support use in frontline angina treatment but no longer plans to seek approval for acute coronary syndrome (3/7) |
Diffusion |
Trans sodium crocetinate |
Agent designed to enhance the diffusion of oxygen into tissue |
Oxygen- deprivation diseases |
Began Phase I trial to evaluate pharmacokinetics and tolerability in 48 healthy volunteers (3/16) |
Inotek |
INO-1001 |
Inhibitor of the nuclear cell death enzyme poly (ADP-ribose) polymerase |
Cardiac reperfusion injury |
Phase II data demonstrated its safety and its potential as a preventative agent; the trial was conducted in 40 subjects (3/27) |
Isis |
ISIS 301012 |
Second-generation antisense drug designed to inhibit apoB-100 |
Homozygous familial hyperholest-erolemia |
Phase II data showed a significant lipid-lowering activity; the product was safe and well tolerated (3/26) |
KAI |
KAI-9803 |
An isozyme-selective delta protein kinase C inhibitor |
To reduce injury associated with heart attack |
Phase I/II data showed it may reduce damage to the heart and improve cardiac function in heart attack patients undergoing balloon angioplasty (3/26) |
Liponex Inc. |
CRD5 |
Works by increasing the synthesis and secretion of apoliprotein A-I |
Dyslipidemia |
Phase I/II data showed it failed to significantly increase high density lipoprotein (HDL) (3/8) |
InterMune Inc. |
Actimmune |
Interferon gamma-1b |
Idiopathic pulmonary fibrosis |
Company scrapped the Phase III trial after an independent data monitoring board found lack of survival benefit compared to placebo (3/6) |
Osiris |
Provacel |
Adult stem cell product |
Heart attack |
A 53-patient study established safety and showed that patients had significantly lower rates of adverse events and significant improvements in heart, lungand overall condition (3/26) |
Pervasis |
Vascugel |
Allogeneic cell therapy designed to restore natural repair and regenerationpathways in the vasculature |
Vascular patency |
Began two Phase II trials to evaluate safety and benefit for the maintenance of vascular patency after creation of arteriovenous access graft and AV fistula for patients undergoing dialysis for end-stage renal disease (3/19) |
Scios Inc. |
Natrecor |
Nesiritide; recombinant B-type natriuretic peptide |
Persistently symptomatic chronic decompensated heart failure |
A 920-patient Phase II study showed a neutral effect on the primary endpoint, a composite of death and cardiorenal hospitalization at 12 weeks (3/26) |
Symphogen A/S* |
Sym001 |
Recombinant, polyclonal antibody, which is comprised of 25 different anti-Rhesus D antibodies |
Idiopathic thrombocyto-penic purpura and to prevent hemolytic disease in newborns |
Began a Phase I trial to test the safety, pharmacokinetics and pharmacodynamics in healthy volunteers (3/12) |
The Medicines |
Angiomax |
Bivalirudin; direct thrombin inhibitor |
Acute coronary syndrome |
One-year findings from the ACUITY trial show that those receiving Angiomax had similar rates of ischemic clinical outcomes compared with more complicated standard therapy (3/26) |
| CENTRAL NERVOUS SYSTEM | ||||
Acadia |
ACP-103 |
Selective 5-HT2A inverse agonist |
Schizophrenia |
Phase II co-therapy trial with anti-psychotic agents in 423 patients demonstrated a statistically significant reduction as measured by a syndrome scale; secondary endpoints also were met (3/19) |
Alexza |
AZ-001 |
Aerosol version of the intravenous drug prochlorperazine; delivered with Alexza's Staccato device |
Migraine |
Phase IIb data showed all doses of the drug hit the primary end- point of two-hour pain relief compared to placebo (3/26) |
Alkermes Inc. |
ALKS 29 |
Oral compound |
Alcohol dependence |
Completed enrollment in a Phase I/II trial (3/6) |
Allon |
AL-108 |
An intranasally formulated eight amino acid neuro-protective peptide based on NAP |
Alzheimer's disease; schizophrenia |
Phase Ib trial confirmed AL-108 was safe and well tolerated in 32 healthy elderly subjects after seven days of dosing (3/7); plans to start a Phase II in schizophrenia-related cognitive impairment (3/27) |
