Company* | Product | Description | Indication | Status (Date) |
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AUTOIMMUNE |
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Angiotech Pharmaceuticals Inc. (Canada; ANPI) | Paxceed | Micellar paclitaxel for injection | Rheumatoid arthritis | Company began a Phase II study (9/24) |
AtheroGenics | AGIX-4207 | An intravenous compound derived from the v-protectant technology platform | Rheumatoid arthritis | Company initiated a Phase II trial (9/4) |
Cambridge Antibody Technology Group plc (UK; CATG; LSE:CAT) | D2E7 | An anti-TNF alpha antibody | Juvenile rheumatoid arthritis and Crohn's disease | Company has entered a Phase III in juvenile RA and a Phase II/III in Crohn's disease (9/11**) |
Chiron Corp. | Betaferon/ Betaseron (FDA- | Interferon beta 1b | Multiple | Phase II data showed the drug to be statistically significant in terms of efficacy compared to placebo in reducing multiple sclerosis lesions as measured by MRI (9/23) |
Cypress Bioscience Inc. (CYPB) | Milnacipran | The first of a new class | Fibromyalgia syndrome | Company completed enrollment in its Phase II trial (9/10) |
Genentech Inc. (NYSE:DNA) | Raptiva (formerly Xanelim) | Efalizumab; humanized antibody | Psoriasis | Phase III data showed Raptiva reached its primary efficacy endpoint of greater improvement in Psoriasis Area and Severity Index scores after 12 weeks (9/17) |
Genmab A/S | HuMax-IL15 | Fully human antibody | Rheumatoid arthritis | Company reported positive results from a Phase I/II study, which showed the product to be safe and well tolerated (9/4); the last patient completed treatment (9/11) |
Genmab A/S (Denmark; CSE:GEN) | HuMax-CD4 | Antibody that targets the Cd4 receptor on T lymphocytes | Psoriasis | Company will begin a Phase IIb study (9/19) |
Genmab A/S (Denmark; CSE:GEN) | HuMax-CD4 | Antibody that targets the CD4 receptor on T lymphocytes | Rheumatoid arthritis | Company is stopping enrollment in Phase II and III trials after Phase II results showed no significant difference in American College of Rheumatology scores compared to patients who received placebo (9/25) |
IDEC Pharmaceuticals Corp. (IDPH) | IDEC-114 | Primatized anti-CD80 monoclonal antibody designed to inhibit the binding of the B7-1 ligand on antigen-presenting cells to the CD28 receptor on T cells | Psoriasis | Company is dropping development following disappointing Phase II data (9/5) |
Millennium Pharmaceuticals Inc. (MLNM) | MLN02 | Monoclonal antibody | Crohn's | MLN02 missed its primary end-point of a decrease of more than 70 points on the Crohn's Disease Activity Index, but it reached a secondary endpoint of disease remission in the Phase II trial (9/16) |
Phytopharm plc (UK; LSE:PYM) | P54 | An extract of the spice turmeric, formulated | Inflammatory bowel disease | Phase IIa results showed there was no difference between P54 and placebo, with a 45% reduction in steroid use in both groups (9/4**) |
CANCER | ||||
Allos Therapeutics Inc. (ALTH) | RSR13 | Efaproxiral; a synthetic allosteric modifier of hemoglobin | Non-small-cell lung cancer | Phase II data showed a median survival rate of 20.6 months, a one-year survival rate of 67% and two-year survival of 37% (9/20) |
AnorMED Inc. (Canada; TSE:AOM) | AMD-3100 | A potential agent in | Cancer | Company initiated a Phase I trial (9/8) |
Antisoma | Pemtumomab | A yttrium-90 radiolabeled antibody formerly called Theragyn | Ovarian cancer | Company completed patient recruitment in a Phase III trial (9/30) |
Biomira Inc. | Theratope | Vaccine; synthetic carbohydrate-based; mimic of cancer antigen sialyl-Tn plus carrier molecule KLH | Metastatic | A Data Safety Monitoring Board recommended the Phase III trial continue; the trial, however, has not met its endpoints of survival and time to disease progression (9/19) |
