Company* (Country; Symbol) Product Description Indication Status (Date)
AUTOIMMUNE
Anesiva Inc. (ANSV) Adlea Long-acting, non-opioid candidate Osteoarthritis Phase II data showed that a 1 mg treatment produced substantial reductions in pain that persisted for up to 12 weeks (7/2)
Barrier Therapeutics Inc. (BTRX) Rambazole Oral; a retinoic acid metabolism-blocking agent Moderate to severe psoriasis Phase II showed the drug was well tolerated; the company selected the 2-mg dose for further development (7/12)
BioCryst Pharmaceuticals Inc. (BCRX) BCX-4208 An orally available small-molecule inhibitor of purine nucleoside phos-phorylase Plaque psoriasis Started a Phase II study (7/17)
Genzyme Corp. (GENZ) Hylastan An injected joint lubricator Osteoarthritis knee pain Pivotal study showed hylastan failed to beat steroids (7/5)
Medarex Inc. (MEDX) and Novartis Pharma AG (Switzerland) ACZ885 A fully human anti-IL-1 beta antibody Muckle Wells syndrome Advanced it into a Phase III trial (7/18)
MedImmune Inc. (LSE:MDI; unit of AstraZeneca plc; UK) MEDI-545 A fully human monoclonal antibody targeting interferon-alpha Systemic lupus erythematosus Began dosing patients in a Phase Ib trial (7/19)
CANCER
Antisoma plc (UK; LSE:ASM) ASA404 Small-molecule vascular disrupting agent designed to target blood vessels that nourish tumors Recurrent, platinum-sensitive ovarian cancer Phase II failed to meet its end-points (7/12)
Avalon Pharmaceuticals Inc. (AVRX) AVN944 A small-molecule inhibitor of inosine monosphospate dehydrogenase Pancreatic cancer Started a Phase II trial (7/12)
Cell Genesys Inc. (CEGE) GVAX Immunotherapeutic Prostate cancer Completed enrollment in its VITAL-1 Phase III trial (7/10)
Cell Therapeutics Inc. (CTIC) Pixantrone An anthracenedione Non-Hodgkin's lymphoma Interim Phase II/III data indicated pixantrone-based combination therapy resulted in complete or partial responses (7/11)
Cougar Biotechnology Inc. (OTC BB: CGRB) CB7630 Abiraterone acetate Prostate cancer Phase I and Phase II data showed that 87% of patients experienced a decline in prostate specific antigen levels with 61% experiencing a confirmed decline in PSA levels of greater than 50% (7/9)
Expression Genetics Inc.* EGEN-001 Formulated using the company's TheraPlas delivery technology; composed of interleukin-12 gene expresion plasmid and a biocompatible delivery polymer Recurrent epithelial ovarian cancer Started a Phase In a study of EGEN-001 in combination with standard chemotherapy (7/20)
Genaera Corp. (GENR) Evizon Squalamine lactate; anti-angiogenesis agent; vas-cular endothelial growth factor inhibitor Prostate cancer Company discontinued the program (7/5)
Genzyme Corp. (GENZ) Mozobil Plerixafor Non-Hodgkin's lymphoma Phase III showed 59% of patients reated with Mozobil in combination with standard-of-care granulocyte-colony stimulating factor achieved the target thresh-old for collection of at least 5M CD34+cells/kg from the peripheral blood, compared with 20% of patients in the G-CSF and placebo group (7/19)
Geron Corp. (GERN) GRN163L Telomerase inhibitor Advanced non- small-cell lung cancer Began a Phase I/II trial (7/9)
Geron Corp. (GERN) GRNVAC1 Telomerase cancer vaccine Acute myelog-enous leukemia Started a Phase I/II trial (7/11)
GTx Inc. (GTXI) Ostarine Selective androgen receptor modulator Cancer cachexia Started a Phase IIb trial (7/3)
Halozyme Therapeutics Inc. (HALO) Enhanze An enzyme-based drug delivery platform based on recombinant human PH20 hyaluronidase or rHuPH20 Cancer In a 15-patient trial, injection of rHuPH20 with Humira showed it was well tolerated at all dose levels, without dose-limiting toxicity, premature withdrawals or serious adverse events (7/10)
ImClone Systems Inc. (IMCL) Erbitux (FDA- approved) Cetuximab Non-small-cell lung cancer Phase III trial missed the primary endpoint of progression-free survival in the 600-patient study, though secondary endpoints in-cluding response rate were achieved (7/12)
