| Company* | Product | Description | Indication | Status (Date) |
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| CANCER |
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| Allos Therapeu- | RSR13 | Synthetic allosteric modifier of hemoglobin that noncovalently binds to hemoglobin, increasing oxygen delivery to hypoxic tissue | Non-small-cell lung cancer | Company updated survival results from a Phase II trial showing a median survival rate of 20.6 months (11/6) |
| AnorMED Inc. | AMD-3100 | Inhibits the binding action of HIV with the CXCR4 chemokine co-receptor | Cancers involving blood and immune systems | Phase I results showed AMD-3100 rapidly mobilizes stem cells out of bone marrow and into the circulatory system (11/7) |
| Cell Genesys | GVAX | Cancer vaccine; immunotherapeutic comprising irradiated and genetically modified tumor cells that secrete granulocyte macrophage-colony stimulating factor | Acute myelogenous leukemia | Company is initiating a Phase II trial (11/27) |
| Cell Therapeu- | Trisenox (FDA- approved) | Arsenic trioxide | Acute promyelocytic leukemia | Company presented data demonstrating that Trisenox induces durable overall and relapse-free survival (11/7) |
| Celsion Corp. | ¿ | Uses targeted heat technology delivered by microwave technology | Benign prostatic hyperplasia | Company completed treatment of all 160 patients in the pivotal Phase II trial (11/29) |
| Dendreon Corp. | Mylovenge | Cancer vaccine designed to trigger the immune system | Multiple myeloma | Company initiated a Phase II trial (11/6) |
| EntreMed | Endostatin | Naturally occurring angiogenesis inhibitor | Neuroendocrine tumors | Company began a Phase II trial (11/28) |
| Genaera Corp. | Squalamine | An angiogenesis inhibitor | Non-small-cell lung cancer | Company began a Phase IIb trial (11/28) |
| Genta Inc. | Genasense | Antisense compound geared toward blocking the production Bcl-2 | Non-small-cell lung cancer | Genta began a randomized trial designed to compare Genasense plus Aventis Pharma Inc.'s Taxotere compared to Taxotere alone (11/5) |
| GenVec Inc. | TNFerade | Delivers the human tumor necrosis factor alpha gene directly to tumors, using GenVec's adenovector gene delivery technology | Cancer | In a clinical study, two of seven patients showed a complete response, two others showed a partial response and three demonstrated stable disease (11/7) |
| GlycoDesign | GD0039 | Orally administered and blocks the production of specific carbohydrates that are important for cancer spread | Metastatic renal cancer | Company started its expanded Phase II trial (11/26) |
| ILEX Oncology | Eflornithine | Orally delivered difluoro- methylornithine; selective irreversible inhibitor of ornithine decarboxylase, an enzyme that controls formation of certain polyamines required by dividing cells | Superficial bladder cancer | Company completed patient enrollment for its Phase III trial (11/30) |
| Immuno- | ¿ | IDM-activated macrophage cells | Bladder cancer | Phase I/II data show the cells significantly reduce tumor recurrence (11/21) |
| ImmunoGen | huC242- | Tumor-activated prodrug | Colorectal, pancreatic and certain non- small-cell lung cancers | Company reported favorable safety data from the initial 27 patients enrolled in a clinical trial (11/1) |
| Inhale Thera- | Inhaleable leuprolide | Peptide analogue | Prostate cancer | A 12-person study showed that a powdered formulation of leuprolide developed with Inhale's Inhance pulmonary delivery technology delivered the drug with a bioavailability of 18%, compared to injectable systemic delivery (11/29) |
| Lorus Thera- | Virulizin | Immunotherapeutic drug that leads to stimulation of macrophages, monocytes and natural killer cells to attack tumor cells | Advanced pancreatic cancer | Company initiated a Phase III trial (11/20) |
| MedImmune | Ethyol (FDA- | Amifostine | Radiation therapy-induced xerostomia | Phase II data indicated that subcutaenously administered Ethyol may provide comparable protective effects as intravenously administered Ethyol (11/6) |
| MGI Pharma | Irofulven | Anticancer compound | Pancreatic cancer | Phase II data showed that eight of 22 patients who received more than one course of treatment were alive at six months (11/8) |
