Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
Berlex Inc. |
Betaseron (FDA-approved) |
Interferon beta-1b |
Multiple sclerosis |
Monitors recommended continuation of the BEYOND trial after the first interim analysis; the trial is designed for more than 2,000 patients (11/22) |
Biogen Idec |
Tysabri (formerly Antegren, natalizumab) |
Humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class |
Multiple sclerosis |
Phase III AFFIRM trial in 942 patients with relapsing, remitting MS showed a statistically significant 66% reduction in relapses vs. placebo after one year (11/8) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Rheumatoid arthritis |
University of Leeds researchers published data showing drug was able to reverse RA symptoms in newly diagnosed patients (11/5) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets tumor necrosis factor-alpha |
Crohn's disease |
Subanalysis from ACCENT I trial showed a three-dose injection produced a significantly greater reduction in pain than one dose (11/2) |
Genentech Inc. |
Rituxan (FDA-approved) |
Rituximab; antibody that binds to the CD20 antigen on the surface of normal and malignant B cells |
Rheumatoid arthritis |
Phase IIb DANCER trial met its primary endpoint vs. placebo on the number of patients achieving an ACR 20 response at week 24 (11/2) |
CANCER | ||||
Adherex |
Exherin |
Cadherin antagonist; small- peptide, tumor/ vascular-targeting agent |
Cancers |
Updated Phase I data on 14 patients showed the agent generally was well tolerated and produced antitumor activity in three patients (11/8) |
Advanced Viral |
AVR118 |
Peptide-nucleic acid complex with immunomodulatory properties |
Advanced malignancies |
Filed IND for Phase II trial to examine safety, tolerability and efficacy in patients with advanced cancer (11/29) |
Adventrx |
CoFactor |
Form of folic acid designed to enhance the antitumor effects of 5-FU |
Metastatic colorectal cancer |
Got FDA approval to begin second stage of Phase II trial, allowing for recruitment of another 25 patients (11/2) |
Alteris |
-- |
Vaccine based on peptide technology targeting EGFRvIII, a tumor-specific splice variant of the receptor |
Malignant glioma |
Phase I study in 16 patients showed a doubling of time to disease progression and an increase in survival vs. historical controls (11/19) |
Amgen Inc. |
Aranesp (FDA-approved) |
Darbepoetin alfa, a recombinant erythropoietic protein |
Anemia from |
Head-to-head trials including 312 patients showed drug dosed once every two weeks was as effective as 40,000 U of epoetin alfa dosed weekly in boosting hemoglobin and reducing the need for blood transfusions (11/24) |
Amgen Inc. |
Panitumumab (formerly ABX-EGF) |
Fully human monoclonal antibody that targets the epidermal growth factor receptor |
Metastatic colorectal cancer |
Interim data from 19 patients in a Phase II trial showed nine patients had objective responses six weeks after first-line therapy (11/1) |
BioCryst |
Forodesine |
Oral purine nucleoside phosphorylase inhibitor; blocks T-cell synthesis |
Leukemias and lymphomas |
Presented data showing activity in a Phase I trial in refractory cutaneous T- ell lymphoma and a Phase I/II trial in B- cell acute lymphoblastic leukemia (11/15) |
Biomira Inc. |
L-BLP25 |
Synthetic MUC1 peptide vaccine that incorporates a sequence of the MUC1 cancer mucin, in a liposomal formulation |
Non-small-cell lung cancer |
Presented data from a Phase IIb trial in patients with Stage IIIb and IV disease showing a survival advantage of 4.4 months vs standard therapy (11/1) |
Bioniche Life |
Urocidin |
Mycobacterial cell wall-DNA complex |
Bladder cancer |
Presented data showing the induction of urinary cytokines and apoptotic markers in patients (11/18) |
ChemGenex |
Quinamed |
Amonafide dihydrochloride; topoisomerase II inhibitor |
Prostate cancer |
Starting a Phase II trial that will use a genotyping-based regimen in patients with hormone-refractory disease who have failed docetaxel therapy (11/1) |
