Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE |
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Biogen Inc. | CDP 571 | A humanized anti-TNF- alpha antibody | Crohn's disease | Product missed its primary endpoint in a Phase III trial (7/30) |
Cell Pathways | CP461 | Oral drug; selective apoptotic antineoplastic drug | Crohn's disease | Company initiated a Phase II trial (7/22) |
Immunex Corp. | Enbrel (FDA- | Etanercept; tumor necrosis factor inhibitor | Psoriasis | Company began a second Phase III trial (7/3) |
La Jolla | LJP 394 | Arrests the production | Lupus | Phase II/III results showed that in 89% of patients with high-affinity antibodies for the drug, LJP 394 treatment prolonged time to and decreased the number of renal flares and delayed the need for high-dose corticosteroid and cyclophosphamide treatments when compared to placebo (7/1) |
Regeneron Pharmaceuticals | Interleukin-1 Trap | Designed to block inter- leukin-1 through a new mechanism of action | Rheumatoid arthritis | Company began a Phase II trial in about 200 patients (7/24) |
CANCER | ||||
AnorMED | AMD-3100 | A potential agent in stem cell transplant by enhancing the effect of Neupogen | Cancer | Phase I results were positive; company intends to start a Phase II trial (7/9) |
Antigenics Inc. | Aroplatin | A liposomal formulation | Metastatic colorectal cancer | Company enrolled the first patient in a Phase II study (7/18) |
Aphton Corp. | G17DT | A targeted therapy designed to induce antibodies that bind to both gastrin 17 and glygastrin and remove them from circulation before they can bind to the cancer cell and initiate cell growth | Metastatic stomach cancer | Phase II results showed 37 of 72 evaluable patients had either a partial or complete tumor response for an overall response rate of 51.4% (7/31) |
AVI BioPharma | Avicine | Cancer vaccine that blocks human chorionic gonadotropin | Late-stage colorectal | Phase II results showed anti-hCG antibodies were detected in 56 patients out of 77 total (7/24) |
Biomira Inc. | BLP25 | Synthetic MUC1 therapeutic vaccine consisting of the 25- amino-acid sequence of the MUC1 cancer mucin, encapsulated in liposomes | Non-small-cell lung cancer | An independent Data Safety Monitoring Board reviewed safety data in a Phase IIb trial and recommended the study continue as planned (7/22) |
Bio-Technology General Corp. (BTGC) | Oxandrolone | Oral synthetic derivative | Cancer-related weight loss | Clinical results showed that 78% of patients were able to gain or stop losing weight (7/8) |
British Biotech | E21R | A modified form of granulocyte macrophage- colony stimulating factor | Acute myeloid leukemia | Company stopped a Phase II study after new preclinical data failed to support the previous high incidence of apoptosis in AML (7/10**) |
British Biotech | MG98 | A second-generation antisense compound designed to inhibit the expression of DNA methyltransferase, an enzyme implicated in tumor growth | Head and neck cancer and renal carcinoma | Company closed recruitment in a Phase II study after patients failed to show a clinical response (7/10**) |
Celgene Corp. | Actimid | Immunomodulatory | Multiple | Phase I/II results showed eight people achieved stable disease, seven experienced a reduction in M-protein of between 25% and 50%, and three experienced a reduction in M-protein of greater than 50%; dose-limiting toxicities included neutropenia and thrombosis (7/8) |
Cell Thera- | Xyotax | Links paclitaxel to a biodegradable polyglutamate polymer | Advanced | Company began its first Phase III trial (7/30) |
EntreMed Inc. | Angiostatin | Used in combination | Non-small-cell lung cancer | Company began a Phase II trial (7/17) |
GenVec Inc. | TNFerade | Delivers the human | Pancreatic | Company began a Phase IIb trial involving about 140 patients (7/17) |
ILEX Oncology | Clofarex | Clofarabine; second- generation nucleoside analogue | Advanced solid tumors | Company began a Phase I trial (7/26) |
KS Biomedix Holdings plc (UK; LSE:KSB) | TransMID | Delivers diphtheria toxin | Malignant brain tumors | Company received approval to start a Phase I trial in the U.S. in up to 30 children (7/10**) |
MGI Pharma | Irofulven | Anticancer compound | Advanced gastrointestinal solid tumors | Company initiated a Phase II trial (7/15) |
Oncolytics | Reolysin | A human, reovirus- | Brain cancer | Company began a Phase I/II trial (7/3) |
Oxford Bio- | TroVax | Cancer gene therapy product | Cancer | Company is planning a Phase II trial (7/17**) |
Sonus Pharma- | Tocosol Paclitaxel | Paclitaxel cancer product that uses the company's vitamin E-based Tocosol delivery technology | Cancer | Phase II data showed the maximum tolerated dose for the colorectal study to be 120 mg/m2; company also completed patient enrollment in the dose-escalation stage of its non-small-cell lung, ovarian and bladder studies (7/19) |