Anesiva Inc. |
Zingo |
A needle-free system that delivers lidocaine powder into the skin via compressed gas |
Pain |
Began a Phase III trial testing Zingo's pain relief in those undergoing peripheral venous access procedures, such as intravenous line placements and blood draws (3/28) |
Arena |
APD125 |
Selective inverse agonist for 5-HT2A receptors |
Chronic insomnia |
Started dosing in a 100-patient Phase II trial of APD125 (3/5) |
Avicena |
PD-02 |
Ultra-pure form of creatine designed to boost production of ATP, or adenosine triphosphate |
Parkinson's disease |
NIH started a Phase III trial with more than 1,720 patients (3/22) |
Avigen Inc. |
AV650 |
Tolperisone; oral agent approved in the EU for treating spasticity and muscle spasms |
Spasticity |
Got OK to start Phase II trial that will assess safety, tolerability, lack of sedation and initial efficacy in spinal cord injury patients suffering from spasticity (3/14) |
Biogen Idec Inc. |
Daclizumab (FDA-approved as Zenapax) |
Humanized monoclonal antibody; interleukin-2 receptor antagonist |
Relapsing multiple sclerosis |
Phase II met its primary endpoint in patients being treated with interferon beta; they showed a significant reduction in the number of new or enlarged gadolinium-contrast-enhancing lesions at week 24 (3/12) |
CeNeRx |
Tyrima |
Has a triple mechansim of action; reversible inhibitor of monoamine oxidase A |
Depression and anxiety |
Phase I trial in 41 subjects demonstrated safety and tolerability; the drug achieved high plasma levels (3/13) |
Clinical Data |
Vilazodone |
Designed as a selective serotonin reuptake inhibitor and a 5HTIA partial agonist |
Depression |
Completed enrollment in a pivotal Phase III study with 410 patients (3/26) |
Corcept |
Corlux |
Mifepristone; oral GR II antagonist with potential mitigating effects on cortisol |
Psychotic major depression |
The last of three Phase III trials failed to meet its primary endpoint (3/20) |
Depomed Inc. |
Gabapentin GR |
An extended-release formulation of gabapentin formulated with Depomed's AcuForm delivery technology |
Postherpetic neuralgia |
Completed patient enrollment in its pivotal Phase III trial with 407 patients (3/8) |
Encysive |
TBC3711 |
A next-generation, highly selective endothelin receptor antagonist |
Resistant hypertension |
First patient has been enrolled in its Phase II dose- manging study (3/21) |
EPIX |
PRX-00023 |
Selective 5-HTIA partial agonist |
Adults with major depressive disorder and an additional diagnosis of anxiety |
Started a Phase IIb trial (3/29) |
Evotec AG |
EVT 302 |
A monoamine oxidase B enzyme |
For smoking cessation |
Started a Phase I study (3/22) |
LAB |
Fentanyl Taifun |
A fast-acting fentanyl formulation delivered using the company's Taifun dry-powder inhaler platform |
Breakthrough pain |
Phase IIb data from 24 patients showed successful dose titration resulting in effective control of pain episodes (3/5) |
MAP |
Tempo Migraine |
An inhaled formulation of dihydroergotamine |
Migraine pain |
It met its primary endpoints in a Phase II program, showing it was well tolerated in those with impaired pulmonary function (3/1) |
MediciNova |
MN-166 |
Works by inhibiting leukotriene activity, phosphodiesterases and nitric oxide synthase |
Relapsing multiple sclerosis |
Phase II data in 297 patients showed the compound did not hit the primary endpoint of reducing the number of lesions on cranial MRI scans, but positive indicators did show up in radiological outcome measures; an independent data safety monitoring board recommended the trial continue (3/27) |
Memory |
MEM 1003 |
Calcium channel modulator |
Bipolar disorder |
MEM 1003 failed to demonstrate efficacy in treating acute mania in patients with bipolar disorder in an 84- patient Phase IIa study (3/5) |
Memory |
MEM 3454 |
Nicotinic alpha-7 receptor partial agonist |
Alzheimer's disease |
Began Phase IIa trial to evaluate safety, tolerability and cognitive effects of three doses vs. placebo in 80 subjects with mild to moderate AD |
MGI Pharma |
Aquavan |