| MGI Pharma | Salagen (FDA- approved) | Tablets; pilocarbine HCl | Head and neck cancer | Clinical data showed that Salagen resulted in statistically significant improvement of salivary flow vs. placebo (11/6) |
| Millennium | LDP-341 | Small-molecule protease inhibitor | Multiple myeloma | Phase I results in 10 patients showed antitumor activity and manageable side effects (11/2) |
| NeoPharm Inc. | IL13-PE38 | Tumor-targeting agent | Malignant glioma | Phase I/II results showed that IL13-PE38 may be effective, safe and effectively administered by positive pressure microinfusion (11/19) |
| Oncolytics | Reolysin | A human reovirus-based product | Cancer | Company completed enrollment for its Phase I trial (11/29) |
| Onyx Pharma- | BAY 43-9006 | Anticancer small-molecule Raf kinase inhibitor | Cancer | Phase I data indicate the compound was well tolerated with few adverse events and no dose-related toxicities (11/1) |
| OSI Pharma- | Tarceva | Epidermal growth factor receptor tyrosine kinase | Non-small-cell lung cancer | Companies initiated a Phase III trial evaluating the use of Tarceva in combination with gemcitabine/cisplatin (11/20) |
| Pharmacyclics | Xcytrin | Motexafin gadolinium injection | Glioblastoma multiforme | Company said Phase I results suggest the potential utility of Xcytrin in treating glioblastoma multiforme (11/7) |
| Regeneron | VEGF Trap | Vascular Endothelial Growth Factor Trap, an angiogenesis inhibitor | Solid tumor malignancies and non-Hodgkin's lymphoma | Company initiated a Phase I trial (11/28) |
| Sonus Pharma- | S-8184 | A paclitaxel cancer product | Non-small-cell lung cancer | Phase I results showed that one of 16 patients showed a partial tumor response (11/12) |
| Stressgen Bio- | HspE7 | Novel immunothera- | Anal dysplasia | Phase II results demonstrated a 75% reduction to low-grade dysplasia at six months following treatment; at 18 months, 50% were in complete remission (11/29) |
| SuperGen Inc. | Decitabine | Inhibits DNA methyl- | Cancer | Phase I data showed encouraging and objective responses in more than half of the patients treated at very low dosages (11/9) |
| SuperGen Inc. | Nipent (FDA- | Pentostatin for injection; chemotherapeutic drug that inhibits adenosine deaminase (blocks DNA synthesis) | Non-Hodgkin's lymphoma and chronic lymphocytic leukemia | Phase II data showed the regimen of Nipent used in combination with rituximab was well tolerated (11/8); Phase I/II data of Nipent in combination with cyclophosphamide showed a 73% response rate in patients with chronic lymphocytic leukemia (11/13); a regimen of Nipent with photophoresis and reduced-dose body irradiation showed an overall response rate of 85% in cancer patients prior to allogeneic bone marrow transplants (11/14) |
| SuperGen Inc. | Rubitecan | Oral chemotherapy compound | Cancer | Phase II data showed the drug is active and well tolerated in patients previously treated for advanced gastric adenocarcinoma (11/12) |
| Supratek | SP1049C | Combination of doxorubicin and Supratek's Biotransport carrier technology | Adenocarcinoma of the esophagus | Phase II enrollment is under way (11/15) |
| CARDIOVASCULAR |
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| Alexion Pharma- | Pexelizumab | Anti-inflammatory C5 inhibitor monoclonal antibody fragment | Acute cardiovascular indications | Company plans to begin a Phase III trial (11/13) |
| Angiogene Inc.* | Beta-Impact | Oliglow radiothera- | Restenosis following balloon angioplasty | Company enrolled the first patients in a Phase I/II trial (11/29) |
| AtheroGenics | AGI-1067 | Oral agent; anti-inflammatory compound with anti-oxidant properties | Restenosis in post-angioplasty patients | Phase II results showed the compound met its primary endpoint (11/12) |
| Corgentech | E2F Decoy | Oligonucleotide; works to prevent occlusion in grafted veins | Coronary artery bypass surgery | Phase IIb trial demonstrated that E25 Decoy significantly reduced graft failure following coronary artery bypass graft surgery (11/14) |
