Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Aphton Corp. (APHT) | GnRH pharmacine | Anti-GnRH immunogen | Advanced prostate cancer | The company presented data of a pilot study showing positive results (9/25) |
Atrix Laboratories Inc. (ATRX) | Leuprogel | New Atrigel formulation containing leuprolide acetate; injected subcutaneously | Testosterone level reduction to reduce prostate cancer risk | Company presented interim data in the multicenter, Phase III trial that enrolled 120 patients (9/26) |
Aventis Pharmaceuticals (unit of Aventis SA [NYSE:AVE]) | Taxotere | Docetaxel; semisynthetic agent derived from needles of the European yew tree | Non-small-cell lung cancer | Researchers presented findings of a multicenter, randomized Phase III study comparing docetaxel plus cisplatin, docetaxel plus carboplatin and vinorelbine plus cisplatin, as well as results from several other clinical trials at the 9th World Conference on Lung Cancer (9/11) |
Axcan Pharma Inc. (AXCA; TSE: AXP) | Photofrin (FDA-approved) | Photosensitive drug (porfimer sodium; produces toxic oxygen compound when light-activated) | High-grade dysplasia associated with Barrett's esophagus and esophageal cancer | Positive Phase III data were presented at the 6th World Congress of the International Organization for Statistical Studies on Diseases of the Esophagus (9/5) |
Biomira Inc. (BIOM; TSE:BRA) | Theratope vaccine | Synthetic carbohydrate-based vaccine; mimic of cancer antigen si alyl-Tn plus carrier molecule KLH | Metastatic breast cancer | Company announced at the Stephens Inc. Anticancer Biopharmaceutical Investment Conference that it will surpass 700 patients in its pivotal Phase III trial (9/18) |
British Biotech (UK; BBIOY) | Marimastat | Oral matrix metalloproteinase inhibitor | Advanced ovarian cancer | Company announced results that showed the combination of carboplatin and marimastat had no statistically significant advantage over carboplatin alone in either primary or secondary endpoints (9/26) |
Calydon Inc.* | CV787 | Oncolytic virus that replicates in human prostate cancer cells | Metastatic prostate cancer | Company began Phase I/II trial (9/28) |
Cell Genesys Inc. (CEGE) | GVAX | Cancer vaccine comprised of tumor cells that have been irradiated and genetically modified to secrete granulocyte macrophage-colony stimulating factor | Non-small-cell lung cancer | Researchers presented follow-up data at the 9th World Conference on Lung Cancer; 18 of 25 patients demonstrated enhanced antitumor immunity (9/12) |
Cytran Inc.* | IM862 | Naturally occurring peptide administered as nose drops | Kaposi's sarcoma | Company is seeking 200 patients for a Phase III, randomized, placebo-controlled, double-blind study being conducted with the AIDS Malignancy Consortium of the National Cancer Institute (9/14) |
EntreMed Inc. (ENMD) | 2-Methoxy-estradiol (2ME2) | Oral compound; naturally occurring antiproliferative and antiangiogenic agent | Advanced breast cancer | First Phase I trial began testing 2ME2 in combination with cytotoxic chemotherapy, Taxotere (9/18) |
Genta Inc. (GNTA) | Genasense | Antisense compound; synthetic DNA strands that bind to mRNA for the bc12 gene | Malignant melanoma | Company said enrollment should be completed in the Phase III trial by mid-summer 2001; it also plans to initiate studies in multiple myeloma, chronic lymphocytic leukemia and acute myelocytic leukemia by the first quarter of 2001 (9/19) |
Genzyme Molecular Oncology (GZMO) | Gene therapy cancer vaccine | Combines melanoma tumor antigens MelanA/MARTI and gp100 | Melanoma | Company initiated a Phase I/II trial to assess safety, efficacy and potency of the gene therapy cancer vaccine (9/26) |