Fospropofol disodium |
Sedative used during bronchoscopy |
Pivotal study met its primary endpoint (3/20) |
Myriad Genetics |
Flurizan |
First in a new class of drugs known as Selective Amyloid Lowering Agents |
Alzheimer's disease |
Phase II data showed that overall, 42% of patients on Flurizan had improvement or no decline in one or more of three primary end- points, cognition, global function and activities of daily living, compared to 10% for the placebo group (3/5); completed enrollment of more than 800 patients in its global Phase III trial (3/20) |
Pharmacopeia |
PS386113 |
Compound that addresses immunoregulation |
Inflammatory disease |
Started a Phase I trial (3/28) |
Pozen Inc. (POZN) |
PA 325 |
A formulation of 325 mg of aspirin surrounded by a 20-mg coating of an immediate release formulation of a proton pump inhibitor |
Pain |
A proof-of-concept, 80-subject study demonstrated a statistically significant benefit on gastrointestinal damage over aspirin (3/6) |
Talecris Bio- |
Plasmin |
Locally acting fibrin-binding thrombolytic derived from human plasma |
Acute peripheral arterial occlusion |
Enrolled the first patient in its Phase I/II trial (3/20) |
TorreyPines |
NGX267 |
A functionally selective muscarinic receptor agonist |
Cognitive impairment associated with schizophrenia |
Began a Phase I trial of NGX267 given once daily for four days to healthy male volunteers (3/12) |
Xytis |
Anatibant |
Selective, small-molecule bradykinin B2 receptor antagonist |
Traumatic brain injury |
Began Phase II trial that will evauate safety, tolerability, mortality and functional improvments in 400 patients in nine countries (3/13) |
YM |
AeroLEF |
Inhaled-delivery composition of free and liposome- encapsulated fentanyl |
Moderate to severe post-surgical pain |
Enrollment has been completed in a Phase IIb trial (3/6) |
| DIABETES | ||||
DiObex Inc.* |
DIO-902 |
A cortisol synthesis inhibitor; 2S, 4R ketoconazole |
Type II diabetes |
Phase IIa trial showed significant reductions in total and LDL cholesterol, as well as trends toward an improvement in glycemic control, in all doses vs. placebo(3/26) |
Phenomix Corp.* |
PHX1149 |
An orally administered inhibitor of the serine protease DPP4 |
Type II diabetes |
Completed a Phase IIa trial, which met its primary endpoint of improved postprandial glucose as well as secondary endpoints related to HbA1c and GLP-1 levels (3/5) |
Transition |
E1-I.N.T. |
Combination of epidermal growth factor analogue and gastrin analogue |
Type II diabetes |
Interim Phase IIa data showed that E1-I.N.T. significantly lowered blood glucose levels for patients using metformin with or without thiazolidine-diones (3/5) |
| INFECTION | ||||
Acambis plc |
ChimeriVax-JE |
Single-dose vaccine against Japanese encephalitis |
Japanese encephalitis |
It met and exceeded the primary immunogenicity endpoint in a pivotal Phase III trial (3/1) |
Acambis plc |
ChimeriVax |
Vaccine against West Nile virus |
West Nile virus |
Began Phase II testing in older adults (3/21) |
Arpida Ltd. |
AR-709 |
DHFR inhibitor with microbiological activity against streptococci and multidrug resistant Streptococcus pneumoniae |
Complicated skin and skin structure infections |
Radiolabeled microdoses of AR0709 achieved good distribution within the lungs in a first- in-man study (3/29) |
Avexa Ltd. |
ATC |
Apricitabine; a nucleoside reverse transcriptase inhibitor |
HIV |
Phase IIb data showed that those who received ATC achieved an average reduction of greater than 0.8 log10 (85%) in the level of HIV in the blood after 21 days of treatment compared with a reduction of less than 0.03 log10 in patients treated with 3TC (3/20) |
Barrier |
Pramiconazole |
Formerly Azoline; broad-spectrum, oral antifungal agent |
Tinea (pityriasis) versicolor |
Phase IIb data showed it met the primary endpoint of effectively treating the common skin fungal infection (3/27) |
Biota |
BTA798 |
Small-molecule inhibitor of human rhinovirus |
Rhinovirus |
Phase I data showed the drug was safe and well tolerated at all doses in 32 healthy volunteers (3/26) |
