Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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AEterna Laboratories Inc. (Canada; AELA) | Neovastat | Orally bioavailable; activates apoptosis of endothelial cells; also inhibits matrix metalloproteinases and vascular endothelial growth factor | Metastatic renal cell carcinoma | Phase I/II trial results showed a two fold increase in median survival time for patients treated with a higher dose of Neovastat (3/26) |
AltaRex Corp. (Canada; TSE:AXO; OTC BB:ALRXF) | OvaRex MAb | Modified murine monoclonal antibody that binds to CA125 cancer antigen | Ovarian cancer | Phase II results showed nearly half of patients treated survived 50 weeks or longer (3/6); company found a correlation between circulating levels of ovarian tumor marker CA125 and the efficacy of OvaRex (3/22) |
AVAX Technologies Inc. (AVXT) | M-Vax | Haptenized autologous cell vaccine | Cancer | Data showed the timing of an induction dose of vaccine is critical to achieve maximum immunological and clinical response; patients who received M-Vax up to a week before receiving cyclophosphamide responded better than those who received them concurrently (3/27) |
BioChem Pharma Inc. (Canada; BCHE) | Troxatyl | Troxacitabine; a DNA chain terminator and DNA polymerase inhibitor | Acute myelogenous leukemia | Troxatyl moved into a Phase III study (3/27) |
Biomira Inc. (Canada; BIOM) | Theratope | Synthetic carbohydrate-based vaccine; mimic of cancer antigen si alyl-Tn plus carrier molecule KLH | Metastatic breast cancer | Company completed enrollment in its 950-patient trial (3/9); positive trial results showed the vaccine was well tolerated and had minimal side effects (3/29) |
Cell Genesys Inc. (CEGE) | GVAX | Cancer vaccine; immuno-therapeutic comprised of irradiated and genetically modified tumor cells that secrete granulocyte macrophage-colony stimulating factor | Multiple myeloma | Company initiated a Phase I/II trial of GVAX (3/7) |
Cell Pathways Inc. (CLPA) | Aptosyn | Small-molecule compound that augments apoptosis in precancerous cells; exisulind | Advanced non-small-cell lung cancer | Company initiated a Phase III study of Aptosyn in combination with Taxotere (3/2) |
EntreMed Inc. (ENMD) | Endostatin | Naturally occurring angio-genesis inhibitor | Metastatic clear cell renal carcinoma | A study demonstrated that endostatin had detectable levels in serum from both healthy subjects and those with CCRC (3/22) |
Genentech Inc. (NYSE:DNA) | Herceptin antibody | Trastuzumab; HER-2 neu | HER2-positive metastatic breast cancer | Pivotal trial results showed patients treated with Herceptin and chemotherapy experienced a significant survival benefit compared to chemotherapy treatment alone (3/15) |
GLYCODesign Inc. (Canada; TSE:GD) | GD0039 | Anticancer compound; orally administered and blocks the production of specific carbohydrates that are important for cancer spread | Metastatic renal cancer, advanced head and neck cancer, breast cancer and cutaneous T-cell lymphoma | Company added five Phase II trials in four cancer indications to its clinical program for GD0039 (3/29) |
Inex Pharmaceuticals Corp. (Canada; INEX) | Onco TCS | Therapeutic consisting of vincristine encapsulated in Inex's transmembrane carrier systems drug delivery technology | Non-Hodgkin's lymphoma | Company began enrolling patients in a Phase II trial (3/26) |
MedImmune Inc. (MEDI) and Applied Molecular Evolution Inc. (AMEV) | Vitaxin | Angiogenesis inhibitor optimized through AME's directed evolution technology platform, which targets the integrin alpha-v-beta-3 | Cancer | MedImmune initiated a Phase I trial (3/13) |
MGI Pharma Inc. (MOGN) | MGI 114 | Irofulven; hydroxymethyl-acylfulvene | Refractory or recurrent advanced epithelial ovarian cancer | Company initiated a new Phase II trial (3/22) |