TransMolecular | 131I-TM- | A radiopharmaceutical containing chlorotoxin from scorpions | Glioma | Company started a Phase I/II trial (7/3) |
Viventia Biotech | VB2-011 | "Totally Human" monoclonal antibody | Solid tumors | Company finished a Phase I/II safety and dose-escalation trial of VB2-011 (7/24) |
CARDIOVASCULAR |
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Alteon Inc. | ALT-711 | A.G.E. crosslink | Diastolic heart failure | Company began a Phase IIa trial (7/16) |
Cardiome Pharma | RSD1235 | Atrial antiarrhythmic | Atrial fibrillation | Company completed dosing in a Phase II trial (7/10) |
CV Therapeutics | CVT-510 | Tecadenoson; a selective A1 adenosine receptor agonist | Paroxysmal supraventricular tachycardia | Company completed patient enrollment in a Phase III trial of CVT-510 (7/25) |
Discovery Laboratories Inc. (DSCO) | Surfaxin | Humanized, synthesized peptide containing surfactant | Acute respiratory distress syndrome | Company completed the dose- ranging part of its Surfaxin Phase II trial (7/19) |
Esperion Therapeutics | ETC-642 | RLT peptide, which mimics the biological properties of apolipoprotein A-I to promote cholesterol removal from arterial walls and other tissues and to enhance reverse lipid transport | Artherosclerosis | Phase I results were positive (7/15) |
Genzyme Biosurgery |
| Gene therapy treatment; an engineered form of the HIF-1 alpha gene | Severe peripheral artery disease | Company completed enrollment in a Phase I trial (7/15) |
Hyseq Pharma- | Alfimeprase | A modified fibrolase | Peripheral arterial occlusion | Company began a Phase I trial (7/1) |
ICOS Corp. | Sitaxsentan | Endothelin receptor antagonist | Pulmonary arterial hypertension | Companies stopped an extension of a Phase IIb/III trial due to liver abnormalities in patients (7/23) |
CENTRAL NERVOUS SYSTEM | ||||
Durect Corp. | Chronogesic | Sufentanil; pain therapy system | Pain | Company began patient dosing in a Phase III trial (7/9) |
Forest | Memantine | Orally available neuroprotective agent that appears to restore damaged nerve cells and block excitatory signals by modulating the N- methyl D-aspartate receptor on cell membranes | Alzheimer's disease | Data showed that treatment with memantine seems to ease the economic burden and reduce care-giving time by more than 50 hours per month compared to placebo (7/22) |
Neurobiological Technologies Inc. (NTII) | Memantine | N-methyl D-aspartate receptor antagonist | Alzheimer's disease | Phase III data showed sustained efficacy of Memantine over 52 weeks to treat Alzheimer's disease (7/25) |
Pozen Inc. | MT 300 | An injectable dihydro- ergotamine mesylate compound | Migraine | Phase III data showed MT 300 met its primary and secondary endpoints (7/22) |
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 | Company said a regulatory filing would be set back a year because of the need for addition- al trials (7/22) |
DIABETES |
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Avanir Pharmaceuticals Inc. (AMEX:AVN) | Neurodex | Orally administered combination of dextromethorphan and an enzyme inhibitor | Diabetic neuropathy | Company began a Phase II trial (7/31) |
ConjuChem Inc. (Canada; TSE:CJC) | DAC: | Subcutaneously injected; created with DAC technology to engineer an analogue of GLP-1 into a drug construct, CJC-1131, which bonds in vivo to albumin | Type II diabetes | Company began a Phase I trial (7/8) |
INFECTION | ||||
Access Pharmaceuticals Inc. (AMEX:AKC) | OraDisc A | A mucoadhesive disc containing amlexanox | Canker sores | Company began a final Phase III trial (7/23) |
Achillion Pharmaceuticals Inc.* | ACH- | An L-nucleoside | HIV/AIDS | Company began a Phase II trial (7/17) |
Amrad Corp. | AM365 | Inhibitor of viral | Hepatitis B | Company is stopping development of AM365 after poor results from a Phase IIa trial (7/17**) |
Essential Therapeutics Inc. (ETRX) and Johnson & Johnson Pharmaceutical Research & Development LLC |
| Lead cephalosporin candidate | Antibiotic- resistant Gram-positive bacteria | Companies initiated Phase I trials (7/25) |
Gilead Sciences | Viread (FDA- | Tenofovir disoproxil fumarate | HIV | Phase III data showed 87% of patients in both the Viread arm and the stavudine arm achieved suppression of HIV RNA below 400 copies/mL following 48 weeks of treatment (7/8); Viread showed durable and sustained anti-HIV activity through 48 weeks, even in highly treatment-experienced patients with multiple thymidine analogue mutations (7/11) |
