Company* (Country; Symbol) | Product | Description | Indication | Status (Date) | |
AUTOIMMUNE | |||||
Immunomedics Inc. (IMMU) | Epratuzumab | A humanized monoclonal antibody that targets the CD22 antigen found on B-cells | Systemic lupus erythematosus | Data showed it inhibits the activation of B-cells from patients with SLE but not from normal subjects (8/16) | |
CANCER | |||||
Allos Therapeutics Inc. (ALTH) | PDX | Antifolate; pralatrexate; a small-molecule agent designed to inhibit dihydrofolate reductase | Relapsed or refractory cutaneous T-cell lymphoma | Started patient enrollment in a Phase I trial of PDX with vitamin B12 and folic acid supplementation (8/15) | |
Antisoma plc (UK; LSE:ASM) | AS1411 | Aptamer that binds to the protein nucleolin and has shown anticancer effects in animal models | Relapsed or refractory acute myeloid leukemia | Started a 70-patient Phase II trial (8/6) | |
Antisoma plc (UK; LSE:ASM) | ASA404 | Small-molecule vascular disrupting agent designed to target blood vessels that nourish tumors | Non-small-cell lung cancer | Phase II data showed one of the largest increases in median survival data reported in patients with the condition (8/22) | |
Ascenta Therapeutics Inc.* | AT-101 | Oral, pan-Bcl-2 inhibitor; apoptotic agent | Hormone-refractory prostate cancer | Phase I/II data indicate the compound has biological activity in combination with docetaxel and prednisone in men with HRPC (8/27) | |
Biomira Inc. (Canada; BIOM) | PX-478 | A small molecule designed to inhibit the activity of hypoxia inducible factor-1 alpha | Advanced metastatic cancer | Enrolled the first patient in a Phase I trial (8/28) | |
CuraGen Corp. (CRGN) | Belinostat | Histone deacetylase inhibitor | Multiple myeloma; and acute myeloid leukemia | Two of four MM patients enrolled in a Phase II study developed acute deterioration in already existing renal insufficiency in the first cycle of treatment; the company began a Phase I/II trial in Europe in up to 70 AML patients (8/7) | |
Cytokinetics Inc. (CYTK) and GlaxoSmithKline plc (UK) | GSK-923295 | Small-molecule inhibitor of centromere-associated protein E | Solid tumors | Started a Phase I trial (8/15) | |
Dendreon Corp. (DNDN) | Neuvenge | An active cellular immunotherapy | HER2/neu-positive breast cancer | Phase I data showed treatment was generally well tolerated and stimulated significant immune responses (8/20) | |
Genta Inc. (GNTA) | Genasense | Oblimersen | Advanced melanoma | Enrolled the first patients in a Phase III trial of Genasense plus dacarbazine (8/21) | |
Genzyme Corp. (GENZ) | Mozobil (AMD3100) | Plerixafor; an antagonist of the SDF-1/CXCR4 complex; it acts to release stem cells from the bone marrow so they can circulate | Multiple myeloma | Phase III data showed 72% of patients treated with Mozobil and G-CSF achieved the target threshold for collection of at least 6M CD34+cells/kg from the peripheral blood with two days or fewer of apheresis sessions, compared with 34% of patients in the G-CSF/placebo group (8/2) | |
Hana Biosciences(HNAB) | Marqibo | Vincristine sulfate injection, Optisome | Relapsed acute lymphoblastic leukemia | Started a Phase II trial (8/3) | |
ImClone Systems Inc.(IMCL) | IMC-1121B | A monoclonal antibody targeted to the vascular endothelial growth factor receptor-2 | Metastatic renal-cell carcinoma | Opened patient enrollment in the first of its Phase II trials (8/24) | |
ImClone Systems Inc. (IMCL) | IMC-A12 | An anti-insulin-like growth factor-1 receptor monoclonal antibody | Advanced prostate cancer | Began enrollment in a Phase II trial (8/29) | |
ImmunoCellular Therapeutics Ltd. (OTC BB: IMUC) | A dendritic cell-based vaccine | Malignant brain tumors | The first three patients have been enrolled in a Phase I trial (8/3) | ||
