|
Company* (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
|
| ||||
AUTOIMMUNE | ||||
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Abbott Laboratories (NYSE:ABT) |
ABT-874 |
Designed to selectively inhibit proteins such as pro-inflammatory interleukins or tumor necrosis factor-alpha |
Psoriasis |
Phase II data demonstrated significantly reduced psoriasis symptoms in the majority of patients treated (5/4) |
| ||||
Alba Therapeutics Corp.* |
AT-1001 |
Orally administered zonulin receptor antagonist |
Celiac disease |
Phase IIa data showed dose-dependent responses were seen in intestinal permeability, and that drug patients had improved symptoms and outcomes (5/7) |
| ||||
Amgen Inc. (AMGN) and Wyeth |
Enbrel (FDA-approved) |
Etanercept; antitumor necrosis factor-alpha antibody |
Nail psoriasis |
Patients showed reduced severity by more than 28% at 12 weeks and reduced signs and symptoms (5/18) |
| ||||
Celgene Corp. (CELG) |
CC-10004 |
Apremilast; oral TNF antagonist |
Psoriasis |
Phase II data showed it achieved its primary endpoint after 12 weeks of treatment (5/22) |
| ||||
ChemoCentryx Inc.* |
Traficet-EN |
An oral, anti-inflammatory agent designed to target the CCR9 receptor |
Crohn's disease |
Phase II data showed the product is well tolerated and had clinical activity (5/24) |
| ||||
Cytos Biotechnology AG (Switzerland; SWX:CYTN) |
CYT007-TNFQb |
Vaccine candidate |
Psoriasis |
Phase I/IIa data showed it was safe and well tolerated (5/24) |
Enzo Biochem Inc. (NYSE:ENZ) |
Alequel |
An oral immune regulation preparation consisting of an autologous protein-containing extract prepared from mucosal tissue colon biopsies of the subject |
Crohn's disease |
Interim Phase II data suggested the approach induced clinical remissions and improved patients' quality of life compared to placebo (5/22) |
| ||||
Human Genome Sciences Inc. (HGSI) |
LymphoStat-B |
Belimumab; human monoclonal antibody that inhibits activity of B-lymphocyte |
Systemic lupus erythematosus |
Began the second of two pivotal Phase III trials (5/30) |
| ||||
La Jolla Pharmaceutical Co. (LJPC) |
Riquent |
Abetimus sodium; B-cell toleragen |
Systemic erythematosus lupus |
Phase III data showed a dose response in the 100 mg, 300 mg and 900 mg groups, with the reductions in median antibody levels between Riquent and placebo at week eight of 30%, 40% and 58% (5/24) |
| ||||
Targeted Genetics Corp. (TGEN) |
tgAAC94 |
Therapy that uses an adeno-associated viral vector to deliver a soluble TNF-alpha receptor protein |
Inflammatory arthritis |
Achieved the enrollment target of 120 patients in a Phase I/II trial (5/24) |
| ||||
CANCER | ||||
| ||||
Alchemia Ltd. (Australia; ASX:ACL) |
HyCAMP |
Formulation of the anticancer drug irinotecan |
Metastatic colorectal cancer |
Phase II data demonstrated superior anticancer activity compared to Camptosar (irinotecan), with a significantly greater number of patients with observed tumor responses (5/29) |
| ||||
Amgen Inc. (AMGN) |
Vectibix (FDA-approved) |
Panitumumab; fully human monoclonal antibody directed against the epidermal growth factor receptor |
Metastatic colorectal cancer |
Phase III showed it prolonged progression-free survival compared to best supportive care (5/1) |
| ||||
Antigenics Inc. (AGEN) |
Oncophage |
Vitespen; cancer vaccine |
Cancer |
Phase III data showed a clinically significant improvement in recurrence-free survival of about 45% (5/21) |
| ||||
Array BioPharma Inc. (ARRY) |
ARRY-520 |
A small molecule, kinesin spindle protein inhibitor |
Cancer |
Started a Phase I trial (5/3) |
| ||||
BioDelivery Sciences International Inc. (BDSI) |
BEMA Fentanyl |
Consists of a small, dissolvable polymer disc formulated with the opioid narcotic fentanyl |
Cancer patients with break-through pain |
Phase III data showed the product demonstrated statistical significance vs. placebo on a summary of pain at 15 minutes, a secondary endpoint (5/14) |
| ||||
Celgene Corp. (CELG) |
Revlimid (FDA-approved) |
Lenalidomide |
Multiple myeloma |
Closed enrollment in a Phase III study comparing dexamethasone with a combined therapy of dexamethasone and Revlimid (5/16) |
| ||||
Celldex Therapeutics Inc. * |
CDX-110 |
Peptide vaccine |
Glioblastoma multiforme |
Began a Phase II/III trial (5/24) |
Cell Genesys Inc. (CEGE) |
GVAX |
Immunotherapy comprised of a single leukemia cancer cell line modified to secrete GM-CSF |
Chronic myelogenous leukemia |
Started three trials with the Johns Hopkins Sidney Kimmel Cancer Center (5/9) |
| ||||
Cel-Sci Corp. (AMEX:CVM) |
Multikine |
Mixture of human cytokines designed to stimulate an immune response |
Head and neck cancer |
Multikine significantly increased long term overall survival in a Phase II study (5/21) |
| ||||
Cougar Biotechnology Inc. (OTC BB:CGRB) |
