Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Antigenics Inc. (AGEN) | Oncophage | Cancer vaccine consisting of purified, patient-specific heat shock protein-peptide complexes | Renal cell carcinoma | Initiated Phase III trial (6/28) |
Ariad Pharmaceuticals Inc. (ARIA) | Argent GvHD | Genetically engineered donor T lymphocytes containing a gene encoding an inactive apoptosis protein that is activated upon administration of an oral drug called AP1903 | Treatment of graft-vs.-host disease in patients who undergo bone marrow transplants | Received approval to begin Phase II trial (6/2) |
British Biotech plc (UK; BBIOY) | Marimastat | Oral matrix metallo-proteinase inhibitor designed to inhibit blood flow to tumors | Glioblastoma | Product failed to beat placebo in a Phase III trial (6/23) |
Cell Pathways Inc. (CLPA) | Aptosyn | Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase | Familial adenomatous polyposis | Reported positive new data from Phase III trial (6/27) |
ImClone Systems Inc. (IMCL) | IMC-1C11 | Chimerized monoclonal antibody that inhibits the the KDR receptor on vascular endothelial cells; KDR is associated with angiogenesis | Metastatic colorectal carcinoma | Initiated patient treatment in Phase I trial (6/1) |
Immunomedics Inc. (IMMU) | CEA-Cide | Humanized antibody against carcinoembryonic antigen; radiolabeled with yttrium-90 | Patients with meta-static colorectal cancer who have failed or were intolerant to previous chemotherapy | Reported results of ongoing Phase II trials (6/5) |
Immunomedics Inc. (IMMU) | LymphoCide | Humanized anti-CD22 antibody consisting of murine binding sites linked to immunoglobulin backbone; labeled with yttrium-90 | Aggressive non-Hodgkin's lymphoma that has failed prior therapy | Reported results from 17-patient trial at the 47th annual meeting of the Society of Nuclear Medicine in St. Louis (SNM) (6/5) |
Matritech Inc. (NMPS) | NMP66 | Test for nuclear matrix proteins | Breast cancer detection | Reported proof-of-clinical-concept data (6/1) |
Maxim Pharmaceuticals (MAXM) | Maxamine | Histamine dihydrochloride; H2 receptor agonist | Stage IV malignant melanoma | Presented positive results including new 24-month survival data, on combination therapy with interleukin-2 at the Perspectives in Melanoma IV conference in Pittsburgh (6/2) |
Milkhaus Laboratory Inc.* | LDI-200 | Chorionic gonadotropin; hormone-based agent | Myelodysplastic syndrome | Reported positive results from open-label, crossover Phase II/III trial (6/7) |
Oncolytics | Reolysin Biotech Inc. (Canada; CDNX: ONC; affiliate of Synsorb Biotech Inc. [Canada; SYBB]) | Reovirus (respiratory enteric orphan virus), which targets solid tumors with an activated Ras gene pathway; reovirus is a naturally occurring virus believed to cause mild infections of the upper-respiratory and gastrointestinal tracts in humans | Various late-stage cancers | Initiated first Phase I trial (6/6) |
Onyx Pharmaceuticals Inc. (ONXX) and Warner-Lambert Co. (now merged with Pfizer Inc. [NYSE:PFE]) | CI-1042 (ONYX-015) | Genetically engineered adenovirus that replicates in and kills tumor cells deficient in p53 tumor-suppressor gene | Recurrent head and neck cancer | Initiated Phase III trial (6/6) |
SafeScience Inc. (SAFS) | GBC-590 | Carbohydrate lectin inhibitor that competitively binds to unique lectins on cancer cells and disrupts the metastatic process | Colorectal carcinoma | Initiated Phase II trial (6/5) |
Techniclone Corp. (TCLN) | Cotara | Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with I-131 (targets necrotic center of tumor) | Brain cancer | Expanded Phase II trial to include the University of Miami as a site (6/1) |
Vion Pharmaceuticals Inc. (VION) and Boehringer Ingelheim (Germany) | Promycin | Porfiromycin; anticancer agent selective for hypoxic cancer cells | Non-resectable head and neck cancer< | Combination of Promycin and radiotherapy failed to beat radiotherapy alone in a Phase III trial (6/22) |
Xenova Group plc (UK; XNVA) | XR5000 | Inhibitor of topoisomerase I and II | Colorectal cancer | Reported disappointing results from one of four Phase II open-label studies; no complete or partial responses were observed (6/1) |