ImmunoGen Inc. (IMGN) | huC242- DM4 | An antibody designed to bind to the CanAg antigen and deliver the company's DM4 cell-killing agent | Stomach cancer | Started a Phase II trial (8/1) | |
Kiadis Pharma BV* (the Netherlands) | Reviroc | Developed to remove residual tumor cells from autologous transplants | Non-Hodgkin's lymphoma | Data from an open-label Phase II trial showed that Reviroc improved overall survival compared to historic controls (8/31) | |
Kosan Biosciences Inc. (KOSN) | KOS-953 | Hsp90 inhibitor tanespimycin | Relapsed/refractory multiple myeloma | Started a Phase II/III study (8/2) | |
Lorus Therapeutics Inc. (Canada; AMEX:LRP; TSX:LOR) | GTI-2040 | Antisense agent that targets R2 | Acute myeloid leukemia | Completed a proof-of-concept trial and started a Phase II trial (8/29) | |
Millennium Pharmaceuticals Inc. (MLNM) | Velcade | Bortezomib | Multiple myeloma | Started a Phase II trial combining Velcade with lenalidomice/dexamethasone and cyclophosphamide in the front line setting (8/15) | |
Myriad Genetics Inc. (MYGN) | Azixa | MPC-6827; small molecule inhibitor of microtubule formation | Non-small-cell lung cancer | Started a third Phase II trial in patients with NSCLC that has spread to the brain (8/16) | |
OncoGenex Technologies Inc.* (Canada) | OGX-427 | Designed to block production of heat shock protein 27 | Breast, ovarian, bladder, prostate or lung cancer | Enrolled the first patient in an open-label, dose-escalation, multicenter Phase I study (8/1) | |
Oxford BioMedica Ltd.(UK; LSE:OXB) | Trovax | Vaccine; modified vaccinia Ankara-encoding 5T4 | Colorectal cancer | Phase II data showed Trovax shrank tumors in six of 17 patients with metastatic disease (8/2) | |
Pharmion Corp. (PHRM) | Vidaza (FDA-approved) | Azacitidne for injection | Myelodysplastic syndrome | Phase III data showed it extended overall survival by 74% (8/2) | |
Prolexys Pharmaceuticals Inc.* |
PRLX 93936 | A structural analogue of a compound called erastin |
Advanced solid tumors |
Began its first Phase I trial (8/29) | |
Proteolix Inc.* | PR-171 | Carfilzomib; a selective proteasome inhibitor | Relapsed or refractory multiple myeloma | Enrolled the first patient in a Phase II trial (8/15) | |
Regeneron Pharmaceuticals Inc. (REGN) | Aflibercept (VEGF Trap) | Inhibits angiogenesis by targeting vascular endo-thelial growth factor; VEGF receptor fusion protein | Prostate cancer and non-small-cell lung cancer | Started two Phase III trials (8/23) | |
Thallion Pharmaceuticals Inc. (Canada; TSX:TLN) | ECO-4601 | A small molecule derived from a nonpathogenic microorganism; inhibits the Ras-MAPK pathway | Advanced cancers | Completed the high-dose extension portion of its Phase I/II trial (8/23) | |
Vion Pharmaceuticals Inc. (VION) | Cloretazine | VNP40101M; anticancer agent | Acute myelogenous leukemia | Accrued 85 patients to the pivotal Phase II trial (8/15) | |
YM BioSciences Inc. (Canada; AMEX: YMI; TSX:YM) and Oncoscience AG* (Germany) | Nimotuzumab | A humanized monoclonal antibody that targets the epidermal growth factor receptor | Diffuse intrinsic pontine glioma | Recruited the 40th and final patient in a Phase III trial combining nimotuzumab with radiation to treat children and adolescents with the disease (8/15) | |
YM BioSciences Inc. (Canada; AMEX: YMI; TSX:YM) and Oncoscience AG* (Germany) | Nimotuzumab | A humanized monoclonal antibody that targets the epidermal growth factor receptor | Glioblastoma multiforme and advanced pancreatic cancer | Started a Phase III trial in glioblastoma multiforme and a Phase IIb/IIIa trial in chemo-therapy-naive patients with ad-vanced pancreatic cancer (8/21) | |
CARDIOVASCULAR | |||||
Biogen Idec Inc. (BIIB) | Adentri | Oral; an A1 adenosine receptor antagonist | Stable heart failure | Phase II showed Adentri for 10 days with standard heart failure therapy was well tolerated and resulted in clinically significant increases in sodium excretion while preserving renal function (8/14) | |
