Company (Country; Symbol) |
Product |
Description |
Indication |
Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Corixa Corp. (CRXA) and Genesis Research and Development Corp. Ltd. (Australia; ASX:GEN) |
PVAC |
Immunotherapeutic based on a process an formulation derived from heat-killed Mycobacterium vaccae |
Psoriasis |
Companies discontinue development after Phase II trial failed to demonstrate a reduction in psoriasis compared to placebo; the product also did not improve treatmen with standard ultraviolet light therapy (12/22) |
|
||||
Genmab A/S |
HuMax-CD4 |
Human antibody that targets the CD4 receptor on T lymphocytes |
Psoriasis |
Company said Phase IIb trial in 118 patients did not achieve statistical significance company is ending development in psoriasis (12/12) |
|
||||
Genzyme |
Genz-29155 |
Small molecule designed to inhibit some activities of tumor necrosis factor |
Multiple sclerosis |
Company started a Phase I trial to test safety in up to 56 healthy volunteers (12/12) |
|
||||
MedImmune |
Vitaxin |
Monoclonal antibody that targets the alpha-v beta-3 integrin |
Psoriasis |
MedImmune began a Phase II trial in 180 patients with plaque psorisis, comparing safety and activity of Vitaxin to placebo (12/17) |
|
||||
Millennium Pharmaceuticals |
MLN3897 (AVE-9897) |
Small molecule designed to block CCR1, a chemokine receptor |
Inflammatory disease |
Companies started a Phase I trial to evaluate safety, tolerability and pharmacokinetics and to get preliminary information on receptor-binding properties (12/22) |
|
||||
Protein Design |
Nuvion (visilizumab) |
Humanized monoclonal antibody directed at CD3 antigen on activated T cells |
Ulcerative colitis |
PDL started open-label Phase I/II trial in patients with severe disease who had not responded to intravenous steroids (12/11) |
|
||||
Tularik |
T487 |
Product binds to CXCR3, a receptor found on the surface of lymphocytes |
Psoriasis |
Tularik began a Phase II safety and efficacy trial comparing the drug to placebo in about 40 patients (12/10) |
|
||||
CANCER | ||||
|
||||
Aastrom Biosciences |
-- |
Vaccine produced by loading tumor-associate peptide antigens onto patient's blood-derived dendritic cells |
Gastrointestinal cancers |
Phase I trial started to examine the safety, feasibility, immune outcome and efficacy (12/11) |
|
||||
AEterna Laboratories Inc. (Canada; AELA) |
Neovastat |
Anti-angiogenic drug |
Non-small-cell lung cancer and renal-cell carcinoma |
AEterna said it will continue the Phase III lung cancer trial but is ending development of the drug in kidney cancer (12/17) |
|
||||
Amgen |
Palifermin |
Recombinant human keratinocyte growth factor |
Oral mucositis in cancer patients |
Additional data from Phase III trial in 212 patients showed drug was associated with a statistically significant improvement in mouth and throat soreness (12/8) |
|
||||
Amgen |
Aranesp (FDA-approved) |
Darbepoetin alfa, a recombinant erythropoietic protein |
Anemia of cancer |
Interim analysis of trial's first 150 patients with nonmyeloid malignancy showed improvement vs. control in mean change in hemoglobin levels (12/6); a head-to-head study showed Aranesp dosed every two weeks provided similar results to epoetin alfa dosed once weekly in boosting hemoglobin and reducing the need for blood transfusions (12/7) |
|
||||
American |
Abraxane |
Paclitaxel delivered via albumin-bound nanoparticle |
Metastatic breast cancer |
Company said researchers reported Phase III data showing drug produced higher response rates and longer time to tumor progression than Taxol (12/5) |
|
||||
AnorMED Inc. |
AMD3100 |
Drug designed to block receptor triggering movement of stem cells out of bone marrow |
Stem cell transplantation in cancer patients |
Phase II data showed drug used with G-CSF improved generation of stem cells vs. G-CSF alone (12/7) |
|
||||
Antigenics |
Oncophage |
