www.bioworld.com/articles/449172
Clinical Trials Update: November 2007
Dec. 17, 2007
| Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| 4SC AG (Germany; FSE:VSC) | SC12267 | New type of small-molecular active agent from the class of disease-modifying anti-rheumatic drugs; works as a selective inhibitor in the biosynthesis of pyrimidine | Rheumatoid arthritis | Phase IIa data showed it was safe and well tolerated (11/29) |
| Amgen Inc. (AMGN) and Wyeth Pharmaceuticals Inc. | Enbrel (FDA-approved) | Etanercept | Rheumatoid arthritis | Data showed Enbrel when given with methotrexate gained clinical remission in 50% of patients with active early disease, compared with 28% who received only methotrexate (11/8) |
| Biogen Idec Inc. (BIIB) | BG9924 | Baminercept; a dual-mechanism lymphotoxin-beta and LIGHT pathway inhibitor | Rheumatoid arthritis | Phase IIa data suggests clinically meaningful improvements in ACR scores and individual core set measurements in RA patients over placebo (11/9) |
| Centocor Inc. (unit of Johnson & Johnson) | CNTO 148 | Golimumab; next-generation human antitumor necrosis factor-alpha monoclonal antibody | Psoriatic arthritis and ankylosing spondylitis | Phase III data showed significant and sustained improvements in the joint and skin manifestations of psoriatic arthritis; and 59% of patients receiving 50 mg and 60% of those receiving 100 mg achieved at least 20% improvement in the Assessment in Ankylosing Spondylitis criteria compared with 22% of patients receiving placebo (11/8) |
| CombinatoRx Inc. (CRXX) | CRx-191 | Nortriptyline-mometasone | Psoriasis | Started a Phase IIa trial (11/6) |
| Human Genome Sciences Inc. (HGSI) | LymphoStat-B | Belimumab; human monoclonal antibody that inhibits activity of B-lymphocyte | Active systemic lupus erythematosus | Phase II demonstrated that LymphoStat-B achieved a sustained improvement in disease activity across multiple clinical measures, decreased the frequency of disease flares over time and was well tolerated through 2.5 years on treatment in combination with standard of care (11/9) |
| LifeCycle Pharma A/S* (Denmark) | LCP-Siro | Contains the immuno-suppressant sirolimus | Autoimmune diseases | Started a Phase I trial (11/29) |
| MedImmune Inc. (LSE:MDI; unit of AstraZeneca plc; UK) | CAM-3001 | MAb targeting GM-CSFR | Rheumatoid arthritis | Started dosing patients in its first Phase I trial (11/26) |
| NicOx SA (France; PARIS:COX) | Naproxcinod | Nitric oxide-donating derivative of naproxen | Osteoarthritis of the knee | Phase III data showed each of the active treatment groups were statistically significantly superior to placebo at two, six and 13 weeks (11/12) |
| Osiris Therapeutics Inc. (OSIR) | Chrondrogen | A preparation of adult stem cells formulated for direct injection into the knee | Osteoarthritis | One-year data showed improvement in joint condition that correlated with a clinically and statistically significant improvement in pain in patients receiving Chrondrogen over hyaluronic acid (11/27) |
| Targeted Genetics Corp. (TGEN) | tgAAC94 | Uses an adeno-associated virus vector to deliver the gene encoding a soluble form of the receptor for TNF-alpha | Inflammatory arthritis | Phase I/II data suggested the therapy showed improvement in patient reported outcome measures (11/12) |
| Trubion Pharmaceuticals Inc. (TRBN) | TRU-015 | Small modular immuno-pharmaceutical drug | Rheumatoid arthritis | Phase IIb data showed it provided statistically significant efficacy (11/9) |
| UCB SA (Belgium; BR:UCB) | Cimzia | Certolizumab pegol; the pegylated Fc-free antitumor necrosis factor compound | Rheumatoid arthritis | Phase III data showed it was significantly more effective added to methotrexate compared to methotrexate alone for the inhibition of progression of structural joint damage in RA (11/8) |
| CANCER | ||||