CB7630 |
Abiraterone acetate; oral, irreversible CYP450c17 enzyme inhibitor |
Prostate cancer |
Phase I and Phase II data showed it was well tolerated at doses as high as 2,000 mg/day with minimal toxicity; they also showed that 60% of patients experienced a confirmed decline in prostate specific antigen levels of greater than 50% (5/22) |
| ||||
CuraGen Corp. (CRGN) and TopoTarget A/S (Denmark; CSE:TOPO) |
PXD101 |
Intravenous belinostat, an HDAC inhibitor |
Soft tissue sarcomas |
Started a Phase I/II clinical trial (5/2) |
Cytogen Corp. (CYTO) |
Prostascint |
Capromab pendetide; brachytherapy; monoclonal antibody that targets prostate specific membrane antigen, conjugated with indium 111 |
Prostate cancer |
Data from a large cohort study demonstrated the value of the imaging product in predicting prognosis in prostate cancer (5/22) |
| ||||
Dendreon Corp. (DNDN) |
Provenge |
Sipuleucel-T; active cellular immunotherapy |
Prostate cancer |
Phase III data showed a prolonged survival benefit for patients first treated with Provenge who then went on to receive docetaxel after disease progression (5/21) |
| ||||
EntreMed Inc. (ENMD) |
Panzem NCD |
2-methoxyestradiol; designed to work by attacking tumor cells through multiple mechanisms |
Recurrent glioblastoma multiforme |
Started a Phase II combination study with Panzem NCD and Temodor (5/29) |
| ||||
Exelixis Inc. (EXEL) |
XL647 |
Designed to inhibit the activity of multiple receptor tyrosine kinases |
Non-small-cell lung cancer |
Began a Phase II trial (5/30) |
| ||||
Gemin X Biotechnologies Inc.* |
GMX1777 |
A water-soluble, intravenously administered prodrug of LEO's CHS828 |
Refractory solid tumors and lymphomas |
Began a Phase I trial (5/8) |
| ||||
Generex Biotechnology Corp. (GNBT) |
AE37 |
Immunotherapeutic vaccine |
Breast cancer |
First patients have been treated in a Phase II trial |
Genitope Corp. (GTOP) |
MyVax |
Personalized immunotherapy |
Follicular non-Hodgkin's lymphoma |
Started a Phase II trial (5/21) |
| ||||
ImmunoCellular Therapeutics Ltd. (OTC BB:IMUC) |
A dendritic cell-based vaccine product |
Brain tumors |
Began a Phase I trial (5/11) |
|
| ||||
Innate Pharma SA (France; PARIS:IPH) |
IPH 1101 |
Immunomodulator that activates non-conventional T-lymphocytes |
Non-Hodgkin's lymphoma |
Started a clinical trial (5/2)** |
| ||||
Inovio Biomedical Corp. (AMEX:INO) |
DNA vaccine delivered using Inovio's electro-poration approach |
Prostate cancer and melanoma |
Phase I/II data indicated that the delivery system was safe and well tolerated (5/22 and 5/24) |
|
| ||||
Introgen Therapeutics Inc. (INGN) |
Advexin |
Adenoviral vector containing the p53 tumor suppressor gene |
Li-Fraumeni Syndrome |
Clinical data showed a benefit in one patient with the rare, inherited form of cancer (5/30) |
| ||||
Mersana Therapeutics Inc.* |
XMT-1001 |
Fleximer-based product that uses a dual-release mechanism to liberate a camptothecin prodrug, which is converted within cells into camptothecin |
Solid tumors |
Began a Phase I trial (5/30) |
| ||||
Molecular Insight Pharmaceuticals Inc.* |
Azedra (formerly Ultratrace MIBG) |
Radiopharmaceutical designed to maximize delivery of MIBG molecules |
Malignant pheochromocytoma |
Started a Phase I/II trial (5/10) |
| ||||
Ortho Biotech Products LP |
Doxil (FDA-approved) |
Liposomal formulation of doxorubicin |
Multiple myeloma |
FDA approved the use of Doxil with Velcade (Millennium Pharmaceuticals Inc.) to treat patients who have not received Velcade previously but have received one prior therapy (5/21) |
| ||||
Peregrine Pharmaceuticals Inc. (PPHM) |
Bavituximab |
A monoclonal antibody designed to target and bind to phophatidylserine |
Advanced cancer |
Phase Ib data showed that 50% of all evaluable patients achieved objective tumor response or stable disease, and 75% receiving the therapy combined with gemcitabine achieved objective tumor response or stable disease (5/31) |
| ||||
Poniard Pharmaceuticals Inc. (PARD) |
Picoplatin |
New-generation platinum therapy |
Small-cell lung cancer |
Began a pivotal Phase III trial (5/1) |
| ||||
Pro-Pharmaceuticals Inc. (AMEX:PRW) |
Davanat |
Carboyhdrate compound designed for targeted delivery |
Chemotherapy-sensitive colorectal cancer |
Stabilized disease was seen in seven of eight patients in a Phase II trial (5/14) |
| ||||
Protherics plc (UK; PTIL) |
OncoGel |
Sustained-release formulation of paclitaxel |
Esophageal cancer |
Phase IIa data showed that OncoGel improved dysphagia symptoms in nine patients (5/22) |
| ||||
Rexahn Pharmaceuticals Inc. (OTC BB:RXHN) |
Archexin |
First-in-class signal inhibitor that directly blocks the production of AKT |
Renal cell carcinoma |
Is beginning a Phase II trial (5/30) |
| ||||
Serenex Inc.* |
SNX-5422 |