Personalized cancer vaccine based on heat- shock protein technology |
Renal-cell carcinoma |
Data monitoring committee said trial should continue as planned, following interim analysis of 650-patient Phase III trial (12/22) |
|
||||
Antigenics |
Oncophage |
Personalized cancer vaccine based on heat-shock protein technology |
Non-Hodgkin's lymphoma |
Lead investigator from Phase II study reported clinical activity in eight out of 14 evaluable patients who has newly diagnosed or relapsed low-grade, indolent disease (12/9) |
|
||||
Antigenics |
HSPPC-70 |
Personalized cancer vaccine based on heat- shock protein technology |
Chronic myelogenous leukemia |
Preliminary data from a Phase I trial in combination with Gleevec showed immunological response in 11 of 17 patients (12/9) |
|
||||
Aton Pharma |
SAHA |
Oral suberoylanilide hydroxamic acid, a histone deacetylase inhibitor |
Cancers |
Aton presented data from various studies in blood cancers, including encouraging results from Phase II trial in cutaneous T- cell lymphoma (12/9) |
|
||||
BioCryst |
BCX-1777 |
Inhibitor of the enzyme purine nucleoside phosphorylase |
T-cell malignancies |
Four of five patients in Phase I trial showed a decrease in malignant cell counts (12/8) |
|
||||
Biogen Idec |
Zevalin (FDA-approved) |
Ibritumomab tiuxetan; monoclonal antibody targeting CD20 combined with radioisotope |
Non-Hodgkin's lymphoma |
Data supported Zevalin's ability to induce long-term, durable remissions in relapsed, refractory or transformed indolent B-cell disease; other data indicated drug has promise in mantle-cell lymphoma (12/6) |
|
||||
Biomira Inc. |
Theratope |
Vaccine combining mimic of cancer antigen sialyl-Tn and carrier molecule KLH |
Metastatic breast cancer |
Companies released final results from Phase III trial that failed; new analysis showed possible survival benefit in subset of women who received hormonal treatment following chemotherapy (12/8) |
|
||||
Celgene |
Actimid (CC-4047) |
Immunomodulatory drug |
Multiple myeloma |
Data from Phase I/II trial showed more than 90% of 44 patients achieved stabilization of disease or better (12/9) |
|
||||
Celgene |
Revimid (CC-5013) |
Immunomodulatory drug |
Multiple myeloma |
Phase II data showed 73 of 91 evaluable patients with progressive disease had a reduction or stabilization in their para-protein levels (12/9) |
|
||||
Cell Genesys |
GVAX |
Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF |
Leukemia |
Preliminary findings of Phase II trial indicated vaccine was well tolerated and may reduce residual leukemic cells, as indicated by decreased levels of WT-1, a genetic marker (12/6) |
|
||||
Cell Therapeutics |
Trisenox (FDA-approved) |
Arsenic trioxide |
Acute promyelocytic leukemia |
Data from two studies of drug and all-trans retinoic acid showed complete response rates in excess of 90% (12/9) |
|
||||
Cel-Sci Corp. (AMEX:CVM) |
Multikine |
Mixture of human cytokines designed to stimulate an immune response |
Head and neck cancer |
Data from Phase I/II trial in 54 patients with advance disease showed the drug rendered the majority of cancer cells susceptible to radiation therapy (12/8) |
|
||||
Centocor Inc. (unit of Johnson & Johnson) |
CNTO 95 |
Fully human antibody targeting the integrin receptors implicated in angiogenesis |
Cancers |
Centocor started a Phase I trial of the product generated with Medarix Inc. technology (12/11) |
|
||||
Corixa Corp. |
Bexxar |
Tositumomab and I-131 tositumomab; radiolabeled monoclonal antibody that binds to CD20 antigen |
Lymphomas |
Various studies showed the drug was active in a number of patients with difficult-to-treat lymphomas (12/8) |
|
||||
Cytogen |
Quadramet |
Samarium-153 lexidrona injection; skeletal-targeting radiopharmaceutical |
Bone pain in multiple myeloma |
Data from a pilot study showed Quadramet in combination with zoledronic acid provided significant pain relief in elderly patients resistant to chemotherapy (12/8) |