ImClone Systems Inc. (IMCL) IMC-A12 A monoclonal antibody targeting insulin-like growth factor-1 receptor Metastatic colorectal cancer Started a Phase II trial with 40 to 72 patients who are refractory to treatment with Erbitux (7/13)
Javelin Pharmaceuticals Inc. (AMEX:JAV) PMI-150 Intranasal ketamine Breakthrough cancer pain Started a Phase III trial (7/31)
Kiadis Pharma BV* (the Netherlands) ATIR Small molecule aimed at allowing blood cancer patients to receive bone marrow transplants without requiring access to a matched donor Blood cancer The U.S. National Institutes of Health is beginning a Phase II trial (7/9)
Light Sciences Oncology Inc.* Litx Light infusion therapy that uses light-emitting diodes to activate LS11 (talaporfin sodium) Colorectal cancer metastatic to the liver Treated the first patient in a Phase III trial (7/17)
Maxygen Inc. (MAXY) MAXY-G34 Pegylated form of granulo-cyte-colony stimulating factor Chemotherapy-induced neutropenia Started a Phase IIa trial (7/2)
MethylGene Inc. (Canada; TSX:MYG) and Pharmion Corp. (PHRM) MGCD0103 Isotype-specific histone deacetylase inhibitor product candidate Refractory chronic lympho-cytic leukemia Started a single-agent Phase II trial with up to 40 patients (7/12)
Millennium Pharmaceuticals Inc. (MLNM) Velcade- based therapy Bortezomib; proteasome inhibitor Multiple myeloma An induction therapy prior to stem cell transplantation produced a high complete remission/complete response rate of 20% (7/2); began a Phase III trial comparing Velcade, dexamethasone; Velcade, thalidomide anddexamethasone; and Velcade, melphalan and prednisone (7/16)
OncoGenex Technologies Inc.* and Isis Pharmaceuticals Inc. (ISIS) OGX-011 Second-generation anti-sense drug designed to inhibit the production of clusterin, a cell survival protein Metastatic hormone refractory prostate cancer Phase II data showed that OGX-011 plus docetaxel achieved improved survival, longer progression-free survival, and more frequent decreases in prostate-specific antigen levels than patients receiving OGX-011 plus mitoxantrone (7/31)
Oncolytics Biotech Inc. (Canada; ONCY) Reolysin A formulation of the human reovirus Sarcomas that have metast-asized to the lung Enrolled the first two patients in a Phase II study (7/20)
OxiGene Inc. (OXGN) Zybrestat Combretastatin-A4 phosphate/CA4P Metastatic anaplastic thyroid cancer Began a pivotal registration study with 180 patients (7/9)
Peplin Ltd. (Australia; ASX:PEP) PEP005 Topical agent designed to kill cancer cells and stimulate an immune response Actinic keratosis Phase IIb data indicate the drug was well tolerated, with no serious adverse events, and resulted in statistically significant lesion clearance at all doses tested (7/19)
Poniard Pharmaceuticals Inc. (PARD) Picoplatin Intravenous picoplatin; a new generation platinum chemotherapy agent Metastatic hormone-refractory prostate cancer Started a Phase II trial in combination with docetaxel (7/31)
ProMetic Life Sciences Inc. (Canada; TSX:PLI) PBI-1402 Orally active, low molecular weight synthetic compound Chemotherapy-induced anemia Phase Ib/II data confirmed clinical activity (7/10)
Pro- Pharmaceuticals Inc. (AMEX:PRW) Davanat Carbohydrate compound designed for targeted delivery Metastatic colorectal cancer Provided data from eight patients in a Phase II trial showing two had tumor shrinkage of greater than 30% (7/9)
Pro- Pharmaceuticals Inc. (AMEX:PRW) Davanat Carbohydrate compound designed for targeted delivery Advanced bile duct and gall-bladder cancers Began dosing patients in a Phase II trial of Davanat with 5-Fluorouracil (7/25)
Protox Therapeutics Inc. (Canada; CDNX:PRX) PRX302 Proaerolysin-based Prostate cancer Top-line Phase I data indicated it was well tolerated, with no significant adverse events (7/10)
Rigel Pharmaceuticals Inc. (RIGL) and Merck KGaA (Germany) R763/ AS703569 A highly potent, orally available Aurora kinase inhibitor Advanced malignancies Began enrolling patients in a Phase I study (7/12)
SuperGen Inc. (SUPG) MP470 Oral, multitargeted tyrosine kinase inhibitor Advanced-stage solid tumors Dosed the first patient in a Phase I trial (7/5)
