Company* |
Product |
Description |
Indication |
Status |
CANCER | ||||
Abgenix Inc. |
ABX-EGF |
Fully human monoclonal antibody |
Non-small-cell lung cancer |
Company initiated a Phase II trial, its second for ABX-EGF (7/31) |
AltaRex Corp. |
OvaRex |
Modified murine monoclonal antibody that binds to CA125 cancer antigen |
Ovarian cancer |
Phase II results validated quality-of-life data associated with the administration of OvaRex MAb, as compared to placebo (7/27) |
Atrix Laboratories Inc. (ATRX) |
Leuprogel Three-Month Depot |
Leuprolide acetate for subcutaneous depot for injection; leuprolide is a luteinizing hormone- releasing hormone agonist |
Advanced prostate cancer |
Phase III results showed 100% suppression of serum testosterone to very low levels (7/10) |
BTG plc |
AQ4N |
Lead compound selected from a series of hypoxic-cell cytotoxins designed to increase the effectiveness of several anticancer drugs, as well as radiotherapy |
Cancer |
Company started a Phase I trial (7/17) |
Celgene |
Thalomid |
Thalidomide; modulates levels of tumor necrosis factor-alpha |
Multiple melanoma |
Two-year event-free and overall survival rates of 20% and 48% were seen in a follow-up of a Phase II trial of 169 advanced and refractory patients (7/9) |
EntreMed |
Endostatin |
Naturally occurring angiogenesis inhibitor |
Cancer |
Company enrolled the first patients in a Phase I/II trial (7/12) |
Enzon Inc. |
Prothecan |
PEG-camptothecin |
Small-cell lung cancer |
Company initiated patient dosing in a Phase II trial (7/24) |
|
MedImmune Inc. (MEDI) |
Vitaxin |
Antibody that has the potential to inhibit growth of new blood vessels by binding to a specific integrin |
Colorectal cancer |
Company began dosing colorectal cancer patients in a Phase I/II trial (7/16) |
MetaPhore Pharma- |
M40403 |
Enzyme mimetic drug |
Advanced skin and end-stage kidney cancers |
Company released initial results from its Phase I study that showed no dose side effects were observed or reported (7/12) |
Ortho Biotech Products LP* |
Doxil |
Liposomal doxorubicin |
Epithelial ovarian cancer |
A study comparing Doxil with topotecan showed the median time to progression was 16.1 weeks for Doxil and 17 weeks for topotecan; the overall response rates were 19.7% and 17%, respectively (7/27) |
OSI Pharma- |
OSI-774 (Tarceva) |
Epidermal growth factor receptor tyrosine kinase |
Non-small-cell lung cancer |
Company initiated a Phase III trial in which Tarceva will be evaluated in combination with carboplatin and paclitaxel (7/25) |
SafeScience |
GBC-590 |
Carbohydrate compound derived from citrus pectin |
Refractory pancreatic adenocarcinoma |
Company completed patient enrollment in a Phase II trial (7/23) |
Vion |
Triapine |
Anticancer agent; inhibitor of the enzyme ribonucleotide reductase |
Cancer |
Company initiated the second Phase I combination trial designed to determine the safety and maximum dose of cisplatin when administered with Triapine (7/16); company initiated a Phase II trial in patients with acute and chronic leukemias (7/23) |
CARDIOVASCULAR | ||||
Alteon Inc. |
ALT-711 |
A.G.E. crosslink breaker compound |
Isolated systolic hypertension |
Company started a Phase IIb trial (7/9) |
Cardiome Pharma Corp. (Canada; OTC BB:COMTF; TSE:COM;) |
RSD1235 |
Anti-arrhythmic drug |
Acute atrial arrhythmia |
Company completed a Phase I trial that showed the product to be safe and well tolerated (7/30) |
Cyanotech |
BioAstin |
Formulation of the microalgae Haematococcus pluvialis, which contains high levels of astaxanthin |
For the reduction of LDL cholesterol, while increasing HDL cholesterol |
Cyanotech initiated a new trial to measure BioAstin's effectiveness in reducing LDL cholesterol while increasing HDL cholesterol (7/6) |
CENTRAL NERVOUS SYSTEM |
||||
Guilford Pharmaceuticals |
NIL-A |
Neuroimmunophilin ligand |
Parkinson's disease |
Company completed a Phase II trial, which showed the product did not reach statistical significance in any of its endpoints (7/26) |
Protein Therapeutics |
¿ |
Oral human gammaglobulin |
Juvenile rheumatoid arthritis |
Company started enrollment for a Phase II trial (7/9) |
Repligen |
¿ |
Human synthetic secretin |
Autism |
Phase II data showed patients had an improvement in symptoms over the eight-week period of the trial (7/20) |
Titan Pharma- |
Spheramine |
Cell therapy product that uses human retinal pigmented epithelial cells that secrete dopamine |
Parkinson's disease |
Phase I/II data demonstrated improvement in motor function and quality of life for Parkinson's patients treated with Spheramine (7/31) |
Titan Pharma- |
Zomaril |
Iloperidone; antipsychotic that has an antagonistic activity on brain receptors for dopamine and serotonin, with preferential affinity for 5HT2A serotonin receptors in humans |
Schizophrenia |
Companies said they will initiate additional dose-related trials, delaying regulatory filing, in order to demonstrate a favorable safety profile when switching from other antipsychotic agents to Zomaril (7/24) |
DIABETES |
||||
DepoMed |
Metformin GR |
Once-daily treatment that uses DepoMed's gastric retention technology |
Diabetes |