|
||||
EntreMed |
Panzem |
2-methoxyestradiol; naturall occurring metabolite of endogenous estrogen |
Multiple myelom |
Preliminary Phase II data demonstrated drug was well tolerated and stabilized disease in patients with plateau or relapsed multiple myeloma (12/7) |
|
||||
Genentech Inc. (NYSE:DNA) and |
Rituxan (FDA-approved) |
Rituximab; antibody that binds to the CD20 antigen on the surface of normal and malignant B cells |
Non-Hodgkin's lymphoma |
Patients in Phase II trial with indolent disease who received Rituxan maintenance therapy had 31 months of progression-free survival, compared to eight months for those re-treated with Rituxan at the time of disease progression (12/8) |
|
||||
Genentech Inc. (NYSE:DNA) |
Rituxan (FDA-approved) |
Rituximab; antibody that binds to the CD20 antigen on the surface of normal and malignant B cells |
Aggressive lymphomas |
Phase III trial named MInT comparing drug plus chemotherapy to chemotherapy alone was stopped early by monitoring board after meeting efficacy endpoint of improving time to treatment failure (12/7) |
|
||||
Genentech Inc. (NYSE:DNA) and |
Rituxan (FDA-approved) |
Rituximab; antibody that binds to the CD20 antigen on the surface of normal and malignant B cells |
Non-Hodgkin's lymphom with indolent disease showed |
Phase III trial as a front-line and maintenance therapy in treating newly diagnosed, diffuse, large, B-cell or aggressive disease showed benefit in time to disease progression when combined with CHOP regimen vs. CHOP alone; another Phase III trial in untreated patients time to failure of 26 months for drug with CVP regimen vs. seven months for CVP alone (12/7) |
|
||||
Genentech Inc. (NYSE:DNA) and Hoffmann-La Roche |
Herceptin (FDA-approved) |
Trastuzumab; monoclonal antibody against HER-2/neu protein |
HER-2-positive metastatic breast cancer |
Phase II trial showed adding Herceptin to docetaxel resulted in an increase in median survival of 51%; overall response rate in 188-patient study also was significantly higher (12/4) |
|
||||
Genitope |
MyVax Personalized Immunotherapy |
Patient- and tumor-specific cell-surface idiotype protein, combined with keyhole limpet hemocyanin |
Agressive non-Hodgkin's lymphoma |
Phase II trial in 27 patients showed patients treated with accelerated regimen may have more extended remissions (12/8) |
|
||||
Genmab A/S |
HuMax-CD20 |
Human antibody that binds to the CD20 antigen |
Relapsed follicular lymphoma |
Genmab filed for approval in the U.S. and UK for dose-escalation Phase I/II trial in 40 patients (12/19) |
|
||||
Genmab A/S |
HuMax-CD4 |
Human antibody that targets the CD4 receptor |
Cutaneous T-cell lymphoma |
Interim results from two Phase II trials showed 55% of the early stage and 38% of the advanced-stage patients achieved at least a partial response (12/7) |
|
||||
Genta |
Genasense |
Oblimersen sodium, inhibits function of bcl-2 protein |
Multiple myeloma |
Genta reported presentation of several studies showing drug enhances the activity of many types of chemotherapy (12/9) |
|
||||
Genta |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Non-Hodgkin's lymphoma |
Investigators in several studies reported drug could be used synergistically to enhance the activity of Rituxan (12/9) |
|
||||
Genta |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Acute myeloid leukemia |
Presentations from studies in patients older than 60 showed safety and potentially enhanced activity when chemotherapy was combined with drug (12/8) |
|
||||
Geron |
-- |
Telomerase therapeutic vaccine |
Metastatic prostate cancer |
Additional Phase I/II data showed all but one of 24 patients had telomerase-specific cellular immune responses, and there were no adverse effects; three patients in high-dose group had stablization of serum PSA values (12/8) |
|
||||
Human |
LymphoRad-131 |