Threshold Pharmaceuticals Inc. (THLD) TH-302 First hypoxia-activated prodrug Advanced solid tumors Started a Phase I trial (7/26)
Tracon Pharmaceuticals Inc.* TRC093 A first-in-class humanized monoclonal antibody that inhibits angiogenesis and tumor cell growth by binding cleaved collagen Cancer Started treatment in a Phase I trial (7/11)
Trion Pharma GmbH* (Germany) and Fresenius Group (Germany) Removab Catumaxomab; a tri-functional antibody de-signed to bind both T cells and epithelial cell adhesion molecule Malignantascites Phase II/III data showed it significantly increased time to tumor progression and had a positive influence on overall survival time (7/17)
YM BioSciences Inc. (Canada; AMEX:YMI) Nimotuzumab A humanized monoclonal antibody that targets the epidermal growth factor receptor Colorectal cancer Enrolled the first patients in a 50-patient initial cohort of its Phase II trial of nimotuzumab in combination with irinotecan (7/31)
Ziopharm Oncology Inc. (ZIOP) ZIO-201 Isophosphoramide mustard Advanced sarcoma Phase II data showed one of 10 patients had a partial response and four have stable disease (7/11)
CARDIOVASCULAR
Ablynx* (Belgium) ALX-0081 An anti-thrombic; a first-in-class nanobody Acute coronary syndrome Phase I data showed the desired pharmacodynamic effect was observed and ALX-0081 was well tolerated and showed no serious adverse events or dose limiting toxicity (7/2)
Amira Pharmaceuticals Inc.* AM103 An oral, next-generation inhibitor of the 5-lipoxy-genase-activating protein Asthma and cardiovascular disease Phase I data showed that a single dose achieves highly significant inhibition of leukotriene synthesis (7/16)
Arena Pharmaceuticals Inc. (ARNA) APD791 An oral agent; a selective inverse agonist of the 5-HT2A serotonin Arterial throm-boembolic diseases Started dosing in a Phase I trial (7/18)
Depomed Inc. (DEPO) Gabapentin GR Targets GABA receptors in the brain Postherpetic neuralgia Top-line data from a Phase III, 407-patient study showed it hit statistical significance in daily pain scores in the first six weeks when dosed once daily, and in the first five weeks when dosed twice daily; the mean reductions in average scores from baseline were 1.83 (in the once-daily arm), 1.72(twice daily) and 1.43 (placebo) (7/10)
DiaDexus Inc.* LP-PLA2 Lipoprotein-associated phospholipase A2, an indicator of vascular inflammation To identify people at high risk for ischemic stroke Study results indicate that LP-PLA2 provides information over and above traditional risk factors to help identify individuals at the highest risk for ischemic stroke (7/5)
LifeCycle Pharma (Denmark; CSE:LCP) LCP-AtorFen A fixed-dose combination of atorvastatin and fenofibrate High cholesterol levels Initiated a Phase II trial (7/12)
Medicure Inc. (Canada; TSX:MPH) Aggrastat (FDA-approved) Tirofiban hydrochloride; glycoprotein Heart attack; patients under- going high-risk percutaneous coronary intervention Follow-up data showed patients treated with Aggrastat plus a sirolimus-eluting stent had sig-nificantly lower cumulative incidence of death, myocardial infarction or target vessel revas-cularization than patients receiving Reopro plus a bare-metal stent (7/11)
Portola Pharmaceuticals Inc.* PRT054021 An oral Factor Xa inhibitor To prevent venous thrombo-embolic events in patients under-going total knee replacement Phase II data showed that the incidence of VTE was 20%, 15% and 10% in the low-dose group, the high-dose group, and the enoxaparin group, respectively (7/11)
Sygnis Pharma AG (Germany; FSE:LIO) AX200 Designed to stop neuronal cell death in the acute phase of stroke Stroke Safety and tolerability were demonstrated in a 44-patient Phase IIa study (7/23)
Talecris Bio- therapeutics Inc.* TAL-05-00018 (Plasmin) Human plasma-derived thrombolytic Peripheral arterial occlusion Phase I data showed the dose-related thrombolytic effect of Plasmin without an increase in dose-related adverse events (7/11)
