Clinical Trials Update: June 2005
Company* | Product | Description | Indication | Status |
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AUTOIMMUNE | ||||
Acorda | Fampridine-SR | Selective neuronal potassium channel blocker | Multiple sclerosis | Began pivotal Phase III trial under FDA SPA to evaluate safety and improved walking in 240 MS patients (6/30) |
Biogen Idec | Tysabri | Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells | Crohn's disease | Phase III ENCORE trial met its primary endpoint of clinical response and all secondary endpoints; the 510 patients had been dosed prior to trials and sales being voluntarily suspended (6/30) |
Centocor Inc. | Remicade (FDA-approved) | Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha | Psoriatic arthritis | New Phase III data showed significantly greater inhibition of structural damage than placebo (6/9); long-term data showed sustained efficacy (6/10) |
Genentech | Rituxan (FDA-approved) | Rituximab; antibody that that targets and selectively depletes CD20-positive B cells | Rheumatoid arthritis | Phase IIb trial in 465 patients who weren't responding to methotrexate showed improved response rates vs. placebo (6/9) |
Immunomedics | Epratuzumab | Humanized anti-CD22 antibody labeled with yttrium-90 | Sjogren's syndrome | Phase I/II trial in 15 patients produced improvements in disease signs and symptoms (6/10) |
Immunomedics | Epratuzumab | Humanized anti-CD22 antibody labeled with yttrium-90 | Lupus | Began pivotal Phase III ALLEVIATE A and B trials that will assess disease activity (6/1) |
Millennium | Velcade (FDA-approved) | Monoclonal antibody that binds to alpha 4 beta 7, a T-cell integrin | Ulcerative colitis | Phase II trial demonstrated statistically significant improvements in remission rates vs. placebo (6/16) |
Pharma- | Tovaxin | Trivalent formulation of | Multiple | Interim data from six patients in Phase I/II trial showed reduced peripheral blood MRTC levels and improved disability scores (6/3) |
QuatRx | Becocalcidiol | Topical vitamin D analogue | Psoriasis | Phase IIb trial in 185 patients demonstrated a statistically significant improvement vs. vehicle in physicians' assessment (6/14) |
Regeneron | IL-1 Trap | Agent designed to attach to and neutralize interleukin-1 | CIAS1-associated periodic syndrome | All four patients in a pilot study experienced positive responses to loading and subsequent doses (6/10) |
Renovis Inc. | REN-850 | Inhibitor of leukocyte trafficking | Multiple sclerosis | Stopped Phase Ia trial and further development after seeing unexpected pharmacokinetics (6/13) |
The Immune | NeuroVax | T-cell receptor peptide vaccine | Multiple sclerosis | Data from ongoing trial demonstrated a significant increase in FOXP3, a gene marker that tracks regulatory T cells (6/21) |
Vertex | VX-702 | Oral p38 MAP kinase inhibitor | Rheumatoid arthritis | Began Phase II trial to evaluate safety, tolerability and activity in 300 patients with moderate to severe RA (6/10) |
CANCER | ||||
Adventrx | CoFactor | Form of folic acid designed to enhance the antitumor effects of 5-FU | Metastatic colorectal cancer | 31 of 48 patients in Phase II trial with 5-FU achieved clinical benefit; 18 patients responded to treatment (6/20) |
Ariad | AP23573 | Oral form of agent designed to inhibit cell-signaling protein mTOR | Endometrial cancer | Began Phase II single-agent trial to evaluate clinical benefit in up to 45 patients (6/30) |
Astex Ltd.* | AT7519 | Cell-cycle inhibitor that targets cyclin-dependent kinases | Refractory solid tumors | Starting a Phase I trial in the U.S. and UK in patients (6/27) |
Biogen Idec | Galiximab | Primatized monoclonal antibody that targets CD80 on the surface of B cells | Relapsed/ refractory follicular non-Hodgkin's lymphoma | Phase II trial in 73 patients showed combination with Rituxan may extend event-free survival vs. Rituxan alone; an overall response rate of 64% was achieved (6/14) |