Gamida-Cell |
StemEx |
Ex vivo expanded cord blood stem/progenitor cells with non-expanded cells from the same unit |
Leukemia |
Phase I/II trial showed treatment significantly reduced the occurrence of GvHD and shortened the time to platelet engraftment (11/15) |
GammaCan |
GCAN 101 |
Therapy based on intravenous immunoglobulin |
Cancers |
Plans to begin a Phase II trial; the approach involves periodical treatments in the years following initial treatment (11/9) |
Gemin X |
GX15-070 |
Small-molecule inhibitor of bcl-2 proteins |
Solid tumors |
Began Phase I trial to evaluate safety and tolerability of multiple doses in solid tumors (11/4) |
Genentech |
Avastin (FDA-approved) |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Metastatic colorectal cancer |
Phase III trial in 829 patients showed drug plus FOLFOX regimen improved overall survival vs. the regimen alone (11/29) |
Genitope |
MyVax Personalized Immunotherapy |
Patient- and tumor-specific cell-surface idiotype protein, combined with keyhole limpet hemocyanin |
Follicular non- Hodgkin's lymphoma |
Monitors recommended a pivotal Phase III trial continue after reviewing safety data on more than 100 patients (11/16) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Advanced multiple myeloma |
Phase III trial failed to meet its primary endpoint of increasing the time to development of progressive disease (11/26) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Relapsed or refractory chronic lymphocytic leukemia |
Phase III trial met primary endpoint on remissions vs chemotherapy alone, but failed to meet secondary endpoints related to time to progression and overall survival (11/8) |
Geron Corp. |
-- |
Telomerase vaccine |
Prostate cancer |
Phase I/II trial showed improved cellular immune responses in those who received a modified version of the hTERT antigen (11/8) |
Guilford |
Gliadel Wafer (FDA-approved) |
Wafer comprised of a biodegradable polymer incorporating carmustine |
Metastatic brain cancer |
Three-year prospective data from 30 patients in PROLONG registry showed nine patient deaths and disease progression in eight patients after a median 27-week follow-up (11/22) |
Hybridon Inc. |
IMOxine |
Immunomodulatory oligo-nucleotide; TLR9 agonist |
Refractory solid tumors |
Phase I trial in 23 patients showed drug was well tolerated, and provided preliminary evidence of dose response (11/22) |
Isis |
LY2181308 |
Antisense agent that targets survivin |
Cancers |
Lilly began a Phase I trial in cancer patients (11/17) |
Kosan |
KOS-862 |
Epothilone D, a |
Non-small-cell |
Stopped a Phase II trial when it failed to meet the objective of tumor response in the first stage of a two-stage trial design; trials of the drug continue in other cancers (11/23) |
Kosan |
KOS-953 |
17-AAG; designed to inhibit heat-shock protein 90 |
Relapsed/refractory myeloma |
Began a Phase Ib trial to test the agent with Millennium Pharmaceuticals Inc.'s approved drug Velcade (11/8) |
Micromet AG* |
MT201 |
Fully human antibody targeting the EpCAM antigen |
Metastatic breast cancer |
Got FDA OK for a Phase II trial in the U.S. (11/23) |
NeoPharm |
IL13-PE38QQR |
Tumor-targeting agent designed to deliver bacterial cytotoxic PE38 |
Malignant glioma |
Phase I/II trial assessed catheter placement on drug distribution using a surrogate imaging tracer (11/22) |
NeoPharm |
LErafAON |
Liposome-entrapped c-raf antisense oligonucleotide |
Advanced cancers |
Began a Phase I trial to determine dose-limiting toxicity and tolerability, as well as pharmacokinetics and treatment effects (11/18) |
NeoPharm |
LEP-ETU |
Liposomal formulation of paclitaxel |
Cancers |
Phase I dose-escalation trial demonstrated preliminary evidence of safety and tolerability in patients (11/2) |
Onyx |
BAY 43-9006 |
RAF kinase and VEGF inhibitor |
Cancers |
Phase I trials showed the drug could be combined with other cancer drugs, and showed no unexpected treatment- related adverse events (11/2) |