Tranzyme Pharma Inc.* TZP-101 A ghrelin agonist Postoperativeileus Started a Phase IIb trial (7/26)
CENTRAL NERVOUS SYSTEM
Adolor Corp. (ADLR) ADL5859 A novel delta opioid agonist Pain Began a Phase II study (7/9)
Affiris* (Austria) Affitope AD01 Alzheimer's vaccine Alzheimer's disease Started a Phase I trial (7/19)
Alkermes Inc. (ALKS) ALKS 29 Oral compound Alcohol dependence Preliminary results from a Phase I/II trial showed statistically significant improvement compared to placebo in percent of days abstinent, percent of heavy drinking days and average number of drinks per day (7/2)
BioLineRx Ltd.* (Israel) BL-1020 The first GABA enhanced antipsychotic Schizophrenia Completed a study showing it blocks dopamine receptors in the human brain (7/17)
Catalyst Pharmaceutical Partners Inc. (CPRX) CPP-109 Vigabatrin; an orally administered, small-molecule compound designed to inhibit psychostimulant-in-duced dopamine release Cocaine dependence Started a Phase II trial (7/10)
Cortex Pharmaceuticals Inc. (AMEX:COR) CX717 An ampakine compound designed to enhance memory and cognition Alzheimer's disease FDA said it could resume enrollment in the Alzheimer's positron emission tomography scan study at all requested dose levels (7/17)
Durect Corp. (DRRX) Posidur Long-acting local anesthetic administered during surgery, where it releases therapeutic levels of bupivacaine Postoperative pain in patients undergoing inguinal hernia repair A Phase IIb trial demonstrated statistically significant reductions in pain and total consumption of supplemental opioid analgesic medications vs. placebo (7/17)
Genzyme Corp. (GENZ) Carticel Autologous cultured chondrocytes Knee pain Clinical data showed significant reductions in knee pain, as well as improvements in function, in-cluding recreational and sports activities (7/16)
Incyte Corp. (INCY) INCB9471 An oral CCR5 antagonist designed to block the virus from entering uninfected cells HIV Phase IIa results demonstrated that it provided a significant decline in viral load when used as a monotherapy in 19 patients (7/24)
Intellect Neuro- sciences Inc. (OTC BB:ILNS) Oxigon A chemically synthesized form of a small, naturally occurring molecule that has unique anti-fibrillo-genic, neuroprotectant and antioxidant properties Alzheimer's diseases Phase Ia results showed no serious adverse effects in any of the subjects throughout the dose levels (7/30)
Javelin Pharmaceuticals Inc. (AMEX:JAV) Dyloject Diclofenac sodium; an injectable nonsteroidal anti-inflammatory drug Postoperative pain Began treating patients in the second of two planned Phase III studies (7/26)
Lexicon Pharmaceuticals Inc. (LXRX) LX6171 Oral drug candidate Cognitive disorders Successfully completed Phase I trials; it proved to be well tolerated at all dose levels with systemic exposure described as "excellent" (7/31)
Manhattan Pharmaceuticals Inc. (AMEX:MHA) Oleoylestrone Oral therapy; synthetic formulation Obesity Each of two Phase IIa trials failed to demonstrate statistically or clinically meaningful weight loss vs. placebo (7/10)
Memory Pharmaceuticals Corp. (MEMY) MEM 3454 A nicotinic alpha-7 receptor partial agonist Alzheimer's disease Completed enrollment of a targeted 80 patients in a Phase IIa trial (7/13)
Orexigen Therapeutics Inc. (OREX) Empatic A drug that combines the sustained formulations of epilepsy drug zondisamide plus the antidepressant buproprion Obesity Phase IIb demonstrated statistically significant weight loss vs. placebo (7/24)
Pipex Pharmaceuticals Inc. (OTC BB: PPXP) Trimesta Estriol Multiple sclerosis Started dosing in a Phase II/III trial for women with relapsing- remitting MS (7/17)
Targacept Inc. (TRGT) TC-5619 A small molecule designed to modulate the activity of the neuronal nicotinic receptor subtype known as alpha7 Schizophrenia/cognitive impairment/ inflammation Started a Phase I trial with healthy volunteers (7/26)
YM BioSciences Inc. (Canada; AMEX:YMI) AeroLEF An inhaled-delivery, composition of free and lipo-some-encapsulated Fentanyl Pain For the first dose administered, 59% reported a pain intensity score of less than or equal to 1, compared to 27% of placebo patients (7/11)
