Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE |
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Actelion Ltd. | Tracleer (FDA- | Bosentan; orally active endothelin receptor antagonist | Digital ulcerations | Clinical results showed the primary endpoint, preventing new digital ulcers, was achieved (8/15) |
Genentech Inc. | Raptiva (formerly Xanelim) | Efalizumab; humanized antibody | Psoriasis | Phase III data showed that most patients who complete one year of therapy maintain a 50% or greater improvement in their condition (8/2) |
Ligand | Avinza | Morphine sulfate extended-release capsules | Osteoarthritis | Avinza provided stable analgesia for one year without an increase in the use of rescue medicines (8/20) |
CANCER |
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Allos Therapeutics | RSR13 | Efaproxiral; a synthetic allosteric modifier of hemoglobin | Brain metastases | Company completed enrollment in a pivotal Phase III trial (8/6) |
Allos Therapeutics | RSR13 | Efaproxiral; a synthetic allosteric modifier of hemoglobin | Cervical cancer | Company initiated a Phase I/II trial (8/14) |
Antisoma plc | TheraFab | Member of the HMFG-1 family of antibody pro- ducts, which bind to the tumor antigen MUC1 | Non-small-cell | Company completed recruitment in a Phase I trial (8/22) |
Aton Pharma Inc.* | - | Suberoylanilide hydroxamic acid | Tumors | Phase I results were encouraging (8/19) |
BioMedicines Inc.* | Biomed 101 | Drug that binds to | Metastatic renal cancer | Company completed enrollment in a Phase Ib trial (8/7) |
Cell Pathways Inc. | Aptosyn | Exisulind; first- | Lung cancer | Company said the National Cancer Institute is sponsoring two Phase II studies of Aptosyn in combination therapies; Phase I results showed the drug combination was well tolerated (8/27) |
Cell Therapeutics | Xyotax | Polyglutamate | Metastatic breast cancer | Company began a Phase II study (8/1) |
Cell Therapeutics | Xyotax | Polyglutamate | Recurrent ovarian cancer | Company began a Phase II study (8/14) |
Cytokinetics Inc.* | - | Small-molecule | Cancer | Company began a Phase I trial (8/12) |
Dendreon Corp. | Provenge | Therapeutic vaccine | End-stage prostate cancer | Phase III data showed Provenge narrowly missed its primary endpoint, time to objective disease progression, but that it works well in men with a Gleason score of 7 or less (8/9) |
Genentech Inc. | Tarceva | Erlotinib HCl; small- molecule epidermal growth factor receptor inhibitor | Chemotherapy- naive Stage IIIB/ IV non-small-cell lung cancer | Companies completed patient enrollment in a Phase III trial (8/1) |
ImmunoGen Inc. | huN901-DM1/ BB-10901 | Tumor-activated | Small-cell lung cancer | Patient treatment is under way in the planned second Phase I study (8/8) |
Large Scale Biology | - | Personalized therapeutic vaccines that use Nicotiana plants with viral vectors for the expression of relevant proteins | Non-Hodgkin's lymphoma | Company reported initial safety results from Phase I trials that were "promising" (8/6) |
Maxim | MX8899 | Topical gel; histamine dihydrochloride | Oral mucositis related to chemotherapy and radiation therapy | Company began a clinical trial with up to 60 patients (8/19) |
NeoPharm Inc. | IL13-PE38 | Tumor-targeting | Recurrent or progressive malignant glioma | Enrollment began in the first global six-site Phase I/II trial (8/16) |
OraPharma Inc. | OC-1012 | Topical drug | Mucositis in bone marrow transplant patients undergoing chemotherapy | Company completed a Phase I trial and uncovered no safety issues with the compound (8/7) |
Pharmacyclics Inc. | Xcytrin | Motexafin | Non-small-cell lung cancer | Company planned to begin a Phase III trial with Xcytrin following a meeting with the FDA (8/22) |
Seattle Genetics | SGN-15 | cBR96-doxorubicin immunoconjugate; antibody drug conjugate product candidate | Advanced ovarian cancer | Company initiated a Phase II trial (8/20) |