Dynavax |
Heplisav |
Immunostimulatory sequence-based vaccine targeting Toll-like receptor 9 |
Chronic hepatitis B virus |
Started a Phase I trial (3/1) |
Enzo |
|
Gene therapy using HGTV43 vector to deliver antisense genes designed to interfere with HIV-1 growth |
HIV |
Began Phase I/II trial in patients with compromised CD4+ cell counts, to test if treatment will create sufficient HIV-1-resistant CD4+ cells to defer disease progression to AIDS (3/13) |
Genelabs |
|
Vaccine for HEV |
Hepatitis E virus |
Data show it was 95.5% effective in preventing disease and had a safety profile similar to placebo (3/1) |
Gilead Sciences |
GS 9137 |
Elvitegravir; integrase inhibitor |
HIV |
Phase II data showed statistically significant reductions in viral load among HIV-positive, treatment-experienced patients given 125 mg of GS 9137 once daily, boosted with 100 mg of ritonavir, compared to those receiving a boosted protease inhibitor (3/2) |
Horizon |
HZT-501 |
A formulation of ibuprofen combined with the H2 receptor antagonist famotidine; an NSAID |
Mild to moderate pain |
Started its Phase III program, which will enroll a total of 1,200 patients between two trials (3/27) |
Indevus |
Nebido |
Testosterone undecanoate product; a long-acting injectable therapy |
Hypogonadism |
Preliminary data indicate an ongoing Phase III will achieve its primary endpoint (3/26) |
Iomai Corp. |
|
Vaccine patch |
Travelers' diarrhea |
Data showed that volunteers who received the vaccine before being exposed to high levels of entero- toxigenic E. coli bacteria had less severe diarrhea and were signifi- cantly less likely to require intravenous fluids than patients who were not vaccinated (3/5) |
Nventa Bio- |
HspE7 |
Vaccine |
Human papil-lomavirus- related diseases |
Phase II data demonstrated an overall response rate of 78% among the 58 evaluable patients (3/6) |
Ocera |
AST-120 |
Oral spherical adsorptive carbon |
Pouchitis |
Initiated a Phase II exploratory study (3/26) |
Optimer |
Difimicin (OPT-80/PAR101) |
Narrow-spectrum antibiotic agent |
Clostridium difficile- associated diarrhea |
Monitors in Phase IIb/III trial said the product would move into Phase III studies, following review of Phase IIb data; the trial in 664 patients will compare the drug to oral vancomycin (3/14) |
Panacos |
Bevirimat (PA-457) |
HIV maturation inhibitor |
HIV |
Revised trial design for Phase IIb trial after tablet formulation used in first cohort produced inadequate plasma levels of drug; the next cohort will use an oral liquid formulation (3/12) |
Replidyne Inc. |
Faropenem medoxomil |
Ester prodrug derivative of the beta-lactam antibiotic faropenem |
Acute otitis media |
Phase II data showed it met its primary objective of showing faropenem was effective in eradicating pathogens from the middle ear (3/6) |
Tibotec |
TMC278 |
A next-generation non-nucleoside reverse transcriptase inhibitor |
HIV |
Phase IIb data showed that 81% of patients receiving the drug in combination with other antiretro-viral agents had reached the primary endpoint of a confirmed plasma viral load <50 copies/mL at 48 weeks (3/1) |
Trimeris Inc. |
Fuzeon (FDA-approved) |
Enfuvirtide; HIV fusion inhibitor |
HIV |
Data showed that 98% of those who received Isentress along with Fuzeon and a darunavir boost achieved undetectable levels of HIV (3/2) |
MISCELLANEOUS | ||||
7TM Pharma |
TM30339 |
Y4 receptor selective agonist |
Obesity |
Began a Phase I/II trial (3/8) |
Advanced |
Ferumoxytol |
Intravenous iron replacement therapy |
Chronic kidney disease |
A data monitoring committee met for the final time and identified no safety concerns with the Phase III studies (3/5); completed enrollment in its final Phase III study in 230 patients on dialysis (3/20) |
AEterna Zentaris |
Cetrorelix |
A luteinizing hormone-releasing hormone antagonist |
Benign prostatic hyperplasia |
Phase IIa data showed the drug was safe and well tolerated at all dosage regimens (3/22) |
AlphaRx Inc. |
Indaflex |
Topical non-steroidal anti- inflammatory drug formulation of indomethacin |
Osteoarthritis of the knee |
Completed the treatment phase of its double-blind, controlled, multicenter Phase II trial (3/5) |
Amicus |
Plicera |
Isofagomine tartrate, AT2101 |
Gaucher disease |
Phase I data showed it was well tolerated and that oral administration resulted in a significant elevation of target enzyme levels (3/21) |
AOP Orphan |
Moli1901 |
Duramycin; polycystic peptide that targets phospholipid phosphati- dylethanolamine |
Cystic fibrosis |
Phase II data showed that subjects ages 12 and older tolerated daily administration of the inhaled drug over 28 days (3/6) |
CollaGenex |
Incyclinide |
Anti-inflammatory |
Acne |
Phase II data showed the minimum effective dose was 10 mg per day (3/1); started enrollment in a 40 mg cohort in the Phase II trial (3/29) |
Collegium |
|
Once-a-day combination product |
Seasonal allergic rhinitis |
Proof-of-concept study showed benefit for its product on nasal symptoms (3/5) |
Emisphere |
Eligen |
Technology that orally delivers glucagon-like peptide-1 and peptide YY 3-36 |
Obesity |
Phase I studies show the technology can orally deliver GLP-1 and PYY (3/29) |
Isotechnika Inc. |
ISA247 |
Immunosuppressive agent |
Kidney transplant |
An independent data monitoring committee recommended continuation of the Phase IIb, following an interim review (3/27) |
Kamada Ltd. |
API |
Alpha-1 antitrypsin inhibitor |
Congenital emphysema and cystic fibrosis |
Began Phase III trials (3/5) |
Lev |
C1-INH |
C1-esterase inhibitor |
Hereditary angioedema |
Pivotal Phase III trial in 71 patients demonstrated a clinically and statistically significant reduction in the time to sustained relief of acute HAE symptoms, vs. placebo (3/14) |
Medivir AB |
MIV-701 |
Inhibits the enzyme cathepsin K |
Osteoporosis |
Is starting its first human trial (3/6) |
NicOx SA |
PF-03187207 |
A nitric oxide-donating prostaglandin F2-alpha analogue |
Glaucoma |
Started the first in a series of trials (3/28) |
Nymox |
NX-1207 |
Investigational agent for BPH |
Benign prostatic hyperplasia |
Long-term, 8- to 19-month data in 116 patients showed statistically significant improvements in both symptom scores and treatment outcomes (3/19) |
Pharmaxis Ltd. |
Bronchitol |
Mannitol formulation delivered via an inhalation device |
Cystic fibrosis |
Phase II trial closed enrollment after entering 25 subjects, fewer than the 42 originally expected (3/2) |
Potentia |
POT-4 |
Complement inhibitor |
Age-related macular degeneration |
Entered Phase I trials (3/20) |
Progenics |
|
A new formulation of oral methylnaltrexone |
Opioid-induced constipation |
Began clinical testing of a new formulation after the initial formulation did not exhibit sufficient clinical activity to advance into Phase III testing (3/7) |
Protox |
PRX302 |
Prodrug designed to kill cancer cells upon activation by prostate specific antigen |
Benign prostatic hyperplasia |
Started a Phase I study (3/28) |
Radius* |
BA058 |
An analog of hPTHrP (human parathyroid hormone-related protein) |
Osteoporosis in postmenopausal women |
Started a Phase II trial (3/20) |
Regeneron |
VEGF |
A fully human, soluble VEGF fusion protein |
Age-related macular degeneration |
Top-line Phase II data showed the product improved vision (3/27) |
Savient |
Puricase |
Pegylated recombinant porcine urate oxidate |
Treatment-failure gout |
Reached its Phase III enrollment target of 200 patients in two six-month trials (3/6) |
ViaCell Inc. |
ViaCyte |
To be used in the cryo-preservation and thawing of human oocytes |
To expand reproduction options |
Began a pivotal study, which will enroll about 300 women (3/20) |
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Notes: * Privately held. BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; NIH = National Institutes of Health; 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; BE = Berlin Stock Exchange; CDNX = Canadian Venture Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TASE = Tel Aviv Stock Exchange; TSX = Toronto Stock Exchange. | ||||