| Adventrx Pharmaceuticals Inc. (AMEX:ANX) | ANX-510 | CoFactor injection | Metastatic colorectal cancer | Will stop enrolling in a Phase III trial because a DSMB cited a slow accrual rate and the lack of significant differences between the treatment and control arms (11/2) |
| Adventrx Pharmaceuticals Inc. (AMEX:ANX) | A vein-saving emulsion equivalent for Navelbine (vinorelbine), the vinca alkaloid | Non-small-cell lung cancer | The product was found to be equal to Navelbine in a marketing-enabling study (11/16) | |
| Allos Therapeutics Inc. (ALTH) | RH1 | Targeted chemotherapeutic agent | Advanced solid tumors or non-Hodgkin's lymphoma | Started patient enrollment in a Phase I trial (11/13) |
| ArQule Inc. (ARQL) | ARQ 171 | A second-generation product in the company's E2F-1 cancer therapy program | Cancer | Symptomatic and asymptomatic QTc prolongation, a measure of cardiac function, was observed in a Phase I dose-escalation trial (11/29) |
| AVAX Technologies Inc. (OTC BB:AVXT) | M-Vax | Vaccine based on a patient's tumor and treated with dinitrophenyl | Metastatic melanoma | Started a pivotal Phase III trial (3/13) |
| AVEO Pharmaceuticals Inc.* | AV-951 | Triple VEGF inhibitor | Refractory renal cell carcinoma | Phase I data showed that all nine patients achieved a partial response or stable disease after treatment (11/6) |
| BiPar Sciences Inc.* | BSI-201 | PARP inhibitor | Triple-negative breast cancer | Started a Phase II study (11/15) |
| Celgene Corp. (CELG) | Revlimid | Lenalidomide | Multiple myeloma | Phase III data of Revlimid plus dexamethasone reported overall survival and median time to disease progression compared to patients receiving dexamethasone plus placebo (11/21) |
| Cell Therapeutics Inc. (CTIC) | Brostallicin | A synthetic, second-generation DNA minor groove binder | Solid tumors | Phase I data combining brostallicin with cisplatin showed 14 of 21 patients experienced stable disease and half of those had durable stable disease for more than six cycles of therapy(11/21) |
| Cleveland BioLabs Inc. (CBLI) | Curaxin CBLC102 | Oral agent that targets p53 and NF-kB | Advanced renal-cell carcinoma | Started a Phase II study (11/26) |
| Cougar Biotechnology Inc. (OTC BB:CGRB) | CB7630 | Abiraterone acetate | Advanced prostate cancer | Phase II data showed the drug is well tolerated with only minimal toxicity in the 10 patients treated so far (11/9) |
| Cytos Biotechnology AG (Switzerland; SWX:CYTN) | CYT004-MelQbG10 | Generated from the Immunodrug platform, which applies immuno-stimulatory DNA sequences to induce targeted T-cell responses | Malignant melanoma | Phase IIa data showed that all dose regimes of the drug were safe and well tolerated, with adverse events including mostly mild to moderate injection site reactions (11/20) |
| Epeius Biotechnologies Corp.* | Rexin-G | A tumor-targeted nano-medicine delivered by intravenous infusion | Recurrent or metastatic osteosarcoma | Opened a Phase II registration trial (11/5) |
| Genentech Inc. (NYSE:DNA) | Avastin (FDA-approved) | Bevacizumab | Glioblastoma multiforme | Phase II data showed that 36% of patients treated with Avastin alone and 51% of those treated with Avastin and irinotecan lived without the disease advancing in six months (11/19) |
| Genmab A/S (Denmark; CSE:GEN) and GlaxoSmithKline plc (UK) | HuMax-CD20 | Ofatumumab | Refractory chronic lymphocytic leukemia | Enrolled 132 patients into its pivotal trial (11/28) |
| Genta Inc. (GNTA) | Genasense | Oblimersen sodium injection | Advanced metastatic melanoma | Phase III data showed five of seven patients demonstrated clinical benefit when Genasense was used with Abraxane and Temodar (11/8) |
| Geron Corp. (GERN) | GRN163L | A telomerase inhibitor | Multiple myeloma | Enrolled the first patient in a Phase I/II trial (11/28) |
| Hana Biosciences (HNAB) | Marqibo | Vincristine sulfate injection, Optisome | Metastatic malignant uveal melanoma | Dosed the first two patients in a Phase II trial (11/20) |