CARDIOVASCULAR |
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Amylin Pharmaceuticals Inc. (AMLN) and Aventis Pharmaceuticals Inc. (NYSE:AVE) | AC3056 | Antioxidant that inhibits vascular cell adhesion molecule expression in human vascular cells | Prevention of restenosis following angioplasty or other procedures to open clogged arteries | Initiated first Phase I trial (6/1) |
AVI BioPharma Inc. (AVII) | Resten-NG | Synthetic polymer antisense compound targeting c-myc oncogene, which has been implicated in cell proliferation | Restenosis | Initiated Phase II trial (6/28) |
Avigen Inc. (AVGN) | Coagulin-B | Gene therapy; use of adeno-associated viral vector to deliver the factor IX gene | Hemophilia B | Reported Phase I/II trial results and announced plan for second trial at the annual meeting of the American Society of Gene Therapy in Denver (ASGT); discussed plan for a second, liver-directed trial (6/5) |
Biopure Corp. (BPUR) | Hemopure (HBOC-201) | Hemoglobin glutamer-250 (bovine); each unit of product contains approximately 30 grams of purified, chemically cross-linked hemoglobin in 250 ml of a balanced salt solution | Alternative to blood cell transfusion in refractory auto-immune hemolytic anemia | Results of using the product on a compassionate-use basis to treat a patient with life-threatening anemia was reported in the 6/1 issue of the New England Journalof Medicine (6/1) |
Corvas International Inc. (CVAS) | rNAPc2 | Injectable anticoagulant recombinant protein, discovered in its original form in blood-feeding hookworms | Prevention of deep vein thrombosis in patients undergoing orthopedic surgery | Completed enrollment in Phase II trial (6/20) |
Centocor Inc. (subsidiary of Johnson & Johnson; NYSE:JNJ) and Eli Lilly and Co. (NYSE:LLY) | ReoPro and Retavase (both FDA-approved) | Reopro (abciximab) is a multireceptor, monoclonal antibody inhibitor of of glycoprotein (GP) IIb/IIIa, (alpha V beta 3) and MAC-1; Retavase is a recombinant tissue plasminogen activator | Heart attack | Data from combination trial of ReoPro and Retavase published in Circulation (6/19) |
Genentech Inc. (NYSE:DNA) | | Recombinant humanized anti-CD18 monoclonal antibody fragment | Heart attack | Preliminary results of Phase II trial showed the product failed to meet primary objectives (6/16) |
CENTRAL NERVOUS SYSTEM |
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Boston Life Sciences Inc. (BLSI) | Altropane | Radioimaging probe for dopamine neurons | Diagnosis of attention deficit disorder | Clinical trial scored highest in panel set up to judge quality and scientific importance of papers presented at the psychiatry session of the SNM meeting (6/7) |
Cephalon Inc. (CEPH) | Provigil (FDA-approved) | Modafinil; oral formulation of synthetic compound that is thought to affect alpha adrenergic receptors in the brain | Sleep deprivation | Reported results of three trials at the 14th Annual Meeting of the Associated Professional Sleep Societies (6/21) |
Genzyme Corp. (GENZ) | NeuroCell-PD | Implants of fetal pig neural cells; intended to function as replacement for brain cells lost to disease | Parkinson's disease | Extended milestone timeline to initiate Phase III trial by six months, to 12/31 (6/29) |
Merck & Co. Inc. (NYSE: MRK) | | Substance P antagonist | Depression | Company reported it is proceeding with ongoing Phase II trials, though enrollment is taking longer than expected (6/14) |
Nastech Pharmaceutical Co. Inc. (NSTK) | | Intranasal formulation designed to improve nasal absorption of butorphanol tartrate, the active ingredient in Stadol NS | Acute migraine pain | Reported Phase I results (6/15) |
Pharmos Corp. (PARS) | Dexanabinol | Non-psychotropic synthetic analogue of marijuana (intravenous) | Severe traumatic brain injury | Company appointed Quintiles Ltd. (UK subsidiary of Quintiles Trans-national Corp. [QTRN]) to monitor and manage data for European Phase III trial scheduled to begin in the third quarter (6/13) |
DIABETES |