Millennium Pharmaceuticals Inc. (MLNM) | LDP-341 | Proteasome inhibitor small molecule that blocks proteasome function | Multiple myeloma | Company initiated a Phase II trial (3/1) |
NeoPharm Inc. (NEOL) | LE-AON | Electrostatic liposome encapsulated antisense cRaf oligonucleotide designed to block the expression of the cRaf protein | Cancer | Company initiated two Phase I/II trials (3/19) |
Onyx Pharmaceuticals Inc. (ONXX) and Bayer AG (Germany) | BAY 43-9006 | A selective agent designed to block the Ras signaling pathway in cells by inhibiting Raf kinase | Cancer | Phase I results demonstrated the compound's mechanism of action and potential applicability in multiple tumor types (3/26) |
OSI Pharmaceuticals Inc. (OSIP) | OSI-774 | A small-molecule anti-EGFR drug candidate used in combination with docetaxel (Taxotere) | Advanced cancer | Company began a Phase Ib trial (3/13) |
Pharmacyclics Inc. (PCYC) | Xcytrin Injection | Motexafin gadolinium | Brain metastases | Company completed enrollment in a Phase III trial (3/14) |
PhotoCure ASA (Norway; OSE:PHO) | Metvix | Photodynamic therapy involving a cream that is activated by light | Precancerous skin lesions | Company completed a Phase III trial, which showed Metvix completely removed 88% of the lesions (3/5) |
Protarga Inc.* | Taxoprexin DHA-paclitaxel | Anticancer therapeutic; DHA-paclitaxel | Cancer | Company began Phase II studies (3/8) |
SafeScience Inc. (SAFS) | GBC-590 | Carbohydrate compound derived from citrus pectin | Colorectal cancer | Phase IIa trial data showed that five out of 23 patients had tumor stabilization from two to six months before disease state progression was observed (3/23) |
SuperGen Inc. (SUPG) | Decitabine | Inhibits DNA methyltransferase activity | Advanced myelodysplastic syndrome | Company began enrollment in a Phase III trial (3/26) |
Supratek Pharma Inc. (Canada)* | Vaccine | DNA vaccine formulated with SP1017 | Melanoma | Company said the vaccine increased survival rates by more than 10-fold compared to the non-formulated DNA vaccine (3/6) |
Telik Inc. (TELK) | TLK286 | Small-molecule drug | Refractory colon cancer | Company began a Phase II trial (3/27) |
Titan Pharmaceuticals Inc. (AMEX:TTP) | Pivanex | Small-molecule drug that attacks cancer cells by cellular differentiation | Liver tumors | Company initiated a Phase I/II study (3/28) |
Vical Inc. (VICL) | Vaxid | Naked DNA vaccine | Low-grade, non-Hodgkin's B-cell lymphoma | Phase I/II data showed positive safety and immunogenicity results (3/27) |
Vion Pharmaceuticals Inc. (VION) | Triapine | Small-molecule ribonucleotide reductase inhibitor | Cancer | Phase I data showed Triapine can be given safely daily for five days, every other week, and is well tolerated (3/28) |
CARDIOVASCULAR |
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Alliance Pharmaceutical Corp. (ALLP) | Oxygent | Intravenous oxygen carrier comprised of liquid perfluorochemical core particles surrounded by a surfactant and suspended in a water-based solution | Patients undergoing cardiac surgery | Preliminary data showed no evidence to link Oxygent directly with an imbalance in certain adverse events, primarily stroke; enrollment of a Phase III study was halted in January due to the adverse events (3/13) |
Alteon Inc. (AMEX:ALT) | ALT-711 | Thiazolium-based compound; an advanced glycosylation end-product crosslink breaker | Cardiovascular disease | Phase IIa study results indicated ALT-711 improved arterial elasticity and reduced pulse pressure (3/19) |
Biogen Inc. (BGEN) and CV Therapeutics Inc. (CVTX) | BG9719 (CVT-124) | A1 adenosine receptor antagonist | Moderate congestive heart failure | Phase II results showed treatment with BG9719, compared to placebo, resulted in renal function improvement, as well as an increase in renal output (3/20) |
Collateral Therapeutics Inc. (CLTX) | Ad4-FGF4 | Angiogenic gene therapy composed of an adenoviral gene therapy vector containing the human fibroblast growth factor-4 angiogenic gene; designed to stimulate blood vessel formulation | Stable exertional angina due to coronary artery disease | Drug appeared safe and well tolerated, as well as efficacious in a Phase I/II trial (3/19) |