Radioiodinated form of B-lymphocyte stimulator protein |
Non-Hodgkin's lymphoma |
Interim results from ongoing Phase I trial showed the drug was well tolerated and biologically active (12/9) |
|
||||
ILEX Oncology |
Campath (FDA-approved) |
Humanized monoclonal antibody that binds to CD52 on cell surfaces |
B-cell chronic lymphocytic leukemia |
Preliminary data from Phase III trial evaluating drug in front-line therapy vs. chlorambucin showed comparable safety, and monitors said trial shoud continue; other data showed drug cleared residual bone marrow disease in most of 29 patients (12/8) |
|
||||
ILEX Oncology |
Oral clofarabine |
Next-generation purine nucleoside antimetabolite |
Pediatric acute leukemia |
Interim results from Phase II trials showed an overall response rate of 29% in studies involving 65 children (12/9) |
|
||||
ILEX Oncology |
Oral clofarabine |
Next-generation purine nucleoside antimetabolite |
Acute myeloid leukemia or myelodysplatic syndrome |
Phase I/II data in adults with first-relapsed and primary-refractory disease showed 41% response rate in trial combining drug with ara-C (12/8) |
|
||||
ILEX Oncology |
Oral clofarabine |
Next-generation purine nucleoside antimetabolite |
Locally advanced or refractory solid tumors |
ILEX started a Phase I trial to test safety and tolerability in 25 patients (12/3) |
|
||||
Immunomedic |
LymphoCide |
Epratuzumab; humanized anti-CD22 antibody labeled with yttrium-90 |
Non-Hodgkin's lymphoma |
Studies with unlabeled epratuzu- mab showed it could be combined safely with rituximab and CHOP regimen; trial with rituximab in indolent NHL showed the combination to be active in certain lymphoma subtypes, but efficacy ad- vantage was not seen (12/8) |
|
||||
Inex |
Onco TCS |
Vincristine encapsulated in Inex's liposomal delivery technology |
Lymphoma |
Data from Phase II trial showed overall response rate of 33% in refractory Hodgkin's disease; Phase II study in refractory dif- fuse large B-cell lymphoma had response rate of 56% in trial with Rituxan (12/8) |
|
||||
Introgen |
INGN 241 |
MDA-7 therapeutic; designed to produce the therapeutic protein |
Solid tumors |
Company presented final Phase I data showing drug was safe and clinically active (12/15) |
|
||||
Introgen |
INGN 225 |
Product using Advexin to stimulate dendritic cells, which are then used as a therapeutic vaccine |
Advanced breast cancer |
Company began a Phase I/II trial testing the vaccine in combination with chemotherapy (12/5) |
|
||||
Ligand |
Ontak (FDA-approved) |
Denileukin diftitox |
Various cancers |
Data presented showed drug may benefit patients with chronic lymphocytic leukemia, B- and T-cell non-Hodgkin's lymphoma, and graft-vs.-host disease resistant to steroids; final Phase II data from NHL study showed drug benefited 54% of 39 patients (12/8) |
|
||||
Kosan Biosciences |
KOS-862 |
Epothilone D |
Cancers |
Kosan started Phase II monotherapy trials in three solid-tumor indications; Kosan and partner Roche also will study KOS-862 in various combination trials (12/8) |
|
||||
Medarex |
MDX-060 |
Fully human antibody believed to target CD30 on activated lymphocytes |
Hodgkin's disease and anaplastic large- cell lymphoma |
Phase I/II results showed one complete and two partial responses, and nine cases of stable disease among 31 patients with refractory disease (12/9) |
|
||||
MedImmune |
Vitaxin |
Monoclonal antibody that targets the alpha-v beta-3 integrin |
Prostate cancer |
MedImmune began a Phase II trial in 165 patients with androgen- independent disease that has metastasized to bone; it will be used with chemotherapy (12/17) |
|
||||
Millennium Pharmaceuticals |
Velcade (FDA-approved) |
Proteasome inhibitor |
Multiple myeloma |
Company stopped control arm of Phase III APEX trial after monitoring committee saw statistical signifance for drug in patients with relapsed or refractory disease (12/15) |
|
||||
Millennium Pharmaceuticals |