Direct Therapeutics | DTI-015 | A chemotherapeutic drug designed for direct injection to brain tumors | Brain tumors | Company completed patient en- rollment in a Phase I/II study (9/25) |
Galenica Pharmaceuticals Inc.* | - | An HER-2 vaccine containing an HER-2-derived antigen combined with Galenica's immune enhancer, GPI-0100 | HER-2 over- expressing cancer | Company began a Phase I trial at the University of Alabama at Birmingham Comprehensive Cancer Center (9/17) |
Genentech Inc. (NYSE:DNA) | Avastin | Bevacizumab, an | Breast cancer | Phase III data showed Avastin missed its primary efficacy endpoint of progression-free survival in relapsed metastatic breast cancer (9/10) |
Genta Inc. | Genasense | Antisense compound geared toward blocking the production Bcl-2 | Cancer or solid tumors | Company initiated a trial in children who have failed standard therapy or who have illnesses for which no therapy exists (9/4) |
Genta Inc. | Genasense | Antisense compound geared toward blocking the production Bcl-2 | Multiple myeloma | Company initiated a trial to assess Genasense in combination with thalidomide and dexamethasone in patients who have failed standard therapy (9/23) |
GenVec Inc. | TNFerade | Delivers the human tumor necrosis factor-alpha gene to tumors, using GenVec's adenovector gene delivery technology | Soft-tissue sarcoma of the extremities | Company completed patient accrual in a Phase I study (9/24) |
Guilford Pharmaceuticals Inc. (GLFD) | Gliadel Wafer (FDA-approved) | Biodegradable polyanhydride polymer wafer implant containing carmustine | High-grade malignant | Phase III follow-up data showed the risk of dying over three to four years after wafer implantation was reduced by 27% (9/19) |
Maxim Pharmaceuticals Inc. (MAXM) | MX8899 | Topical gel; histamine dihydrochloride | Radiation- induced dermatitis | Company began a clinical study with up to 30 patients (9/18) |
MediGene AG (Germany; Neuer Markt:MDG) | NV1020 | Oncolytic herpes simplex virus vector | Colorectal carcinoma | Phase I results helped establish well-tolerated doses and showed evidence that the vector replicates in tumor tissue (9/11**) |
NeoPharm Inc. | IL13-PE38 | Tumor-targeting agent | Malignant | Phase I/II data indicate the agent has cell-killing effects against the tumor cells when infused prior to surgical resection of the tumor; prolonged survival has been observed to beyond one year (9/9) |
Novacea Inc.* | DN-101 | Formulation of calcitriol | Prostate cancer | Company began a Phase II/III trial of DN-101 in combination with Taxotere (9/18) |
Onyx Pharmaceuticals Inc. (ONXX) and Bayer Corp. | BAY 43-9006 | A small-molecule Raf kinase inhibitor | Hepatocellular carcinoma | Company began a single-agent Phase II study (9/4) |
OSI Pharmaceuticals Inc. (OSIP) and F. Hoffmann-La Roche Ltd. (Switzerland) | Tarceva | Erlotinib HCl; small- molecule epidermal growth factor receptor inhibitor | Non-small-cell lung cancer | Companies completed patient enrollment in a Phase III trial evaluating Tarceva as a first-line agent in combination with standard chemotherapy (9/12) |
PharmaMar (subsidiary of | ET-743 (Yondelis) | Obtained from the tunicate Ecteinascidia turbinata, the sea squirt | Soft-tissue and Ewing's | Clinical results showed the drug had evidence of efficacy in child- hood and adult cancers unresponsive to conventional therapy (9/25**) |
PhotoCure | Hexvix | Diagnostic using fluorescence cystoscopy | Bladder cancer | Company finished a Phase III study of Hexvix in detection of bladder cancer (9/3) |
Progen | PI-88 | Anticancer therapeutic; sulfated oligosaccharide | Cancer | Company said the first patient began treatment in the Phase I trial (9/5) |
