Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE |
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Amgen Inc. | Kineret | Anakinra; a direct and selective blocker of interleukin-1 | Rheumatoid | Clinical data showed Kineret-treated patients experienced 36% less bone and joint destruction compared to patients treated with placebo plus methotrexate (10/28) |
Cambridge | Humira | Adalimumab; an anti-TNF alpha antibody | Rheumatoid | Phase III results showed Humira met its primary endpoints (10/28) |
Celgene Corp. | CC-401 | C-Jun-N-terminal kinase inhibitor | Acute | Company started a Phase I trial in healthy volunteers (10/21) |
Centocor Inc. | Remicade | Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood | Psoriatic arthritis | Clinical data showed that patients given Remicade experienced improvement in their joints; the average reduction of the Psoriasis Area and Severity Index was 81% compared to an average increase of 36% for placebo (10/28) |
Genentech Inc. | Rituxan | Rituximab; monoclonal antibody therapy | Rheumatoid | Phase II results showed a higher number of Rituxan patients experienced ACR20, ACR50 and ACR70 responses as compared with placebo patients (10/28) |
IDEC Pharma- | Rituxan (FDA- | A non-radiolabeled | Rheumatoid | Phase II results showed that combinations of Rituxan and methotrexate resulted in statistically significant improved efficacy compared to methotrexate alone (10/1) |
Isis Pharma- | Alicaforsen | Antisense inhibitor of intercellular adhesion molecule-1 | Crohn's disease | Phase II results showed the drug may produce clinical disease remission when patients receive appropriate doses (10/22) |
Vertex Pharmaceuticals Inc. (VRTX) | Pralnacasan | Orally active inhibitor | Rheumatoid | Phase IIa results showed patients receiving a higher dose had statistically significant reductions in the inflammatory biomarkers C- reactive protein, erthrocyte sedimentation rate and serum amyloid A (10/29) |
CANCER | ||||
Anosys Inc.* | - | Acellular anticancer | Melanoma | Phase I results showed that three of six patients who received an active dose of the vaccine achieved clinical benefit, either prolonged disease stabilization up to 12 months or tumor shrinkage (10/21) |
Antisoma plc | Pemtu- | A yttrium-90 radiolabeled antibody formerly called Theragyn | Gastric cancer | Phase II results showed pemtumomab to be generally well tolerated in a group of eight patients who had received surgery to remove or reduce their tumor (10/24) |
Aphton Corp. | G17DT | Antigastrin immunogen | Pancreatic cancer | Phase III data showed patients had a median survival time that was 53% longer than the placebo group (10/28) |
Aton Pharma | SAHA | An inhibitor of histone deacetylase | Cutaneous T-cell lymphoma and peripheral T-cell lymphoma | Company initiated a single-agent Phase II study of SAHA (10/30) |
Biomira Inc. (Canada; BIOM) | Theratope | Vaccine; synthetic carbohydrate-based mimic of cancer antigen sialyl-Tn plus carrier molecule KLH | Metastatic | Company completed enrollment in its Phase II pilot study (10/9) |
Celgene Corp. | Thalomid | Thalidomide; modulates levels of tumor necrosis factor alpha | Multiple myeloma | Clinical results of Thalomid used in combination with dexamethasone showed 64% of patients achieved a greater than 50% reduction in M-protein (10/31) |
Cell Thera- | Xyotax | Links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer | Non-small-cell | Company began a Phase III trial (10/7); company plans to initiate two more Phase III trials (10/23) |
Cel-Sci Corp. (AMEX:CVM) | Multikine | Immunotherapy drug; natural mixture of human cytokines, including interleukin-2 | Head and neck cancer | Company completed Phase II enrollment and all patients completed treatment (10/15) |
Genentech | Herceptin | Trastuzumab; monoclonal antibody developed against the HER-2/neu protein | Breast cancer | Clinical results of Herceptin used in combination with GlaxoSmithKline plc's Navelbine showed a 78% overall response rate (10/28) |
Genta Inc. | Genasense | Antisense compound | Chronic myeloid leukemia | Companies began a clinical trial of Genasense used in combination with Gleevec (10/2) |
Genta Inc. | Genasense | Antisense compound geared toward blocking the production of Bcl-2 | Non-Hodgkin's lymphoma | Companies initiated a clinical trial of Genasense in combination with Rituxan (10/29) |
GlycoGenesys | GCS-100 | Carbohydrate compound derived from citrus pectin | Pancreatic adenocarcinoma | Phase IIa results showed 35% of patients experienced stable disease from 0.63 to 13.6 months (10/30) |
ILEX Oncology | Clofarabine | A second-generation nucleoside analogue | Hematologic malignancies | Company began a Phase I/II trial to study it in combination with the chemotherapy drug ara-C (cytarabine) (10/22) |