Hemispherx Biopharma Inc. (AMEX:HEB) | AMP 719 (Ampligen) | Immunotherapeutic; double-stranded synthetic RNA compound poly 1; poly C124 | AIDS | Phase IIb data showed that after a median of 4.5 months, Ampligen patients on HAART experienced a mean HIV-1 viral load decrease of 0.50 log using the Roche Amplicor assay (7/11) |
NicOx SA | NCX 950 | A nitric oxide-donating salbutamol salt; inhaled formulation | Respiratory infections | Company reported positive results from a Phase I/II trial (7/10**) |
Oxxon |
| Hepatitis B virus drug candidate | Hepatitis B | Company moved the product into Phase II trials after Phase I trials showed it was safe and well tolerated (7/1) |
Progenics Pharmaceuticals Inc. (PGNX) | PRO 542 | Viral entry inhibitor | HIV | Phase II data showed that PRO 542 produces an antiviral response in HIV-infected individuals for whom available antiretroviral medications have failed (7/8) |
SciClone Pharmaceuticals Inc. (SCLN) | Zadaxin | Thymalfasin, thymosin alpha 1 | Hepatitis B | Clinical study demonstrated that Zadaxin helps clear the Hepatitis B virus in patients in the immune-tolerant phase of the infection (7/16) |
Serono SA (Switzerland; NYSE:SRA) | Serostim (FDA- | Somatropin (rDNA | AIDS-related metabolic complications | A Phase II/III study indicated that Serostim has a potential role in the treatment of body compo- sition issues associated with lipodystrophy; it also showed in a Phase IV study that it could restore lean body mass (7/9) |
The Immune Response Corp. (IMNR) | Remune | HIV-1 immunogen | HIV | Data suggest that Remune induces helper T-cell immune responses aimed specifically at HIV in chronically infected HIV- positive individuals taking highly antiretroviral therapy (7/8); Phase II data showed treatment stimulated HIV-specific immune responses that correlated with control of virus in a three-year trial (7/11) |
Triangle Pharmaceuticals Inc. (VIRS) | Coviracil | Emtricitabine; a | HIV | Phase III results showed that 87% of patients on once-a-day Coviracil showed persistent virologic response through six months, compared to 80% of the twice- daily Zerit patients; Coviracil patients also had significant improvements in immunologic function (7/31) |
Trimeris Inc. | T-20 | A fusion inhibitor | HIV | Clinical data showed patients receiving T-20 were less likely to experience virological failure or relapse over 24 weeks (7/8); Phase III data suggested subcutaneous delivery was well accepted by a majority of patients after the first eight weeks of treatment (7/9) |
Trimeris Inc. | T-1249 | A second-generation fusion inhibitor candidate | HIV | Phase I/II results showed that T-1249 was well tolerated and exhibited antiviral activity (7/3) |
MISCELLANEOUS | ||||
Dyax Corp. | DX-890 | A recombinant inhibitor | Cystic fibrosis | Phase IIa results showed no ad- verse changes compared to base- line; patients had inhibition of sputum neutrophil elastase following the therapy (7/16) |
ILEX Oncology | Apomine | A non-hormonal therapeutic agent known as bisphosphonate esters | Osteoporosis | Company began a Phase I/II trial (7/29) |
Millennium Pharmaceuticals Inc. (MLNM) | MLN977 | Second-generation compound in the class of asthma therapies known as 5-LO inhibitors, which block the production of leukotrienes | Asthma | Company is stopping development of MLN977 due to safety issues in a 193-patient Phase II trial; three patients experienced elevations in liver enzymes that were attributed to the drug (7/15) |
Protein Design | Nuvion | Visilizumab; humanized monoclonal antibody directed at the CD3- antigen | Ulcerative | Company initiated a Phase I trial (7/9) |
Regeneron Pharmaceuticals Inc. (REGN) | Axokine | Genetically re-engineered version of a naturally occurring human protein known as ciliary neurotrophic factor | Obesity | Company completed enrollment in two additional studies in its Phase III program of Axokine in obesity (7/25) |
SangStat | ABX-CBL | Anti-CD147 | Steroid-resistant graft-vs.-host disease in allogeneic bone marrow trans- plants | Companies completed enrollment in a Phase II/III study (7/16) |
Vernalis Group | VR1065 | A 5-HT2c receptor agonist | Obesity | Companies decided not to continue with additional Phase I trials (7/30) |
V.I. Technologies | Inactine | Pathogen-reduction red blood cell system | Red blood cell transfusions | Company will initiate Phase III studies with 270 patients (7/1) |
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Notes: | ||||
* Privately held |
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** Denotes the date the item ran in BioWorld International. |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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AMEX = American Stock Exchange; ASX = Australian Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; TSE = Toronto Stock Exchange |
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