Seattle Genetics Inc. (SGEN) | SGN-30 | Monoclonal antibody | Hematologic malignancies | Company completed a Phase I trial showing SGN-30 was well tolerated (9/4) |
Sonus Pharmaceuticals Inc. (SNUS) | Tocosol Paclitaxel | Paclitaxel cancer | Non-small-cell lung, bladder, ovarian and colorectal cancers | Phase II data demonstrated objective tumor antitumor responses in all four cancers and a disease control rate ranging from 37% to 89% (9/18) |
SuperGen Inc. | Decitabine | Inhibits DNA methyl- | Hematological malignancies | Clinical results of a low dose showed promising activity with a relatively low degree of toxicity (9/20) |
Vical Inc. | Allovectin-7; | DNA lipid complex containing the human gene encoding the HLA-B7 antigen; gene-based drug injected directly into tumors that uses lipid DNA complex with a gene encoding interleukin-2 to stimulate an immune response | Metastatic melanoma and head and neck cancer; and prostate or kidney cancer | Vical is not completing its Phase III trial in metastatic melanoma due to the improbability of it achieving its desired endpoints; it also is closing a Phase II trial in head and neck cancer; the company also said it would no longer develop Leuvectin for prostate or kidney cancer after discontinuing a Phase II trial last year (9/18) |
Vion Pharmaceuticals Inc. (VION) | Tapet VNP20009 | A Salmonella bacteria cancer vector | Advanced solid tumors or lymphomas | Company initiated a Phase I trial (9/17) |
YM BioSciences Inc. (Canada; AIM:YMB; TSE:YM) | - | Epidermal growth factor cancer vaccine | Non-small-cell lung cancer | Company completed enrollment in a Phase II trial (9/5) |
CARDIOVASCULAR |
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Actelion Ltd. (Switzerland; SWX:ATLN) | Veletri | Tezosentan; intravenous dual endothelin receptor antagonist | Acute heart failure | Clinical results were positive with hemodynamic effects achieved at doses of 5 mg/h and 25 mg/h (9/12) |
Alteon Inc. (AMEX:ALT) | ALT-711 | A.G.E. crosslink breaker | Systolic hyper- tension and left-ventricular hypertrophy | Company completed enrollment in two Phase II trials (9/18) |
Ark Therapeutics Ltd.* (UK) | EG010 | A point-of-care test kit | Cardiovascular disease | Company started clinical trials (9/18**) |
Cardiome | RSD1235 | Atrial antiarrhythmic | Atrial | Phase II results showed RSD1235 was effective in terminating atrial fibrillation and in converting atrial fibrillation to normal heart rhythm (9/3) |
Esperion Therapeutics Inc. (ESPR) | ETC-642 | RLT peptide that mimics the biological properties of apolipoprotein A-I to promote cholesterol removal from arterial walls and other tissues and to enhance reverse lipid transport | Atherosclerosis | Company initiated a Phase I trial in up to 20 patients (9/18) |
Icagen Inc.* | ICA-17043 | Small molecule that targets a specific ion channel, known as the Gardos channel, located on the membrane of red blood cells | Sickle-cell disease | Phase Ib results showed the drug produced no evidence of dose-limiting or serious treatment- related side effects (9/24) |
Medicure Inc. (Canada; CDNX: MPH) | MC-1 | Cardiovascular drug | Ischemia and ischemic reperfusion | Company completed patient enrollment in a Phase II trial to evaluate the cardioprotective effect of MC-1 against damage caused by ischemia and ischemic reperfusion (9/16) |
Neuron Therapeutics | NeurySol aneurysmal | Artificial cerebrospinal fluid, for removal of | Subarachnoid hemorrhage | Company began a clinical trial (9/12) |
Pharmacyclics | Antrin | Motexafin lutetium injection | Coronary artery disease | Phase I results indicated the treatment is feasible and well tolerated (9/25) |