ImmunoGen Inc. (IMGN) and SmithKline Beecham (NYSE:SBH) | huC242-DM1/SB-408075 | Tumor-Activated Prodrug | Colorectal and pancreatic cancer | Company said the product entered a second Phase I/II trial (9/21) |
Immunomedics Inc. (IMMU) | LymphoCide | Humanized anti-CD22 monoclonal antibody, epratuzumab | Non-Hodgkin's lymphoma (NHL) | Company is beginning a Phase III pivotal trial in patients with low-grade or indolent NHL (9/26) |
MGI Pharma Inc. (MOGN) | Irofulven | Hydroxymethylacyl-fulvene | Liver cancer | Company initiated a Phase II trial at Beth Israel Deaconess Medical Center (9/27) |
OSI Pharmaceuticals Inc. (OSIP) | OSI-774 | Orally active inhibitor of the epidermal growth factor receptor | Non-small-cell lung cancer | Investigators presented early data of a Phase II study at the 9th World Conference on Lung Cancer; four of 12 patients had objective partial responses and another four had disease stabilization (9/13) |
Pharmacyclics Inc. (PCYC) | Xcytrin | Motexafin gadolinium injection | Stage IIIA non-small-cell lung cancer; glioblastoma multiforme | Company initiated two Phase I trials (9/7) |
SafeScience Inc. (SAFS) | GBC-590 | Carbohydrate lectin inhibitor that competitively binds to unique lectins on cancer cells and disrupts the metastatic process | Colorectal carcinoma | Company completed enrollment of a Phase II trial with 23 patients (9/21) |
StressGen Biotechnologies (TSE:SSB) | HspE7 | Recombinant fusion product composed of heat shock protein 65 from Mycobacterium bovis BCG and the protein E7, derived from the human papilloma virus dysplasia | Advanced cancer of the uterine cervix | Company initiated patient treatment in a Phase II trial(9/6) |
SuperGen Inc. (SUPG) | Nipent (FDA-approved) | Pentostatin for injection; chemotherapeutic drug that inhibits adenosine deaminase (blocks DNA synthesis) | GVHD | Studies presented at the Leukemia 2000 medical conference show Nipent is active in GVHD and a number of hematological malignancies (9/18) |
SuperGen Inc. (SUPG) | Rubitecan | Oral chemotherapy in the camptothecin class | Chronic myeloid leukemia, chronic myelomonocytic leukemia and myelodysplastic syndrome | Studies presented at the Leukemia 2000 medical conference show that 43% of patients tested experienced a complete response, partial response or hematologic improvement (9/15) |
Therion Biologics Corp.* and the National Cancer Institute | Prostvac VF | Vaccine | Prostate cancer | Company and NCI have initiated two additional Phase II trials (9/7) |
Vical Inc. (VICL) | Leuvectin | Gene encoding interleukin-2 (complexed with lipid) administered by direct intratumoral injection | Prostate cancer | Company announced interim results from an ongoing Phase II trial showing Leuvectin to be safe and well tolerated (9/25) |
Zarix Inc.* | Thymitaq | Nolatrexed dihydrochloride | Unresectable hepatocellular carcinoma | Initiated patient enrollment in pivotal Phase III randomized study (9/28) |
CARDIOVASCULAR |
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AtheroGenics Inc. (AGIX) | AGI-1067 | Anti-inflammatory compound with antioxidant properties | Post-angioplasty restenosis | Company completed enrollment of 300 patients in the Phase II trial (9/26) |
Avant Immunotherapeutics Inc. (AVAN) | TP10 | Soluble form of complement receptor 1, designed to inhibit complement proteins | Infants undergoing cardiac surgery | Company plans to initiate a double-blind, placebo-controlled Phase IIb study (9/15) |
COR Therapeutics Inc. (CORR) | Integrilin | Eptifibatide injection; small-molecule compound (derived from rattlesnake venom) that inhibits GPIIb/IIIa receptor that mediates platelet aggregation | Unstable angina | PURSUIT study results were published in Circulation showing Integrilin added to aspirin and heparin significantly reduced the occurrence of heart attack or death (9/5) |