ImClone | Erbitux | Cetuximab; designed to target and block the epidermal growth factor receptor | Refractory | Company began patient enrollment in a Phase II trial (10/7) |
Introgen Therapeutics | Advexin | p53 gene therapy | Breast cancer | Company began treating patients in a Phase II trial studying Advexin in combination with two chemotherapeutic drugs, docetaxel and doxorubicin (10/29) |
KS Biomedix | KSB303 | A radiolabeled | Pancreatic | Company plans to begin a Phase I/II trial (10/16**) |
Maxim | Ceplene | Histamine | Advanced | Phase III data of Ceplene in combination with interleukin-2 showed that the rate of three-year survival for patients treated with the Ceplene/IL-2 combination was about two times the rate of survival for control patients (10/21) |
Medarex Inc. | MDX-010 | A fully human | Metastatic melanoma | Company initiated two Phase II trials in metastatic melanoma and prostate cancer (10/29) |
NeoPharm Inc. | - | Liposome-encapsulated Mitoxantrone | Advanced | Phase I data showed that plasma PK measurements were similar across all dose levels, with neutropenia being the primary dose-limiting toxicity (10/21) |
Northwest Biotherapeutics | DCVax- Prostate | Dendritic cell-based immunotherapy | Prostate cancer | Company is suspending recruitment in the Phase III trial in an effort to conserve resources (10/10) |
OSI Pharma- | OSI-211 | A liposomal formulation of the topoisomerase I inhibitor lurtotecan | Ovarian cancer | Company initiated two Phase I trials (10/1) |
Pharmacyclics | Xcytrin | Motexafin gadolinium | Brain metastases | Phase III data showed that Xcytrin significantly prolonged the time to neurologic progression and decreased deaths due to brain tumor progression in patients with brain metastases from lung cancer (10/8) |
Pharmacyclics | Xcytrin | Motexafin gadolinium | Glioblastoma multiforme | Phase II results showed that more than 80% of 25 patients were alive at six months (10/9) |
PrimaBioMed | - | Dendritic cell-based | Cancer | Phase I results showed the therapy caused no side effects (10/23) |
Protarga Inc.* | Taxoprexin | Synthetic small molecule made by chemically linking paclitaxel to the natural fatty acid docosahexa- | Melanoma | Company will begin a Phase III trial in December (10/3) |
QLT Inc. | Visudyne | Verteporfin therapy | Multiple basal cell carcinoma | Companies started patient enrollment in two Phase III trials using photodynamic therapy with verteporfin (10/11) |
SuperGen Inc. | Decitabine | Inhibits DNA methyltransferase activity | Myelodysplastic syndrome | Phase II results confirm the drug's mechanism of action: the reversal of DNA hypermenthylation (10/29) |
Telik Inc. | TLK286 | Small-molecule antitumor drug that is activated by GST P1-1 | Non-small-cell | Company initiated the first in a series of planned clinical trials of TLK286 in combination with standard chemotherapy (10/7) |
Vion Pharma- | Triapine | Inhibitor of the | Squamous cell cancer of the head and neck | Company initiated a Phase II trial of Triapine as a single agent (10/9) |
Wilex AG* | WX-UK1 | A small-molecule inhibitor of the uPA (urokinase-type plasminogen activator) system | Advanced gastric, pancreatic and ovarian cancers | Company initiated a Phase Ib/IIa trial (10/14) |
CARDIOVASCULAR | ||||
AtheroGenics | AGI-1067 | V-protectant drug | To reduce post-angioplasty restenosis | Phase II data showed AGI-1067 met its primary endpoint of reducing post-angioplasty restenosis (10/4) |
AVI BioPharma | Resten-NG | Antisense compound that targets and blocks c-myc, a regulatory gene that is the key factor in the cascade of effects that lead to restenosis in angioplasty patients | To prevent coronary artery restenosis after angioplasty and stent placement | Phase II data were positive (10/1) |
CV Therapeutics | Teca- | A selective A1 adenosine receptor agonist | Abnormally rapid heart rhythm | Phase III data showed it met its primary endpoint of converting the abnormal rate to a normal or sinus rhythm (10/22) |
GlycoDesign | GH9001 | An antithrombotic | Venous thromboembolism and acute coronary syndromes | Phase I results showed the drug was well tolerated; adverse events were mild and not considered clinically significant (10/24) |
La Jolla Pharmaceutical Co. (LJPC) | LJP 1082 | Composed of four copies of a recombinant protein attached to a synthetic organic platform designed to reduce disease-causing antibodies | Stroke, heart | Phase I/II results showed that patients receiving higher doses of LJP 1082 had larger reductions in antibodies to LJP 1082; the drug was well tolerated (10/28) |
Neurochem Inc. | Cerebril | Small organic molecule that has been designed to modify the course of hemorrhagic stroke | Recurrent | Company plans to start a Phase II trial (10/25) |
NicOx SA | NCX 4016 | Nitric oxide-donating derivative of aspirin | Cardiovascular disease | Company will start a Phase II study in the U.S. (10/24) |