SuperGen Inc. | Decitabine | Inhibits DNA methyl- transferase activity | Sickle-cell anemia | Company received from the FDA orphan drug designation for decitabine (9/17) |
Vasogen Inc. (Canada; TSE:VAS; AMEX:VSV) | - | Immune modulation therapy | Chronic heart failure | Clinical results demonstrated a reduction in the risk of death and hospitalization, and improvements in a clinical composite score and improvements in electrocardiogram measures (9/25) |
CENTRAL NERVOUS SYSTEM | ||||
Cellegy Pharmaceuticals Inc. (CLGY) | Cellegesic | Nitroglycerin ointment | Pain caused by chronic anal fissures | Company is beginning an additional Phase III trial (9/9); Phase III data showed significant and rapid decreases in average pain intensity, worst pain and pain at defecation (9/19) |
Cephalon Inc. | Provigil (FDA- | Modafinil tablets; oral formulation of the | Attention deficit hyperactivity disorder | Clinical data of 248 children showed Provigil significantly improved symptoms of ADHD (9/17) |
Forest Laboratories Inc. (NYSE:FRX) | Memantine | Orally available neuro- protective 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 | Company completed a Phase III study, which showed a significant benefit in adding memantine treatment to a donepezil (Aricept) therapeutic regimen (9/10) |
Innovative Drug Delivery Systems Inc.* | - | Formulation of intranasal morphine | Pain | Phase I results indicated it may offer a safe, noninvasive and rapid-onset alternative to conventional opioids (9/8) |
Ionix Pharmaceuticals Ltd.* (UK) | - | Intranasal opioid | Pain | Company began a Phase I study (9/10) |
Oxford Natural Products Ltd.* (UK) | ONP-04 | A prodrug of tetrahydrocannabinol, | Pain | Company completed Phase I trials (9/4**) |
Pozen Inc. | MT 100 | Formulation of two approved drugs, a fast-release metoclopramide and naproxen sodium | Migraine | Phase III results showed the therapy to be well tolerated over a year of treatment (9/5) |
Vernalis | Frovatriptan | 5HT 1B/1D agonist | Menstrually associated migraine headaches | Clinical results showed that both 2.5 mg and 5 mg of frovatriptan were effective in reducing the incidence, severity and duration of migraines, compared to placebo (9/3) |
DIABETES |
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Amylin Pharmaceuticals Inc. (AMLN) | Symlin | Pramlintide acetate | Type I diabetes | Company completed enrollment of 250 people in a clinical trial (9/5) |
Aradigm Corp. (ARDM) and Novo Nordisk A/S (Denmark; NYSE: NVO) | NN1998 | The AERx insulin Diabetes Management System | Type I diabetes | Company began a Phase III program (9/3) |
Generex Biotechnology Corp. (Canada; GNBT) | Oralin | Oral insulin spray | Type I and II diabetes | Data showed that Oralin might be a safe and effective replacement for injected insulin (9/3) |
Insmed Inc. | INS-1 | Orally active insulin | Type II diabetes and polycystic ovary syndrome | Poor Phase II results forced the company to terminate further development of the product (9/10) |
INFECTION |
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Acambis plc | ACAM1000 | Vaccinia (cowpox) vaccine | Smallpox | Company completed a Phase I trial (9/3) |
Achillion Pharmaceuticals Inc.* | ACH-126,443 | L-nucleoside Beta-L- | Hepatitis B | Phase I/II results showed the agent produced potent anti-HBV activity (9/30) |
Agouron Pharmaceuticals Inc. (unit of Pfizer Inc.) | Viracept | Nelfinavir mesylate; metabolized primarily | Hepatitis C | Clinical results showed Viracept was generally well tolerated in patients co-infected with hepatitis C and HIV (9/30) |
Antex Biologics Inc. (AMEX:ANX) | Helivax | Oral vaccine developed using the company's Nutriment Signal Transduction technology | Helicobacter pylori | Company plans to begin two Phase II trials (9/30) |