Cardium (AMEX:CXM) | Generx | Alferminogene tadenovec; Ad5FGF-4 | Heart disease | Phase IIb and Phase III data Therapeutics showed significant improvements in multiple clinical measures of heart disease among women who received Generx compared with those who received placebo (8/28) | |
EPIX Pharmaceuticals Inc. (EPIX) | PRX-08066 | A 5-HT2B antagonist | Pulmonary hypertension associated with chronic obstructive pulmonary disease | Phase IIa data demonstrated statistically significant reductions in systolic pulmonary artery pressure vs. placebo (8/7) | |
ImaRx Therapeutics Inc. (IMRX) | SonoLysis | Combines ImaRx's MRX-801 microbubbles with ultrasound to break up blood clots and restore blood flow to tissues | Ischemic storke | A Data and Safety Monitoring Board granted the company permission to proceed to the second dose cohort in its Phase I/II trial combining SonoLysis with tPA (8/28) | |
Nuvelo Inc. | Alfimeprase | Thrombolytic drug; recom- | Central venous | Began enrollment in the prev- | |
(NUVO) | binant enzyme that acts by directly degrading fibrin | catheter occlusion | iously discontinued SONOMA-3 Phase III trial (8/22) | ||
Pharming Group NV (the Netherlands; Euronext:PHARM) | Rhucin | A recombinant version of the human C1 inhibitor, which is produced in the milk of transgenic rabbits | Hereditary angioedema | Company stopped a placebo-controlled trial on ethical grounds after an interim analysis showed none of the treated patients experienced a relapse, and no adverse events were reported (8/22)** | |
CENTRAL NERVOUS SYSTEM | |||||
Accera Inc.* | Ketasyn | AC-1202; neuronal cell-targeting agent | Age-associated memory impairment | Phase II data showed the drug had a positive and clinically meaningful effect on memory in older adults (8/29) | |
Anesiva Inc. (ANSV) | Zingo (FDA-approved) | Lidocaine hydrochloride monohydrate; powder intradermal injection system | To reduce pain associated with peripheral venous access procedures | Completed enrollment in a Phase III study (8/28) | |
Cephalon Inc. (CEPH) | Fentora | A fentanyl buccal tablet | Noncancer breakthrough pain | Data from a third Phase III trial showed statistically significant improvements in pain intensity vs. placebo (8/16) | |
DOV Pharmaceutical Inc. (OTC BB: DOVPW) | DOV 21,947 | Lead triple reuptake inhibitor | Depression and obesity | Phase Ib data indicated that the drug was safe and well tolerated | |
Genaera Corp. (GENR) | MSI-1436 | Trodusquemine; designed to inhibit the enzyme target protein tyrosine phosphatase 1B | Obesity | Phase I data demonstrated safety and tolerability (8/8) | |
Memory Pharmaceuticals Corp. (MEMY) | R4996/ MEM 63908 | A partial agonist of the nictotinic alpha-7 receptor | Alzheimer's disease, schizophrenia and other nervous system disorders | Dosing was initiated for the first study participant in the Phase I program (8/30) | |
NeurAxon Inc.* | NXN-188 | Small-molecule product that incorporates both 5-HT agonism and inhibition of neuronal nitric oxide synthase | Acute migraine | Phase I data showed it was well tolerated with no drug-related adverse events (8/14) | |
Neurochem Inc. (NRMX) | Alzhemed | Tramiprosate | Alzheimer's disease | Failed to meet its primary end-point in a Phase III trial (8/27) | |
Newron Pharmaceuticals (SWX:NWRN) and Merck Serono (Switzerland) | Safinamide | An add-on treatment to dopamine agonist therapy | Early stage Parkinson's disease | Phase III data showed it did not reach statistical significance with the primary endpoint of time to intervention (8/22) | |
Obecure Ltd.* (Israel) | Histalean | Comprised of betahistine, an H1 receptor agonist and partial H3 receptor antagonist | Obesity | Phase II data suggested strong gender and age effects, with greatest efficacy in women 50 or younger (8/30) | |