COR Therapeutics Inc. (CORR) | Integrilin and TNKase | Prevents reocclusion of the stented artery by blocking certain receptors, known as GP IIb-IIIa, on platelets responsible for thrombus development | ST-segment elevation myocardial infarction | Study results of Integrilin combined with a half dose of TNKase in patients showed the therapy fully restored blood flow through blocked arteries, supplying oxygen-starved heart muscle in 70% of patients within an hour of initiation of therapy (3/19) |
Curis Inc. (CRIS) | Vascugel | Biodegradable implant containing human endothelial cells that will be wrapped at the junction of the bypassed and grafted coronary blood vessels at the time of the coronary artery bypass graft surgery and tissue perfusion | To prevent complications related to cardiovascular surgical procedures and to maintain long-lasting blood flow | Company initiated a Phase I trial (3/28) |
Emisphere Technologies Inc. (EMIS) | Heparin | Oral heparin tablets formulated with Emisphere's delivery agent, Sodium N-[10-(2 hydroxybenzoyl)amino] decanoate | Prevention of deep vein thrombosis | Company began clinical testing (3/9) |
Esperion Therapeutics Inc. (ESPR) | ETC-216 | Comprised of ApoA-1 Milano and phospholipid (AIM); synthetic HDL | Cardiovascular disease | Company saw initial positive, results in a Phase I trial in which AIM was well tolerated with no serious side effects (3/29) |
Genentech Inc. (NYSE:DNA) and Actelion Ltd. (Switzerland; SWX:ATLN) | Veletri | Tezosentan; intravenous dual endothelin receptor antagonist | Acute heart failure | Phase III results were positive demonstrating statistically significant blood circulation benefits (3/20) |
NitroMed Inc.* | BiDil | Combination drug containing isosorbide dinitrate and hydralazine hydrochloride | Heart failure | Company initiated a study to confirm the efficacy of BiDil in treating African American heart failure patients (3/19) |
Pharming Group NV (the Netherlands; EASDAQ:PHAR) and Baxter Healthcare Corp. | | A recombinant human C1 inhibitor | Hereditary angioedema | Companies started a Phase I trial (3/9) |
Scios Inc. (SCIO) | Natrecor | Recombinant form of B-type natriuretic peptide | Acute congestive heart failure | Company initiated a new study (3/19); an article published in the Journal of Cardiac Failure showed data in which Natrecor improves blood circulation and alleviates symptoms (3/20) |
Texas Biotechnology Corp. (AMEX:TXB) | Argatroban | Anticoagulant; synthetic direct thrombin inhibitor that blocks the activity of thrombin | Acute ischemic stroke | Company began enrollment in a Phase II trial (3/14) |
CENTRAL NERVOUS SYSTEM |
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Angiotech Pharmaceuticals Inc. (Canada; ANPI) | Micellar Paclitaxel | Intravenous therapy of FDA-approved paclitaxel | Multiple sclerosis | Company completed enrollment of a 189-patient Phase II study (3/1) |
AtheroGenics Inc. (AGIX) | AGIX-4207 | Orally administered treatment | Rheumatoid arthritis | Company began enrollment in a Phase I trial (3/27) |
Boston Life Sciences Inc. (BLSI) | Atropine | Radio-imaging agent | Attention deficit hyper-activity disorder | Phase II results indicated the agent identified adults with ADHD (3/12) |
Diacrin Inc. (DCRN) and Genzyme General (GENZ) | Neurocell-PD | Pig brain cells intended to function as replacement for brain cells lost to disease | Parkinson's disease | Early Phase II trial data showed no difference in improvement between those treated with Neurocell-PD and those in the control group (3/16) |
Durect Corp. (DRRX) | Duros sufentanil | Uses the Duros osmotic delivery system to deliver sufentanil, an opioid | Chronic pain | Company completed patient enrollment in a Phase II trial (3/9) |