Pharmacyclics |
Xcytrin |
Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis |
Glioblastoma multiforme |
Two Phase I trials showed drug plus cranial irradiation in 55 patients demonstrated tolerability and an apparent survival advantage vs. radiation alone (11/19) |
Pharmacyclics |
Xcytrin |
Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis |
Advanced tumors |
Interim Phase I data showed drug and Taxotere produced partial responses in five of nine evaluable patients; also, began Phase I trial with Taxotere and cisplatin in the first-line treatment of non-small-cell lung cancer (11/1) |
PharmaMar |
Yondelis |
Trabectedin; ET-743; derived from the sea squirt Ecteinascidia turbinata |
Solid tumors |
Trials showed combination of drug with Doxil was safe and feasible; trial of drug and carboplatin showed preliminary antitumor activity (11/2) |
PharmaMar |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Advanced melanoma |
Phase II study of Aplidin as a second-line therapy demonstrated an acceptable safety profile (11/2) |
Point |
Talabostat |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Non-small-cell lung cancer |
First stage of Phase II trial with Taxotere in Stage IIIB/IV disease met tumor-response criteria, allowing continuation into the second stage of the study (11/30) |
Point |
Talabostat (PT-100) |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Cancers |
Phase I data on healthy volunteers suggested drug generally was well tolerated and sustained inhibition of a target enzyme, dipeptidyl peptidase IV (11/4) |
Raven |
RAV12 |
High-affinity IgG1 chimeric antibody |
Advanced adenocarcinoma |
Filed IND for a Phase I trial to test safety and tolerability in cancer patients (11/16) |
Spectrum |
EOquin |
Bioreductive prodrug |
Superficial bladder cancer |
Phase II trial in recurrent, refractory disease showed 18 of 28 patients achieved a complete response after six weekly treatments (11/11) |
Vical Inc. |
Allovectin-7 |
DNA plasmid/lipid complex containing the DNA sequences encoding HLA-7 and ß2 microglobulin |
Metastatic melanoma |
Updated data from high-dose Phase II trial showed increases in response duration and survival, and no safety concerns (11/5) |
CARDIOVASCULAR | ||||
Alexion |
Pexelizumab |
Monoclonal antibody; terminal complement inhibitor |
Coronary artery bypass graft surgery |
Additional data from Phase III PRIMO-CABG trial showed the drug reduced the composite endpoint of death or myocardial infarction in each of seven pre-specified risk-factor patient groups; the same result was seen with four other pre-specified baseline risk factors (11/10) |
Amgen Inc. |
Aranesp (FDA-approved) |
Darbepoetin alfa; recombinant erythropoietic protein |
Anemia |
Began TREAT trial to test the impact of treating anemia on cardiovascular outcomes in 4,000 patients with chronic kidney disease and Type II diabetes (11/1) |
AtheroGenics |
AGI-1067 |
Oral agent designed to inhibit the production of VCAM-1 and other molecules in the inflammatory process |
Atherosclerosis |
Phase IIb CART-2 trial showed the drug reduced plaque volume by 2.3% vs. standard care, a statistically significant amount, but less than was seen in interim data reported in September (11/22) |
AVI |
Resten-NG |
Antisense agent that targets the transcription factor c-myc |
Cardiovascular restenosis |
Phase II AVAIL trial showed a statistically significant effect in preventing restenosis vs. the control arm and the sub-therapeutic dose arm (11/10) |
Cardiome |
RSD1235 |
Oral formulation of drug designed to selectively block ion channels in the heart |
Atrial fibrillation |
Began Phase Ib trial after selecting a controlled-release formulation in a Phase Ia trial (11/29) |
Dyax Corp. |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein |
Hereditary angioedema |
Final results from Phase II EDEMA1 trial showed statistical significance for the primary endpoint of improving HAE symptoms (11/15) |