Corvas International Inc. (CVAS) | rNAPc2 | Injectable anticoagulant recombinant protein, discovered in its original form in flood-feeding hookworms | Deep-vein thrombosis | Company announced positive results from a Phase II trial showing it reduces the risk of developing DVT by greater than 50% as compared to low molecular weight heparins (9/14) |
Diacrin Inc. (DCRN) and Temple University | Skeletal muscle cells | Autologous myoblasts | To repair damaged heart muscle | Company and university transplanted a patient's skeletal muscle cells into a damaged area of his heart in Phase I trial (9/25) |
Genzyme Transgenics Corp. (GZTC) and Genzyme General (GENZ) | rhATIII | Recombinant human antithrombin III produced in the milk of goats | To restore heparin sensitivity and manage coagulation during cardiopulmonary bypass surgery | Companies said the primary endpoint of reduction in the use of frozen plasma was statistically significant in a second Phase III trial (9/7) |
Scios Inc. (SCIO) | Natrecor | Nesiritide; a recombinant form of B-type natriuretic peptide, a naturally occurring hormone that aids healthy functioning of the heart | Acute congestive heart failure | Results of the Vasodilation in the Management of Acute Congestive heart failure (VMAC) trial were presented at the 73rd SSAHA meeting in New Orleans (9/7) |
CENTRAL NERVOUS SYSTEM |
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Axonyx Inc. (AXYX) | Phenserine | Brain-targeted, reversible inhibitor of acetylcholinest-erase enzyme | Alzheimer's disease | Company announced results of a Phase I trial, which confirm the drug to be safe and well tolerated; the company intends to start a Phase II trial by the end of the year (9/12) |
Biogen Inc. (BGEN) | Avonex | Recombinant interferon beta-1a | Clinically definite multiple sclerosis | Company announced publication in New England Journal of Medicine study results showing Avonex significantly reduces the rate of individuals developing CDMS (9/25) |
Nymox Pharmaceutical Corp. (NYMX) | 7C Gold test | Measures neural thread protein in urine | Alzheimer's disease | Company announced at the 2nd Manhattan Alzheimer Conference that new clinical studies show positive results (9/14) |
Pharmos Corp. (PARS) | Dexanabinol | Non-psychotropic-synthetic analogue of marijuana (intravenous) | Severe traumatic brain injury | Company presented results of a Phase II trial demonstrating the drug improved orientation and memory, at the annual meeting of the Congress of Neurological Surgeons (9/27) |
Sepracor Inc. (SEPR) | (S)-zopiclone | A single-isomer version of racemic zopiclone, a non-benzodiazepine, rapid-acting hypnotic | Insomnia | Company began Phase III patient enrollment (9/6) |
Titan Pharmaceuticals Inc. (AMEX:TTP) | Zomaril | Iloperidone; antipsychotic that has an antagonistic activity on a wide range of brain receptors for dopamine and serotonin, with preferential affinity for 5HT2A serotonin receptors in humans | Schizophrenia | Company announced positive safety and efficacy data from a Phase III study involving more than 600 patients in the U.S., Europe, Canada, Australia and South Africa (9/25) |
DIABETES |
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Amylin Pharmaceuticals Inc. (AMLN) | Symlin and AC2993 | Pramlinitide acetate; synthetic analogue of human pancreatic hormone amylin; and synthetic exendin-4; 39-amino-acid peptide that exhibits anti-diabetic activity similar to the mammalian hormone glucagon-like peptide | Type I and Type II diabetes | Phase III data of Symlin were presented at the 36th Annual Meeting of the European Society for the Study of Diabetes showing 52 weeks of treatment improved glycemic and weight control in people with Type I diabetes; data of AC2993 trials also were presented (9/18) |
DepoMed Inc. (AMEX:DMI) | Metformin GR | Company's extended-release form of Glucophage | Type II diabetes | Company initiated a Phase II trial comparing Metformin GR with Glucophage (9/27) |
Diamyd Medical AB* (Sweden) | Insulin | Oral formulation | Type I diabetes | The Lancet published Phase II study results; no statistical difference was found between the oral administration of insulin and a placebo (9/13) |
Flamel Technologies S.A. (France; FLMLY) | Metformin | Formulation of controlled-released Metformin using Micropump technology | Type II diabetes | Company announced successful results of a Phase I study (9/25) |
INFECTION |
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Abbott Laboratories | Kaletra | Lopinavir/ritonavir; protease inhibitor | HIV | Data presented at ICAAC show Kaletra used in combination with other antiretroviral therapy provides effective viral suppression for almost two years in most patients (9/17) |
Agouron Pharmaceuticals Inc. (a Pfizer Inc. [NYSE:PFE] company) | Capravirine | Non-nucleoside reverse transcriptase inhibitor | HIV | Company initiated additional trial as part of combination therapy in people who have failed previous therapy (9/18) |
AntexBiologics Inc. (AMEX:ANX) | Helivax | Oral vaccine produced using Nutriment Signal Transduction technology, which regulates bacterial growth | Helicobacter pylori | Enrollment was completed in the Phase I trial; Results to be announced in the first quarter of 2001 (9/12) |
Aronex Pharmaceuticals Inc. (ARNX) | Nyotran | Liposomal formulation of nystatin | Invasive aspergillus | Data presented at ICAAC showed Nyotran was well tolerated with objective responses in 6 out of 19 evaluable patients (9/19) |
Cubist Pharmaceuticals | Cidecin | Daptomycin for injection | Bacteremia; Gram-positive infections | Data were prestented at the 40th ICAAC meeting on Phase I and II trials, showing no serious adverse events and positive results in treating Gram-positive infections, including bacteremia (9/19) |
Gilead Sciences Inc. (GILD) | Tenofovir DF | Tenofovir disoproxil fumarate | HIV | Phase II results were presented at ICAAC showing the drug was associated with significant and sustained antiviral activity (9/18) |
Micrologix Biotech Inc.* (Canada) | MBI 226 | Antimicrobial drug | Bacterial and fungal bloodstream infections | Phase III trial initiated (9/20) |
Nabi (NABI) | StaphVAX | Staphylococcus aureus conjugate vaccine | S. aureus bacteremia | Phase III results presented at ICAAC showed reduction in infection for the first 10 months of the study, but the trial did not reach statistical significance by demonstrating a decrease at the one-year follow-up (9/19) |
Ribozyme Pharmaceuticals Inc. (RZYM) and Eli Lilly & Co. (NYSE:LLY) | LY466700 | Chemically synthesized ribozyme designed to selectively cut hepatitis C virus RNA in a conserved region and inhibit viral replication | Hepatitis C | Companies completed a safety and pharmacokinetic study that showed the drug was well tolerated over 28 days (9/11) |
Ribozyme Pharmaceuticals Inc. (RZYM) | Heptazyme | Anti-hepatitis C ribozyme | Hepatitis C | Company repurchased its rights from Eli Lilly & Co. and will initiate Phase II trials (9/28) |
Synsorb Biotech (Canada; TSE:SYB; SYBB) | Synsorb Pk | Orally delivered carbohydrate attached to inert, insoluble support; binds to toxins secreted by bacteria in the gastrointestinal tract | Prevention of hemolytic uremic syndrome | Company announced an additional clinical trial will be needed to complete development following discussions with regulatory authorities in the U.S. and Canada (9/26) |
The Medicines Co. (MDCO) | CTV-05 | A strain of human Lactobacillus | Bacterial vaginosis | Company started a large, randomized trial of CTV-05 as an adjunct to standard antibiotic treatment of bacterial vaginosis (9/6) |
Triangle Pharmaceuticals Inc. (VIRS) and Abbott Laboratories (NYSE:ABT) | DAPD | Dioxolane purine nucleoside reverse transcriptase inhibitor that is rapidly converted in humans into its active metabolite, DXG | HIV | Preliminary data of a Phase I/II trial in which DAPD produced decreases in viral loads were presented at ICAAC (9/18) |
ViroLogic Inc (VLGC) | PhenoSense HIV | Drug resistance test to detect and measure hypersusceptibility | HIV | Data presented at ICAAC show that hypersusceptibility to non-nucleoside reverse transcriptase inhibitors is prevalent among patients with previous HIV treatment experience (9/18) |
MISCELLANEOUS |
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Alkermes Inc. (ALKS) | Medisorb Naltrexone | Injectable sustained-release formulation of naltrexone | Alcoholism and opiate abuse | Enrollment completed of 42 subjects in double-blind, placebo-controlled study (9/27) |
Biopure Corp. (BPUR) | Hemopure | Hemoglobin glutamer-250 (bovine) | Alternative to red blood cell transfusion in patients undergoing orthopedic surgery | Company completed enrolling 680 patients in the U.S., Europe, Canada and South Africa in the pivotal Phase III trial (9/6) |
Cellegy Pharmaceuticals Inc. (CLGY) | Tostrelle | Transdermal testosterone gel | Testosterone deficiency | Company completed a Phase I/II trial that showed the gel was well tolerated (9/20) |
Curis Inc. (CRIS) | Chondrogel | Minimally invasive tissue augmentation product | Vesicoureteral reflux | Enrollment was completed in a pivotal Phase III trial; data are expected to be available in late 2001 (9/19) |
Genzyme General (GENZ) | Fabrazyme | Agalsidase beta; enzyme replacement therapy | Fabry disease | Pivotal trial results were statistically significant and are published on the web site of the American Society of Human Genetics (9/6) |
Human Genome Sciences Inc. (HGSI) | Repifermin | Keratinocyte Growth Factor-2 | Chronic venous ulcers | Company said it will advance its clinical development program based on promising results from a Phase IIa trial reported at the World Wound Healing Congress (9/13) |
InKine Pharmaceutical Co. (INKP) | Visicol | Sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP | Gastrointestinal endoscopy | Published article in the Sept. issue of Gastrointestinal Endoscopy of study of 305 patients undergoing diagnostic colonoscopy randomized to Colyte, Fleet Phospho-Soda and Visicol groups; results showed no significant differences in cleansing efficacy, but there was less nausea, abdominal pain and bloating in the sodium phosphate tablet group (9/13) |
Iomed Inc. (AMEX:IOX) | Dexamethasone | Company's Phoresor System delivers dexamethasone | Epicondylitis | Company plans to begin next month a Phase III study (9/28) |
Ligand Pharmaceuticals Inc. (LGND) and Pfizer Inc. (NYSE:PFE) | Lasofoxifene | A selective estrogen receptor modulator | Osteoporosis | Pfizer initiated Phase III trials (9/26) |
NexMed Inc. (NEXM) | Alprox-TD | Topical treatment; incorporates alprostadil with NexACT drug delivery system | Erectile dysfunction | Company completed testing of 190 patients in a Phase II trial; the trial was randomized, double-blind and placebo-controlled (9/19) |
PPL Therapeutics plc* | Alpha-1-Antitrypsin | Derived from sheep's milk | Cystic fibrosis | Company announced positive results in its one-year safety study (9/20) |
Zonagen Inc. (ZONA) | Vasofem | Phentolamine mesylate-based product | Female sexual dysfunction | Encouraging data from a double-blind, randomized and placebo-controlled study were presented at the FIGO World Congress of Gynecologists (9/7) |