Nastech Pharmaceutical Co. Inc. (NSTK) | Triptan | Nasally administered selective serotonergic agent | Migraine pain | Company began a Phase I trial in the U.S. (3/5) |
NeoTherapeutics Inc. (NEOT) | Neotrofin | Leteprinim potassium | Parkinson's disease | Company began a Phase II trial (3/29) |
Neurogen Corp. (NRGN) and Pfizer Inc. | NGD 97-1 | GABA (gamma aminobutyric acid receptor agonist) | Alzheimer's disease | Companies initiated Phase II studies (3/15) |
Teva Neuroscience (division of Teva Pharmaceutical Industries Ltd.; TEVA) | Copaxone | Glatiramer acetate for injection | Relapsing-remitting multiple sclerosis | A study found Copaxone produced a 29% reduction in enhancing lesions compared to placebo and reduced the number of relapses in RRMS patients by 33% compared to placebo (3/6) |
DIABETES |
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Amylin Pharmacueticals Inc. (AMLN) and Alkermes Inc. (ALKS) | AC2993 LAR | A long-acting-release formulation of AC2993 (synthetic exendin-4), based on Alkermes' Medisorb injectable sustained-release delivery technology | Type II diabetes | Companies initiated a Phase I trial (3/26) |
Calyx Therapeutics Inc.* | CLX-0901 | Water-soluble, orally active small molecule shown to bind to the insulin receptor | Diabetes | Company began a Phase II trial (3/22) |
Insmed Inc. (INSM) | SomatoKine | Recombinant protein being developed as an insulin sensitizer | Diabetes | Phase II data indicated Somato-Kine produced reductions in patients' average daily insulin requirements and average daily fasting glucose levels (3/22) |
INFECTION |
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AnorMED Inc. (Canada; TSE:AOM) | AMD-3100 | Inhibitor of the CXCR4 chemokine receptor | HIV | Company initiated a Phase I trial to study the white blood cell-increasing effects of AMD-3100 (3/19) |
Cubist Pharmaceuticals Inc. (CBST) | Cidecin | Daptomycin, a novel cyclic lipopeptide antibiotic derived from a fermentation product of Streptomyces roseosporous | Skin and soft tissue infections | Pivotal Phase III results showed Cidecin achieved its primary endpoint of demonstrating equivalency to comparator agents (3/14) |
Human Genome Sciences Inc. (HGSI) | Albuferon | Created by fusing interferon alpha to albumin | Hepatitis C | Company began a Phase I trial (3/23) |
Inhibitex Inc.* | SA-IGIV | Staphylococcus aureus immune globulin intravenous | Infectious endocarditis | Company began patient enrollment for a Phase II trial (3/8) |
IntraBiotics Pharmaceuticals Inc. (IBPI) | Protegrin IB-367 | A rinse; synthetically derived analogue of naturally occurring protegrins | Ventilator-associated pneumonia | Phase IIa data indicate the compound was well tolerated and demonstrated antimicrobial activity (3/9) |
IntraBiotics Pharmaceuticals Inc. (IBPI) | Ramoplanin Oral | Naturally occurring antibiotic | Bloodstream infections due to vancomycin-resistant enterococci | Company said its Phase III trials will be delayed a year or more due to difficulties enrolling 950 patients (3/12) |
The Immune Response Corp. (IMNR) | Remune | HIV-1 Immunogen used in addition to HAART (highly active antiretroviral therapy) | HIV | Preliminary data from an open-label study suggests treatment may help HIV-positive individuals maintain control of the virus during structured treatment interruptions of the HAART regimen (3/13) |
Versicor Inc. (VERS) | V-Echinocandin | Anidulafungin; intravenous antifungal agent | Esophageal candidiasis | Company entered a pivotal Phase III trial (3/22) |
ViroPharma Inc. (VPHM) | Picovir | Antiviral drug; pleconaril; inhibits the function of the picornavirus capsid | Common cold | Preliminary analyses of two Phase III studies showed that Picovir reached the primary endpoints of reduction in time to eliminate a runny nose and reduction or elimination of all other disease symptoms (3/15) |
MISCELLANEOUS |