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AMBI Inc. (AMBI) | Chromax (marketed) | Bioavailable source of chromium picolinate | Sydrome X | Reported data from a pre-clinical trial at the 60th Scientific Sessions of the American Diabetes Association in San Antonio, Texas (ADA) (6/14) |
Amylin Pharmaceuticals Inc. (AMLN) | AC2993 | Synthetic exendin-4; 39-amino-acid peptide that exhibits anti-diabetic activity similar to the mammalian hormone glucagon-like peptide | Type II diabetes | Reported data from dose-frequency Phase II study (6/9) |
Aradigm Corp. (ARDM) < | AERx Pumonary Delivery System (insulin) | Insulin delivered via fine aerosol mists that are deposited deep into the lung; handheld electonic inhaler guides patient to breathe correctly and consistently | Type I diabetes | Presented results of Phase II trial at the ADA meeting (6/12) |
Inhale Therapeutic Systems Inc. (INHL), Aventis Pharma (France; NYSE:AVE) and Pfizer Inc. (NYSE:PFE) | | Dry powder formulation of recombinant insulin, delivered via pulmonary delivery | Types I and II diabetes | Presented 30-month Phase II data at the ADA meeting (6/14) |
INFECTION |
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Atrix Laboratories Ltd. (subsidiary of Atrix Laboratories [ATRX]) | Atridox (FDA-approved) | Doxycycline 8.8% product applied as a gel to affected area, where it conforms to the shape of the periodontal pocket and solidifies, releasing doxycyline over a period of about 7 days | Periodontal disease | Presented study results at International Association of Dental Research in Washington, D.C. (6/5) |
Aviron (AVIR) | | Genetically engineered live virus vaccine | Cytomegalo-virus | Initiated Phase I trial (6/30) |
Cel-Sci Corp. (AMEX:CVM) | Multikine | Natural mixture of human cytokines, including interleukin-2 | HIV | Presented data on safety and cell-mediated immunity at the 1st International Conference on Vaccine Development and Immunotherapy in HIV in Palm Beach, Fla. (6/30) |
Eli Lilly and Co. (NYSE: LLY) | Zovant | Recombinant human activated protein C | Severe sepsis | Stopped enrollment on recommendation of independent data and safety monitoring board, which found positive results for the endpoint of 28-day all-cause mortality (6/29) |
Enzo Biochem Inc. (NYSE:ENZ) | EHT899 | Orally available viral protein | Chronic hepatitis B | Commenced Phase II trial (6/14) |
Enzo Biochem Inc. (NYSE:ENZ) | HGTV-43 | Genetic antisense medicine; insertion of gene that synthesizes antisense molecule to HIV-1 directly into blood cells (patient's stem cells treated ex vivo to render them HIV-resistant, then reinfused into patient) | HIV infection | Reported preliminary results of Phase I trial data at the ASGT meeting (6/2) |
Gilead Sciences Inc. (GILD) | Tenofovir DF | Orally administered nucleotide reverse transcriptase inhibitor | HIV infection in antiretroviral naove patients | Initiated enrollment in a second multinational Phase III trial (6/12) |
Hemispherx Biopharma Inc. (AMEX:HEB) | Ampligen | Double-stranded synthetic RNA compound poly I: poly C12U | HIV infection | Initiated Phase II/III trial (6/20) |
The Immune Response Corp. (IMNR) and Agouron Pharmaceuticals Inc. (subsidiary of Pfizer Inc. [NYSE:PFE]) | Remune | Envelope depleted, inactivated AIDS virus (emulsified with adjuvant); therapeutic vaccine | HIV infection | Companies said enrollment in 96-week, randomized blinded trial, previously announced 5/10, was halted while protocol changes are reviewed (6/9); presented preliminary interim results from Phase II trial at the 5th European Conference on Experimental AIDS Research in Madrid (6/21) |
IntraBiotics Pharmaceuticals Inc. (IBPI) | Ramoplanin Oral | Naturally occurring antibiotic that kills Grampositive bacteria | Prevention of bloodstream infection due to the presence of vancomycin-resistant Enterococcus in cancer patients known to carry VRE bacteria in their intestines | Initiated Phase III trial (6/29) |
Micrologix Biotech Inc. (Canada; TSE:MBI) | MBI 594AN | Antibiotic targeting Propionibacterium acnes | Acne | Completed Phase I trial (6/28) |
Oxo Chemie Inc. (subsidiary of Oxo Chemie AG; Switzerland) | Macrokine (WF10) | Macrophage regulation drug containing proprietary chlorite | Hepatitis C infection | Initiated Phase II trial (6/29) |
Palatin Technologies Inc. (AMEX:PTN) and Mallinckrodt Inc.(NYSE: MKG) | LeuTech | Antibody-based infection imaging agent | Diagnosis of equivocal appendicitis | Presented positive results of Phase III trial at the SNM meeting and reported the FDA's Medical Imaging Drugs Advisory Panel would review the biologics license application for LeuTech on 7/10 (6/7) |
Pathogenesis Corp. (PGNS) | TOBI (FDA-approved) | Tobramycin solution for inhalation | Bronchiectasis | Initiated enrollment in Phase II trial (6/29) |
Peptide Therapeutics Group plc (UK; LSE:PTE) | Arilvax | Live attenuated yellow fever vaccine | Prevention of yellow fever in travelers | Reported positive results in a pivotal Phase III trial (6/5) |
Triangle Pharmaceuticals Inc. (VIRS) | DMP-450 | Potent, selective inhibitor of HIV-1 protease that belongs to the cyclic ureas | HIV infection | Presented initial results of Phase I/II trial at the 4th International Workshop on HIV Drug Resistance and Treatment Strategies (IDRT) in Sitges, Spain (6/12) |
Triangle Pharmaceuticals Inc. (VIRS) | DAPD | Dioxolane purine nucleoside reverse transcriptase inhibitor that is rapidly converted in humans into its active metabolite, DXG | HIV infection | Presented data on the antiviral acitivity of DAPD in HIV-infected patients who have failed multiple antiviral drugs and results from short-term Phase I/II trial at the IDRT meeting (6/12) |
MISCELLANEOUS |
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Axys Pharmaceuticals Inc. (AXPH) | APC 2059 | Topical cream formulation of tryptase inhibitor (tryptase involved in mast cell-mediated inflammation) | Ulcerative colitis | Completed interim data analysis of Phase II trial and decided to continue the study through the end of the year as planned (6/1) |
Biomatrix Inc. (NYSE:BXM) | Synvisc (FDA-approved) | An elastoviscous hylan therapeutic | Osteoarthritis of the hip | Reported preliminary results of clinical trial at the Annual European Congress of Rheumatology in Nice, France (6/29) |
Cangene Corp. (Canada; TSE:CNJ) | | Recombinant human growth hormone | Short stature in children with growth hormone deficiency and girls with Turner's Syndrome | Initiated two separate pivotal trials (6/2) |
Cellegy Pharmaceuticals Inc. (CLGY) | Anogesic | Proprietary formulation of nitroglycerin ointment | Anal fissures | Reported positive results of Phase III trial at the annual meeting of the American Society of Colon and Rectal Surgeons in Boston (ASCRS) (6/27) |
Cellegy Pharmaceuticals Inc. (CLGY) | Anogesic | Proprietary formulation of nitroglycerin ointment | Reduction of pain in patients undergoing hemorrhoid surgery | Reported trial results at ASCRS meeting (6/27) |
Connetics Corp. (CNCT) | | Recombinant human relaxin | Scleroderma | Data from Phase II trial were published in the 6/6 issue of the Annals of Internal Medicine (6/6) |
Discovery Laboratories Inc. (DSCO) | SuperVent Aerosol Solution | Tyloxapol (non-anionic alkalaryl and polyether alcohol); anti-inflammatory inhibitor of NF-(kappa)B | Cystic fibrosis | Reported additional data from Phase IIa trial (6/1) |
Genelabs Technologies Inc. (GNLB) | GL701 | Dehydropieandosterone (DHEA); naturally occurring hormone produced by the adrenal glands | Systemic lupus erythematosus | Reported statistically significant positive results from the second Phase III trial at the 82nd Annual Meeting of the Endocrine Society in Toronto (6/23) |
Gliatech Inc. (GLIA) | Adcon T/N | Gel developed to inhibit postsurgical adhesions following tendon and peripheral nerve surgeries | Patients receiving tendon or peripheral nerve surgeries | Reported results of blinded, randomized trial at the Federation of European Societies for Surgery of the Hand 5th Congress in Barcelona (6/28) |
Gliatech Inc. (GLIA) | Adcon-L (FDA-approved) | Anti-adhesion barrier gel (semisynthetic carbohydrate polymer) | Reduction of peridural scar associated with lumbar diskectomy surgery | Presented data at the International Intradiscal Therapy Society 13th Annual Meeting (6/13) |
Human Genome Sciences Inc. (HGSI) | BlyS | B lymphocyte stimulator that stimulates B cells to mature into plasma B cells, which produce antibodies | Common variable immunodeficiency | Initiated clinical trials (6/23) |
Immunex Corp. (IMNX) and Wyeth-Ayerst Pharmaceuticals (the pharmaceutical division of American Home Products Corp. [NYSE:AHP]) | Enbrel (FDA-approved) | Entanercept; recombinant, soluble T75 tumor necrosis factor receptor (TNFr) linked to the Fc portion of human IgG1 | Adult rheumatoid arthritis that inadequately responds to disease-modifying drugs | Presented U.S. and European long-term clinical trial data at 15th Annual Meeting of the European League Against Rheumatism in Nice, France (6/23) |
Integra LifeSciences Holdings Corp. (IART) | | Peripheral nerve regeneration conduit; bioresorbable collagen tube that is sutured to each end of the severed nerve bundle | Median nerve injuries | Initiated enrollment in Phase II trial (6/28) |
Maret Pharmaceuticals Inc.* | MARstem | Peptide analogue of the human hormone angiotensin | Restoration of red blood cells to minimize anemia in end-stage renal disease | Initiated Phase I/II trial (6/6) |
NitroMed Inc.* | NMI-870 | Nitric oxide-enhanced compound of the alpha2 blocker Vohimbine | Female sexual arousal disorder | Reported Phase II results at the 26th International Academy of Sex Research Conference in Paris (6/26) |
Novavax Inc. (AMEX: NOX) | Androsorb | Topical cream formulation containing nanosome encapsulated testosterone | Testosterone-deficient post-menopausal women | Initiated Phase I trial (6/20) |
OraSense Ltd. (joint venture of Elan Corp. plc [Ireland; NYSE:ELN] and Isis Pharmaceuticals Inc. [NYSE: ISIP]) | | Oral formulation of ISIS 2503, an inhibitor of H-ras (anticancer) | | Presented results from a proof-of-concept Phase I trial at the American Society of Pharmacology and Experimental Therapeutics and the American Society for Biochemistry and Molecular Biology in Boston; trial in healthy volunteers was designed to test the feasibility of oral delivery of antisense products (6/5) |
StressGen Biotechnologies Corp. (TSE:SSB) | HspE7 | Recombinant fusion product composed of heat shock protein 65 (Hsp65) from Mycobacterium bovis BCG and the protein E7, derived from the human papilloma virus | Anal dysplasia | Based on interim analysis of Phase II trial, company will proceed directly into a Phase III trial (6/26) |
Targeted Genetics Corp. (TGEN) | tgAAV-CF | Gene therapy; use of adeno-associated viral vector to deliver normal CFTR (cystic fibrosis transmembrane regulator) gene into nasal passage | Cystic fibrosis | Presented Phase I data at the ASGT meeting (6/5) |
Techniclone Corp. (TCLN) and Schering AG (Germany) | Oncolym | LYM-1 murine monoclonal antibody to HLA-DR10 protein (cell surface marker present on 80% of lymphoma cells), labeled with I-131 | Non-Hodgkin's lymphoma | Schering subsidiary Berlex Laboratories will initiate Phase II/III trial (6/22) |
United Therapeutics Corp. (UTHR) and Cortech Inc. | UT-77 | Serine elastase inhibitor | Chronic obstructive pulmonary disease | United Therapeutics discontinued UT-77 drug development project based on preclinical results and Phase II trial (6/27) |
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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AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; CDNX = Canadian Venture Exchange TSE = Toronto Stock Exchange |
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ND = Not disclosed. |
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ADA = The 60th annual meeting of the American Diabetes Association in San Antonio, Texas. |
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ASCRS = The annual meeting of the American Society of Colon and Rectal Surgeons in Boston |
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ASGT = The 3rd annual meeting of the American Society of Gene Therapy in Denver. |
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SNM = The 47th annual meeting of the Socieyt of Nuclear Medicine in St. Louis. |
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