Biogen Idec | Zevalin (FDA-approved) | Ibritumomab tiuxetan; monoclonal antibody targeting CD20 combined with radioisotope | Diffuse large B-cell lymphoma | Data were presented showing drug is as effective as a second- line treatment in patients not eligible for stem cell transplantation (6/13) |
BioVex Ltd.* | OncoVEX | Oncolytic virus that delivers the gene for GM-CSF | Malignant melanoma | Got OK from the FDA to begin Phase II trials (6/6) |
Celgene Corp. | Revlimid | Lenalidomide; derivative of Thalomid (thalidomide) | Myelodysplastic syndromes | Data from ongoing Phase II (MDS-002) trial showed 51% of patients responded to treatment; 33% became transfusion independent (6/6) |
Cell | GVAX | Vaccine comprises non-patient-specific tumor cells modifiedto secrete GM-CSF | Cancers | Company is ending development in lung cancer and myeloma as part of move to save money by focusing on the most promising indications (6/7) |
Chiron Corp. | CHIR-258 | Orally available tyrosine kinase inhibitor | Multiple myeloma | Chiron and the Multiple Myeloma Research Consortium began a Phase I trial to assess safety, tolerability and pharmacokinetics in patients (6/2) |
Cytogen | Quadramet (FDA-approved) | Samarium-153 bound to a small-molecule, bone-seeking phosphonate | Cancers | Positive data were reported from studies in prostate cancer and bone metastases (6/21) |
Genta Inc. | Genasense | Oblimersen sodium; inhibits function of bcl-2 protein | Non-Hodgkin's lymphoma | Trial with rituximab in 35 relapsed/ refractory patients showed an overall response rate of 42% (6/13) |
Genentech | -- | Topical antagonist of the Hedgehog signaling pathway | Basal-cell carcinoma | Began Phase I trial to evaluate safety and tolerability of a multi-dose regimen in patients (6/8) |
Genmab A/S | HuMax-CD20 | Human antibody that binds to the CD20 antigen | Follicular non- Hodgkin's lymphoma | Objective response rates of up to 63% were seen in relapsed/refractory patients still in follow-up from Phase I/II safety trial (6/10) |
Human Genome | HGS-ETR1 | Mapatumumab; agonistic human monoclonal antibody to TRAIL receptor 1 | Advanced non- Hodgkin's lymphoma | Interim data from Phase II trial in 40 patients demonstrated tolerability and signs of clinical activity (6/13) |
ImClone | Erbitux | Cetuximab; antibody that blocks the epidermal growth factor receptor | Head and neck cancer | Analysis of Phase III IMCL-9815 trial with radiation in first-line treatment confirmed it met its primary endpoint of locoregional control vs. radiation alone (6/8) |
ImmunoGen | huC242-DM4 | Tumor-activated prodrug targeting the CanAg antigen | Cancers | Began Phase I trial in patients to evaluate safety, pharmacokinetics and dosing(6/24) |
Introgen | Advexin | Adenoviral vector containing the p53 tumor-suppressor gene | Various cancers | Presented data showing potential applications of the drug alone and in combination therapies in several cancers (6/2) |
Kosan | KOS-1022 (DMAG) | Second-generation heat- shock protein 90 inhibitor | Hematologic malignancies | Began a Phase I trial to assess safety and pharmacokinetics of escalating doses in patients with leukemias (6/6) |
Kosan | KOS-953 | 17-AAG; designed to inhibit heat-shock protein 90 | Multiple myeloma | Preliminary Phase I single-agent data and data from a Phase Ib combination trial both showed signs of anticancer activity(6/3) |
MediciNova | MN-029 | Vascular-targeting agent | Solid tumors | The company began a second Phase I trial of the drug (6/17) |
MediGene AG | G207 | Herpes simplex virus engineered to replicate in and kill cancer cells | Malignant melanoma | Began Phase I trial to evaluate safety, tolerability, efficacy trends and synergies with radiation therapy in about 20 patients (6/9) |