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Abgenix Inc. (ABGX) | ABX-IL8 | Fully human monoclonal antibody directed against interleukin-8 | Moderate to severe psoriasis | Phase IIa results presented at the American Academy of Dermatology meeting showed the drug was associated with a statistically significant improvement in plaque psoriasis (3/5) |
Adolor Corp. (ADLR) | ADL 8-2698 | Small-molecule therapeutic that blocks opioid-induced bowel paralysis without blocking post-operative analgesic performance | Post-operative ileus | Company began enrollment in a Phase III trial of 180 patients (3/19) |
AeroGen Inc. (AEGN) | AeroDose | Ipratropium inhaler; a small portable hand-held device that uses AeroGen's aerosol generator technology to aerosolize liquids | Respiratory disorders | Company entered Phase II trials with AeroDose (3/13) |
Applied Genetics Inc. Dermatics* | T4N5 Liposomes Lotion | Uses liposomes to deliver DNA repair enzymes into the skin | Xeroderma pigmentosum | Study results show the drug uses liposomes to deliver DNA repair enzymes into the skin that reverse DNA damage caused by sunlight (3/15) |
Atrix Laboratories Inc. (ATRX) | Atrisone dapsone | Topical gel in SMP technology | Moderate to severe acne | Phase I/II trial results indicated Atrisone reduced lesions by about one-half over the 28-day study (3/6) |
Biogen Inc. (BGEN) | Amevive | Alefacept; human LFA-3 IgG1 fusion protein | Moderate to severe chronic plaque psoriasis | Results presented at the American Academy of Dermatology meeting showed the retreatment with Amevive displayed responses within four weeks that tended to be more rapid with the second course of treatment; the retreatment study followed an initial Phase II study (3/5) |
BioMarin Pharmaceutical Inc. (BMRN) and Genzyme General (GENZ) | Aldurazyme | Recombinant human alpha-L-iduronidase; enzyme replacement therapy | MPS-1 | Companies completed patient enrollment of a pivotal Phase III trial of Aldurazyme (3/2) |
BioMarin Pharmaceutical Inc. (BMRN) | rhASB | Recombinant human arylsulfatase B; enzyme replacement therapy | MPS-VI | BioMarin completed patient enrollment of a Phase I trial (3/2) |
Centocor Inc.* | Remicade (FDA-approved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha | Moderate to severe psoriasis | Phase II results indicated infliximab could benefit patients with moderate to severe psoriasis (3/7) |
Claragen Inc.* | CC10 | Recombinant human protein | Chronic lung disease | Company began a multicenter clinical study of CC10 in chronic lung disease in premature infants (3/8) |
CollaGenex Pharmaceuticals Inc. (CGPI) | Periostat | Doxycycline hyclate | Osteoporosis, osteopenia and periodontitis | Studies indicated that the therapy can reduce bone loss in the jaws of postmenopausal women; the studies were presented at the American Association for Dental Research meeting (3/9) |
Curis Inc. (CRIS) | Chondrogel | Minimally invasive tissue augmentation product | Stress urinary incontinence | A pilot study published in the February issue of Neurology and Urodynamics indicated patients with stress urinary incontinence experienced significant improvement in their conditions (3/9) |
DrugAbuse Sciences Inc.* | Naltrexone depot | Injectable sustained-release formulation of naltrexone | Alcohol dependence | Company completed patient enrollment in a Phase III trial (3/5) |
Dynavax Technologies Corp.* | AIC anti-allergy vaccine | Short-course form of immunotherapy | Ragweed allergy | Phase II results showed the injections were well tolerated, with the exception of self-limited local reactions (3/20) |
Genzyme General (GENZ) and Pharming Group NV (the Netherlands; EASDAQ:PHAR) | Recombinant human alpha-glucosidase | Enzyme replacement therapy | Pompe disease | Phase I/II results indicate the therapy may be able to reduce heart size and improve cardiac function (3/20); companies began a Phase II/III trial in infants (3/30) |