Phase II data confirmed findings indicating the safety and efficacy and relative tolerability; it showed that the GR formulation was as effective as the IR formulation and the differences among the treatments were not significant (7/31) |
Restoragen |
Betatropin |
Recombinant glucagon-like peptide-1 |
Type II diabetes |
Phase II and Phase I/II results indicated the therapy produced a statistically significant reduction in glycated hemoglobin (7/5) |
INFECTION | ||||
Achillion |
ACH-126,443 |
Beta-LFd4C |
Chronic hepatitis B |
Company began a Phase Ib/II study of the compound (7/24) |
Cangene |
¿ |
Anti-hepatitis C hyperimmune product |
Hepatitis C |
Company stopped its Phase II trial in liver transplant recipients after an independent monitoring board found no statistical difference between patients receiving the drug and those receiving placebo (7/12) |
Cubist Pharma- |
Cidecin |
Daptomycin for injection; a novel cyclic lipopeptide antibiotic derived from a fermentation product of streptomyces roseosporous |
Skin and soft tissue infection |
Company completed enrollment in the second of its Phase III trials (7/16) |
Medinox Inc.* |
NOX-100 |
Small-molecule, nitric oxide-blocking agent designed to bind and inactivate excessive amounts of NO |
Sepsis |
Company started a Phase I/IIa trial (7/9) |
Micrologix |
MBI 853NL |
Anti-infective; intranasally delivered |
Hospital-acquired Staphylococcus aureus |
Company suspended its plans for a Phase II efficacy study due to Phase Ib results that showed further studies would involve greater risk, time and costs than could be justified (7/16) |
Trinity Medical |
Remune |
HIV-1 immunogen |
HIV |
Clinical studies showed there was no mutation of the virus (7/11) |
XTL Biopharma- |
XTL-002 |
Human monoclonal antibody shown to reduce viral levels of HCV |
Hepatitis C |
Company began Phase I studies (7/3) |
MISCELLANEOUS | ||||
Adolor Corp. |
ADL 8-2698 |
Oral nonabsorbed small- molecule opioid receptor antagonist |
Opioid bowel dysfunction |
Company started enrollment in a Phase III trial (7/9) |
Amarillo |
Lozenges |
The lozenges contain 50 international units of natural human interferon alpha |
Fibromyalgia syndrome |
Phase II study in which patients did not have an injury that contributed to the syndrome showed the therapy was statistically significant (7/17) |
BioMarin |
¿ |
Recombinant human N- acetylgalactosamine 4- sulfatase, an enzyme |
Maroteaux-Lamy syndrome |
Company completed the 24-week treatment stage of its Phase I trial (7/25) |
Discovery |
Surfaxin |
Humanized, peptide- containing surfactant designed to lower surface tension at the air-water interface in the rings |
Idiopathic respiratory distress syndrome |
Company began patient enrollment in a Phase III trial in premature infants (7/9) |
Genentech Inc. (NYSE:DNA) and XOMA Ltd. (XOMA) |
Xanelim |
Efalizumab |
Psoriasis |
Phase III data showed that all endpoints were met, indicating the ability of Xanelim to provide long-term control of psoriasis symptoms in patients with moderate to severe forms of the disease (7/31) |
GenStar Therapeutics (AMEX:GNT) |
Maximum AD |
Factor VIII gene therapy |
Hemophilia A |
Phase I data demonstrated an increase in Factor VIII clotting factor levels from less than 1% up to 3% (7/12) |
ICOS Corp. |
IC747 |
Orally active, small-molecule LFA-1 antagonist |
Inflammatory conditions |
Phase I trial began (7/2) |
ISTA |
Vitrase |
Injectable enzyme; hyaluronidase |
Severe vitreous hemorrhage |
ISTA completed patient enrollment in the second of its Phase III trials (7/5) |
Metabolex |
MBX-102 |
Single isomer of racemic drug |
Lowering lipids (glucose, cholesterol and triglycerides) |
Company began a Phase I trial (7/9) |
MedImmune |
Siplizumab |
Humanized monoclonal antibody that has the potential to suppress the immune system |
Psoriasis |
Company began dosing patients in a Phase I trial (7/26) |
Neurochem |
Fibrillex |
Anti-amyloid drug |
Secondary amyloidosis |
Company saw positive Phase I safety data (7/17) |
Neurocrine |
NBI-34060 |
Type 1 GABA-a, a receptor agonist; chemically distinct from benzodiazepines |
Chronic insomnia |
Company received positive efficacy results in all four doses of NBI-34060 in a Phase II study (7/17) |
Oxford |
Vevesca |
Oral capsule formulation of a glucosyltransferase inhibitor |
Type I Gaucher disease |
Company initiated a clinical study in the U.S. (7/13) |
Phytopharm |
P57 |
Appetite suppressant derived from a South African plant |
Obesity |
Company completed the second stage of its Phase II study and no serious side effects were experienced by any of the 18 patients (7/18**) |
Regeneron |
Axokine |
Genetically reengineered version of a naturally occurring human protein known as ciliary neurotrophic factor |
Obesity |
Company initiated a Phase III trial (7/31) |
Targeted |
tgAAV-CF |
Gene therapy product that uses an adeno- associated virus vector delivery system |
Cystic fibrosis |
Phase II data showed no serious adverse events (7/10) |
XOMA Ltd. |
Neuprex |
Recombinant bactericidal/ permability increasing protein |
Crohn's disease |
Company initiated a Phase II trial (7/26) |
Notes: | ||||
* Privately held | ||||
** Denotes the date the item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; TSE = Toronto Stock Exchange | ||||