FibroGen Inc.* |
FG-2216 |
Small-molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase |
Anemia |
Phase I trial in healthy volunteers showed the agent was safe, well tolerated and significantly increased production of endogenous erythropoietin (11/1) |
GenVec Inc. |
-- |
Transplantation of autologous myoblast cells |
Congestive heart failure |
Follow-up data from three trials demonstrated the feasibility and safety of the treatment (11/8) |
Guilford |
Aggrastat (FDA-approved) |
Tirofiban hydrochloride; glycoprotein IIb/IIIa receptor antagonist |
For use in coronary stent procedures |
The STRATEGY trial demonstrated that use with a drug-eluting stent resulted in a significantly lower rate of death, MI, stroke and binary restenosis at six months vs. abciximab and a bare metal stent; also, began Phase III TENACITY trial to evaluate if dose retains at least 50% of the benefit of abciximab in patients undergoing PCI with coronary stent placement, and to evaluate safety and efficacy vs. heparin with tirofiban or abciximab (11/12) |
Millennium |
Integrilin (FDA-approved) |
Eptifibide; glycoprotein IIb/IIIa inhibitor |
Cardiac conditions |
The CLEAR Platelets trial showed that adding Integrilin to a common regimen provided better platelet inhibition and prevention of heart muscle damage associated with elective coronary stenting in low to moderate risk patients (11/8); Integrilin did not beat bivalirudin in the PROTECT trial on the primary endpoint of coronary flow reserve, but did in improving myocardial perfusion (11/6) |
NitroMed |
BiDiL |
Nitric oxide-enhancing agent consisting of isosorbide dinitrate and hydralazin |
Heart failure |
Phase III A-HeFT trial in African-Americans showed a 43% improvement in survival with standard therapy vs. standard therapy and placebo (11/8) |
Sanguine |
PHER-O2 |
Synthetic red blood cell product |
Blood substitute |
Virginia Commonwealth University is conducting a trial for the U.S. Navy for the oxygenation treatment of the bends (11/1) |
Valentis Inc. |
Deltavasc |
Del-1 angiogenesis gene plus VLTS 934 (PINC polymer) |
Peripheral arterial disease |
Presented further Phase II results showing Deltavasc and VLTS 934 groups both demonstrated statistically significant improvements in exercise tolerance and ankle brachial index vs. baseline (11/8) |
V.I. |
Inactine |
Pathogen-reduction system |
Blood substitute |
Suspended enrollment in Phase III surgical study after identification of an immune response in one patient (11/23) |
CENTRAL NERVOUS SYSTEM | ||||
Aeolus |
AEOL 10150 |
Small-molecule catalytic antioxidant |
Amyotrophic lateral sclerosis |
Began a Phase I trial in 30 patients to evaluate safety, tolerability and pharmacokinetics (11/15) |
Avanir |
Neurodex |
Oral combination of dextromethorphan and an enzyme inhibitor, quinidine |
Diabetic neuropathy |
Phase II trial in 36 adults with the condition demonstrated the drug was well tolerated and produced significantly decreased pain intensity vs. baseline (11/12) |
DOV |
Ocinaplon |
Agent that modulates a subset of GABA-A receptors |
Anxiety |
Began a pivotal Phase III trial to test the agent against placebo in 375 patients (11/23) |
Endo |
Oxymorphone ER |
Extended-release formulation of oxymorphone |
Pain |
Began Phase III trial after getting final approval under an FDA SPA (11/22) |
NeuroSearch |
NS2359 |
Agent designed to enhance the function of dopamine, noradrenaline and serotonin |
Attention deficit hyperactivity disorder |
Phase II trial in 126 adult patients did not meet its primary efficacy endpoint, although it did improve certain parameters (11/8) |
Pharmos |
Dexanabinol |
A tricyclic dextro- |
Cognitive impairment in CABG patients |
Phase II trial in coronary artery bypass graft patients showed efficacy on one measure but no benefit on another vs. placebo (11/22) |
TransForm |
TPI-926 |
Reformulation of an existing marketed product |