IDEC Pharmaceuticals Corp. (IDPH) | IDEC-114 | Primatized anti-CD80 moncolonal antibody | Moderate to severe psoriasis | Phase I/II results presented at the American Academy of Dermatology meeting showed that 40% of patients achieved the clinical endpoint (3/5) |
IDEC Pharmaceuticals Corp. (IDPH) | IDEC-152 | A primatized anti-CD23 monoclonal antibody | Allergic asthma | Phase I data showed reductions in IgE levels and an encouraging safety profile (3/19) |
Immunex Corp. (IMNX) | Enbrel (FDA-approved) | Tumor necrosis factor receptor | Psoriatic arthritis | The company said a Phase III trial has produced positive data (3/22) |
Immunex Corp. (IMNX) | Nuvance | A recombinant human version of a naturally occurring protein thought to act by binding to interleukin-4, a protein present in asthmatic lungs | Asthma | Phase II data show that Nuvance did not meet efficacy endpoints (3/22) |
InterMune Pharmaceuticals Inc. (ITMN) | Actimmune | A gamma interferon therapy | Cystic fibrosis | Phase II results showed that inhaled gamma interferon could reduce chronic airway inflammation in cystic fibrosis patients (3/13) |
La Jolla Pharmaceutical Co. (LJPC) | LJP 394 | Molecule (toleragen) that binds to the surface of B cells and shuts off production of antibodies to double-stranded DNA | Lupus | Phase II/III data showed that as the dose of LJP 394 increased, the number of renal flares decreased in drug-treated patients relative to placebo patients; a Phase III trial is under way (3/28) |
Ligand Pharmaceuticals Inc. (LGND) | Ontak | Denileukin diftitox | Moderate to severe psoriasis | Pilot study data showed all six patients achieved at least a 30% decrease in Psoriasis Area and Severity Index (3/6) |
NeoTherapeutics Inc. (NEOT) | Neotrofin | Leteprinim potassium | Spinal cord injury | Company initiated a 12-week, open-label study (3/26) |
Neurocrine Biosciences Inc. (NBIX) | CRF1 receptor | Corticotrophin-releasing factor receptor antagonist | Depression and anxiety | Company completed a Phase I trial (3/8) |
NexMed Inc. (NEXM) | Alprox-TD | Topical treatment | Severe erectile dysfunction | Company completed testing in a Phase II efficacy and safety study (3/12) |
Phytopharm plc (UK; LSE:PYM) | P57 | Orally administered appetite suppressant derived from an extract of a South American plant | Obesity | Company started a Phase IIa trial (3/14**) |
Protein Design Labs Inc. (PDLI) | SB240683 | Humanized anti-IL-4 antibody | Mild to moderate asthma | Phase I results showed the antibody was well tolerated and had a half-life of 18 to 21 days (3/22) |
Regeneron Pharmaceuticals Inc. (REGN) | Axokine | Genetically re-engineered version of a naturally occurring human protein known as ciliary neurotrophic factor | Obesity | Phase II results showed patients maintained their average weight loss for three months (3/1) |
SR Pharma plc (UK; LSE:SPA) | SRL 172 | Immune potentiator | Atopic dermatitis | Phase II results showed a mean 48% reduction in surface area and 68% reduction in severity of the dermatitis, compared with 4% and 18% in the placebo group (3/21**) |
Symbollon Corp. | IoGen (SYMBA) | Molecular iodine | Fibrocystic breast disease | Phase II data indicated an overall reduction of about 50% of breast pain and tenderness, compared to a 10% increase in patients receiving placebo (3/14) |
XOMA Ltd. (XOMA) | Xanelim delivered | Efalizumab subcutaneously | Moderate to severe plaque psoriasis | Phase I/II and Phase III data presented at the American Academy of Dermatology's annual meeting showed 75% of patients given Xanelim achieved 50% or better PASI (Psoriasis Area and Severity Index) improvement (3/5) |
Notes: |
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* Privately held. ** 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; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OSE = Norwegian Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange |
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