Velcade (FDA-approved) |
Proteasome inhibitor |
Advanced, refractory multiple myeloma |
Preliminary Phase I/II results from investigative study showed drug combined with thalidomide produced a partial response in more than 50% of patients; separate study with liposomal doxorubicin also showed benefit (12/9) |
|
||||
Millennium Pharmaceuticals |
Velcade (FDA-approved) |
Proteasome inhibitor |
Non-Hodgkin's lymphoma |
Results of a Phase II trial showed overall response rate of 50% for 20 of the 22 evaluable patients in the mantle-cell lymphoma group; separate Phase II in indolent NHL also showed benefit (12/8) |
|
||||
NeoRx |
Skeletal Targeted Radiotherapy |
Small-molecule carrier of the radionucleotide holmium-166 |
Multiple myeloma |
Long-term follow-up from Phase I/II trial showed three-year survival rate of 90% of the 10 patients treated with the dose planned for Phase III (12/8) |
|
||||
Novuspharma SpA |
Pixantrone |
Anthracycline agent |
Non-Hodgkin's lymphoma |
Data from Phase I study in which drug was used as part of CHOP regimen showed a major objective response rate of 77% among 22 patients (12/9) |
|
||||
Pharmacyclics |
Xcytrin |
Motexafin gadolinium; small-molecule texaphyrin designed to inhibit apoptosis |
Relapsed chronic lymphocytic leukemia |
Company started a Phase II trial of the drug as a single agent in up to 30 patients (12/11) |
|
||||
Seattle Genetics |
SGN-30 |
Monoclonal antibody |
Hematologic malignancies |
Phase I study in 24 patients with relapsed or refractory CD30-positive disease produced one compplete response and stable disease in six patients; drug was well tolerated (12/8) |
|
||||
SuperGen |
Nipent (FDA-approved) |
Pentostatin for injection |
Chronic lymphocytic leukemia |
Company presented data from five different trials showing the activity of the drug as part of combination therapy (12/8) |
|
||||
SuperGen |
Nipent (FDA-approved) |
Pentostatin for injection |
Non-Hodgkin's lymphoma |
Phase II study in combination with rituximab showed response rate of 60%; pilot combination study showed response rate of 83% in 24 patients, with nine complete responses (12/8) |
|
||||
VasGene |
Veglin |
Antisense oligonucleotide that binds VEGF |
Cancers |
Phase I data on 26 refractory patients showed the drug was safe at various doses and demonstrated evidence of activity in some patients (12/8) |
|
||||
Xycte |
Xcellerated T Cells |
Activated T cells from patient designed to enhance natural immune responses |
Chronic lyphocytic leukemia and multiple myeloma |
Company presented data from Phase I/II trials that showed reduction of enlarged lymph nodes and spleens in CLL and recovery of lymphocytes and T cells in multiple myeloma (12/10) |
|
||||
CARDIOVASCULAR | ||||
|
||||
Angiogenix |
Acclaim |
Organic nitrate combined with L-arginine |
Chronic angina |
Company began a 170-patient Phase II study in eight countries (12/8) |
|
||||
Celgene |
Revimid (CC-5013) |
Immunomodulatory drug |
Refractory anemias due to myelodysplastic syndromes |
Phase II data showed 24 of 36 evaluable patients experienced an erythroid response to Revimid (12/8) |
|
||||
Cell Therapeutics |
Trisenox (FDA-approved) |
Arsenic trioxide |
Myelodysplasia |
Preliminary data from two Phase II trials showed 28 of 120 patients experienced a major or minor hematologic response (12/7) |
|
||||
Dyax |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein |
Bleeding control |
Phase I trial in patients undergo- ing cardiopulmonary bypass in the course of coronary artery bypass graft surgery met pharmacokinetic and safety endpoints (12/26) |
|
||||
Esperion |
ETC-642 |
Complex of a 22-amino-acid peptide and phospholipids designed to mimic HDL |
Acute coronary syndromes |
Phase I trial showed agent was safe and well tolerated at all dose levels (12/16) |
|
||||
Isis |
ISIS 301012 |
Second-generation antisense inhibitor of ApoB-100 |