Undisclosed CNS disorder |
Began a Phase II trial in patients suffering from a disease of the CNS (11/15) |
Vernalis plc |
Frova (FDA-approved) |
Frovatriptan; 5HT 1B/1D agonist |
Menstrually related migraine |
Began a confirmatory Phase IIItrial in 600 patients whose migraines were not adequately treated with acute therapies (11/23) |
XenoPort |
XP13512 |
Transported produg of the approved agent gabapentin (Pfizer Inc.'s Neurontin) |
Neuropathic pain |
Phase I trial demonstrated safety, tolerability and dose-proportional pharmacokinetics (11/4) |
DIABETES | ||||
Amylin |
Exenatide LAR |
Long-acting formulaiton of an incretin mimetic |
Type II diabetes |
Phase II trial showed safety, tolerability and sustained release; the companies and Eli Lilly and Co. will move the product into a multiple-dose Phase II trial (11/2) |
Generex |
Oralyn |
Oral insulin spray formulation |
Diabetes |
Presented various positive data from studies of Ora-lyn and the company's RapidMist Diabetes Management System (11/1) |
INFECTION | ||||
ActivBiotics |
Rifalazil |
Anti-chlamydial agent |
Acute non-gonococcal urethritis |
Phase II trial in 170 men with NGU met all primary endpoints; it demonstrated a statistically significant dose response on clinical cure rates (11/1) |
Aerogen Inc. |
-- |
Aerozolized formulation of amikacin |
Ventilator-associated pneumonia |
Filed IND to begin a Phase II trial with more than 100 patients to define the effective dose and monitor clinical responses (11/8) |
AEterna |
Impavido |
Oral miltefosine |
Recurrent visceral leishmaniasis |
Compassionate-use progam in 39 HIV patients who had failed other agent showed the drug generally was well tolerated and produced positive responses (11/15) |
Anadys |
Isatoribine (ANA245) |
Agent designed to regulate innate immunity by interacting with toll-like receptor 7 |
Hepatitis C |
Phase Ib trial showed the drug was safe, well tolerated and bio- logically active, and reduced viral load (11/3) |
Anadys |
ANA380 (LB80380) |
Oral prodrug of the nucleotide analogue ANA317 (LB80317) |
Hepatitis B |
Phase I/II trial showed a reduction in viral load of more than 99.9% in patients receiving 60 mg or more for four weeks (11/1) |
Basilea |
BAL5788 |
Ceftobiprole; broad-spectrum cephalosporin antibiotic |
Complicated skin and skin-structure infections |
Began international Phase III STRAUSS trial to study efficacy vs. vancomycin in 700 patients (11/4) |
Chiron Corp. |
Menjugate |
A conjugate vaccine against Neisseria meningitidis serogroup C |
To prevent meningococcal C disease |
Company completed Phase III trial and said it would not be filing for approval of the product (11/12) |
Cubist |
HepeX-B |
Combination of two fully human monoclonal antibodies, libivirumab and exbivirumab |
Hepatitis C |
Monitors in a Phase II trial recommended the trial continue after reviewing data on the first 15 patients (11/23) |
DOR |
RiVax |
Genetically engineered vaccine against ricin |
Ricin infection |
The University of Texas Southwestern Medical Center began a Phase I trial to assess safety and immunogenicity in human volunteers (11/30) |
Dynavax |
-- |
Prophylactic vaccine based on immunostimulatory sequences |
Hepatitis B |
Phase II trial showed faster protective antibody responses and that they were maintained longer than with GlaxoSmithKline plc's Engerix-B (11/1) |
Gilead Sciences |
Hepsera (FDA-approved) |
Adefovir dipivoxil; a nucleotide analogue |
Hepatitis B |
144-week data from Study 437 demonstrated continued inhibition of viral replication and normal-ization of liver enzymes (11/2) |
Human Genome |
Albuferon |
Albumin interferon-alpha; long-acting form of interferon-alpha |
Hepatitis C |
Began Phase II trial in combination with ribavirin to evaluate safety, tolerability and efficacy in patients with chronic disease (11/30) |
Human Genome |
Albuferon of interferon-alpha |
Albumin interferon-alpha; long-acting form |
Hepatitis C |