Apovia AG* (Germany) | MalariVax | Vaccine based on | Malaria | Company initiated a Phase I trial (9/16) |
Avant Immuno- therapeutics Inc. (AVAN) | Peru-15 | Oral vaccine that | Cholera | Phase II results showed that a single oral dose of 108 cfu produced a significant immune response and was well tolerated in vaccinated individuals (9/30) |
Bavarian Nordic A/S (Denmark; CSE:BAVA) | MVA-BN | Nef vaccine | HIV | Phase I/II results showed it induces an HIV-specific immune response and exhibits a strong safety profile in HIV-infected individuals (9/23) |
BioDelivery Sciences International Inc. (BDSI) | - | Autologous | HIV | A trial with 10 patients showed the product to be safe and potentially effective (9/23) |
Cubist Pharmaceuticals Inc. (CBST) | Cidecin | Daptomycin for | Infective endocarditis | Company enrolled the first patient in a Phase III trial (9/5) |
Cytovax Biotechnologies Inc. (Canada; TSE:CXB) | Cytovaxine | A peptide vaccine that uses the company's Anti-Adhesin Technology to prevent infection | Pseudomonas aeruginosa infections | Company enrolled the last subject in a Phase I trial (9/27) |
Dynavax Technologies Corp.* | - | Immunostimulatory DNA sequence vaccine | Hepatitis B | Company began a Phase II study (9/4) |
ID Biomedical Corp. (Canada; IDBE; TSE:IDB) | FluINsure | Intranasally delivered trivalent influenza vaccine | Influenza | Company completed enrollment in a Phase II trial (9/5); Phase I results showed the vaccine is a trivalent product and was strongly immunogenic (9/30) |
Inhibitex Inc.* | Veronate | Antibody-based product that belongs to a class of drugs referred to as immune globulins | To prevent Staphylococcus infections | Company began a Phase I trial (9/12) |
InSite Vision | ISV-401 | DuraSite formulation | Acute bacterial conjunctivitis | Phase II data demonstrated safety and efficacy (9/25) |
IntraBiotics Pharmaceuticals Inc. (IBPI) | Iseganan | Hydrochloride oral | Mucositis | Company stopped development following a Phase III failure (9/30) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin (FDA- approved) | Bexarotene gel 1% | Chronic severe hand dermatitis | Company said a third of patients experienced clinical improvement of 90% or more in a Phase I/II study (9/8) |
Maxim Pharmaceuticals Inc. (MAXM) | Ceplene | Histamine | Hepatitis C | Company said a Data Safety Monitoring Board reported no safety concerns associated with the triple-drug combination of Ceplene, Peg-Intron and Rebetol (9/10) |
PowderJect Pharmaceuticals plc (UK; LSE:PJP) | Fluvirin | Powder injection flu vaccine | Flu | Company started a Phase I study (9/18**) |
Progenics Pharmaceuticals Inc. (PGNX) | PRO 542 | HIV entry inhibitor | HIV | Phase II data showed single doses reduced HIV concentrations in blood by 60% to 80% (9/27) |
SciClone Pharmaceuticals Inc. (SCLN) | SCV-07 | A compound designed to enhance the immune system | Tuberculosis | The compound demonstrated the capability to significantly in- crease the rate at which treated tuberculosis patients become noncontagious (9/30) |
Serono SA (Switzerland; NYSE:SRA) | Serostim | Somatropin (rDNA origin) for injection | HIV-related metabolic complication | Clinical results showed a reduction in abnormal adipose tissue accumulation, as well as cardiovascular risk factors (9/30) |
The Medivir Group* | MIV-210 | Nucleoside analogue | HIV and hepatitis B | Phase I results showed MIV-210 was active against HIV and hepatitis B virus (9/30) |
Trimeris Inc. (TRMS) and Hoffmann-La Roche Inc. | Fuzeon | A fusion inhibitor | HIV | Phase III data showed Fuzeon in combination with other antiretrovirals provided benefit to treatment-experienced HIV patients at 24 weeks (9/30) |