Scios Inc. | Natrecor | Nesiritide; recombinant B-type natriuretic peptide | Heart failure | Clinical results showed that the length of hospital stay for patients who received IV vasoactive infusion therapy in emergency was 6.4 days vs. 9.5 days for those who started the therapy after admission (10/8) |
Texas Biotechnology Corp. (TXBI) | Argatroban | A direct thrombin inhibitor anticoagulant | Stroke | Phase II results showed that Argatroban met the primary endpoint of safety with no statistical difference in symptomatic intra- cranial hemorrhage rates between Argatroban and placebo (10/2) |
CENTRAL NERVOUS SYSTEM | ||||
Celltech Group | Metadate | Methylphenidate HCl, | Attention deficit hyperactivity disorder | Clinical results demonstrated a statistically significant and clinically relevant reduction in ADHD symptom scores in favor of Metadate CD as compared with Ortho-McNeil Pharmaceuticals Inc.'s Concerta (10/15) |
Cephalon Inc. | Provigil | Modafinil tablets; oral formulation of the synthetic compound | Sleep disorders related to shift | Phase III results showed statistical significance in both primary endpoints; company expects to file a supplemental BLA by the end of the year (10/23) |
Endo Pharma- | MorphiDex | Morphine and the N- methyl-D-aspartate- | Chronic pain | The second of three Phase III trials showed MorphiDex did not meet its primary or secondary endpoints (10/28) |
Immune Network Ltd. (Canada; OTC BB: IMMFF) | - | Dapsone-based candidate | Alzheimer's | Phase II results showed that dapsone used on disease progression was not statistically significant (10/16) |
Pain Therapeutics | OxyTrex | Next-generation version of oxycodone; | Osteoarthritic | Company initiated a multidose study in 350 patients (10/28) |
Phytopharm plc | P58 | Oral treatment; | Age-related cognitive dysfunction | Company completed a Phase I repeat-dose study of P58, showing the product was safe and biologically active (10/9**) |
Pozen Inc. | MT300 | New, improved formulation of dihydroergotamine | Migraine | Phase III data showed MT300 achieved its primary endpoint of sustained pain relief and showed statistical significance in secondary endpoints on a sustained basis (10/4) |
Repligen Corp. | RG1068 | Human synthetic secretin | Autism | Phase II results showed no serious adverse events, and the drug was well tolerated in the 124 patients treated (10/16) |
DIABETES |
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Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly and Co. | AC2993 | Synthetic exendin-4; a 39-amino-acid peptide | Type II diabetes | Companies completed enrollment in the first of three Phase III trials (10/28) |
INFECTION | ||||
Avant Immuno- therapeutics Inc. (AVAN) and DynPort Vaccine Co. LLC | - | Vaccine consisting of a highly purified protein, a protective antigen, derived from the anthrax bacterium | Anthrax | Companies initiated a Phase I trial (10/15) |
British Biotech | BB-83698 | Antibiotic and peptide deformylase inhibitor | Community- acquired | Companies started Phase I testing in hospitalized patients (10/1) |
Cubist Pharma- | Cidecin | Daptomycin for injection | Infections | Phase III data showed patients treated with Cidecin required fewer concomitant medications due to adverse events and ex- perienced fewer hypersensitivity reactions requiring discontinuation of therapy than those in comparator arms (10/25) |
Innogenetics | - | E1-based therapeutic | Hepatitis C | Phase II results from an extension study showed an improved or stable Ishak histology score for 79% of patients (10/17) |
InterMune | Oritavancin | Second-generation glycopeptide antibiotic | Complicated skin and skin structure infections | Company completed patient enrollment in a Phase III trial (10/24) |
MedImmune | Synagis | Humanized monoclonal antibody | Respiratory syncytial virus | Company released Phase III data showing Synagis reduces respiratory syncytial virus-related hospitalizations in young children with congenital heart disease (10/18) |
NeuTec Pharma | Aurograb | Antibody-based treatment for the hospital superbug, methicillin-resistant Staphylococcus aureus | Staphylococcus aureus | Company began a Phase II trial in systemically ill patients (10/16**) |
Stressgen Biotechnologies Corp. (Canada; TSE:SSB) | HspE7 | Immunotherapeutic | Genital warts | Data showed HspE7 achieved complete responses of genital warts among a clinically significant percentage of patients for up to 24 months (10/7) |
Versicor Inc. | Anidula- | Intravenous infusion | Esophageal | Versicor completed enrollment of 600 patients in a pivotal Phase III trial (10/7) |
Vertex Pharma- | GW433908 | Protease inhibitor; calcium phosphate ester prodrug of amprenavir | HIV | Phase III data showed GW433908 met its endpoints (10/24) |