Cardiovascular disease |
Isis began a Phase I study in 40 healthy volunteers with elevated cholesterol to assess safety, toler- ability and pharmacokinetics (12/29) |
|
||||
Northfield Laboratories |
PolyHeme |
Oxygen-carrying blood substitute derived from human blood |
Blood loss |
Company received clearance to begin enrollment in pivotal Phase III urban ambulance trial testing product against saline solution (12/22) |
|
||||
Novacea Inc.* |
DN-101 |
Contains calcitriol, a naturally occurring hormone and the biologically active form of vitamin D |
Myelodysplatic syndromes |
Company stopped enrollment in single-agent trial after only two of first 15 patients achieved a response (12/22) |
|
||||
XOMA Ltd. (XOMA) and Millennium Pharmaceuticals Inc. (MLNM) |
MLN2222 (CAB-2) |
Recombinant protein complement inhibitor |
Heart attack |
Companies started Phase I trial in healthy volunteers to assess safety and other endpoints; drug is being developed for use with cardiopulmonary bypass (12/18) |
|
||||
ZymoGenetic |
rhThrombin |
Recombinant human thrombin |
Control of bleeding |
ZymoGenetics plans to begin a Phase I/II dose-escalation study to assess safety and efficacy in spinal surgery (12/3) |
|
||||
CENTRAL NERVOUS SYSTEM | ||||
|
||||
ExonHit Therapeutics SA* (France) |
EHT 0202 |
Neuron protective agent |
Neuro-degenerative disorders |
ExonHit began a Phase I trial to assess safety in healthy volunteers (12/4) |
|
||||
Axonyx |
Phenserine |
Inhibitor of acetylcholin- esterase and beta-amyloid precursor protein |
Alzheimer's disease |
Company broadened Phase IIb trial to include a sub-study that will use brain scans to assess disease progression (12/19) |
|
||||
Cypress Bioscience Corp. (CYPD) |
Milnacipran |
Agent that acts on norepinephrine and serotonin |
Fibromyalgia syndrome |
Phase II data in 125 patients showed drug provided superior pain relief vs. placebo (12/11) |
|
||||
Icagen Inc.* |
ICA-69673 |
Compound that targets an ion channel expressed primarily in the central nervous system |
Epilepsy |
Company started a Phase I trial in healthy male volunteers (12/23) |
|
||||
Neurochem Inc. (Canada; NRMX) |
Alzhemed |
Small molecule designed to interfere with association between glycosamino-glycans and A-beta protein |
Alzheimer's disease |
Interim results in 23 patients in Phase II extension study showed benefit (12/9) |
|
||||
Neurocrine Inc. (NBIX) |
Indiplon |
Non-benzodiazapine that acts on specific subtype of GABA-A receptors |
Insomnia |
Preliminary results from Phase I/II trial showed statistically sig- nificant improvement in patients who wake up in the middle of the night (12/9) |
|
||||
NPS Pharmaceuticals |
Isovaleramide (NPS 1776) |
Broad-spectrum neuromodulator |
Migraine |
NPS began a Phase IIa trial in 200 patients, testing its effectiveness against placebo (12/16) |
|
||||
Phytopharm plc (UK; LSE:PYM) |
PYM50018 |
Product based on Asian plant extract believed to have neuroprotective effects |
Amyotrophic lateral sclerosis |
Company got approval for Phase I trial in eight healthy adult subjects (12/3) |
|
||||
Repligen Corp. (RGEN) |
RG1068 |
Synthetic human secretin |
Refractory schizophrenia |
Company initiated a Phase II trial to include 45 patients (12/10) |
|
||||
DIABETES | ||||
|
||||
Depomed Inc. (AMEX:DMI) and Biovail Corp. |
Metformin GR |
Extended-release formulation of diabetes drug metformin |
Type II diabetes |
Companies reported second Phase III trial hit endpoint of controlling glucose levels; trial compared product and glyburide to glyburide alone (12/10) |
|
||||
INFECTION | ||||
|
||||
Anadys Pharmaceuticals Inc.* |
Isatoribine (ANA245) |
Nucleoside analogue believed to act on Toll-like receptor 7 |
Chronic hepatitis C |
Results from Phase Ib trial showed drug was safe and well tolerated, and appeared biologically active in HCV patients (12/5); another presentation showed a decrease in viral load (12/17) |
|