Versicor Inc. | Dalbavancin | A glycopeptide agent | Skin and soft- tissue infections | Phase II results showed dalbavancin administered once a week for two weeks had higher clinical and microbiological response rates than a variety of standard- care regimens, including vancomycin (9/5) |
Vertex Pharmaceuticals Inc. (VRTX) | GW433908 | Protease inhibitor; calcium phosphate ester prodrug of amprenavir | HIV | Phase III results showed that 73% of 166 patients achieved undetectable viral load, compared to 54% of 83 patients taking Pfizer Inc.'s Viracept (9/27) |
MISCELLANEOUS |
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Adolor Corp. (ADLR) | Alvimopan | Small-molecule opioid receptor antagonist | Opioid- induced bowel dysfunction | Company completed enrollment in the first Phase III trial (9/5) |
Alcon Research Ltd. (NYSE: | Anecortave Acetate | Injected every six months near the | Age-related macular degeneration | Alcon began enrolling 500 patients in a Phase III study to compare Anecortave Acetate with Visudyne (9/4) |
Alizyme plc | ATL-962 | Lipase inhibitor | Obesity | Phase Ib results showed the drug was safe and well tolerated (9/4**) |
AtheroGenics | AGI-1096 | A selective anti-inflammatory agent and antioxidant derived from AtheroGenics' v-protectant technology platform | Prevention of organ transplant rejection | Phase I results showed the product was well tolerated (9/26) |
Entropin Inc. (ETOP) | Esterom | Topical medicinal preparation | Impaired shoulder function | Phase II/III results were not statistically significant and subgroup analyses of the data contained no noteworthy findings; company is discontinuing development (9/9) |
GenoMed | Quinapril | Angiotensin 1- | Chronic kidney disease | Company found that a higher dose of quinapril was effective in delaying chronic kidney disease due to diabetes or high blood pressure in both white and black men (9/10) |
Genzyme | Cerezyme | Imiglucerase for injection; enzyme replacement therapy | Type I | More than 1,000 patients achieved clinical success when Cerezyme prevented and reversed the progression of the major clinical manifestations of Gaucher's disease (9/9) |
GTC Biothera- peutics Inc. (GTCB) | rhATIII | Recombinant human antithrombin III | Hereditary deficiency of antithrombin | Clinical results showed an in- crease in plasma antithrombin activity similar to that observed when plasma-derived anti- thrombin products are used in routine clinical practice (9/8) |
Incara Pharmaceuticals Corp. (OTC BB: INCR) and Elan Corp. plc (Ireland) | Deligoparin (formerly OP2000) | Ultra-low-weight | Ulcerative | A Phase II/III trial failed to meet its primary or secondary end- points (9/17) |
Indevus Pharmaceuticals Inc. (IDEV) | Trospium | Trospium chloride | Overactive bladder | Phase III data showed trospium reached both primary endpoints and secondary endpoints (9/24) |
NPS Pharmaceuticals Inc. (NPSP) | Preos | Parathryroid hormone | Osteoporosis | Company said it met the patient enrollment target in its clinical trial (9/30) |
Palatin Technologies Inc. (AMEX:PTN) | PT-141 | Peptide analog of (alpha)- MSH ([alpha]- melanocyte-stimulating hormone) | Sexual dysfunction | Phase IIa results showed that PT-141 had a positive effect on the primary and secondary endpoints (9/24); Phase I results showed the product was safe in women and yielded significant improvement in vaginal blood flow (9/26) |
Sucampo Pharmaceuticals Inc.* | RU-8811 | A functional fatty acid in protecting against liver disease in animal models | Non-alcoholic steatohepatitis disease | Company began a Phase II trial (9/24) |
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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; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; MSE = Madrid Stock Exchange; NYSE = New York Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange | ||||