| IDM Pharma Inc. (IDMI) | Uvidem | Vaccine consisting of mature dendritic cells loaded with lysates of tumor cell lines | Melanoma | Phase II data showed the drug induced immune response and was well tolerated in patients with advanced disease (11/2) |
| ImClone Systems Inc. (IMCL) and Bristol-Myers Squibb Co. | Erbitux (FDA-approved) | Cetuximab | Metastatic colorectal cancer | Phase III data showed Erbitux administered as a single-agent increased survival in a 572-patient trial (11/15); data showed that patients with unresectable cancer refractory to systemic chemotherapy can achieve substantial regression of their liver metastases with Erbitux, which can increase their potential as candidates for complete surgical resection (11/29) |
| Immutep SA* (France) | ImmuFact IMP321 | T cell adjuvant for therapeutic vaccines | Metastatic breast cancer | Interim Phase I/II data showed strong increases in the number of monocytes and CD8-positive T cells and associated clinical responses (11/28) |
| Innovive Pharmaceuticals Inc. (OTC BB:IVPH) | Oral tamibarotene | Refractory acute promyelocytic leukemia | The first patient has been treated in a pivotal Phase II trial (11/15) | |
| Keryx Biotherapeutics Inc. (KERX) | KRX-0401 | Perifosine; oral agent that modulates AKT and other signal transduction pathways | Rare sarcomas; malignant glioblastoma and malignant anaplastic gliomas | Phase II data showed a 40% over-all clinical benefit in subsets of patients with chemotherapy-insensitive sarcomas (11/5); Phase II data showed the median progression-free survival and overall survival in the anaplastic glioma group was nine weeks and 49 weeks, respectively (11/19) |
| Keryx Biotherapeutics Inc. (KERX) | KRX-0401 | Perifosine; oral agent that modulates AKT and other signal transduction pathways | Advanced renal-cell carcinoma | Phase II data showed that four of 13 evaluable patients had a partial response and an additional four patients achieved long-term stable disease for a 62% overall clinical benefit rate (11/9) |
| Kinex Pharmaceuticals LLC* | KX2-391 | Src kinase inhibitor | Advanced malignancies | Started Phase I trials (11/27) |
| Medivation Inc. (MDVN) | MDV3100 | Selective androgen receptor modulator | Hormone-refractory prostate cancer | Phase I/II data showed it reduced serum levels in patients enrolled in the first two dose groups (11/5) |
| Novacea Inc. (NOVC) | Asentar | DN-101; a high-dose oral formulation of calcitriol, a biologically active form of vitamin D | Prostate cancer | Halted a Phase III trial because of a higher rate of deaths in patients receiving the drug (11/5) |
| Pharmion Corp. (PHRM) | Ambrubicin | A third-generation synthetic anthracycline | Second-line, chemo-sensitive small-cell lung cancer | Phase II data indicated a favorable response rate and survival data in patients with extensive disease (11/9) |
| Poniard Pharmaceuticals Inc. (PARD) | Picoplatin | Intravenous; a platinum-based chemotherapy agent | Metastatic colorectal cancer | Started a Phase II trial (11/2) |
| Progen Pharmaceuticals Ltd. (Australia; PGLA) | PI-88 | Anti-angiogenesis drug also designed to inhibit tumor promoting factors | Liver cancer | Phase II data showed it at least doubled the time to disease recurrence calculated at the 60th percentile in patients who had a high risk of recurrence in the 12-month period (11/5) |
| Qiagen NV (the Netherlands; QGEN) | FastHPV | A molecular test for cancer-causing types of human papillomavirus | To reduce cervical cancer | Data showed it could reduce cervical cancer by as much as 56% if given just three times over a woman's life and combined with appropriate treatment (11/8) |
| Raven Biotechnologies Inc.* | RAV12 | High-affinity IgG1 chimeric antibody | Adenocarcinomas | Phase I/IIa data showed that a fractionated dosing regimen allows delivery of RAV12 with an acceptable level of toxicity (11/19) |
| Seattle Genetics Inc. (SGEN) | SGN-40 | A humanized monoclonal antibody that targets the CD40 antigen | Multiple myeloma | Started a Phase IIb trial (11/1) |