MediGene AG | Polyphenon E Ointment | Product from green tea leaves designed to block virus binding to cells | Actinic keratosis | Phase II trial in 62 patients showed a reduction in visible skin lesions vs. placebo (6/30) |
Millennium | Velcade | Bortezomib; proteasome inhibitor | Various lymphomas | Positive data were reported from a Phase II trial with rituximab in indolent lymphoma (6/13) |
Millennium | Velcade | Bortezomib; proteasome inhibitor | Multiple myeloma | Published data from single-agent and combination Phase II trials showed overall response rates ranging from 88% to 95% (6/8); Phase III APEX trial showed superiorty to dexamethasone in patients with relapsed MM (6/16) |
NeoPharm | IL13-PE38QQR | Tumor-targeting agent designed to deliver bacterial cytotoxic PE38 | Glioblastoma multiforme | Monitors recommended Phase III PRECISE trial continue as planned, following an interim analysis (6/27) |
Northwest | DCVax-Brain | Dendritic cell-based immunotherapy made from patients' cells | Brain cancer | Starting a Phase II trial in 150 newly diagnosed glioblastoma multiforme patients (6/1) |
Peregrine | Cotara | Chimeric tumor-necrosis therapy antibody attached to iodine-131 | Brain cancer | 51-patient study validated the use of convection-enhanced delivery for administering Cotara (6/1) |
Point | Talabostat | Small molecule designed to stimulate proliferation of hematopoietic progenitor cells | Metastatic pancreatic cancer | Began Phase II trial in up to 60 patients to evaluate six-month survival and other endpoints in combination with gemcitabine (6/23) |
TransMolecular | 131I-TM-601 | Radiopharmaceutical containing a synthetic version of chlorotoxin (TM-601), which is derived from scorpion venom | Recurrent high-grade glioma | Began Phase II trial; initially, dosing will be tested in 12 patients; then safety and efficacy will be evaluated in 54 patients (6/1) |
Vertex | VX-680 | Small-molecule inhibitor of Aurora kinases | Hematologic cancers | They began an additional Phase I trial to evaluate safety and tolerability in patients with hematologic malignancies (6/17) |
CARDIOVASCULAR | ||||
Affymax Inc.* | Hematide | Peptide-based erythropoiesis- stimulating agent | Anemia | Phase I trial in healthy volunteers demonstrated safety and a sustained effect on red blood cell production (6/7) |
Alexion | Eculizumab | Humanized monoclonal antibody designed to block complement protein C5 | Paroxysmal nocturnal hemoglobinuria | Follow-up data from a pilot trial showed drug maintained statistically significant reductions in red blood cell destruction and blood transfusions (6/28) |
Alteon Inc. | Alagebrium | A.G.E. crosslink breaker | Systolic hypertension | Discontinued Phase IIb SPECTRA trial after interim evaluation indicated the drug had not demonstrated efficacy (6/9) |
Arginox | Tilarginine | Agent designed to inhibit the production of nitric oxide | Cardiogenic shock | Began pivotal Phase III TRIUMPH trial that will evaluate reduced mortality vs. placebo in 650 patients (6/28) |
CardioVascular | Cardio Vascu-Grow | Agent designed to facilitate the growth of new blood vessels | Coronary heart disease | Monitors who reviewed data from four patients in a Phase I trial concluded it was safe to continue (6/15) |
CoTherix Inc. | Ventavis (FDA-approved) | Inhaled formulation of iloprost, a prostacyclin analogue | Pulmonary hypertension | Began Phase II ACTIVE trial to assess safety and efficacy in 50 patients with PH associated with idiopathic pulmonary fibrosis (6/1) |
Dyax Corp. | DX-88 | Recombinant small protein designed to inhibit human plasma kallikrein | Hereditary angioedema | Phase I data will allow for subcutaneous rather than intravenous delivery; also, reported positive interim data from the first 120 HAE attacks in a Phase II trial (6/30) |