A heat-shock protein 90 inhibitor; orally administered small molecule |
Cancer |
Started a Phase I trial (5/31) |
| ||||
Spectrum Pharmaceuticals Inc. (SPPI) |
EOquin |
Apaziquone for intravesical instillation; activated by reductase enzymes found in cancer cells |
Non-invasive bladder cancer |
Started its pivotal Phase III trials (5/2) |
| ||||
Spectrum Pharmaceuticals Inc. (SPPI) |
Satraplatin |
Oral platinum compound |
Hormone-refractory prostate cancer |
Phase III data showed a median time to pain progression of 66.1 weeks for the satraplatin arm compared to 22.3 weeks for placebo (5/22) |
| ||||
Tapestry Pharmaceuticals Inc. (TPPH) |
TPI 287 |
A next-generation taxane |
Hormone-refractory prostate cancer |
Started enrolling patients in a Phase II trial (5/9) |
| ||||
Vion Pharmaceuticals Inc. (VION) |
Cloretazine |
VNP40101M; small-molecule alkylating agent that is designed to work by damaging DNA by releasing the chloro-ethylating agent 90CE into the blood stream |
Relapsed adult myelogenous leukemia |
Vion suspended enrollment and further patient treatment pending a review of all data based on a recommendation of a data safety monitoring board (5/23) |
| ||||
Viventia Biotech Inc.* (Canada) |
Vicinium |
Armed antibody administered using intravesical instillation |
Bladder cancer |
Phase I/II data showed it was well tolerated at all dose levels with no maximum tolerated dose reached (5/25) |
| ||||
Ziopharm Oncology Inc. (ZIOP) |
ZIO-101 |
Organic arsenic |
Primary liver cancer |
Dosed the first patient in a Phase II trial (5/10) |
| ||||
CARDIOVASCULAR | ||||
| ||||
Acusphere Inc. (ACUS) |
Imagify |
Perflubutane polymer microspheres |
Coronary artery disease |
Phase III failed to achieve end-point but exceeded the criteria for success on accuracy and sensitivity (5/1) |
| ||||
Alliance Pharmaceutical Corp. (OTC BB:ALLP) |
Oxygent |
Perfluorochemical emulsion |
To prevent postoperative ileus resulting from hypoxia during major surgery |
Is starting a Phase IIb trial with 128 patients (5/16) |
| ||||
BioMarin Pharmaceutical Inc. (BMRN) |
6R-BH4 |
Sapropterin dihydrochloride |
Sickle cell disease |
Started treatment in a Phase IIa trial (5/2) |
| ||||
Cardium Therapeutics Inc. (OTC BB:CDTP) |
Generx |
Alferminogen tadenovec, Ad5FGf-4 |
Myocardial ischemia |
Started recruiting female patients for a Phase III trial (5/16) |
| ||||
Celladon Corp.* and Targeted Genetics Corp. (TGEN) |
Mydicar |
Uses an adeno-associated virus vector to deliver the SERCA2a gene to heart muscle tissue |
Heart failure |
Started a Phase I trial (5/16) |
| ||||
Danube Pharmaceuticals Inc.* |
DNB-001 |
A first-in-class oral therapy with dual potent IOP-reducing and tissue protective effects |
Ocular hypertension |
Started a Phase II study in 60 patients (5/16) |
| ||||
DeCODE genetics Inc. (Iceland; DCGN) |
DG051 |
Small-molecule inhibitor of leukotriene A4 hydrolase |
To prevent heart attacks |
Phase I data showed it reduced leukotriene B4 production in a dose-dependent manner (5/1) |
| ||||
Discovery Laboratories Inc. (DSCO) |
Surfaxin |
Engineered version of natural human lung surfactant |
Respiratory distress syndrome |
One-year follow-up of Phase III trials showed that Surfaxin had a statistically significant survival advantage in premature infants compared to existing animal-derived surfactants (5/31) |
| ||||
Dyax Corp. (DYAX) |
DX-88 |
Ecallantide; a recombinant small protein shown to inhibit human plasma kallikrein |
To prevent blood loss during cardiothoracic surgery |
Began patient treatment in the Phase II trial (5/14) |
| ||||
Gilead Sciences Inc. (GILD) |
Ambrisentan |
An endothelin receptor antagonist |
Pulmonary arterial hypertension |
Long-term data showed that improvements in six-minute walk distance observed during the first 12 weeks of treatment were sustained for at least 48 weeks and the one-year probability of survival was 95% (5/21) |
| ||||
InterMune Inc. (ITMN) |
Pirfenidone |
Small-molecule p38-gamma inhibitor |
Idiopathic pulmonary fibrosis |
Completed patient enrollment in CAPACITY, a Phase III trial (5/16) |
| ||||
Isis Pharmaceuticals Inc. (ISIS) |
ISIS 301012 |
Second-generation antisense drug designed to inhibit apoE-100 |
Homozygous familial hypercholesteremia |
Phase II data showed that three patients who completed 12 weeks of treatment at 300 mg/week achieved 45%, 50% and 51% additional reductions in LDL-cholesterol beyond that achieved with lipid-lowering therapy (5/16) |
| ||||
Kai Pharmaceuticals Inc.* |
KAI-1455 |
A selective epsilon protein kinase C activator |
To reduce ischemic injury during planned surgical procedures |
Began dosing subjects in a Phase I trial (5/4) |
| ||||
Medicure Inc. (Canada; AMEX:MCU) |
MC-1 |
Naturally occurring small molecule that protects cardiomyocytes |
To reduce ischemic reperfusion injury |