DIABETES
Metabasis Therapeutics Inc. (MBRX) CS-917 Inhibits gluconeogenesis Diabetes It failed a Phase IIb trial (7/17)
Metabolex Inc.* MBX-102 JNJ 39659100; an insulin sensitizer Type II diabetes Completed enrollment in the 400-patient Phase II/III trial (7/19)
Sirtris Pharmaceuticals Inc. (SIRT) SRT501 Agent that targets SIRT1, a member of the human sirtuin family of enzymes Type II diabetes Phase Ia data showed SRT501 had an improved exposure in terms of curve and maximal concentrations when compared to resveratrol (7/17)
XOMA Ltd. (XOMA) XOMA 052 A monoclonal antibody targeting interleukin-1 beta Type II diabetes Started Phase I testing (7/16)
INFECTION
Acambis plc (UK; LSE:ACM) ACAM-FLU-A Vaccine designed to target all A strains of the influenza virus Influenza Started a Phase I trial (7/24)
Advanced Life Sciences Holdings Inc. (ADLS) Cethromycin A once-a-day antibiotic Community-acquired pneumonia Supplemental efficacy data confirmed it met its non-inferiority endpoint in a Phase III trial (7/2)
AlphaVax Inc.* Influenza vaccine based on the company's replicon vector technology Influenza Interim Phase I data showed the vaccine is safe and well tolerated (7/30)
Anadys Pharmaceuticals Inc. (ANDS) and Novartis Pharma AG (Switzerland) ANA975 Oral prodrug of isatoribine, a Toll-like receptor-7 agonist Hepatitis C virus infection Companies decided to discontinue development because results to date do not support further clinical evaluation (7/27)
Arpida Ltd. (Switzerland; SWX:ARPN) Iclaprim Antibiotic; an intravenous new member of the diamino-pyrimidine class Complicated skin and skin structure infections Phase III trials showed it met the primary endpoint of non-inferiority to Pfizer Inc.'s Zyvox (7/16)
Avant Immuno- therapeutics Inc. (AVAN) Ty800 Single-dose, oral vaccine Typhoid fever Started enrolling 180 healthy volunteers in a Phase II study (7/30)
Avexa Ltd. (Australia; ASX:AVX) ATC Apricitabine; a cytidine analogue, an inhibitor of HIV reverse transcriptase HIV Phase IIb data showed that ATC demonstrated significant clinical activity against a range of drug-resistant HIV, including HIV strains harboring the lamivudine-resistance mutation (7/26)
BioCryst Pharmaceuticals Inc. (BCRX) Peramivir Influenza neuraminidase inhibitor Influenza Started a Phase II trial in hospitalized patients (7/24)
Biolex Therapeutics Inc.* and OctoPlus NV (the Netherlands; AMSTERDAM:OCTO) Locteron A controlled-release interferon alpha product Chronic hepatitis C Phase IIa data of Locteron in combination with ribavirin showed an early virologic re- sponse in 100% of patients treated (7/26)
Biota Holdings Ltd. (Australia; ASX:BTA) and MedImmune Inc. (LSE:MDI; unit of AstraZeneca plc; UK) BTA9881 Antiviral drug Respiratory syncytical virus Began a Phase Ia trial (7/17)
Genzyme Corp. (GENZ) Tolevamer Clostridium-difficile-toxin binder Clostridium-difficile associated diarrhea It failed to beat the standard prescribed oral dose of the antibiotic vancomycin in the first of two Phase III trials (7/6)
Gilead Sciences Inc. (GILD) Truvada (FDA- approved) Emtricitabine and tenofovir disoproxil fumarate HIV Phase III data showed 71% of Truvada/Sustiva patients compared to 58% of Combivir/Sustiva patients achieved and maintained viral load less than 400 copies/mL (7/23)
MedImmune Inc. (LSE:MDI) RSV/PIV-3 Vaccine Respiratory syncytial virus and parainflu-enza virus Type 3 infections Began dosing in a Phase I trial (7/3)
Monogram Biosciences Inc. (MGRM) and Pfizer Inc. Maraviroc A CCR5 antagonist CCR5-tropic HIV-1 Phase III data showed rates of virologic suppression were 70.6% compared to 73.1% in the efavirenz group for less than 400 copies/mL, and 65.3% vs. 69.3% at less than 50 copies/mL (7/25)
Novavax Inc. (NVAX) Virus-like particle-based pandemic influenza vaccine Influenza Began vaccinating healthy volunteers in a Phase I/IIa trial (7/31)