Virocell Inc.* | BG-777 | Immunomodulator | Viral and bacterial infections | Company completed Phase I trials and the drug was shown to be well tolerated (10/4) |
Zycos Inc.* | ZYC101a | DNA-based therapeutic that works by inducing T cells to attack cervical cells infected by HPV | Cervical dysplasia caused by human papillomavirus | Phase IIb results showed that cervical dysplasia was resolved in 70% of young patients treated with ZYC101a, compared to 23% of patients treated with placebo (10/23) |
MISCELLANEOUS | ||||
Actelion Ltd. (Switzerland; SWX:ATLN) | Tracleer (FDA- | Orally available dual endothelin receptor agonist | Scleroderma | Clinical results showed Tracleer significantly reduced the occurence of digital ulcers (10/29) |
Acusphere | AI-SR | A dry powder, sustained- release microparticle formulation of a marketed asthma drug | Asthma | Phase I results demonstrated sustained release of the drug relative to the commercially available inhaled formulation (10/7) |
Alizyme plc | Renzapride | 5-HT4 receptor agonist/ 5-HT3 receptor antagonist | Constipation- predominant irritable bowel syndrome | Company completed recruitment of 500 patients in a Phase IIb trial (10/2**) |
Amarin Corp. | LAX-101 | Compound that inhibits certain | Huntington's | Phase III data showed the product met its primary endpoint but missed statistical significance in secondary endpoints (10/28) |
Antares Pharma | LibiGel | A transdermal testosterone | Female sexual dysfunction | Companies initiated a Phase II trial (10/14) |
BioSante Pharmaceuticals Inc. (OTC BB:BISP) | LibiGel | Testosterone gel | Female sexual dysfunction | Company initiated a Phase II trial of LibiGel (10/7) |
Genentech Inc. (NYSE:DNA) | RhuFab V2 | Ranibizumab; a humanized | Wet form of age-related macular degeneration | Phase Ib/II data showed that 50 out of 53 patients had stable or improved vision (10/1) |
Human Genome Sciences Inc. (HGSI) | Albutropin | Long-acting recombinant human growth hormone | Growth hormone deficiency | Phase I data showed that Albutropin was well tolerated, had a prolonged half-life and was biologically active in adults (10/8) |
Inspire Pharma- | INS37217 Ophthalmic | A single-dose intravitreal injection | Rhegmatogenous retinal detachment | Phase I/II data showed the drug was well tolerated at all doses tested (10/2) |
Nabi Biopharma- | NicVAX | Nicotine conjugate | Nicotine dependence | Phase I data showed a single dose resulted in an immune response and generated nicotine- specific antibodies (10/3) |
Novavax Inc. | Estrasorb | Estradiol topical emulsion | Postmenopause | Phase III data showed that at least 2.5 to 3 times more patients using Estrasorb, compared with those using placebo, achieved a complete cessation of moderate to severe hot flashes over a seven-day period (10/4) |
NPS Pharma- | ALX 0600 | Analogue of naturally occurring peptide GLP2; enhances the growth rate of epithelium in the small intestine | Gastrointestinal disorders | Phase I results showed that patients in the fourth and fifth cohorts responded positively to the administration of the drug with indications of improved nutrient and energy absorption (10/21) |
OrthoLogic | Chrysalin | Mimics specific attributes of the thrombin molecule | Tissue and bone repair | Phase I/II data showed no drug- related adverse events (10/7) |
Rigel Pharma- | R112 | The first of a new class of drugs that works against mast cells | Allergic rhinitis | The Phase I safety trial is completed, and the company plans to file for permission to begin another trial (10/8) |
Selective | Gene- | Technology developed | Non-healing foot | Company began treating the first patient in a Phase I trial (10/10) |
Targacept | TC-2403-12 | A neuronal nicotinic | Ulcerative colitis | Company completed Phase I trials (10/7) |
Targeted | tgAAVCF | Gene therapy product that uses an adeno-associated virus vector delivery system | Cystic fibrosis | Phase II results showed the candidate met its primary endpoint of demonstrating safety and tolerability (10/4) |
Transkaryotic Therapies Inc. (TKTX) | Iduronate- | Enzyme replacement | Hunter syndrome | Phase I/II trial results showed evidence of clinical activity in reduction of cardiac mass and in stabilized pulmonary function (10/16) |
Vela Pharma- | Cyclobenza- | Muscle relaxant | Fibromyalgia | Company completed a 36- patient Phase II study of very low-dosage cyclobenzaprine; results indicated that the drug reduced musculoskeletal pain and fatigue, and improved sleep (10/28) |
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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. | ||||
AIM = Alternative Investment Market of the London Stock Exchange; AMEX = American 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 | ||||
BLA = Biologics License Application | ||||
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