Tularik Inc. | T67 | A drug that binds irreversibly to beta-tubulin | Hepatocellular carcinoma | Company plans to begin a pivotal Phase III trial with 750 patients (8/27) |
Vion Pharmaceuticals | VNP40101M | Drug candidate from the sulfonyl hydrazine prodrug family of anticancer agents | Leukemia | Company began a Phase I trial (8/8) |
CARDIOVASCULAR |
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Actelion Ltd. | Tracleer (FDA- | Bosentan; orally active endothelin receptor antagonist | Pulmonary arterial hypertension | Clinical results of Tracleer in com- bination with intravenous epoprostenol showed a greater improvement in total pulmonary vascular resistance, compared to those receiving epoprostenol alone (8/7) |
Avant Immuno- | CETi-1 | Cholesterol management vaccine | Low levels of high-density lipoprotein cholesterol | Company completed enrollment in a Phase II study (8/1) |
ConjuChem Inc. | DAC:TI | A locally acting thrombin inhibitor designed to prevent localized clotting | Blood clots | Company is discontinuing development in a Phase I trial, which showed the product was safe; efficacy trials would be too costly, the company said (8/9) |
Dyax Corp. | DX-88 | A small protein that inhibits an enzyme in the blood called kallikrein | Cardiopulmonary bypass | Company initiated a Phase I/II trial to evaluate DX-88 in patients undergoing cardiopulmonary bypass (8/28) |
Hollis-Eden | HE2200 | Immune-regulating hormone | Elevated cholesterol | Company will begin a Phase II trial (8/5) |
InterMune Inc. | Actimmune (FDA- | Interferon gamma-1b | Idiopathic pulmonary fibrosis | Phase III data showed Actimmune failed to meet its primary endpoint of progression-free survival, but did show a survival benefit (8/28) |
Sangart Inc.* | Hemospan | An oxygen transport technology; a chemically modified hemoglobin solution prepared from outdated human blood | For red blood cell transfusions | Company reported no adverse events in a Phase I trial (8/2) |
Viron Therapeutics | VT-111 | Anti-inflammatory therapy | Cardiovascular disease | Company began a Phase I trial (8/19) |
CENTRAL NERVOUS SYSTEM |
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Cellegy | - | Topical nitroglycerin | Vulvodynia | Clinical results showed an improvement in pain was reported by 91.5% of the 34 patients; a common side effect was headache (8/21) |
Cephalon Inc. | CEP-1347 | Orally active and cell- and blood-brain-barrier permeable small-molecule inhibitor of stress-activated protein kinase pathway | Parkinson's | Companies initiated a North American Phase II/III trial (8/1) |
ConjuChem Inc. | DAC:Opioid | Created with ConjuChem's Drug Affinity Complex technology, giving the drug a longer duration of activity in the body | Moderate to | Company reported mixed results from three clinical trials, which showed the product to be safe, but it did not meet its primary endpoint (8/9) |
DOV Pharmaceutical | Bicifadine | A chemically distinct molecule that enhances and prolongs the actions of norepinephrine and serotonin | Post-surgical | Phase II results showed the agent was effective compared to placebo and at least equivalent to codeine (8/7) |
Pozen Inc. (POZN) | MT 100 | Formulation of two approved drugs, a fast- release metoclopramide and naproxen sodium | Migraine pain | Phase IIIb results showed MT 100 provided superior sustained pain relief and two-hour pain relief compared to placebo (8/22) |
Transition | - | Interferon-enhancing therapy | Multiple sclerosis | Company began a Phase I trial (8/20) |
DIABETES |
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Selective Genetics | Gene-Activated Matrix to | Technology developed | Chronic diabetic foot ulcers | Company began treating the first patient in a Phase I study (8/28) |
INFECTION | ||||
Advanced Viral | Product R | A biopolymer chemistry that possesses novel immunomodulator activity; a peptide- nucleic acid | HIV/AIDS | Clinical results published in the July/August 2002 issue of HIV Clinical Trials showed a statistically significant increase in CD4- positive lymphocytes and weight gain in treated patients (8/20) |