Phase I/II trial in 122 patients showed drug was well tolerated, biologically active and reduced viral load in dose-dependent manner (11/2) |
Idenix |
NM 283 |
Oral nucleoside analogue |
Hepatitis C |
Presented positive data from a Phase I trial and an ongoing Phase IIa trial (11/1) |
Idenix |
Telbivudine |
Oral nucleoside agent |
Hepatitis B |
Viral dynamics analysis from a Phase IIb trial showed faster and more profound viral clearance than with lamivudine alone (11/1) |
Idenix |
Valtorcitabine |
Agent that specifically targets HBV DNA polymerase |
Hepatitis B |
Phase I trial demonstrated safety and reductions in viral load (11/1) |
Inhibitex Inc. |
Aurexis |
Humanized monoclonal antibody based on MSCRAMM protein platform technology |
S. aureus infections |
Phase I trial in healthy volunteers showed the agent generally was safe and well tolerated; also, monitors said a Phase II trial should continue after looking at data from 40 patients (11/1) |
InterMune |
Infergen (FDA-approved) |
Interferon alfacon-1 |
Hepatitis C |
Investigators presented data from trials with ribavirin showing safety and efficacy in various HCV settings (11/2) |
InterMune |
Infergen and Actimmune (both FDA-approved) |
Interferon alfacon-1 and interferon gamma-1b |
Hepatitis C |
Retrospective analysis involving PEG nonresponders showed 23 of 50 patients taking combination had undetectable viral loads after 24 weeks (11/1) |
MedImmune |
Numax |
Third-generation variant of the anti-RSV antibody Synagis |
Respiratory syncytial virus |
Began a Phase III trial to evaluate safety and efficacy in reducing RSV disease in healthy, full-term Native American infants (11/15) |
MedImmune |
Numax |
Third-generation variant of the anti-RSV antibody Synagis |
Respiratory syncytial virus |
Began a Phase III trial in 5,750 high-risk infants to compare safety and efficacy to Synagis, MedImmune's approved drug (11/1) |
MedImmune |
FluMist (FDA-approved) |
Influenza vaccine delivered as a nasal mist |
Influenza |
Began a Phase I/II trial to compare safety and efficacy to the injectable influenza vaccine in children with HIV (11/1) |
Nabi Bio-pharmaceuticals |
Altastaph |
Staphylococcus aureus immune globulin (human); polyclonal antibody |
S. aureus infections in neonates |
Phase II trial in 200 premature, low-birth-weight neonates demonstrated safety, but failed to show efficacy because only three patients each in the placebo and drug arms became infected (11/18) |
Panacos |
PA-457 |
Small-molecule maturation inhibitor designed to block a step in processing of the HIV Gag protein |
HIV |
Patients taking the higher doses in a Phase I/II trial experienced reductions in viral load (11/23) |
Pharmasset |
Racivir |
Nucleoside analogue |
HIV |
Began Phase II RCV-201 trial to assess safety, tolerability and antiviral effect of substituting Racivir for lamivudine in treat- ment-experienced patients (11/10) |
Rigel |
R803 |
Small-molecule non-nucleoside HCV polymerase inhibitor |
Hepatitic C |
A lack of bioavailability was cited in the product failing to reduce viral levels in a statistically significant manner (11/22) |
StressGen |
HspE7 |
Fusion product consisting of heat-shock protein fused to human pappilomavirus antigen |
High-grade cervical dysplasia |
21-patient Phase II trial showed a 40% response rate (11/17) |
Tanox Inc. |
TNX-355 |
Humanized anti-CD4 monoclonal antibody; designed to inhibit viral entry |
HIV |
Presented Phase Ib data showing the agent appeared to be safe and well tolerated, and produced a transient reduction in viral load (11/9) |
Theravance |
Telavancin (TD-6424) |
Lipoglycopeptide antibiotic believed to have multiple mechanisms of action |
Skin and skin-structure infections |
Phase II FAST trial in 167 patients showed similar efficacy and adverse events as standard therapy, with an efficacy advantage in a patient subset (11/2) |
Vertex |
VX-950 |
Oral protease inhibitor |
Hepatitis C |