Phase II data demonstrated a statistically significant lower incidence of atrial fibrillation in the MC-1 groups compared to placebo between postoperative day four and the end of the trial (5/31) |
| ||||
Momenta Pharmaceuticals Inc. (MNTA) |
M118 |
A next-generation anticoagulant |
Acute coronary syndromes |
Started dosing in a Phase I study (5/14) |
| ||||
NicOx SA (France; FSE:NXO) |
NCX 1000 |
Nitric oxide-donating derivative of ursodeoxycholic acid |
Portal hypertension |
Phase IIa data from 11 patients did not demonstrate the efficacy required to support continuation of the study; company is not pursuing further development (5/11) |
| ||||
Northfield Laboratories Inc. (NFLD) |
PolyHeme |
Oxygen-carrying blood substitute derived from human blood |
Blood loss |
Pivotal data showed it missed its dual primary efficacy endpoints of superiority and non-inferiority a month after injury, as well as its primary safety endpoint (5/23) |
| ||||
Pipex Pharmaceuticals Inc. (OTC BB:PPEX) |
Coprexa |
Oral tetrathiomolybdate |
Refractory idiopathic pulmonary fibrosis |
Phase I/II data were positive and has led to a 12-month, randomized, double-blind, placebo-controlled trial (5/25) |
| ||||
SkyePharma plc (UK; LSE:SKP) and Sciele Pharma Inc. (SCRX) |
Sular |
A calcium channel blocker that uses SkyePharma's Geomatrix technology |
High blood pressure |
Completed a clinical program that showed the new Sular formulation is bioequivalent to Sciele's currently marketed Sular (5/14) |
| ||||
Trigen Ltd.* (UK) |
PR-15 |
A platelet adhesion inhibitor |
To manage arterial thrombosis |
Completed the first Phase I (5/1) |
| ||||
CENTRAL NERVOUS SYSTEM | ||||
| ||||
Accera Inc.* |
AC-1202 |
Orally available, liquid compound converted by the liver into ketone bodies |
Alzheimer's disease |
Phase IIb data showed that those who did not have the ApoE4 genotype responded particularly well to treatment (5/1) |
| ||||
Acorda Therapeutics Inc. (ACOR) |
Fampridine-SR |
A sustained-release tablet; selective neuronal potassium channel blocker |
Multiple sclerosis |
Phase III data showed the average increase in walking speed was 25.2% vs. 4.7% for the placebo group (5/3) |
| ||||
Active Biotech AB (Sweden; SSE:ACTI) |
Laquinimod |
Oral 0.6-mg dose; small molecule immunomodulatory agent |
Multiple sclerosis |
36-week Phase IIb data showed it significantly reduced MRI disease activity by 38% (5/1) |
| ||||
Anesiva Inc. (ANSV) |
4975 |
Long-acting, non-opioid candidate |
Postsurgical pain associated with total knee replacement |
Phase II data showed a significant reduction in pain (5/1) |
| ||||
Avicena Group Inc. (OTC BB:AVGO) |
AL-02 |
Neuroprotective agent |
Amyotrophic lateral sclerosis |
Started a Phase I study (5/14) |
| ||||
Biogen Idec Inc. (BIIB) and Vernalis plc (UK; LSE:VER) |
BIIB014 |
An adenosine A2A receptor antagonist |
Parkinson's disease |
Began Phase II testing (5/8) |
| ||||
BioLineRx Ltd.* (Israel) |
BL-1020 |
GABA-enhanced antipsychotic |
Schizophrenia |
Phase I data showed it was well tolerated and demonstrated biochemical evidence of dopamine blockade (5/22) |
| ||||
BioMS Medical Corp. (Canada; TSX:MS) |
MBP8298 |
Synthetic peptide |
Multiple sclerosis |
Completed enrollment in its Phase II (5/3) |
| ||||
Cephalon Inc. (CEPH) |
Fentora |
Fentanyl buccal tablet |
Breakthrough pain |
Phase III trial showed it is beneficial (5/1) |
| ||||
Ceregene Inc.* |
CERE-110 |
A gene therapy product designed to deliver nerve growth factor |
Alzheimer's disease |
Presented positive interim Phase I data showing it was well tolerated (5/3) |
| ||||
Durect Corp. (DRRX) and Voyager Pharmaceutical Corp.* |
Memryte |
Durin implant technology with leuprolide acetate |
Alzheimer's disease |
Phase III trial turned up positive outcome trends among women, but no positive effect among men (5/18) |
| ||||
EpiCept Corp. (EPCT) |
EpiCept NP-1 |
Topical analgesic cream |
Managing pain |
Data showed it was safe and well tolerated in all age groups studied (5/3) |
| ||||
FoldRx Pharmaceuticals Inc.* |
Fx-1006A |
Small-molecule compound designed to inhibit the formation of amyloid deposits |
Familial amyloid polyneuropathy |
Started the Phase II/III study (5/29) |
| ||||
Genaera Corp. (GENR) |
MSI-1436 |
Trodusquemine, an appetite suppressant |
Obesity |
Began enrolling patients in the first human study (5/7) |
| ||||
Genentech Inc. (NYSE:DNA) and Biogen Idec Inc. (BIIB) |
Rituxan (FDA-approved) |
Rituximab; antibody that targets and depletes CD20-positive B-cells |
Multiple sclerosis |
Phase II data showed the total number of gadolinium lesions was reduced in a statistically significant manner vs. placebo (p<0.0001) (5/1) |
| ||||
Medivation Inc. (MDVN) |
Dimebon |
Neuroprotectant agent that's been on the market in Russia since 1983 |