Orthogen AG* (Germany) | Orthokine | Endogenous protective proteins produced using the Orthokine procedure | Disc-related back pain | Orthokine produced better results over six months than cortisone treatment (8/29) | |
Targacept Inc. (TRGT) | AZD3480 | Acts selectively on neuronal nicotinic receptors | Cognitive deficits in schizophrenia | Started a Phase IIb trial (8/23) | |
TorreyPines Therapeutics Inc. (TPTX) | Tezampanel | An AMPA/kainate receptor antagonist that selectively binds to certain AK receptors to potentially block the transmission of pain signals | Migraine headaches | Started a Phase I trial (8/27) | |
Transition Therapeutics Inc. (Canada; TTHI; TSX:TTH) and Elan Corp. plc (Ireland; NYSE:ELN) | ELND-005/AZD-103 | Scyllo-cyclohexanehexol; oral agent that acts on beta amyloid | Alzheimer's disease | Product was safe and well-tolerated at all doses and dosing regimens examined; there were no severe or serious adverse events observed in the Phase I studies (8/30) | |
Valeant Pharmaceuticals International(NYSE:VRX) | Retigabine | A first-in-class neuronal potassium channel opener | Epilepsy | Completed enrollment in the first of two Phase III trials (8/28) | |
DIABETES | |||||
Alimera Sciences* and pSivida Ltd. (Australia; PSDV) | Medidur | A tiny insert, injected intravitreally to deliver a low dose of fluocinolone acetonide to the retina for up to three years | Diabetic macular edema | Began enrollment for the first human pharmacokinetic study (8/22) | |
AtheroGenics Inc. (AGIX) | AGI-1067 | Oral anti-inflammatory antioxidant drug | Diabetes | Patient enrollment is under way in a Phase III trial (8/23) | |
CombinatoRx Inc. (CRXX) | CRx-401 | Insulin sensitizer that combines a sustained-released dose of bezafibrate and a low dose of diflunisal | Type II diabetes | Dosed the first patient in a Phase IIa trial (8/15) | |
Elixir Pharmaceuticals Inc.* | Mitiglinide (formerly Glufast) | Mitiglinide calcium hydrate | Type II diabetes | Started a Phase III trial (8/20) | |
Generex Biotechnology Corp. (GNBT) | Oral-lyn | Oral insulin spray | Type I diabetes | Clinical data showed regular insulin and Oral-lyn had similar glucodynamic effects in subjects with Type I diabetes receiving a twice-daily insulin analogue as baseline therapy (8/14) | |
MacroGenics Inc.* | Teplizumab | CD3 monoclonal antibody | Type I diabetes | Started a pivotal Phase II/III trial (8/2) | |
Oramed Pharmaceuticals Inc. (Israel; OTC BB: ORMP) | Oral insulin gel capsule | Diabetes | Completed a Phase Ia trial; no significant adverse events were noted in the drug group other than the expected insulin-related hypoglycemic side effects (8/14) | ||
Rheoscience A/S* (Denmark) and Dr. Reddy's Laboratories (India) | DRF2593-307 | Balaglitazone; an insulin sensitizer that acts as a partial PPAR gamma agonist | Diabetes | The first patient has been dosed in a Phase III study (8/1) | |
INFECTION | |||||
Accentia Bio-pharmaceuticals Inc. (ABPI) | SinuNase | Intranasal lavage of 0.01%amphotericin B | Refractory chronic sinusitis | Interim Phase III data showed improvement in polyposis by endoscopy in about 50% of patients and improvement in sinus inflammation by CT scan in about 50% of patients (8/15) | |
Artisan Pharma Inc.* | ART-123 | A recombinant, soluble thrombomodulin agent designed to target both anticoagulant and systemic anti-inflammatory pathways | Disseminated intravascular coagulation in sepsis | Launched a Phase IIb trial (8/21) | |
BioMarin Pharmaceutical Inc. (BMRN) | Kuvan | Sapropterin dihydrochloride; small molecule | Phenylketo-nuria | Phase III data suggested treatment results in significant reductions in blood Phe levels in some patients (8/13) | |
Cadence Pharmaceuticals Inc. (CADX) | Intravenous acetaminophen | Acute pain | Completed patient enrollment in a pivotal Phase III study in acute pain following gynecologic surgery (8/30) | ||
CuraGen Corp. (CRGN) | Velafermin | Growth factor that promotes both epithelial and mesenchymal cell proliferation | To prevent severe oral mucositis | Enrollment has been completed in the Phase II study (8/7) | |
Human Genome Sciences Inc. (HGSI) | Albuferon | Albinterferon alfa-2b | Chronic hepatitis C | Completed enrollment of a target 1,331 patients in a Phase III trial (8/28) | |
Implicit Bioscience Pty. Ltd. (Australia) | Intranasal oglufanide disodium | Chronic hepatitis C viral infection | A Phase IIa trial is under way (8/27) | ||
Intercell AG (Austria; Vienna: ICLL) | IC41-202 | Vaccine that comprises five synthetic peptides harboring HCV and T-cell epitopes, as well as the adjuvant IC30, which consists of poly-L-arginine | Hepatitis C virus | Phase II data indicated a 40% reduction in viral load, a statistically significant result (8/22)** | |
Iomai Corp. (IOMI) | Patch-based vaccine for enterotoxigenic E. coli bacteria | Traveler's diarrhea | Phase II data showed statistically significant protection from traveler's diarrhea vs. placebo (8/1); Phase I data showed that all patients who received the vaccine mounted a response (8/9) | ||
MedImmune Inc. (LSE:MDI) | Motavizumab (formerly Numax) | Third-generation variant of the anti-RSV antibody Synagis | Respiratory syncytial virus | Phase III data showed the product reduced hospitalizations due to RSV by 83% vs. placebo (8/24) | |
Meridian Bioscience Inc. (VIVO) | Parvovirus B19 vaccine | Parvovirus | Began a Phase I/II trial (8/28) | ||
Pharmasset Inc. (VRUS) | R7128 | A nucleoside polymerase inhibitor | Hepatitis C virus | Completed patient enrollment in its multiple ascending dose study of R7128 to treat HCV (8/2) | |
Romark Laboratories LC* | Alinia | Nitazoxanide; a small-molecule compound from the thiazolides class that targets cell-signaling pathways used in viral replication | Hepatitis C virus | Started a Phase II trial (8/15) | |
TaiGen Biotechnology Inc.* (Taiwan) | Nemonoxacin | TG-873870; oral drug; quinolone antibiotic | Community-acquired pneumonia | Completed enrollment of a target 265 patients in a Phase II trial (8/10) | |
ViroPharma Inc. (VPHM) and Wyeth Pharmaceuticals | HCV-796 | An orally dosed non-nucleoside polymerase inhibitor | Hepatitis C virus | Companies discontinued dosing in a Phase II study after a safety board identified a potential association between HCV-796 and an elevation of the levels of serum transaminases (8/10) | |
MISCELLANEOUS | |||||
Altus Pharmaceuticals Inc. (ALTU) | ALTU-237 | An orally delivered crystalline formulation of an oxalate-degrading enzyme | Hyperoxalurias and prevention of recurrent kidney stones | Started a Phase I trial (8/14) | |
Akela Pharma Inc. (Canada; TSX:AKL) | CGRP | A 37 amino acid, natural neuropeptide produced in the lung in response to allergic stimuli | Asthma | Started a Phase IIb trial (8/27) | |
Ambrilia Biopharma Inc. (Canada; TSX:AMB) | Octreotide | Prolonged-release formulation; octreotide acetate for injectable suspension | Acromegaly | Completed patient recruitment in a pivotal Phase III trial (8/28); data from the first clinical trial showed it normalizes the major marker for acromegaly, insulin-like growth factor-1, and suppresses high-growth hormone plasma levels (8/29) | |
Antares Pharma (AMEX:AIS) | Anturol | A transdermal oxybutynin ATD gel | Overactive bladder | Started a pivotal trial of Anturol (8/23) | |
Ardana plc (UK; LSE:ARA) | ARD-07 | Oral growth hormone secretagogue | To diagnose growth hormone deficiency | Enrolled the first patient in a Phase III trial (8/15)** | |
Biopartners Holdings AG* (Switzerland) | Valtropin | Biosimilar recombinant human growth hormone | Growth hormone deficiency | Phase III data showed it demonstrated equivalent safety and efficacy to the reference product (8/14) | |
Cobalis Corp. (OTC BB:CLSC) | PreHistin | Cyanocobalamin; agent designed to modulate levels of IgE, reducing the over-production of histamines | Moderate to moderately severe seasonal allergic rhinitis | Top-line results from two Phase III trials showed very low symptom levels in both placebo and PreHistin-treated patient groups, leaving no room to demonstrate a meaningful effect (8/2); the trials did not achieve their primary endpoint (8/28) | |
CollaGenex Pharmaceuticals Inc. (CGPI) | Col-118 | Topical formulation that incorporates a compound believes to reduce erythema by constricting enlarged blood vessels in facial tissue | Erythema | Phase II data demonstrated a highly statistically significant dose-response relationship in the reduction of erythema (8/28) | |
Kosan Biosciences Inc. (KOSN) and Pfizer Inc. | PF-04548043 | Formerly KOS-2187; motilin receptor agonist | Gastroesopha-geal reflux disease | Started a Phase I trial (8/6) | |
Kiadis Pharma BV* (the Netherlands) | Rhitol | A small-molecule drug designed to selectively accumulate in reactive immune cells and to eliminate those cells upon photo-activation | Steroid-resistant or intolerant chronic graft-vs.-host disease | Enrolled the last patient in its Phase I/II trial (8/29)** | |
Kythera Bio-pharmaceuticals Inc.* | ATX-101 | Liposculpting agent | To reduce unwanted submental fat | Started a Phase II study (8/28) | |
MediciNova Inc. (MNOV) | MN-221 | A selective beta2adrenergic receptor agonist | Preterm labor | A Phase Ib trial showed that target plasma concentrations were achieved with an intra-venous priming followed by maintenance infusion dosing paradigm (8/17) | |
MedImmune Inc. (LSE:MDI; unit of AstraZeneca plc; UK) | MEDI-528 | Monoclonal antibody targeting interleukin-9 | Mild, persistent asthma | Started a Phase IIa trial (8/1) | |
Opko Health Inc. (AMEX:OPK) | Bevasiranib | siRNA drug | Wet age-related macular degeneration | First patient was dosed in a Phase III trial (8/30) | |
Palatin Technologies Inc. (AMEX:PTN) | Bremelanotide | Melanocortin receptor agonist | Erectile dysfunction | The FDA noted that the drug may raise blood pressure in certain patients, delaying the start of pivotal trials (8/30) | |
PDL BioPharma Inc. (PDLI) | Nuvion | Visilizumab; humanized monoclonal antibody | Ulcerative colitis | Company discontinued development of the pivotal Phase III program due to insufficient efficacy and an inferior safety profile compared to intravenous steroids alone (8/29) | |
Pervasis Therapeutics Inc.* | Vascugel | An allogeneic cell therapy product that may restore natural repair and regeneration pathways in traumatized human vasculature | Maintenance of vascular patency arteriovenous access grafts and AV fistulae in dialysis patients with end-stage renal disease | Completed enrollment for its two Phase II trials (8/13) | |
Regeneron Pharmaceuticals Inc. (REGN) and Bayer HealthCare AG (Germany) | VEGF Trap-Eye | VEGF inhibitor that binds and blocks 1-to-2 orders of magnitude | Wet age-related macular degeneration | Began a Phase III trial comparing it with Lucentis (8/3) | |
Unigene Laboratories Inc. (OTC BB:UGNE) | Calcitonin | Oral calcitonin designed to deliver a more consistent dose while maintaining therapeutic blood levels of the peptide using Enteripep oral delivery technology | Osteoporosis | Started a study in the U.S. (8/2) | |
Urigen Pharmaceuticals Inc. (OTC BB:URGP) | URG-101 | Intravesical lidocaine-heparin formulation | Painful bladder syndrome/interstitial cystitis | Started a Phase II study (8/14) | |
Notes: | |||||
* Privately held. BLA = Biologics license application; DMC = Data Monitoring Committee; 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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. |