Phase Ia trial showed the agent was well tolerated and had favor- able pharmacokinetic properties in healthy volunteers (11/1); began 60-subject Phase Ib trial that will include both healthy volunteers and chronic HCV patients (11/8) |
MISCELLANEOUS | ||||
Alexion |
Eculizumab |
Humanized monoclonal antibody designed to block complement protein C5 |
Paroxysmal nocturnal hemoglobinuria |
Began pivotal Phase III TRIUMPH trial under an FDA SPA that will include about 75 patients (11/1) |
Amgen Inc. |
Sensipar (FDA-approved) |
Cinacalcet HCl; oral calcium calcimimetic |
Secondary hyperparathyroidism |
Data from one-year trial confirmed the benefits of the drug independent of the vitamin D dose (11/1) |
APT |
AHCQ |
Aerosolized hydroxy-chloroquine, a disease-modifying antirheumatic drug |
Various conditions |
Phase I trial showed a favorable safety profile and pharmacokinetics, and tolerable taste (11/19) |
Arena |
APD356 |
Small-molecule, selective 5HT2C serotonin receptor agonist |
Obesity |
Phase Ib trial showed the agent was well tolerated and supported a move into Phase II trials (11/30) |
Auxilium |
Testim |
Topical 1% testosterone gel |
Hypogonadism |
Trial in 48 patients with HIV demonstrated a statistically significant improvement in sex-related endpoints vs. AndroGel (11/17) |
BioBalance Corp. (OTC BB: BBAL) |
Probactrix |
Strain of E. coli in a BioBalance formulation |
Irritable bowel syndrome |
Began a trial in 210 patients to test the ability of the agent to reduce symptoms of IBS and improve quality of life (11/16) |
BioMarin |
Phenoptin |
Sapropterin hydrochloride; form of the enzyme cofactor 6R-BH4 |
Phenylketonuria |
Following talk with the FDA, said it would begin a Phase III trial in 1Q:05 to test changes in blood phenylalanine levels vs. placebo (11/30) |
BioSante |
LibiGel |
Transdermal testosterone gel |
Female sexual dysfunction |
Phase II trial in 46 surgically menopausal women demonstrated statistically significant benefits vs. baseline and placebo (11/1) |
Connetics |
Extina |
2% ketoconazole formulated with Connetics' foam delivery vehicle |
Seborrheic dermatitis |
The FDA issued a non-approvable letter, saying the product was not superior to placebo foam (11/23) |
CuraGen Corp. |
CR002 |
Fully human antibody against platelet-derived growth factor-D |
Kidney inflammation |
The product was moved into a Phase I trial to evaluate safety, tolerability and pharmacokinetics (11/18) |
Hemispherx |
Ampligen |
RNA drug with potential action as an immuno-modulator and antiviral |
Chronic fatigue syndrome |
Presented new data from positive pivotal Phase III trial showing increased exercise capacity vs. placebo (11/1) |
Microbia Inc.* |
MD-1100 |
Superagonist of the guanylate cyclase-C receptor |
Irritable bowel syndrome |
Began Phase I trial to evaluate safety and pharmacokinetics in healthy volunteers (11/1) |
OxiGene Inc. |
CA4P |
Combretastatin A4 prodrug; a vascular targeting agent |
Myopic macular degeneration |
Began a Phase II trial to assess safety and efficacy in patients with active choroidal neovascularization associated with MMD (11/19) |
RegeneRx Bio- |
Thymosin beta-4 |
Naturally occurring peptide with multiple mechanisms of action |
Chronic pressure ulcers |
Began a Phase II trial to evaluate several doses vs. placebo in patients (11/2) |
Sirna |
Sirna-027 |
Chemically modified short interfering RNA targeting vascular endothelial growth factor receptor-1 |
Wet age-related macular degeneration |
Began Phase I trial to evaluate safety, tolerability and biological activity following a single intra-vitreal injection (11/23) |
ZymoGenetics |
TACI-Ig |
Antagonist protein that binds to the TNF cytokines BLyS and APRIL |
B-cell malignancies and autoimmune diseases |
A trial in 23 healthy volunteers showed the agent was safe and well tolerated at all dose levels tested (11/8) |
| | ||||
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; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