Alzheimer's disease |
Six-month Phase II data showed that both subgroups improved vs. placebo on all five efficacy endpoints studied (5/4) |
| ||||
Neurogen Corp. (NRGN) |
NG2-73 |
Selective modulator of gamma aminobutyric receptors |
Insomnia |
Phase I and Phase IIa data showed it rapidly induced sleep in a transient insomnia study (5/23) |
| ||||
Opexa Therapeutics Inc. (OPXA) |
Tovaxin |
A subcutaneous T-cell vaccine |
Multiple sclerosis |
Completed patient enrollment in a 150-patient Phase IIb study (5/17) |
| ||||
Pozen Inc. (POZN) and GlaxoSmithKline plc (UK) |
Trexima |
Single tablet containing sumatriptan 85 mg formulated with RT Technology and naproxen sodium 500 mg |
Migraine |
Showed significantly more patients using Trexima early in migraine attacks were pain-free at two hours (5/2) |
| ||||
Prestwick Pharmaceuticals Inc.* |
Xenazine |
Tetrabenazine; dopamine depletor that works by selectively blocking the VMAT2 transporter |
Chorea associated with Huntington's disease |
Clinical data showed Xenazine maintained reduction of chorea up to 80 weeks in patients who completed treatment in a 13-week trial (5/4) |
| ||||
Nabi Bio-pharmaceuticals (NABI) |
NicVAX |
Nicotine conjugate vaccine |
Smoking cessation |
NicVAX met its primary endpoint in an ongoing Phase IIb trial (5/2) |
| ||||
Neurogen Corp. (NRGN) |
NGD-4715 |
Small molecule antagonist at the melanin concentrating hormone receptor-1 |
Obesity |
Compound was safe and well tolerated at all doses in its first clinical trial (5/2) |
| ||||
Orexigen Therapeutics Inc. (OREX) |
Contrave |
A fixed-dose product that combines sustained-release formulations of bupropion and naltrexone |
Obesity |
Moved Contrave into the second of four Phase III studies (5/22) |
| ||||
Shire plc (UK) |
Vyvanse (FDA-approved) |
Lisdexamfetamine dimesylate |
Attention deficit hyperactivity disorder |
Phase III data showed that 95% of children taking Vyvanse daily for 12 months had overall improvement (5/24) |
| ||||
Synthetic Blood International Inc. (OTC BB: SYBD) |
Oxycyte |
An oxygen carrier, perfluorocarbon-based blood substitute and therapeutic oxygen carrier |
Traumatic brain injury |
Phase IIa data showed it met its primary endpoint of increasing patients' oxygen tension levels compared with baseline (5/15) |
| ||||
Vanda Pharmaceuticals Inc. (VNDA) |
Iloperidone |
5HT2/D2 antagonist |
Schizophrenia |
Phase III data showed it met its primary endpoint of improvement on the positive and negative symptom scale vs. placebo (5/25) |
| ||||
DIABETES | ||||
| ||||
AtheroGenics Inc. (AGIX) |
AGI-1067 |
Oral small molecule; an anti-oxidant |
Diabetes |
Plans to start a Phase III trial after a failed Phase III in atherosclerosis indicated encouraging data in Type II diabetes patients (5/31) |
| ||||
Cardium Therapeutics Inc. (OTC BB:CDTP) |
Excellarate |
A DNA-based collagen gel |
Diabetic foot ulcers |
Advancing Excellarate into a Phase IIb trial (5/1) |
| ||||
Biovitrum AB (Sweden; SSE:BVT) |
BVT.115959 |
A2A agonist |
Diabetic neuropathic pain |
Started a Phase II trial (5/3) |
| ||||
Oculus Innovative Sciences Inc. (OCLS) |
Dermacyn |
Topical treatment; an oxychlorine formulation manufactured using Oculus' Microcyn technology |
Diabetic foot infections |
Began a 60-patient, randomized and open-label Phase II trial (5/21) |
| ||||
Trophos SA* (France) |
TRO19622 |
Compound believed to promote the survival of a range of neurons |
Diabetic neuropathy |
Enrolled the first patients in its Phase IIa trial (5/16) |
| ||||
INFECTION | ||||
| ||||
Amarillo Biosciences Inc. (OTC BB:AMAR) and CytoPharm Inc.* (Taiwan) |
Interferon alpha |
Oral human interferon alpha |
Hepatitis C |
Engaged a clinical research organization to conduct a clinical trial in 152 patients (5/31) |
| ||||
Avant Immunotherapeutics Inc. (AVAN) |
Ty800 |
Vaccine against Salmonella typhi, the cause of typhoid fever |
Typhoid fever |
Phase I/II data showed the single-dose, oral vaccine was well tolerated and immunogenic (5/18) |
| ||||
Cytheris SA* (France) |
CYT107 |
Recombinant interleukin |
Hepatitis C and oncology |
Plans to start two Phase I/IIa trials (5/31) |
| ||||
Innate Pharma SA (France; PARIS:IPH) |
IPH 1101 |
Immunomodulator that activates non-conventional T-lymphocytes |
Non-Hodgkin's lymphoma |
Started a clinical trial (5/2)** |
| ||||
Intarcia Therapeutics Inc.* |
Omega interferon |
Injectable therapeutic; recombinant, glycosylated human type-1 interferon |
Hepatitis C virus |
Phase II data of the therapy with ribavirin compared to omega interferon alone showed the combination treatment is well tolerated and shows antiviral activity (5/21) |
| ||||
Iomai Corp. (IOMI) |
Influenza vaccine patch; adjuvant called LT |
Influenza |
Phase I data showed the patch did not work as well as injected vaccine (5/25) |
|
| ||||
MedImmune Inc. (MEDI) |
Numax |
Motavizumab |
To prevent respiratory syncytial virus |
In a Phase III trial, Numax overall demonstrated 26% fewer RSV hospitalizations than Synagis (5/8) |
| ||||
NanoBio Corp.* |
NB-002 |
Topical treatment |
Onychomycosis |
Phase I safety data was positive (5/22) |
| ||||
Nektar Therapeutics Inc. (NKTR) |
NKTR-061 |
Inhaled Amikacin; developed using Nektar's micropump technology |
Gram-negative pneumonia |
Phase IIa data showed the use of aerosol antibiotics with systemic therapy might be effective in treating mechanically ventilated patients with hospital-acquired illness (5/21) |
| ||||
Optimer Pharmaceuticals Inc. (OPTR) |
OPT-80 |
An RNA polymerase inhibitor |
Clostridium difficile-associated diarrhea |
Started another Phase III trial (5/1) |
| ||||
Pacgen Bio-pharmaceuticals Corp. (Canada; CDNX:PGA) |
PAC-113 |
Peptide-based antifungal drug candidate |
Oral Candida infection |
Phase I/II data showed it was generally safe, well tolerated and active in the treatment of the infection (5/7) |
| ||||
Progenics Pharmaceuticals Inc. (PGNX) |
PRO 140 |
A humanized monoclonal antibody that targets a distinct site on CCR5 |
HIV |
First clinical trial showed patients receiving 5 mg/kg achieved an average maximum decrease of viral concentrations of 98.5% (5/1) |
| ||||
Sequella Inc.* |
SQ109 |
An oral diamine antibiotic |
Tuberculosis |
Phase Ia data showed it was safe and well tolerated up to 300 mg (5/2) |
| ||||
Theratechnologies Inc. (Canada; TSX:TH) |
TH9507 |
A stabilized analogue of the growth hormone-releasing factor |
HIV-associated lipodystrophy |
Completed 52 weeks of treatment in the first Phase III study (5/2) |
| ||||
Transport Pharmaceuticals Inc.* |
SoloVir |
Electrokinetic transdermal system with single-use drug cartridges containing Transport's acyclovir gel formulation |
Cold sores |
Began a Phase II trial (5/1) |
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VASTox plc (UK; LSE:VOX) |
Neurodisorder drugs; small molecule candidates |
Parkinson's disease symptoms |
Phase I data showed they were safe and significantly suppressed saliva and sebum production (5/23) |
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MISCELLANEOUS | ||||
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Aastrom Biosciences Inc. (ASTM) |
BRC |
Bone Repair Cell, a mixture of stem and progenitor cells derived from a patient's own bone marrow |
Osteonecrosis of the femoral head |
Company will being a pivotal trial with 120 patients (5/8) |
| ||||
AEterna Zentaris Inc. (AEZS) and Spectrum Pharmaceuticals (SPPI) |
Ozarelix |
Fourth-generation luteinizing hormone-releasing hormone antagonist |
Lower urinary tract symptoms secondary to benign prostatic hyperplasia |
Phase II data showed it was well tolerated and demonstrated statistically significant and clinically meaningful efficacy (5/23) |
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AlphaRx Inc. (OTC BB:ALRX) and Proprius Pharmaceuticals Inc.* |
Indaflex |
2.5% topical indomethacin cream |
Osteoarthritis of the knee |
Did not meet primary endpoints in a Phase II trial (5/15) |
Altus Pharmaceuticals Inc. (ALTU) |
ALTU-135 |
A blend of lipase, protease and amylase created with Altus' protein crystallization technology |
For pancreatic enzyme replacement |
Started a pair of pivotal efficacy and safety trials (5/10) |
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Basilea Pharmaceutica Ltd. (Switzerland; SWX:BSLN) |
Alitretinoin |
Once-daily oral treatment |
Chronic hand eczema |
Phase III data confirm the product's efficacy (5/21) |
CollaGenex Pharmaceuticals Inc. (CGPI) |
Incyclinide |
Anti-inflammatory |
Acne |
Suspended further enrollment in the Phase II's 40 mg cohort after one patient experienced significant photo-toxicity (5/2); discontinued treatment of all enrolled patients in that cohort (5/7) |
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Cypress Bioscience Inc. (CYPB) |
Milnacipran |
Norepinephrine serotonin reuptake inhibitors |
Fibromyalgia |
A second Phase III trial achieved statistical significance at both doses and against both primary endpoints (5/23) |
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Cytos Biotechnology AG (Switzerland; SWX:CYTN) |
CYT003-QbG10 |
Virus-like particle packaged with an immunostimulatory sequence |
Allergic diseases |
Phase II data showed two formulations were safe and well tolerated and demonstrated a statistically significant increase in the median allergen tolerance against baseline (5/15) |
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Emisphere Technologies Inc. (EMIS) |
SMC021 |
Oral calcitonin |
Osteoarthritis |
Started a Phase III program (5/24) |
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Genaera Corp. (GENRD) |
MSI-1436 |
Inhibits protein tyrosine phosphatase 1B, or PTP-1B; trodusquemine |
Obesity |
Dosing began in a Phase I trial (5/16) |
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Genzyme Corp. (GENZ) |
Genz-112638 |
Oral therapy; a ceramide analogue designed to inhibit the enzyme glucosylceramide synthase |
Gaucher's disease |
Genzyme completed enrollment of its ongoing Phase II trial (5/16) |
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Gilead Sciences Inc. (GILD) |
Aztreonam lysine |
Inhaled antibiotic |
Cystic fibrosis |
Phase III data showed it met its primary efficacy endpoint of improved respiratory symptoms at day 28 (5/30) |
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Indevus Pharmaceuticals Inc. (IDEV) |
Supprelin-LA |
Histrelin acetate subcutaneous implant 50 mg |
Central precocious puberty |
FDA approved the product (5/3) |
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Inspire Pharmaceuticals Inc. (ISPH) |
Epinastine nasal spray formulation |
Seasonal allergic rhinitis |
Phase II data demonstrated dose-related effects on the primary endpoint of improvement in total nasal symptom score, with the higher dose of 0.1% achieving statistical superiority over placebo (5/8) |
|
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Isotechnika Inc. (Canada; TSX:ISA) |
ISA247 |
Immunosuppressive agent |
Kidney transplant |
Phase IIb data has shown improvement across all ISA247 dosing groups similar to that observed in the tacrolimus group; the product also showed reduced side effects vs. tacrolimus (5/7) |
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ISTA Pharmaceuticals Inc. (ISTA) |
Bepotastine |
A non-sedating, highly selective antagonist of the histamine 1 receptor that stabilizes mast cells and suppresses the migration of eosinophils into inflamed tissues |
Allergic conjunctivitis |
Phase II/III data showed both tested concentrations were statisitcally significant in the reduction of the first primary end-point, ocular itching, when dosed twice a day, and in one concentration when dosed once a day (5/8) |
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Kamada Ltd. (Israel; TASE:KMDA) |
Alpha-1 antitrypsin |
Aerosolized version using an optimized eFlow Electronic Nebulizer (PARI Pharma GmbH) |
Congenital emphysema and cystic fibrosis |
Concluded the first of two stages of its Phase I study (5/29) |
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Kamada Ltd. (Israel; TASE:KMDA) and PARI Pharma GmbH (Germany) |
Alpha-1 antitrypsin |
Aerosolized AAT delivered with an optimized eFlow device |
AAT deficiency |
Phase I data were positive (5/31) |
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LifeCycle Pharma A/S (Denmark; CSE:LCP) |
LCP-Tacro |
A once-daily tacrolimus tablet |
Organ transplantation |
Phase I data showed it delivers consistently higher bioavailability of about 50% compared to Prograf (5/31) |
Limerick NeuroSciences Inc.* |
LNS 5310 |
Candidate designed to improve bioavailability of existing drugs to reduce their neurotoxicity |
To reduce nausea and vomiting |
Started a Phase I trial (5/22) |
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Manhattan Pharmaceuticals Inc. (AMEX:MHA) |
Oleoyl-estrone |
Oral therapy; synthetic formulation |
Obesity |
Finished patient dosing in two Phase IIa trials, one for common obesity and the second for morbid obesity (5/10) |
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Marinus Pharmaceuticals Inc.* |
Ganaxalone |
3b-methylated synthetic analog of the neurosteroid allopregnanolone, a metabolite of progesterone |
Partial onset seizures |
Company is enrolling patients in a Phase IIb study (5/4) |
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MedImmune Inc. (MEDI) |
IL-9 |
Targets interleukin-9 |
Asthma |
Phase I data showed it was well tolerated (5/24) |
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MGI Pharma (MOGN) |
Aquavan |
Fospropofol disodium injection |
For patients undergoing colonoscopy |
Aquavan met its primary end-point in a pivotal Phase III trial (5/23) |
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Microbia Inc.* |
Linaclotide |
Peptide designed to act on guanylate cyclase C, a receptor found on intestinal cells |
Irritable bowel syndrome |
Phase II data showed it accelerated colonic transit and improved bowel function (5/21) |
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Millennium Pharmaceuticals Inc. (MLNM) |
MLN0002 |
A monoclonal antibody designed to bind to the T-cell integrin alpha 4 beta 7 |
Gastrointestinal diseases |
Resumed clinical development and initiated patient dosing in a Phase II program with healthy volunteers and ulcerative colitis patients (5/17) |
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Napo Pharmaceuticals Inc. (LSE:NAPL) and Trine Pharmaceuticals Inc.* |