Nventa Bio- pharmaceuticals Corp. (TSX:NVN) HspE7 Vaccine for human papillomavirus-related diseases High-grade cervical intra-epithelial neoplasia Phase II data showed 95% of patients had disease regression or their disease remained stable (7/23)
Orchestra Therapeutics Inc. (OTC BB:OCHT) IR103 Second-generation HIV vaccine HIV Company discontinued development because Phase II data did not show a clear advantage over its original whole-killed HIV vaccine, Remune (7/18)
Pharmaxis Ltd. (Australia; PXSL) Bronchitol Inhalable dry powder formulation of mannitol delivered twice daily Bronchiectasis All 362 patients have completed the efficacy phase of its global Phase III trial (7/5)
Photopharmica Holdings Ltd.* (UK) PPA 904 A member of the phenothiazinium family of photosensitizers; topical photodynamic therapy Microbial disease in wounds Successfully completed a Phase II trial; it achieved a statistically significant reduction in the bacterial load of chronic leg ulcers and diabetic foot ulcers compared to placebo (7/10)
Polydex Pharmaceuticals Ltd. (Canada; POLXF) Ushercell A potential microbicide also known as cellulose sulfate HIV Phase III data showed there were more seroconversions in the Ushercell group than the placebo group, but not at a statistically significant level (7/25)
Progenics Pharmaceuticals Inc. (PGNX) PRO140 CCR5 humanized mono-clonal antibody HIV Phase Ib data showed dose dependent and statistically significant viral load reductions (7/25)
Repros Therapeutics Inc. (RPRX) Proellex Progesterone receptor modulator Uterine fibroids and endometri-osis New data showed patients exposed to the drug for up to six months demonstrated a benign endometrium based on the biopsies (7/26)
Samaritan Pharmaceuticals Inc. (AMEX:LIV) SP-01A Oral HIV entry inhibitor HIV Phase IIb data showed a reduction in the amount of viral infection in the blood of those taking SP-01A (7/20)
Starpharma Holdings Ltd. (Australia; ASX:SPL) VivaGel SPL7013 Gel; vaginal microbicide To prevent HIV and vaginal herpes Began a U.S. trial (7/11); results show it was well tolerated in men when applied topically once daily for seven days and left in place for nine hours (7/24)
Theratechnologies Inc. (Canada; TSX:TH) TH9507 A stabilized analogue of the growth hormone-releasing factor HIV-associated lipodystrophy Phase III data showed that patients treated with 2 mg daily of TH9507 significantly improved their perception of belly image compared to the placebo group (7/18)
Theravance Inc. (THRX) TD-1792 Heterodimer antibiotic Complicated skin and skin structure infections A Phase II trial met its primary endpoint of non-inferiority to vancomycin (7/10)
Tibotec Pharmaceuticals Ltd.* (Ireland) Prezista (Darunavir)/ritonavir HIV Phase III data showed that 77% of treatment-experienced patients taking Prezista with an optimized background regimen of antiretroviral agents, reached a viral load of less than 400 copies/mL at week 48, compared to 68% of patients taking lopinavir/ritonavir with OBR (7/6)
Trimeris Inc. (TRMS) and F. Hoffmann-La Roche Ltd. (Switzerland) Fuzeon (FDA-approved) Enfuvirtide HIV Started patient dosing in a trial to test Fuzeon in combination with an investigational integrase inhibitor (7/17); data showed Fuzeon used with darunavir/ritonavir achieved undetectable HIV of less than 50 copies per mL of blood in 64% of treatment experienced patients (7/23)
Vertex Pharmaceuticals Inc. (VRTX) Reyataz Atazanavir HIV A head-to-head study with Glaxo-SmithKline plc's Lexiva showed similar efficacy and lipid effects (7/25)
Vical Inc. (VICL) ----- DNA vaccine Cytomegalovirus Began enrollment of the 20th hematopoietic stem cell transplant recipient in the company's Phase II trial (7/11)
ViroPharma Inc. (VPHM) Camvia Maribavir; anti-CMV agent To prevent cytomegalovirus in patients under-going liver transplantations Company began a second Phase III trial to evaluate it against oral ganciclovir (7/5)
MISCELLANEOUS
Advanced Magnetics Inc. (AMAG) Ferumoxytol Intravenous iron replacement therapy Chronic kidney disease Phase III data showed statistically significant improvement vs. oral iron on the primary end-point of increased hemoglobin levels (7/23)