ProdiGene Inc.* | - | Oral corn vaccine, produced using its transgenic plant technology | Travelers' | Company began a Phase I trial (8/12) |
Stressgen | HspE7 | Immunotherapeutic to treat diseases caused by the human papillomavirus | Recurrent respiratory papillomatosis | Company completed enrollment in a Phase II trial (8/8) |
The Immune | Remune | HIV-1 immunogen | HIV | Clinical results showed that Remune might give relief for HIV-infected patients from the adverse side effects of antiretroviral therapies (8/15) |
MISCELLANEOUS |
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AVI BioPharma Inc. | AVI-4126 | Neugene antisense | Polycystic kidney disease | Company completed a Phase Ib trial of AVI-4126 (8/1) |
CollaGenex | Periostat | Doxycyline hyclate | Rosacea | Company began a Phase III trial and is enrolling 210 patients (8/13) |
Corgentech Inc.* | E2F Decoy | An oligonucleotide or short strand of DNA; designed to block neointimal hyperplasia and redirect graft biology to strengthen the vessel wall | To prevent graft failure following coronary arterial bypass grafting surgery | Company started enrolling 2,500 patients in a Phase III trial (8/14) |
Eyetech | Macugen | An aptamer designed to bind and neutralize vascular endothelial growth factor | Wet age-related macular degeneration | Eyetech completed enrollment in its two Phase III trials (8/7) |
Genaera Corp. | Squalamine | Angiogenesis inhibitor that blocks a number of angiogenic growth factors, including vascular endothelial growth factor | Wet age-related macular degeneration | Company began a Phase I/II trial with 40 patients (8/21) |
Immusol Inc.* | VitrenASE | A product expected to reduce the incidence of repeat retinal detachment in patients who undergo surgical repair | Proliferative vitreoretinopathy | Company began a Phase II trial (8/13) |
Incara Pharmaceutical Corp. (INCR) agent | Deligoparin | Oligosaccharide | Ulcerative colitis | Company stopped a Phase II/III trial three months early due to limited financial resources (8/26) |
Inspire | INS37217 | A P2Y(2) agonist; intranasal | Perennial allergic | Phase II data showed statistically significant improvement in treatment groups compared to placebo (8/13) |
Metabolic | AOD9604 | Injection; human growth hormone | Obesity | Company completed its Phase IIa trial by single-dose oral administration (8/27) |
Miravant Medical Technologies (MRVT) | SnET2 | Tin ethyl etiopurpurin; photodynamic therapy | Wet age-related macular degeneration | Phase III data showed that subsets of patients demonstrated stabilized or improved visual acuity at two years, although SnET2 did not achieve the primary efficacy endpoint when all patients were included (8/27) |
Neurochem Inc. (Canada; TSE:NRM) | Fibrillex | Anti-amyloid drug | Secondary amyloidosis continue (8/28) | The Data Safety Monitoring Board unanimously recommended the Phase II/III trial for Fibrillex |
NexMed Inc. | Alprox-TD | Cream treatment, which incorporates alprostadil, an off-patent vasodilator, with NexMed's NexACT platform technology | Erectile | Company closed enrollment of two Phase III studies (8/13) |
QLT Inc. (Canada; | Visudyne | Verteporfin therapy | Predominantly classic subfoveal choroidal neovascularization | Company completed enrollment in a Phase IIIb trial (8/27) |
Texas Biotechnology | Bimosiamose | Inhaled therapy; small-molecule selectin antagonist | Asthma | Companies initiated a Phase IIa trial (8/27) |
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Notes: |
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* Privately held. |
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Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. |
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ASX = Australian Stock Exchange; CDNX = Canadian Venture Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange |
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