Crofelemer syndrome |
Agent extracted from the rainforest plant Croton lechleri |
Diarrhea-predominant irritable bowel |
Phase IIa data showed it was safe and led to significant improvement in pain (5/23) |
Nymox Pharmaceutical Corp. (NYMX) |
NX-1207 |
Investigational agent for BPH |
Benign prostatic hyperplasia |
Phase I/II data showed NX-1207 had a mean improvement of 8.6 points in the primary outcome endpoint of AUA Symptom Score value 42 months after treatment vs. the 3.5 to 5 points reported in published studies of currently approved BPH drugs (5/7) |
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Obecure Ltd.* (Israel) |
OBE101 |
Candidate comprised of betahistamine |
Weight management |
Launched a Phase II trial testing OBE101 in improving plasma lipid profiles of patients treated with Simvastatin, a generic cholesterol-lowering drug (5/16) |
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Palatin Technologies Inc. (AMEX:PTN) |
Bremelanotide |
First in a new class called melanocortin receptor agonists |
Erectile dysfunction |
Phase IIb data showed it improved both self-esteem and sexual relationship in men (5/23) |
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PDL BioPharma Inc. (PDLI) |
Nuvion |
Visilizumab; humanized monoclonal antibody |
Intravenous steroid-refractory ulcerative colitis |
Long-term follow up data from Phase I and Phase I/II trials demonstrated that treatment on day 1 and day 2 was adequately tolerated and resulted in a sustained clinical response for up to 310 days (5/22) |
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PTC Therapeutics Inc.* |
PTC124 |
Oral agent that targets nonsense mutations |
Duchenne muscular dystrophy |
Interim Phase II data showed treatment was associated with increases in muscle dystrophin expression and reductions in serum creatinine kinase values in at least 50% of evaluable patients (5/4) |
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Regeneron Pharmaceuticals Inc. (REGN) |
VEGF Trap-Eye |
A fully human, soluble VEGF fusion protein |
Neovascular form of age-related macular degeneration and diabetic macular edema |
Phase II data were positive (5/9) |
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Repligen Corp. (RGEN) |
RG1068 |
Synthetic human secretin; used with magnetic resonance imaging |
To improve assessment of pancreatic duct structures |
Phase II data showed an improvement in sensitivity of detection of structural abnormalities of the pancreatic duct of about 20%, with no loss in specificity (5/10) |
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Sirion Therapeutics Inc.* |
ST-601 |
Topical ophthalmic emulsion containing the steroid compound difluprednate |
Anterior uveitis |
Started a Phase III program (5/1) |
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Sirion Therapeutics Inc.* |
ST-603 |
Cyclosporine |
Dry eye syndrome |
Started a Phase III program (5/1) |
Spectrum Pharmaceuticals Inc. (SPPI) |
Ozarelix |
Fourth-generation luteinizing hormone-releasing hormone |
Benign prostatic hypertrophy |
Reached its enrollment target in a Phase IIb trial |
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Sucampo Pharmaceuticals Inc.* |
Amitiza |
Lubiprostone, given 8 mcg twice a day |
Irritable bowel syndrome |
Study showed the active ingredient may improve symptom relief rates in adults in two Phase III trials (5/21) |
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Telomerase Activation Sciences Inc.* |
TA-65 |
A telomerase activator |
Anti-aging |
Interim data from a 24-week study that included 36 male subjects ages 60 to 85 showed measurable anti-aging benefits in the areas of immune system function, vision, sexual function, skin condition and energy levels (5/15) |
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Theravance Inc. (THRX) |
TD-5108 |
Gastrointestinal motility compound |
Chronic constipation |
Phase I data showed it has a pharmacokinetic profile consistent with once-daily dosing and prokinetic activity in healthy subjects (5/25) |
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Topigen Pharmaceuticals Inc.* |
TPI ASM8 |
Inhaled RNA-targeted drug |
Asthma |
Phase II data showed significant inhibitory effects on allergen-induced responses (5/22) |
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Y's Therapeutics Inc.* |
YSPSL |
A recombinant molecule resulting from the fusion of P-selectin glycoprotein injury in liver transplant patients ligand and human IgG1 |
To prevent ischemic reperfusion |
Started a Phase II trial (5/2) |
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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; SPA = Special protocol assessment. | ||||
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