Isis | ISIS 301012 | Capsule formulation of second- generation anti- sense inhibitor of ApoB-100 | Cholesterol management | Phase I trial in 36 volunteers showed rapid and prolonged reductions in ApoB- 00, along with reductions in lipoprotein and total cholesterol levels (6/9) |
Millennium | Integrilin (FDA-approved) | Eptifibide; glycoprotein IIb/IIIa inhibitor | Acute coronary syndromes | Began EARLY ACS trial to assess safety and efficacy vs. placebo in 10,500 patients with non-ST elevation ACS (6/28) |
Myogen Inc. | Enoximone | Small-molecule inhibitor of Type III phospho-diesterase | Chronic heart failure | Phase III ESSENTIAL I & II trials in patients with advanced CHF failed to demonstrate a statistically significant benefit in any of the three co-primary endpoints(6/26) |
Sangamo | EW-A-401 | Agent encoding a zinc finger DNA-binding protein transcription factor designed to activate all isoforms of the VEGF-A gene | Critical limb ischemia | Began a Phase I trial in up to 16 patients to assess safety, as well as to gather efficacy data (6/23) |
Surface | SLx-2101 | Selective, oral PDE-5 inhibitor | Cardiovascular diseases | Began a Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in healthy male subjects (6/8) |
V.I. | Inactine | Pathogen-reduction system | Blood substitute | The company is ending development of the product; enrollment was suspended in a Phase III trial in November 2004 after an adverse event was seen (6/30) |
ZymoGenetics | rhThrombin | Recombinant human thrombin | For use in intraoperative bleeding | Phase II trial showed the product may be a safe and effective tool to stop bleeding in vascular surgery (6/20) |
CENTRAL NERVOUS SYSTEM | ||||
Acadia | ACP-103 | Small-molecule, 5-HT2A inverse agonist | Parkinson's disease | An interim trend analysis from the first 30 patients in a Phase II trial showed improved reductions in psychotic symptoms vs. placebo (6/22) |
Amarin Corp. | Miraxion (LAX-101c) | Compound that inhibits certain enzymes, including phospholipases and caspases | Huntington's disease | Began Phase III trial to assess the drug's impact on signs and symptoms in 300 patients with mild to moderate HD (6/14) |
Aradigm | Intraject system | Needle-free delivery system for a triptan | Migraine and cluster headaches | Self-injection study in healthy subjects achieved bioequivalent blood plasma levels to a marketed injected product (6/29) |
Arena | APD125 | Antagonist at the 5-HT2A serotonin receptor | Insomnia | Phase I trial demonstrated safety and a statistically significant increase in the amount of deep sleep, and positive signals in other sleep parameters (6/30) |
Avanir | Neurodex | Oral combination of dextromethorphan and an enzyme inhibitor, quinidine | Diabetic neuropathic pain | Began Phase III trial that will assess efficacy, safety and tolerability vs. placebo (6/23) |
Cortex | CX717 | Ampakine analogue | Sleep deprivation | The Defense Advanced Research Projects Agency is sponsoring a trial using a simulated night shift work paradigm (6/21) |
Myriad | Flurizan | Selective amyloid beta 42 lowering agent | Alzheimer's disease | Moderate AD patients given 800 mg twice daily demonstrated a 45% slowing of decline (p=0.059) in their performance of activities of daily living (6/20) |
Neurochem | Alzhemed | Small molecule designed to interfere with association between glycosaminoglycans and A-beta protein | Alzheimer's disease | Monitors recommended continuation of Phase III trial after second interim review, including data from 742 patients (6/13) |
Neurocrine | Indiplon | Capsule form of a non- benzodiazepine agent that targets the GABA-A receptor | Insomnia | Phase III trial in 358 elderly patients showed significant improvements in latency to sleep onset; another study in elderly patients demonstrated significant improvement in sleep maintenance vs. placebo (6/14) |
NeurogesX | NGX-4010 | High-concentration trans- capsaicin dermal patch | Postherpetic neuralgia | Began 300-patient Phase III trial to study pain reduction vs. a control patch (6/15) |
Neurologix | -- | Gene therapy entailing injection of a virus directly into the brain | Parkinson's disease | Preliminary data from Phase I trial in 12 patients suggested no safety concerns (6/8) |
Sepracor | Lunesta (FDA-approved) | Eszopiclone tablets; a non- enzodiazepine agent | Insomnia | Positive data were presented from trials with Prozac in patients with major depressive disorder (6/21); statistically significant data were reported in two other patient populations (6/20) |
Solstice | Myobloc (FDA-approved) | Botulinum toxin type B | Cervical dystonia | Head-to-head trial in 111 toxin-naive subjects with CD showed drug to be clinically equivalent to Botox for efficacy (6/21) |
Somaxon | Silenor | Low dose of the approved depression drug doxepin | Insomnia | Began a Phase III trial that will measure sleep maintenance, as well as sleep onset and duration (6/9) |
TorreyPines | NGX267 | Selective cholinergic muscarinic receptor agonist (M1 subtype) | Alzheimer's disease | Filed an IND to begin clinical testing of the product (6/7) |
DIABETES | ||||
Agennix Inc.* | Talactoferrin | Topical talactoferrin alfa | Diabetic ulcers | Phase II trial in 55 patients met its primary endpoint of 75% or better healing at the end of 12-week dosing (6/13) |
Alkermes | -- | Inhaled insulin system based on Alkermes' AIR delivery technology | Type I diabetes | Phase II trial in 259 patients showed similar blood sugar levels to treatment with injected insulin (6/14) |
Amylin | Byetta (FDA-approved) | Exenatide; incretin mimetic | Type II diabetes | Long-term data from open-label extension of pivotal trial showed sustained improvements in glucose control and progressive weight reduction (6/10) |
Amylin | Symlin (FDA-approved) | Pramlintide acetate; an analogue of human amylin | Type I and II diabetes | Phase II trial in 204 obese diabetics showed a statistically significant 3.6% weight loss vs. placebo (6/3) |
Generex | Oral-lyn | Oral insulin spray formulation | Diabetes | Presented data from various studies showing glucodynamic profiles and metabolic effects (6/14) |
Isis | ISIS 113715 | Antisense inhibitor of protein tyrosine phosphatase (PTP-1B) | Type II diabetes | Interim data from Phase II trial showed drug reduced HbA1C and plasma glucose after six weeks of dosing (6/14) |
Keryx Bio- | KRX-101 | Sulodexidel; oral heparinoid compound | Diabetic nephropathy | Began Phase III trial to test the drug against placebo in about 1,000 patients; also began Phase IV study in 2,200 patients (6/29) |
MannKind | Technosphere Insulin | Dry-powder, inhaled insulin formulaiton | Type II diabetes | Data from two studies showed the benefit of use in conjunction with an oral diabetes medication (6/14); began pivotal Phase III trial to evaluate pulmonary safety (6/29) |
Nektar | Exubera | Dry-powder, inhaled insulin formulation | Type I and II diabetes | Two-year Phase III trials demonstrated effective, sustained glycemic control in Type II patients; trial in 226 Type I patients showed effectiveness in achieving tight glycemic control (6/14) |
INFECTION | ||||
Barrier | Hyphanox | Tablet formulation of itraconazole, an antifungal agent | Vaginal candidiasis | Phase III non-inferiority trial failed to meets its primary endpoint of therapeutic cure vs. fluconazole (6/29) |
Cadence | CPI-226 (MX-226) | Omiganan pentahydro- | Catheter-related infections | Starting a Phase III trial under an FDA SPA to evaluate efficacy vs. 10% povidone-iodine in about 1,250 patients (6/27) |
Chemokine | CTCE-0214 | Stable peptide agonist of stromal cell-derived factor-1 | Infections | Phase I trial in 24 subject demonstrated safety and efficacy results that warrant continued investigation (6/1) |
Chiron Corp. | PA-824 | Tuberculosis drug candidate | Tuberculosis | The Global Alliance for TB Drug Development began Phase I trials (6/14) |
Cubist | Cubicin (FDA-approved) | Daptomycin for injection; a bactericidal antibiotic | Staphylococcus aureus | Phase III endocarditis and bacteremia trial met its primary end-points of non-inferiority; an sNDA filing is planned (6/27) |
DOR | RiVax | Fragment of ricin toxin | Ricin vaccine | Early results from Phase I trial in volunteers showed the agent was safe and immunogenic (6/15) |
Dynavax | -- | Vaccine combining immunostimulatory sequence with HBV surface antigen | Hepatitis B | Phase II/III trial in older population showed statistically significant superiority in protective antibody response and robustness of protective effect vs. Engerix-B (6/14) began pivotal Phase III trial to compare efficacy to Engerix-B in 400 older patients (6/23) |
Gilead Sciences | Hepsera (FDA-approved) | Adefovir dipivoxil; a nucleotide analogue | Hepatitis B | Phase III Study 438 in 185 patients supported the efficacy and tolerability of the drug at 144 weeks (6/30) |
Gilead | GS 9137 (JTK-303) | Oral HIV integrase inhibitor | HIV | Began Phase I/II trial to evaluate tolerability, safety and antiviral activity in HIV-positive patients (6/21) |
Immtech | DB289 | Oral, dicationic antiviral agent | African sleeping sickness | FDA agreed to SPA on pivotal Phase III trial that will evaluate efficacy vs. pentamidine in 250 patients in Africa (6/16) |
MedImmune | CAIV-T | Trivalent vaccine; next generation of FluMist | Influenza | Phase III trial met its objective of producing similar immune responses to FluMist (6/16) |
Oscient | Factive (FDA-approved) | Gemifloxacin mesylate; a fluoroquinolone antibiotic | Community- acquired pneumonia | Pivotal Phase III trial in 460 patients showed non-inferiority of five-day treatment vs. the approved seven-day treatment (6/6) |
Protein | FluBIOk | Influenza vaccine derived from recombinant hemagglutinin | Influenza | Trial in 460 healthy subjects met its primary endpoints by showing safety and inducing strong titers against influenza (6/14) |
SciClone | Zadaxin | Synthetic preparation of thymosin alpha-1 | Hepatitis C | Six of 30 nonresponsive patients taking drug with pegylated interferon alpha and ribavirin achieved a sustained viral response (6/21) |
TaiGen | TG-873870 | Novel quinolone antibiotic | Infections | Began a Phase Ib trial that will examine safety and dosing (6/18) |
MISCELLANEOUS | ||||
Alteon Inc. | Alagebrium | A.G.E. crosslink breaker | Erectile dysfunction in diabetics | The FDA put a hold on Phase IIa EMERALD trial pending submission of additional data on preclinical toxicity tests (6/9) |
Altus | TheraCLEC | Oral enzyme-replacement therapy designed to replace digestive enzymes | Pancreatic insufficiency | Phase II trial in 125 patients with cystic fibrosis demonstrated a statistically significant improvement in fat absorption (6/20) |
Altus | ALTU-238 | Long-acting crystalline formulation of recombinant human growth hormone | Growth hormone deficiency | Successfully completed Phase I trial and said it plans to begin a Phase II trial in adults (6/6) |
Arena | APD356 | Small-molecule, selective 5HT2C serotonin receptor agonist | Obesity | Began Phase IIb trial to evaluate safety and weight loss over 12 weeks in 400 patients (6/23) |
CollaGenex | Oracea | Non-antimicrobial tetracycline derivative | Rosacea | Two Phase III trials totaling 537 patients demonstrated statistical significance vs. placebo (6/6) |
Genaera | Evizon (squalamine) | Anti-angiogenesis agent; vascular endothelial growth factor inhibitor | Wet age-related macular degeneration | Reached agreement with FDA on SPA for pivotal trials (6/27); began first of two trials under the SPA, a trial to demonstrate safety and benefit on visual acuity at one year (6/30) |