| Corvas Inter- | UK-279,276 | Neurophil inhibitory factor, or rNIF | Ischemic stroke | Phase IIb enrollment has been completed (11/14) |
| CV Therapeu- | CVT-510 | A selective A1 adenosine receptor agonist | Atrial fibrillation | Phase II results showed CVT-510 consistently reduced heart rate from baseline without decreasing blood pressure (11/19) |
| CV Therapeu- | Ranolazine | Part of pFOX (partial fatty acid oxidation) inhibitors | Angina | Phase III results showed the drug met its primary efficacy endpoint with a statistically significant increase in patients' symptom-limited exercise duration compared to placebo (11/14) |
| Esperion Thera- | ETC-588 | Large unilamellar vesicles | Acute coronary syndromes | Company reported positive preliminary results from a Phase IIa trial (11/27) |
| GenVec Inc. | BioBypass | Angiogenic gene therapy that delivers vascular endothelial growth factor 121 | Peripheral vascular disease | Phase I results demonstrated that BioBypass was well tolerated with injection site swelling being the only consistently recorded drug-related side effect (11/13) |
| Hemosol Inc. | Hemolink | Oxygen therapeutic; a red-blood cell substitute | Primary cardiac bypass grafting surgery | Company received approval to begin a clinical trial with 180 patients in the U.S. and the UK (11/26) |
| La Jolla Pharma- | LJP 1082 | Composed of four copies of a recombinant protein attached to a synthetic organic platform designed to reduce disease-causing antibodies | Stroke, deep- vein thrombosis and other conditions | Company initiated a Phase I/II trial (11/8) |
| Valentis Inc. | VEGF165 | Gene delivered with Valentis' lipid delivery system | Peripheral arterial disease | Phase II results showed VEGF165 can induce angiogenesis in the legs of patients; also, the safety issues associated with adenoviral vectors were not seen in patients receiving the gene delivered with the system (11/14) |
| CENTRAL NERVOUS SYSTEM |
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| Durect Corp. | Chronogesic | A three-month continuous infusion subcutaneous implant | Chronic pain | Company began a Phase III trial (11/1) |
| Interferon | Alferon N & Betaseron | Interferon alfa-n3 and interferon beta-1b | Multiple sclerosis | Data showed a reduction in the volume of T2-weighted MS brain lesions in both treatment groups as compared to increased lesion volume in the untreated control group (11/8) |
| Nastech Pharma- | Interferon beta | Nasally administered | Multiple sclerosis | Company began a Phase I U.S. trial (11/28) |
| DIABETES |
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| Centocor Inc. | ReoPro | Abciximab, an anticlotting agent | Diabetes patients undergoing angioplasty | Follow-up trial data indicate that ReoPro-treated patients were less likely to die during the six months following the procedure; they also fared better when looking at the combined endpoint of death, recurrence of heart attack and any urgent procedures to open coronary arteries (11/12) |
| Ortec Interna- | OrCel | A collagen sponge seeded with allogeneic epidermal and dermal cells | Diabetic ulcers | Data showed a greater than 100% improvement over standard care with a twice-as-fast rate of healing for the Orcel-treated group (11/13) |
| Theratechnol- | ThGRF (TH 9507) | Growth hormone-releasing factor analogue | Type II diabetes | Company plans to initiate a Phase II trial to evaluate the safety of two doses (11/20) |
INFECTION | ||||
| Agouron | Viracept (FDA- approved) | Nelfinavir myselate; | HIV | Data on the long-term extension phase of the pivotal study of Viracept in combination with AZT and 3TC showed that the majority of patients maintained antiretroviral activity and achieved replenishment of CD4 lymphocytes (11/5) |
| Amerimmune | Cytolin | Intravenous formulation of a murine monoclonal antibody | HIV/AIDS | Company completed a Phase Ia trial that showed Cytolin was safe and well tolerated (11/29) |
| Antex Bio- | Helivax | Oral vaccine | Gastrointestinal infections and disease caused by Helicobacter pylori | A Phase Ib trial showed volunteers were positive for immune cell proliferation, cytokine production and secretory IgA antibodies (11/9) |
| Antigenics | AG-702 | Recombinant vaccine using Antigenics' heat shock protein technology | Genital herpes | Company initiated a Phase I trial (11/7) |
| BioMarin | Aldurazyme | Enzyme replacement therapy | Mucopoly- | Phase III results were positive, and the company plans to file regulatory applications early next year (11/2) |
| Chiron Corp. | Tifacogin | Recombinant form of tissue factor pathway inhibitor, thought to block tissue-factor-mediated clotting in small blood vessels | Sepsis | Tifacogin did not meet its primary endpoint of reducing 28-day all-cause mortality in a Phase III trial (11/21) |
| CV Technologies Inc. (Canada; | CVT-E002 | A multicomponent phytopharmaceutical | Acute viral respiratory illness | Phase II results were positive showing that 1% of the treated group, compared to 7% of the placebo group, got influenza illness; and 1% of the treated group, compared to 9% of the placebo group, got influenza or syncytial virus illness (11/30) |
| Enzo Biochem | EHT899 | Orally available viral protein | Hepatitis B | Phase II results showed a dramatic improvement in key liver necroinflammatory scores, with 33% of the subjects showing improvement (11/12) |
| Gilead Sciences | Adefovir | Reverse transcriptase inhibitor | Hepatitis B and liver disease | Phase II data of patients receiving the monotherapy and those receiving a combination therapy with lamivudine exhibited a time-wighted average decrease in serum HBV DNA from baseline (11/9); Phase III data demonstrated adefovir dipivoxil 10 mg significantly improved liver function and reduced levels of virus in patients with chronic hepatitis B virus infection (11/12) |
| Hollis-Eden | HE2000 | Immune regulating hormone | HIV | Data indicated that treatment significantly reduced elevated levels of a number of well-known inflammatory mediators throughout the five-month treatment period (11/8) |
| InterMune Inc. | Infergen | Interferon alfacon-1 | Hepatitis C | Company released positive results from a Phase IV trial comparing the use of Infergen plus ribavirin to the use of interferon alfa-2b plus ribavirin; patients treated with Infergen and ribavirin achieved a sustained virologic response of 56% (11/12) |
| Maxim Pharma- | Ceplene | Histamine | Hepatitis C | Pilot study results of Ceplene in combination with interferon-alpha and ribavirin showed a sustained complete viral response in 38% of evaluable patients (11/12) |
| Oxxon | ¿ | Vaccine | Hepatitis B | Company entered Phase I trials with the vaccine (11/7**) |
| Ribozyme | Heptazyme | Anti-hepatitis C and hepatitis B ribozyme | Hepatitis C and hepatitis B | Phase I results demonstrated that Heptazyme was well tolerated and was efficiently absorbed after subcutaneous administration (11/13) |
| Stressgen | HspE7 | Novel immunothera- | Recurrent respiratory papillomatosis | Company initiated a Phase II trial in pediatric patients who require frequent surgery (11/19) |
| Triangle Pharm- | Coviracil | A cytosine nucleoside analogue | Hepatitis B | Coviracil was well tolerated at all doses in a Phase I trial (11/13) |
| Trimeris Inc. | T20-305 | T20 in combination with oral antiretrovirals | HIV | Companies are initiating patient enrollment in a U.S. study involving 450 adults (11/7) |
| Versicor Inc. | Dalbavancin | Once-weekly treatment; a novel second-generation glycopeptide agent | Staphylococcal and other Gram-positive hospital infections | Phase I results showed that daily and weekly dosing are well tolerated; a Phase II study is under way (11/28) |
| Vical Inc. | MuStDO 5 | Multigene vaccine incorporating five genes for Plasmodium falciparum antigens plus a naked DNA agent encoding granulocyte macrophage-colony stimulating factor, an immune stimulant | Malaria | Vical completed an initial Phase II trial (11/13) |
| ViroPharma | VP 50406 | Chemical compound | Hepatitis C | The compound failed to show the desired level of antiviral activity in Phase IIa trials, causing the companies to stop development (11/12) |
MISCELLANEOUS | ||||
| Alexion Phar- | 5G1.1 | Humanized monoclonal antibody C5 complement inhibitor | Rheumatoid arthritis | Phase II data showed the drug met its primary endpoint in one of the treatment groups after three months of treatment (11/14) |
| Alteon Inc. | ALT-711 | A.G.E. Crosslink | End-stage renal disease | Company began a Phase I trial (11/7) |
| Amgen Inc. | Kineret | Anakinra; interleukin-1 receptor antagonist | Arthritis | Phase II results with 1,414 patients showed that, at the end of six months, the most frequent adverse event was a mild to moderate reaction at the injection site; results from other Phase II/III studies showed Kineret improved quality of life for patients (11/12) |
| Angiotech | Paxceed | Systemic formulation of micellar paclitaxel | Psoriasis | Phase II results showed five patients experienced a 50% to 75% improvement in disease severity when treated over six months with monthly intravenous infusions (11/19) |
| AVI Bio- | AVI-4557 | Third-generation Neugene antisense compound that targets the liver enzyme, cytochrome P450, responsible for drug metabolism | To keep drugs in their active forms longer and to decrease their toxicities | Company completed collection of data for its Phase I trial; data indicated no drug-related toxicity or safety issues (11/6) |
| Cambridge | CAT-192 | Human anti-TGF_ monoclonal antibody | Diffuse systemic sclerosis | Companies initiated a Phase I/II trial (11/12) |
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| Cellegy Phar- | Tostrex | A transdermal testosterone gel | Hypogonadism | Cellegy completed enrollment into an ongoing Phase III trial (11/6) |
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| Centocor | Remicade | Infliximab; a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane in the blood | Active spondy- | A study with 40 patients showed that at 12 weeks, patient and physician global assessment improved in the infliximab group, while no improvements were seen in placebo patients (11/13) |
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| Connetics | OLUX | Clobetasol proprionate foam 0.05%; super-high potency corticosteroid | Dermatoses | Phase IV results showed that patients experienced a statistically significant improvement compared to placebo (11/5) |
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| Corporate | orBec | Oral dual-release formulation of beclo- methasone dipropionate | Crohn's disease | Company initiated a Phase II trial (11/1) |
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| CytRx Corp. | CRL-5861 | Purified poloxamer 188 | Acute sickle cell crisis | Phase III data showed that CRL-5861 shortened the duration of the painful crisis episodes commonly experienced by sickle cell patients (11/7) |
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| Emisphere | Cromolyn | A nonsteroidal anti-allergy medication delivered with an Emisphere carrier in an oral capsule formulation | Allergies | Phase I results showed effective absorption from the gastrointestinal tract (11/29) |
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| Genmab | HuMax-CD4 | Fully human antibody | Psoriasis | Phase II results showed a statistically significant dose response in doses up to 160 mg; the drug was safe and well tolerated (11/12) |
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| Hollis-Eden | HE2200 | Immune-regulating hormone drug candidate | Immune dysregulation diseases, such as inflammatory bowel disease | Company completed a Phase I study with subcutaneously administered HE2200 (11/26) |
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| Human | Lympho- | Human monoclonal antibody targeting BLyS | Systemic lupus erythematosus and other autoimmune diseases | The company is proceeding with a Phase I trial (11/1); clinical data showed positive results in patients with inflammatory arthritis and those with osteoarthritis or traumatic arthritis, and Sjogren's syndrome (11/14) |
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| ICOS Corp. | IC485 | PDE4 inhibitor | Inflammatory conditions | Company initiated a Phase I trial (11/5) |
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| Immunex | Enbrel | Tumor necrosis factor-inhibiting drug | Ankylosing spondylitis | Phase II results showed that 80% of 20 patients reached the composite endpoint of improvement (11/12) |
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| Immunex | Enbrel | Tumor necrosis factor-inhibiting drug | Psoriatic arthritis | Phase III results showed 59% of 101 patients receiving Enbrel achieved an ACR20 response compared to 15% of 104 patients receiving placebo (11/12) |
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| IntraBiotics | Iseganan | Antibiotic; oral solution | Oral mucositis | Company began enrollment in the final Phase III trial of its antibiotic to prevent and treat oral mucositis in chemotherapy patients (11/7) |
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| Isis Pharma- | ISIS | Antisense inhibitor of intercellular adhesion molecule-1 | Crohn's disease | Company initiated a Phase III trial after examining the failed Phase IIb trial and tweaking a dosing scheme (11/29) |
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| Isis Pharma- | Isis | Antisense inhibitor of tumor necrosis factor-alpha | Rheumatoid arthritis | Company initiated clinical testing (11/19) |
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| La Jolla | LJP 394 | Molecule (toleragen) that binds to the surface of B cells and shuts off production of antibodies to double-stranded DNA | Lupus renal disease | Phase II/III results indicated that treatment with LJP 394 appeared to be as effective as current immunosuppressive therapy in reducing antibodies to double-stranded DNA (11/14) |
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| Micrologix | MBI | Topical drug; bactolysin compound (cationic peptide) | Acne | Phase II preliminary results of 75 patients showed a 32% total acne reduction; study was conducted in the U.S. (11/30) |
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| Millennium | MLN | Molecule that inhibits a novel carboxypeptidase enzyme | Metabolic disorders | Companies initiated a Phase I trial (11/27) |
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| Neurocrine | NBI- | A non-benzodiazepine compound that acts against chronic insomnia through a specific site of the GABA-A receptor | Chronic insomnia | Company began a Phase III trial with 500 patients (11/16) |
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| NexMed Inc. | Alprox-TD | Cream that combines alprostadil and NexACT transdermal delivery technology | Erectile dysfunction | Company conducted two U.S. Phase II studies in which 83% of patients reported satisfaction with treatment (11/1); company initiated two Phase III trials (11/13) |
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| NPS Pharma- | ALX1-11 | Full-length human parathyroid hormone | Osteoporosis | Company will expand patient enrollment in the Phase III study, and plans to begin a new study in women receiving hormone replacement therapy (11/26) |
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| Pharmacia | CDP870 | Humanized, pegylated TNF-alpha inhibitor | Rheumatoid arthritis | Phase II results indicated that higher doses appeared to lead to better results (11/12) |
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| Protein | SMART Anti- | Interferon antibody | Crohn's disease | Company released promising preliminary results from an ongoing Phase I/II trial (11/5) |
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| Protein | Zenapax | Humanized antibody | Asthma | Company initiated a Phase II trial (11/27) |
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| Regeneron | Interleukin-1 Cytokine Trap | Antagonist that mimics the body's natural receptors | Rheumatoid arthritis | Preliminary Phase I results show the IL-1 Trap was generally well tolerated and displayed a favorable safety profile (11/14) |
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| Scil Bio- | SMART | Humanized compound | Psoriasis | Company initiated a Phase Ib trial (11/5) |
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| Vivus Inc. | Alista | Topical formulation of alprostadil | Female sexual dysfunction | Company saw positive results from a Phase II study (11/29) |
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| Notes: |
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| * 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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