BioMimetic Therapeutics Inc. (BMTI) GEM OS1 Bone Graft Combines recombinant platelet-derived growth factor with a synthetic bone matrix, beta tri-calcium phosphate Foot and ankle indications A 20-patient pilot trial showed that 39% of patients receiving GEM OS1 exhibited fusion, as defined by osseous bridging of greater than 50% of the joint surface, compared to 33% of autograft patients at six weeks (7/13)
Cobalis Corp. (OTC BB:CLSC) PreHistin Agent designed to modulate levels of IgE, reducing the over-production of histamines Hay fever Two Phase III trials showed very low symptom levels in both placebo and drug groups, failing to hit statistical significance in the primary endpoint (7/6)
Cytos Biotechnology AG (Switzerland;SWX:CYTN) CYT003- QbG10 sequence Virus-like particle packaged with an immunostimulatory Atopic dermatitis It was well tolerated in a Phase IIa trial (7/3)
DOR BioPharma Inc. (OTC BB: DORB) orBec Oral beclomethasone dipropionate To prevent acute graft-vs.-host disease after allogeneic hematopoietic cell transplantation Started patient enrollment in a Phase II trial with up to 138 patients (7/12)
Endo Pharmaceuticals Inc. (ENDP) Ketoprofen patch Soft-tissue injuries Two Phase III trials failed to demonstrate efficacy (7/12)
Genaera Corp. (GENR) Lomucin Talniflumate; anti-inflammatory drug with activity against the hCLCA1 chloride channel Cystic fibrosis Company discontinued the program (7/5)
Hollis-Eden Pharmaceuticals Inc. (HEPH) HE3286 Orally bioavailable small-molecule adrenal steroid hormone Metabolic disorders Phase I demonstrated the compound is orally bioavailable in humans and appears to be safe and well tolerated (7/16)
Hutchison China MediTech Ltd.* (China) HMPL-004 A pro-inflammatory cytokine inhibitor Mild to moderate ulcerative colitis Phase II data showed it was well tolerated and had an equivalent drop in symptoms with the com-parator drug, Mesalazine (7/4)**
LAB International Inc.* (Canada) Growth hormone releasing hormone analogue Chronic kidney disease Phase II data showed the drug induced a fivefold increase in endogenous growth hormone secretion and a near-doubling of circulating insulin-like growth factor compared to placebo (7/12)
MedImmune Inc. (LSE:MDI; unit of AstraZeneca plc; UK) Monoclonal antibody targeting the interleukin-5 receptor Mild asthma Phase I data suggested it successfully depleted eosinophils (7/23)
Medivation Inc. (AMEX:MDX) Dimebon Neuroprotectant agent that's been on the market in Russia since 1983 Huntington's disease Began treatment of the first patient in a Phase II trial (7/30)
Mpex Pharmaceuticals Inc.* MP-376 An aerosol formulation of a powerful antibiotic Cystic fibrosis Started a Phase Ib trial (7/18)
Opko Health Inc. (AMEX:OPK) Bevasiranib siRNA drug Wet age-related macular degeneration Started a Phase III trial (7/11)
Progenics Pharmaceuticals Inc. (PGNX) and Wyeth Pharmaceuticals MNTX Oral methylnaltrexone; peripherally acting muopioid receptor antagonist Opioid-induced constipation Phase I data showed a majority of patients had a bowel movement after receiving the higher of two doses (7/20)
TargeGen Inc.* TG100801 Administered as an eye drop; designed to suppress VEGF-mediated leakage and additional kinase targets Age-related macular degeneration Started a Phase II trial (7/30)
Tercica Inc. (TRCA) Increlex Mecasermin [rDNA origin] injection Short stature with primary insulin-like growth factor-1 deficiency Completed patient enrollment in a Phase IIIb trial (7/20)
TransPharma Medical Ltd.* (Israel) ViaDerm- hPTH Transdermally delivered doses of hPTH Osteoporosis Phase I data showed a safety profile similar to the Forteo sub-cutaneous injection (7/16)
Uluru Inc. (AMEX:ULU) Hydrogel Nanoparticle wound dressing Severely burned joints Began a clinical study to evaluate the mobility of severely burned joints (7/26)
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; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange.