Company* (Symbol) | Product |
Description | Indication | Status (Date)** |
CANCER | ||||
AltaRex Corp. (Canada; TSE:AXO) |
OvaRex MAb | Anti-idiotype induction therapy-based vaccine; consists of modified murine monoclonal antibody that binds to CA125 cancer antigen |
Advanced-stage ovarian cancer | Presented retrospective data at the 31st Annual Meeting of the Society of Gynecologic Oncologists in San Diego (1/8) |
OvaRex MAb |
Anti-idiotype induction therapy-based vaccine; consists of modified murine monoclonal antibody that binds to CA125 cancer antigen | Advanced-stage ovarian cancer | Data Safety Monitoring Board recommended continuation of potentially pivotal trial (1/4) | |
Amgen Inc. (AMGN) and Praecis Pharmaceuticals Inc.* | Abarelix; synthetically modified peptide that acts as gonadotropin-releasing hormone antagonist | Prostate cancer | Completed two Phase III trials (1/25) | |
Atrix Laboratories Inc. (ATRX) |
Atrigel formulation of leuprolide acetate; product is injected subcutaneously as a liquid, then solidifies and releases a predetermined dose of leuprolide continuously over a 30-day period as it is reabsorbed |
Prostate cancer |
In first 36 patients of ongoing Phase III trial, product reduced testosterone to levels known to inhibit tumor growth in prostate cancer (1/19) | |
Biomira Inc. (Canada; BIOM) | BLP 25 vaccine | Synthetic MUC-1 therapeutic vaccine; consists of 25-amino-acid sequence of the MUC-1 cancer mucin, encapsulated in liposomes; supresses tumor angiogenesis |
Advanced non-small-cell lung cancer |
Initiated second stage of Phase II trial program (1/25); presented Phase I and II data at a Keystone Symposium titled "Cellular Immunity and Immunotherapy of Cancer" in Santa Fe, N.M. (1/26) |
British Biotech plc (UK; BBIOY) | Marimastat |
Oral matrix metallo-proteinase inhibitor designed to inhibit blood flow to tumors |
Advanced pancreatic cancer | Combination of marimastat and gemcitabine failed to show significant improvement in survival in multi-center pivotal Phase III trial; additional trials are slated to report in 2000 (1/25) |
Cangene Corp. (Canada; TSE:CNJ) | Leucotropin | Granulocyte macrophage colony stimulating factor (GM-CSF) |
Mobilization of peripheral blood stem cells in breast cancer patients | Cangene terminated U.S. Phase III trial early, citing slow recruitment and recent reports that high-dose chemotherapy and stem-cell transplantation may not be clinically superior to standard dose regimens in certain breast cancer patients (1/6) |
Cephalon Inc. and TAP Holdings Inc. (partnership between Takeda Chemical Industries Ltd. [Japan] and Abbott Laboratories [NYSE:ABT]) | CEP-701 | Oral signal transduction modulator that inhibits certain growth factors by inhibiting the trk kinase | Prostate cancer | Initiated Phase II clinical program that includes a study in patients whose prostate is being surgically removed and a study in patients with hormone-resistant tumors (1/12) |
Dendreon Corp.* |
Therapeutic cancer vaccine that involves the isolation of a patient's dendritic cells and activation of these cells using a prostate tumor vaccine | Advanced prostate cancer | Initiated treatment in Phase III trial (1/26) |
|
Genta Inc. (GNTA) |
G3139 |
Antisense drug that targets mRNA produced by the bcl-2 gene, which is believed to be an apoptosis inhibitor |
Relapsed small-cell lung cancer | National Cancer Institute initiated Phase I/II study of G3139 in combination with paclitaxel (1/5) |
Human Genome Sciences Inc. (HGSI) |
Repifermin |
Keratinocyte growth factor-2 therapeutic protein (genomics derived); KGF-2 is activated when there is an epithelial tissue wound | Mucositis associated with bone marrow transplantation for treatment of cancer |
Initiated dosing in Phase II trial (1/19) |
Immunomedics Inc. (IMMU) |
CEA-Cide |
Humanized antibody against carcinoembryonic antigen; radiolabeled with yttrium-90 | Advanced, metastatic medullary thyroid cancer | Data from 12-patient proof-of-principle trial published in 1/00 issue of The Journal of Nuclear Medicine (1/26) |
Isis Pharmaceuticals Inc. (ISIP) |
ISIS 5132 | Antisense oligonucleotide that targets c-raf-1 mRNA expression |
Advanced-stage cancer |
Mechanism of action trial data published in 12/99 issue of Clinical Cancer Research (1/12) |
Matrix Pharmaceutical Inc. (MATX) | Intradose injectable gel | Biodegradable gel containing cisplatin and epinephrine (intra-tumoral injection) | Recurrent or refractory head and neck cancer |
Completed enrollment in two Phase III registration-directed trials (1/13) |
NeoRx Corp. (NERX) | Skeletal Targeted Radiotherapy |
Product delivers holmium-166 radionuclide to bone and adjacent bone marrow |
Multiple myeloma | Reported Phase I trial results and that Phase II enrollment is close to completion (1/13) |
Neurocrine Biosciences Inc. (NBIX) |
NBI-3001 |
Blood cell-derived growth factor (IL-4, which binds to IL-4 receptors on malignant brain tumors) combined with Pseudomonas exotoxin (an anticancer toxin); product is administered via a special catheter that permits delivery directly into brain tumor | Glioblastoma multiforme malignant brain tumors |
Neurocrine presented a review of data from an ongoing Phase I/II trial at the First Union Securities Brain and Spine Symposium conference (1/19) |
CARDIOVASCULAR | ||||
3-Dimensional Pharmaceuticals* | 3DP 4815 | Oral anticoagulant thrombin inhibitor |
Arterial and venous thrombosis |
Initiated Phase I trial (1/20) |
AVANT Immunotherapeutics (AVAN) |
TP10 |
Soluble form of complement receptor 1 (CR1), designed to inhibit complement proteins |
Reduction of consequences of reperfusion injury in infants undergoing cardiopulmonary bypass | Completed enrollment in open label Phase II trial (1/13) |
BioPure Corp. (BPUR) |
Hemopure | 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 red blood cell transfusion in orthopedic surgery |
Continued to enroll patients in pivotal Phase III trial following independent panel's review of safety data at the halfway point of the trial (1/12) |
Genzyme Transgenics Corp. (GZTC) and Genzyme General (GENZ) | Recombinant human antithrombin III (rhATIII) produced in transgenic mammals |
Restoration of heparin sensitivity in heparin-resistant patients | Reported results of Phase III trial that met primary endpoint of reduction in the use of fresh frozen plasma (1/10) | |
Hemosol Inc. (Canada; TSE: HML) |
Hemolink |
Hemoglobin replacement product derived from red blood cells | Coronary artery bypass grafting surgery |
Completed Phase II trial (1/10) |
Transkaryotic Therapies Inc. (TKTX) and Aventis SA (NYSE:AVE) |
GA-EPO | Gene-activated erythropoietin; gene in human cells is activated in situ to produce EPO | Anemia of renal failure in dialysis and pre-dialysis patients |
Completed dosing in pivotal Phase III trials (1/11) |
CENTRAL NERVOUS SYSTEM | ||||
Cellegy Pharmaceuticals Inc. (CLGY) |
Anogesic in a proprietary formulation | Nitroglycerin ointment |
Reduction of pain associated with hemorrhoid surgery | Expanded and accelerated Phase II trial following findings from Phase III study in pain reduction of anal fissures (1/20) |
Cephalon Inc. (CEPH) |
Provigil tablets (FDA-approved) |
Modafinil; oral formulation of synthetic compound that is thought to affect alpha-adrenergic receptors in the brain | Multiple sclerosis fatigue |
Reported data from placebo-controlled study (1/13) |
Provigil tablets (FDA-approved) |
Modafinil; oral formulation of synthetic compound that is thought to affect alpha-adrenergic receptors in the brain |
Improvement of performance and alertness during shift work |
Reported data from placebo-controlled study (1/13) |
|
Interneuron Pharmaceuticals Inc. (IPIC) and Takeda Chemical Industries Ltd. (Japan) |
CerAxon | Citicholine sodium; organic molecule that consists of cytidine and choline (components of brain cell membranes) |
Moderate to severe ischemic stroke |
Failed to meet primary endpoint improvement in neurological function in Phase III trial (1/10) |
Orphan Medical Inc. (ORPH) |
Xyrem | Sodium oxybate oral solution |
Narcolepsy symptoms of cataplexy and excessive daytime sleepiness |
Results of two pivotal Phase II clinical trials were presented at the First Union Securities Brain and Spine Conference in New York (1/19) |
Neurobiological Technologies Inc. (OTC BB:NTII) and Merz + Co. GmbH & Co. (Germany) |
Memantine | Orally available neuro-protective agent that appears to restore damaged nerve cells and block excitatory signals by modulating the N-methyl-D-aspartate (NMDA) receptor on cell membranes |
AIDS-related dementia | Completed enrollment in Phase II trial (1/31) |
Sepracor Inc. (SEPR) |
Single-isomer form of desmethylsibutramine, a serotonin, norepin-ephrine and dopamaine re-uptake inhibitor (single-isomer form of Meridia, marketed by Knoll Pharmaceutical Co. [unit of BASF AG; Germay]) |
Multiple CNS indications including depression and attention deficit hyperactivity disorder | Initiated Phase I trial (1/31) | |
Single-isomer form of zopiclone, a non-benzodiazepine rapid-acting hypnotic (single-isomer form of Imovane, marketed by Rhone-Poulenc Rorer Inc. [NYSE:RPR]) | Insomnia |
Initiated efficacy trial (1/18) | ||
DIABETES | ||||
Amylin Pharmaceuticals Inc. (AMLN) | AC2993 | Synthetic exendin-4 | Type II diabetes | Reported preliminary results of dose-finding Phase II study (1/7); reported additional analyses from Phase II trial first reported 10/99 (1/10) |
Diamyd Medical AB (Sweden; SBI: DIAMb) | Diamyd | Type I diabetes vaccine; recombinant human GAD65 (glutamic acid decarboxylase) | Treatment and/or prevention of Type I diabetes |
Completed Phase I trial; data reported at Miami meeting of the National Institute of Diabetes and Digestive and Kidney Diseases (1/31) |
Generex Biotechnology Corp. (Canada; OTC BB:GNBT) |
Oralin/Oralgen |
Oral form of insulin |
Type I diabetics and healthy volunteers | Completed short-term trials (1/12) |
Neurobiological Technologies Inc. (OTC BB:NTII) and Merz + Co. GmbH & Co. (Germany) |
Memantine |
Orally available neuro-protective agent that appears to restore damaged nerve cells and block excitatory signals by modulating the N-methyl-D-aspartate (NMDA) receptor on cell membranes |
Painful diabetic neuropathy | Reported preliminary results of Phase IIb dose-ranging trial (1/19) |
INFECTION | ||||
Agouron Pharmaceuticals Inc. (subsidiary of Warner-Lambert Co.; NYSE: WLA) | Capravirine; non-nucleoside reverse transcriptase inhibitor |
HIV infection |
Reported data from second pharmacokinetic trial; data from both trials presented at the 7th Conference on Retroviruses and Opportunistic Infections in San Francisco (1/30) | |
Viracept (FDA- approved) | Nelfinavir mesylate; HIV protease inhibitor |
HIV infection |
Presented data from three trials at the 7th Conference on Retroviruses and Opportunistic Infections in San Francisco (1/30) |
|
AVANT Immunotherapeutics Inc. (AVAN) |
Peru-15 |
Cholera vaccine |
Prevention of cholera infection | AVANT will collaborate with the Walter Reed Army Institute of Research and the National Institutes of Health on a Phase IIb scheduled to begin this year (1/18) |
The Immune Response Corp. (IMNR) and Agouron Pharmaceuticals Inc. (subsidiary of Warner-Lambert Co.; NYSE:WLA) | Remune | Envelope-depleted, inactivated HIV (emulsified with adjuvant) |
HIV infection |
Facility-sponsored trial at Cedars-Sinai Medical Center in Los Angeles will test Remune in combination with highly active antiretroviral therapy in early-stage HIV infection (1/25) |
Micrologix Biotech Inc. (Canada; TSE: MBI) |
MBI 226 |
Peptide antibiotic |
Prevention of central venous catheter-related bloodstream infection |
Completed Phase II trial and reported results (1/12) |
Peptide Therapeutics Group (LSE:PTE) |
Vaccine against Clostridium difficile-associated diarrhea and colitis |
Clostridium difficile-associated diarrhea and colitis | Reported results of Phase I/II trial funded by the National Institute of Allergy and Infectious Diseases and conducted by Peptide Therapeutics' U.S. subsidiary, OraVax Inc. (1/20) | |
SciClone Pharmaceuticals (SCLN) | Zadaxin | Thymosin alpha 1; synthetic version of naturally occuring peptide hormone thymosin (immunomodulator) |
Hepatitis B virus infection | Initiated Phase II trial of Zadaxin in combination with lamivudine, an FDA-approved nucleoside analogue marketed by BioChem Pharma Inc. (Canada; BCHE) (1/27) |
Trimeris Inc. (TRMS) and Hoffmann-La Roche Inc. (Switzerland) | T-20 | Antiviral fusion-inhibiting compound (twice-daily subcutaneous injection) | HIV infection | Reported 32-week results from ongoing open-label Phase II trial of T-20 in combination regimen (1/28) |
Vical Inc. (VICL) and Merck & Co. Inc. (NYSE: MRK) | Naked DNA vaccine; intramuscular injection |
Prevention of HIV infection | Initiated Phase I trial (1/7) |
|
MISCELLANEOUS | ||||
Aradigm Corp. (ARDM) and Genentech Inc. (NYSE:DNA) | Inhalation solution of recombinant human dornase alfa (active ingredient of Genentech's Pulmozyme) |
Cystic fibrosis |
Initiated Phase IIa trial (1/24) |
|
Carrington Laboratories Inc. (CARN) |
Aliminase (formerly CARN 1000) | Oral anti-inflammatory complex carbohydrate |
Ulcerative colitis | Completed patient enrollment in Phase III trial (1/12) |
Discovery Laboratories Inc. (DSCO) |
Surfaxin | Lucinactant (sinapultide); lung surfactant containing the peptide KL4, a 21-amino-acid peptide modeled after the SP-B protein in the human surfactant system | Full-term infants with meconium aspiration syndrome | Initiated pivotal Phase III trial (1/27) |
Surfaxin |
Lucinactant (sinapultide); lung surfactant |
Acute respiratory distress syndrome containing the peptide KL4, a 21-amino-acid peptide modeled after the SP-B protein in the human surfactant system | Halted Phase II/III trial due to improved manufacturing process allowing for less viscous formulation; company plans to initiate new trial in the indication with new formulation (1/27) |
|
Emisphere Technologies Inc. (EMIS) and Novartis Pharma (Switzerland) | Solid oral dosage form of calcitonin |
Osteoporosis | Reported results of Phase I trial (1/11) |
|
ICOS Corp. (ICOS) |
IC351 | Inhibits cGMP-destroying enzyme PDE5, thus allowing cGMP to accumulate and reinforce signal to increase blood flow |
Erectile dysfunction and female sexual dysfunction |
Began enrollment of healthy female volunteers for pharmacokinetic studies (1/12) |
Pafase (formerly rhPAF-AH) |
Recombinant platelet activating factor acetylhydrolase; degrades PAF and thereby lessens inflammatory response | Prevention of acute respiratory distress syndrome in at-risk patients | Completed enrollment in Phase II trial (1/12) |
|
Inspire Pharmaceuticals Inc.* |
INS365 Ophthalmic Solution |
Small molecule that stimulates the P2Y2 receptor, a key mediator of mucosal hydration and mucociliary clearance |
Dry-eye disease |
Initiated Phase II trial (1/5) |
OrthoLogic Corp. (OLGC) | Chrysalin | Synthetic peptide that represents a portion of the receptor binding domain of the human thrombin molecule; by mimicking specific attributes of thrombin, product stimulates healing processes |
Fractures |
Initiated enrollment in Phase I/II trial (1/12) |
Notes: | ||||
* Indicates a privately held company | ||||
** The dates listed indicate the issue dates of press releases, and are not necessarily the dates on which stated events took place. | ||||
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; SBI=Stockholm Borsinformation; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange | ||||
ND = Not disclosed | ||||