| Seattle Genetics Inc. (SGEN) | SGN-33 | Lintuzumab; a monoclonal antibody | Acute myeloid leukemia | Started a Phase IIb trial (11/9) |
| Synta Pharmaceuticals Corp. (SNTA) | Elesclomol | Formerly STA-4783; a small molecule designed to increase the oxidative stress level in cancer cells to the point at which they undergo apoptosis | Metastatic melanoma | Started a pivotal Phase III trial (11/12) |
| Tapestry Pharmaceuticals Inc. (TPPH) | TPI 287 | A next-generation taxane | Hormone-refractory prostate cancer | Phase II data showed that 60% of second-line patients showed clinical benefit (11/5) |
| Thallion Pharmaceuticals Inc. (Canada; TSX:TLN) | ECO-4601 | A novel small molecule derived from a non-pathogenic microorganism | Advanced cancer | Phase I/II data showed it was safe and well tolerated up to 480mg/m2/day (11/16) |
| TransMolecular Inc.* | TM-601 | A synthetic version of chlorotoxin, a naturally occurring peptide derived from scorpion venom | Recurrent malignant glioma | Phase II interim data showed that the overall survival from the time of recurrence for the highest dosing regimen was estimated at 12.1 months vs. 9 months for the lowest dose group (11/19) |
| Vertex Pharmaceuticals Inc. (VRTX) and Merck & Co. Inc. | MK-0457 (VX-680) | The most advanced Aurora kinase inhibitor | Chronic myelogenous leukemia | Preliminary safety data indicated a potential cardiovascular effect in one patient treated with MK-0457; recruitment was suspended in the ongoing Phase II trial (11/21) |
| VioQuest Pharmaceuticals Inc. (OTC BB:VQPH) | Lenocta | Sodium stibogluconate; a protein tyrosine phosphatase inhibitor | Advanced-stage solid tumors | First patient was dosed in an open-label Phase IIa study (11/26) |
| Ziopharm Oncology Inc. (ZIOP) | ZIO-201 | Isophosphoramide mustard | Soft tissue and bone sarcomas | Phase II data showed that of 44 evaluable patients, 48% of those treated had stable disease or better, with a median progression-free survival of 10 weeks (11/5) |
| CARDIOVASCULAR | ||||
| Actelion Ltd. (Switzerland; SWX:ATLG) | Pivlaz | Clazosentan; an endothelin receptor antagonist | For patients at risk of vasospasm following aneurysmal subarachnoid hemorrhage | Company is moving it into a pivotal Phase III trial (11/14**) |
| ActivBiotics Inc.* | Rifalazil | An antibiotic | Intermittent claudication associated with peripheral arterial disease | Phase III data showed the drug failed statistically any clinically-relevant PAD parameters (11/7) |
| Advanced Cell Technology Inc. (OTC BB:ACTC) | Myoblast therapy | Doses of 30, 100, 300 or 600 million autologous skeletal myoblasts via intracardiac injection | Heart failure | Clinical data demonstrated marked improvement in heart failure symptoms after 12 months (11/7) |
| ARCA Discovery Inc.* | Bucindolol | Beta-blocker and vasodilator | Heart failure | Phase III data showed the drug caused a significant reduction in cardiovascular hospitalizations (11/8) |
| Archemix Corp.* | ARC1779 | An aptamer designed to bind to and inhibit the function of the von Willebrand Factor protein; an anti-thrombotic | For use in patients with acute coronary syndrome undergoing emergency percutaneous coronary intervention | Started a Phase IIa trial (11/13) |
| Cardiome Pharma Corp. (Canada; CRME) | Vernakalant | Oral; selective ion channel blocker | Atrial fibrillation | Company plans to add 20% more patients to a Phase IIb trial (11/26) |
| CV Therapeutics Inc. (CVTX) | Ranexa (FDA-approved) | Ranolazine extended-release tablets | Chronic angina | Data showed it reduced the relative risk of the primary composite endpoint of cardiovascular death, myocardial infarction or recurrent ischemia by 21% compared to placebo in 1,936 patients (11/5) |
| Cytos Biotechnology AG (Switzerland; CYTN) | CYT006-AngQb | Vaccine designed to produce an anti-angiotensin II antibody response | Hypertension | Phase IIa data showed that both doses (100 mcg and 300 mcg) were safe and well tolerated, and no vaccine-related adverse events were reported (11/6) |