||||
AVI BioPharma |
AVI-4020 |
Neugene antisense drug |
West Nile virus |
Phase I/II data in 10 patients demonstrated no safety concerns (12/30) |
|
||||
ID |
FluINsure |
Trivalent influenza vaccine for intranasal administration |
Influenza |
ID said analysis of data from challenge study in humans showed efficacy vs. placebo (12/5) |
|
||||
InterMune Inc. (ITMN) |
Actimmune (FDA-approved) |
Interferon gamma-1b |
Idiopathic pulmonary fibrosis |
Company began pivotal Phase III INSPIRE trial, a study in 600 patients with mild to moderate lung function impairment; the endpoint is survival (12/16) |
|
||||
InterMune |
Infergen and Actimmune (both FDA-approved) |
Interferon alfacon-1 and interferon gamma-1b |
Hepatitis C |
Retrospective analysis of 32 non-responders treated with drugcombination showed 65% had at least a 2-log decline in viral load (12/16) |
|
||||
Peninsula Pharmaceuticals Inc.* |
Doripenem (S-4661) |
Member of the carbapenem class of antibacterials |
Urinary tract infections |
Company said product met Phase II study endpoints of micro biological efficacy, clinical efficacy and safety (12/10); company began Phase III trial in up to 450 patients at 50 centers in the U.S., Europe and South America (12/23) |
|
||||
Vertex Pharmaceuticals Inc. (VRTX) |
Merimepodib (VX-497) |
Small-molecule inhibitor of the enzyme inosine mono-phosphate dehydrogenase |
Hepatitis C |
Phase II data of drug with pegylated interferon and ribavirin in nonresponders showed statistically significant decrease in viral levels (12/17) |
|
||||
VirXsys Corp.* |
VRX496 |
Process under which T cells are removed from HIV patient, treated with HIV lentiviral vector, and then reintroduced to patient |
HIV/AIDS |
A third patient will be treated in a Phase I trial following safety analysis from first two patients (12/18) |
|
||||
MISCELLANEOUS | ||||
|
||||
Alkermes Inc. (ALKS) |
Vivitrex |
Extended-release injectable formulation of naltrexone |
Alcohol dependence |
Phase III study demonstrated a statistically significant decrease in heavy drinking over six-month study; however, overall men benefitted and women did not (12/8) |
|
||||
Esperion Therapeutics Inc. (ESPR) |
ETC-1001 |
Small-molecule lipid- regulating agent |
Lipid disorders |
Phase I results showed the drug was safe and well tolerated in healthy volunteers (12/4) |
|
||||
FibroGen Inc.* |
FG-3019 |
Fully human antibody directed against connective tissue growth factor |
Idiopathic pulmonary fibrosis |
FibroGen started a Phase I trial in up to 27 patients to assess safety, tolerability, pharmacokinetics and immunogenecity (12/18) |
|
||||
Jerini |
Icatibant |
B2 bradykinin receptor antagonist |
Refractory ascites in liver cirrhosis |
Jerini said Phase IIa study demonstrated positive results, and it will pursue development (12/2) |
|
||||
Rigel Pharmaceutical |
R112 |
Agent designed to interrupt the signal from the IgE receptor |
Allergic rhinitis |
Phase I trial showed R112 was safe and well tolerated at three diferent doses (12/11) |
|
||||
Theratechnologies Inc. (Canada; TSE:TH) |
ThGRF |
Analogue of growth hormone-releasing factor |
Recovery in hip fracture |
Product did not demonstrate improvement in functional recovery following hip fracture surgery in eldery patients in Phase II trial (12/9) |
|
||||
Theravance Inc.* |
GSK 159797 |
Long-acting, beta-2 agonist |
Respiratory diseases |
Companies said early Phase II trials in 38 patients with mild asthma showed product was well tolerated and improved forced expiratory volume (12/3) |
|
||||
ViaCell Inc.* |
CB001 |
Stem cells isolated from umbilical cord blood and multiplied by company |
Reconstitution of blood and immune system |
Company started a Phase I/II trial to assess safety and reconstitution in adult patients with advanced stages of hematologic cancers (12/4) |
|
||||
| | ||||
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange. | ||||