Halozyme | Cumulase | Ex vivo formulation of recombinant human PH20 hyaluronidase | Treatment of oocytes | Drug-treated oocytes demonstrated significantly increased fertilization rates in a trial vs. the standard bovine-derived hyaluronidase extract (6/22) |
Halozyme | rHuPH20 | Recombinant human hyaluronidase | For use in breaking down hyaluronan | Phase I trial in 100 volunteers showed no allergic reactions to the product (6/21) |
Indevus | Sanctura | Once-daily version of FDA-approved trospium chloride agent | Overactive bladder | Pilot Phase II trial demonstrated similar efficacy to the approved twice-daily drug (6/15) |
Isolagen Inc. | Isolagen Process | Autologous cellular therapy | Interdental papillary insufficiency | Phase II trial demonstrated statistical superiority to placebo at four months after treatment (6/30) |
Neurochem | Fibrillex | Glycosaminoglycan mimetic with anti- myloid properties | Amyloid A amyloidosis | Further analyses from Phase II/III trial showed reductions in the risk of renal decline or all-cause mortality (6/5); another analysis showed early clinical effect (6/9) |
Nymox | NX-1207 | Investigational drug for BPH | Benign prostatic hyperplasia | Follow-up data from 18-23 months in Phase I and II trials showed statistically significant symptomatic improvements (6/8) |
Sucampo | Tacrolimus | Eye-drop formulation of tacrolimus | Dry-eye syndrome | Company voluntarily suspended development program after safety concerns were seen in another product containing tacrolimus (6/24) |
Symbollon | IoGen | Iodine-based oral drug | Breast pain associated with fibrocystic breast disease | Began first Phase III pivotal trial of drug to evaluate clinical effects in about 175 women (6/14) |
Santarus Inc. | Zegerid | Immediate-release capsule formulation of the proton pump inhibitor omeprazole | Gastrointestinal conditions | Trial in 36 patients showed significantly reduced gastric acidity throughout the night vs. Protonix (6/14) |
Tercica Inc. | Increlex | Mecasermin injection; recombinant human insulin-like growth factor-1 | Short stature caused by IGF deficiency | Presented pharmacokinetic and safety data from various studies (6/6 and 6/7) |
Theravance | GSK159797 | Inhaled, longer-acting Beta2 agonist | For use as a bronchodilator | Phase II trial showed clinically significant increases in bronchodilation over 24 hours with little impact on heart rate (6/27) |
Theravance | GSK656398 (formerly TD-5742) | Inhaled, long-acting muscarinic antagonist; bronchodilator | Chronic obstructive pulmonary disease | Partner GlaxoSmithKline plc began Phase I trial to assess safety, tolerability and pharmaco-kinetics (6/13) |
Threshold | TH-070 | lonidamine; an indazole- 3-carboxylic acid | Benign prostatic hyperplasia | Began Phase II trial to evaluate dosing, safety and activity in about 200 patients (6/27) |
Transkaryotic | Iduronate-2- sulfatase | Enzyme-replacement therapy | Hunter syndrome (MPS II) | Pivotal Phase III AIM trial showed a statistically significant improvement in forced vital capacity and six-minute walk test, the primary endpoints (6/20) |
Vernalis plc | Frova (FDA-approved) | Frovatriptan; 5HT 1B/1D agonist | Menstrually related migraine | Six-month data from Phase III trial indicate the drug is well tolerated; no serious adverse events were reported (6/27) |
Vivus Inc. | Avanafil | Oral phosphodiesterase type-5 inhibitor | Erectile dysfunction | Phase II trial in 284 patients demonstrated statistical significance vs. placebo (6/23) |
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; EMEA = European Medicines Agency; FDA = Food and Drug Administration; IND = Investigational new drug application; MAA = Marketing authorization 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; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OSE = Osaka Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||