| Isis Pharmaceuticals Inc. (ISIS) | ISIS 301012 | Mipomersen sodium | High cholesterol | Phase II data showed a 42% reduction in apoB, and a 48% reduction in low-density lipoprotein cholesterol, beyond reductions achieved with statin therapy alone (11/13) |
| Lev Pharmaceuticals Inc. (OTC BB:LEVP) | Cinryze | A C1 inhibitor | Acute hereditary angioedema | Phase III data showed that patients receiving the drug saw symptoms begin to fade in a median time of two hours vs. more than four hours for patients on placebo (11/12) |
| LifeCycle Pharma A/S* (Denmark) | LCP-AtorFen | Fixed-dose combination product of atorvastatin and lowest dose feno-fibrate | Dyslipidemia | Completed patient enrollment in a Phase II trial comparing it with Lipitor (11/20) |
| Millennium Pharmaceuticals Inc. (MLNM) | MLN1202 | A humanized monoclonal antibody | Atherosclerotic cardiovascular disease | Met its primary endpoint of reducing C-reactive protein levels in a Phase II trial (11/6) |
| NicOx SA (France; PARIS:COX) | Naproxcinod | Nitric oxide-donating derivative of naproxen | Blood pressure | Data showed patients had lower blood pressure than those receiving the nonsteroidal anti-inflammatory agent naproxen (11/9) |
| Regado Biosciences Inc.* | REG1 Anti-Coagulation System | A combination of RB006 and its rapidly acting antidote, RB007 | For patients undergoing elective percutaneous coronary intervention | Enrolled the first patient in a Phase IIa study (11/1) |
| Rigel Pharmaceuticals Inc. (RIGL) | R788 | Gamatinib fosdium; an oral Syk kinase inhibitor | Immune thrombocytopenic purpura | Phase II data showed the drug can improve platelet counts (11/9) |
| Synvista Therapeutics Inc. (AMEX:SYI) | ALT-711 | Alagebrium; designed to act as an advanced glycation end-product (AGE)-cross-link breaker | Chronic heart failure | Dosed the first patient in its 100-patient Phase II trial (11/12) |
| Theravance Inc. (THRX) | GSK961081 | A bifunctional muscarinic antagonist-beta2 agonist | Chronic obstructive pulmonary disease | Started a Phase II study (11/1) |
| Topigen Pharmaceuticals Inc.* (Canada) | TPI 1020 | Inhaled nitric oxide-donating derivative of the corticosteroid budesonide | Chronic obstructive pulmonary disease | Dosed the first patients in a Phase II trial (11/19) |
| United Therapeutics Corp. (UTHR) | Viveta | Treprostinil | Pulmonary arterial hypertension | Phase III data showed it robustly met its primary endpoint (11/1) |
| CENTRAL NERVOUS SYSTEM | ||||
| 7TM Pharma A/S (Denmark) | Obinepitide | An analogue of two hormones involved in appetite regulation | Obesity | Phase I/II data showed it effectively inhibits food intake (11/28) |
| Acorda Therapeutics Inc. (ACOR) | Fampridine-SR | Sustained release 4-aminopyridine | Multiple sclerosis | Completed enrollment in its Phase III trial with 240 patients (11/30) |
| Active Biotech AB (Sweden; SSE:ACTI) and Teva Pharmaceutical Industries Ltd. (Israel) | Laquinimod | An oral liquid | To prevent the progression of relapsing-remitting multiple sclerosis | Began enrolling patients in a Phase III study (11/7) |
| Alpharma Inc. (NYSE:ALO) | ALO-01 | An abuse-deterrent that combines an extended-release opioid with a sequestered core of antagonist naltrexone | For pain relief | Phase III data showed it demonstrated significant pain relief, meeting the primary endpoint (11/30) |
| Array BioPharma Inc. (ARRY) | ARRY-797 | A small-molecule p38 inhibitor | Pain in dental patients undergoing third molar extraction | Began dosing in a Phase II trial (11/20) |
| Avigen Inc. (AVGN) | AV411 | Ibudilast | Neuropathic pain | Top-line Phase IIa data showed it was safe and well tolerated; it also indicated a favorable dose-to-blood plasma level relationship (11/5) |
| BioMS Medical Corp. (Canada; TSX:MS) | MBP8298 | A synthetic peptide | Secondary progressive multiple sclerosis | More than 133 patients have enrolled in a pivotal Phase III study (11/12) |
| Brane Discovery Srl* (Italy) | BND-11624 | A pyrrolidinone derivative for neuropathic pain | Neuropathic pain | Started a Phase I trial (11/27) |
| Ceregene Inc.* | CERE-120 | A gene-therapy product; delivers the neurturin gene | Parkinson's disease | Completed enrollment of a Phase II trial (11/14) |
| CytRx Corp. (CYTR) | Arimoclomol | Small molecule designed to protect cells by activating molecular chaperone proteins | Amyotrophic lateral sclerosis | Data showed the compound administered at 400 mg three times daily was safe and well tolerated (11/26) |
| GW Pharmaceuticals plc (UK; LSE:GWP) and Otsuka Pharmaceutical Co. Ltd. (Japan) | Sativex | Composed of two cannabinoids - CBD and THC | Pain in advanced cancer | Began the first U.S. Phase II/III trial (11/26) |
| Meditor Pharmaceuticals Ltd.* (Israel) | MTR106 | Tablet formulation of MTR104; a low molecular weight S-Alkylisothioronium | Migraine | Phase II data showed it was safe and well tolerated with no serious adverse events (11/7) |
| Memory Pharmaceuticals Corp. (MEMY) | MEM-3454 | A nictonic alpha-7 receptor partial agonist | Alzheimer's disease | Phase IIa data demonstrated a statistically significant effect on the QESM compared to placebo (11/2) |
| Nabi Biopharmaceuticals (NABI) | NicVAX | Nicotine conjugate vaccine | Nicotine addiction | Phase IIb data showed a statistically significant number of patients were able to quit and remain abstinent over the 12-month period (11/7) |
| Neurologix Inc. (OTC BB:NRGX) | Injection of an adeno-associated virus vector carrying an inhibitory gene (glutamic acid decarboxylase) into one side of the subthalmic nucleus | Advanced Parkinson's disease | Phase I data demonstrated the ability to quiet the abnormal brain activity that is correlated with the motor deficits characterizing the disease (11/20) | |
| Neuromed Pharmaceuticals* | NMED-1077 | OROS Hydromorphone | Chronic moderate to severe pain | Dosed the first patient in its pivotal Phase III trial (11/1) |
| Prana Biotechnology Ltd. (Australia; PRAN) | PBT2 | Small molecule that binds metal ions | Alzheimer's disease | The data safety monitoring board completed its third and final review of an ongoing Phase IIa trial and confirmed the study is safe to continue (11/29) |
| QRxPharma Pty. Ltd. (Australia; ASX:QRX) | Q80031R | An immediate-release dual opioid pain therapy | Pain | Treated patients in the first of several studies in an ongoing Phase III program (11/26) |
| Repligen Corp. (RGEN) | RG2417 | An oral formulation of uridine | Bipolar disorder | Phase IIa data showed a statistically significant improvement in the two primary endpoints (11/8) |
| Sosei Group Corp.* (Japan) and NeuroDiscovery Ltd. (Australia; BE:N6A) | SD118 | Oral therapy | Neuropathic pain | Began a multiple dose ascending Phase I study (11/27) |
| Valeant Pharmaceuticals International (NYSE:VRX) | Retigabine | A neuronal potassium channel opener | Pain associated with postherpetic neuralgia | Enrolled the first patient in a 180-patient Phase IIa trial (11/28) |
| Vivus Inc. (VVUS) | Qnexa | A combination phentermine/topiramate drug | Obesity | Began the first of two pivotal Phase III trials (11/9); began the second Phase III trial (11/16) |
| DIABETES | ||||
| AtheroGenics Inc. (AGIX) | AGI-1067 | Anti-inflammatory agent | Diabetes | Stopped testing the highest dose, 300 mg, based on further review of the overall risk/benefit profile (11/12) |
| Cardium Therapeutics Inc. (AMEX:CXM) | Excellarate | A DNA-based topical gel | Non-healing diabetic foot ulcers | Started recruiting participants for its Phase IIb trial (11/14) |
| Exelixis Inc. (EXEL) | XL784 | A small-molecule inhibitor of ADAM-10 and MMP-2 | Albuminuria due to diabetic nephropathy | Phase II data showed that, after 12 weeks of treatment, the baseline normalized ACR in the XL784 group was 9.9% lower than in the placebo group (11/5) |
| Sangamo BioSciences Inc. (SGMO) | SB-509 | A formulation of a zinc finger DNA-binding protein transcription factor | Diabetic neuropathy | Phase Ib data showed statistically significant improvements in quantitative measurements of neurological health (11/6) |
| Speedel Holding Ltd. (Switzerland; SWX:SPPN) | SPP100 | A renin inhibitor | Proteinuria in diabetes | Phase III data showed it further lowers proteinuria when administered on top of losartan (11/5) |
| INFECTION | ||||
| Advanced Life Sciences Holdings Inc. (ADLS) | Cethromycin | A once-a-day antibiotic | Community-acquired pneumonia | Phase III data showed it cured 83.1% of patients and Biaxin cured 81.1%; in addition to achieving the primary endpoint, it had favorable safety results (11/15) |
| Arpida Ltd. (Switzerland; SWX:ARPN) | Inclaprim | Intravenous agent | Complicated skin and skin structure infections | Phase I data showed iclaprim had no significant effect on the pharmacokinetics and pharmacodynamics of warfarin (11/20) |
| Barrier Therapeutics Inc. (BTRX) | Pramiconazole | Antifungal agent; oral | Onychomycosis | Data showed no clinically relevant changes seen in any of the 32 healthy volunteers dosed with up to 6 g of pramiconazole given over a five-day period, as compared to placebo (11/27) |
| Bavarian Nordic A/S (Denmark; CSE:BAVA) | Imvamune | A third-generation smallpox vaccine | Smallpox | Completed a Phase II trial (11/29) |
| BioAlliance Pharma SA (France; PARIS:BIO) | Loramyc | Bioadhesive buccal tablet containing the antifungal agent miconazole | Oropharyngeal candidiasis; oral herpes | Completed patient enrollment in the pivotal Phase III trial of 540 patients (11/16); extended an ongoing Phase III trial to the U.S. (11/28) |
| Biota Holdings Ltd. (Australia; PK:BTAHY) | CS8958 | A long-acting neuraminidase inhibitor | Influenza | Entered Phase II trials (11/26) |
| Gilead Sciences Inc. (GILD) | Viread | Tenofovir disoproxil fumarate | Chronic hepatitis B | Phase III data showed superior efficacy results in Viread-treated patients compared to those receiving Hepsera (11/2) |
| Human Genome Sciences Inc. (HGSI) | Albuferon | Albinterferon alfa-2b | Chronic hepatitis C | Completed enrollment and initial dosing in ACHIEVE 2/3, the second of two pivotal trials (11/1); Phase IIb data showed positive results among treatment-naive patients, difficult-to-treat patients and for quality-of-life issues (11/5) |
| Immtech Pharmaceuticals Inc. (AMEX:IMM) | Pafuramidine | Oral candidate | To prevent malaria | Completed its first exploratory trial and intends to continue development (11/2) |
| Inovio Biomedical Corp. (AMEX:INO) and Tripep AB (Sweden; SSE:TPEP) | ChronVac-C | A DNA vaccine | Chronic hepatitis C virus infection | Treated the first subject in a Phase I/II trial (11/27) |
| MacroChem Corp. (OTC BB:MACM) | EcoNail | A topical antifungal lacquer; contains econazole and MarcroChem's enhancer SEPA | Onychomycosis | Phase II data showed it caused an improvement in 54% of patients (11/6) |
| Naryx Pharma Inc.* | Sybryx | Tobramycin solution for nasal inhalation | Chronic sinusitis | Completed enrollment of a 180-subject Phase IIb trial (11/27) |
| NovaBay Pharmaceuticals Inc. (AMEX:NBY) | NVC-422 | A non-antibiotic anti-infective; Aganocide compound | Methicillin-resistant Staphylococcus aureus | Phase I data showed it was safe and well tolerated when applied to the anterior nares (11/26) |
| Pacgen Biopharmaceuticals Corp. (Canada; CDNX:PGA) | PAC-113 | A 12 amino-acid antimicrobial peptide derived from a naturally occurring histatin protein found in human saliva | Oral Candidiasis infection | Started a Phase IIb dose-ranging trial for an optimized formulation (11/19) |
| Pharmasset Inc. (VRUS) | R7128 | An oral prodrug of PSI-6130, a cytidine nucleoside analogue polymerase inhibitor | Chronic hepatitis C | Phase I data found the drug to be safe and well tolerated with antiviral activity (11/2) |
| Vertex Pharmaceuticals Inc. (VRTX) | Telaprevir | Protease inhibitor | Hepatitis C virus | Phase IIb data showed the drug beat standard of care but had lower than expected sustained viral response (11/2) |
| MISCELLANEOUS | ||||
| Amira Pharmaceuticals Inc.* | AM103 | Oral drug; inhibitor of 5-lipoxygenase-activating protein | Inflammatory diseases linked to the leukotriene pathway | Completed a Phase I trial (11/1) |
| Avicena Group Inc. (OTC BB:AVGO) | HD-02 | Agent that incorporates ultra-pure form of creatine | Huntingdon's disease | A dose evaluation study showed that 30 g was the optimum dose (11/19) |
| Cypress Biosciences (CYPB) | Milnacipran | 100 mg and 200 mg; norepinephrine serotonin reuptake inhibitors | Fibromyalgia syndrome | Phase III data showed statistically significant and clinically meaningful improvements in both pain and other core symptoms (11/8) |
| Cytochroma Inc.* (Canada) | CTAP101 | Capsules; vitamin D prohormone | Vitamin D insufficiency in chronic kidney disease | Began dosing in a Phase I/II trial (11/20) |
| Cytos Biotechnology AG (Switzerland; SWX:CYTN) | CYT003-QbG10 | An immunotherapeutic product | Allergic disease | Started two Phase II trial (11/29) |
| Dynogen Pharmaceuticals Inc.* | DDP733 | Pumosetrag | Irritable bowel syndrome | Dosed the first patient in a Phase IIb trial (11/8) |
| Indevus Pharmaceuticals Inc. (IDEV) | Octreotide (FDA-approved) | Implant form | Acromegaly | Phase II data showed it effectively suppressed levels of GH and IGF-1 at rates similar to those seen with the injectable form of the drug (11/28) |
| Inspire Pharmaceuticals Inc. (ISPH) | Epinastine | Nasal spray | Seaonal allergic rhinitis | Started a Phase III trial (11/28) |
| ISTA Pharmaceuticals Inc. (ISTA) | Xibrom (FDA-approved) | Bromfenac sodium ophthalmic solution QD | For patients undergoing cataract surgery | Phase III data showed the drug was statistically significantly superior to placebo in more than 500 patients (11/12) |
| Kiadis Pharma BV* (the Netherlands) | ATIR | Designed to selectively eliminate immune cells | Graft-vs.-host disease | Phase II data demonstrated technical feasibility of the semiclosed cell processing system developed for the study and has resulted in no acute GVHD in patients so far (11/28) |
| Neurotech Pharmaceuticals Inc.* | NT-501 | An intraocular polymer implant containing Ciliary Neurotrophic Factor | Early- and late-stage retinitis pigmentosa and dry age-related macular degeneration | Completed enrollment in three ongoing trials, two Phase II/III trials for the pigmentosa indications, and a Phase II trial for age-related macular degeneration (11/6) |
| Nventa Biopharmaceuticals Corp. (TSX:NVN) | HspE7 | A therapeutic vaccine candidate for diseases caused by the human papillomavirus | Cervical intraepithelial neoplasia | Phase I safety data showed everything was normal and met the limits prescribed in the trial protocol (11/27) |
| Osteologix Inc. (OTC BB:OLGX) | NBX101 | Strontium malonate | Postmenopausal women with low bone mineral density | Phase II data showed the study met its primary endpoint of significantly decreasing CTX-1 (11/5) |
| Plethora Solutions Holdings plc (UK; LSE:PLE) | PSD503 | A metered dose, topical gel formulation of phenylephrine | Stress urinary incontinence | Phase II data confirmed positive clinical effect and safety (11/29) |
| Quark Pharmaceuticals Inc.* | AKli-5 | An siRNA compound | Acute renal failure | Began a Phase I trial (11/19) |
| SkyePharma plc (UK; SKYE) | Flutiform | Comprised of fluticasone and formoterol | Asthma | Completed a Phase III trial (11/2) |
| Notes: | ||||
| * Privately held. | ||||
| BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment. | ||||
| Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
| AMEX = American Stock Exchange; ASX = Australian Stock Exchange; BE = Berlin Stock Exchange; BR = Brussels Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock 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; TSX = Toronto Stock Exchange. | ||||