Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Allos Therapeutics Inc. (ALTH) | RSR13 | Synthetic allosteric modifier of hemoglobin that noncovalently binds to hemoglobin, increasing oxygen delivery to hypoxic tissue | Non-small-cell lung cancer | Completed patient enrollment in a Phase II trial in patients undergoing chemotherapy followed by radiation therapy (8/2) |
Celgene Corp. (CELG) | Thalomid (FDA- approved) | Thalidomide; thought to act by modulating levels of tumro necrosis factor-alpha | Advanced colorectal cancer | Published interim analysis of a pilot trial combining Thalomid with irinotecan in The Lancet (8/11) |
Cell Pathways Inc. (CLPA) | CP461 | Compound that triggers selective apoptosis in neo-plastic cells by inhibiting cyclic GMP phosphodiesterase | Cancer | Completed Phase IB testing with encouraging safety results (8/3) |
Cel-Sci Corp. (AMEX:CVM) | Multikine | Natural mixture of human cytokines, including interleukin-2 | Head and neck cancer | Presented updated Phase I/II findings showing tumor elimin- ation, tumor reduction and activa- tion of the immune system; data were reported at the 5th Interna- tional Congress on Head and Neck Cancer in San Francisco (8/3) |
Corixa Corp. (CRXA) | Melacine | Therapeutic cancer vaccine made of lysed cells from 2 melanoma cell lines with a broad array of melanoma antigens, combined with Detox adjuvant (contains monophosphoryl lipid A and mycobacterial cell- wall skeleton) | Stage IV metastatic melanoma | Completed a 253-patient Phase III trial comparing Melacine and Intron A therapy with Intron A alone (8/16) |
Inex Pharmaceuticals Corp. (Canada; INEX) | Onco-TCS | Therapeutic consisting of vincristine encapsulated in Inex's transmembrane carrier systems drug delivery technology | Small-cell lung cancer | Initiated Phase II trial (8/23) |
Inex Pharmaceuticals Corp. (Canada; INEX) | Onco TCS | Therapeutic consisting of vincristine encapsulated in Inex's transmembrane carrier systems drug delivery technology | Relapsed solid tumors in children and adolescents | Initiated second Phase II trial to broaden development for Onco TCS beyond relapsed aggressive non-Hodgkin's lymphoma (8/24) |
Intracel Corp.* | HumaRAD | Fully human monoclonal antibody-based product that delivers radiation directly to a tumor | Head and neck cancer | Demonstrated safety and feasibility in a 10-patient pilot study (8/2) |
Intracel Corp.* | OncoVAX | Cancer vaccine; incorporates recombinant prostate-specific antigen plus adjuvant in liposomal formulation | Stage II colon cancer | Reported finding of three trials demonstrating significant improvement in the recurrence- free interval and recurrence-free survival (8/31) |
LifeTime Pharmaceuticals* | Beta LT | Beta-alanyl cysteamine disulfide; synthetic small- molecule immune stimulator | Cancer | Announced early closure of both initial Phase I/II trials, which have achieved all targeted goals (8/2) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin Capsules (FDA- approved) | Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors; oral formulation | Non-small-cell lung cancer | Follow-up study showed Targretin capsules in combination with chemotherapy may increase patient survival (8/14) |
Oxigene Inc. (OXGN) | Declopramide | Oral formulation of DNA repair inhibitor based on the N-substituted benzamide class of compounds | Advanced-stage solid tumors | Announced results of two Phase I trials to be presented at the 25th ESMO Congress in Hamburg (8/1) |
Pfizer Inc. (NYSE:PFE) | Prinomastat | Matrix metalloprotease inhibitor | Advanced hormone-refractory prostate cancer and advanced non- small-cell lung cancer | Two Phase III clinical trials were halted when the product failed to meet efficacy objectives in combination with standard chemotherapy (8/4) |
Scotia Holdings plc (UK; LSE:SOH) | Foscan | Temoporfin, mTHPC; photodynamic therapeutic that uses non-thermal lasers to activate light-sensitive drug | Head and neck cancer | Presented results from trials on more than 250 patients at the 5th International Conference on Head and Neck Cancer in San Francisco (8/2) |
SuperGen Inc. (SUPG) and Abbott Laboratories (NYSE:ABT) | Rubitecan | Oral chemotherapy in the camptothecin class | Various cancers | The company said Phase III trials are "continuing full force" despite some delays; the company targets an NDA for mid-2001 (8/31) |
Techniclone Corp. (TCLN) | Cotara | Tumor necrosis therapy; chimeric monoclonal anti- body that targets DNA-associated histone antigens, labeled with I-131 (targets necrotic center of tumor) | Brain cancer | Expanded Phase II trial to include Northwestern University (8/3) |
Vical Inc. (VICL) | Allovectin-7 | DNA/lipid complex containing the human gene encoding the HLA- B7 antigen; intra-tumoral injection | Head and neck cancer | Released results from Phase I and Phase II studies showing Allovectin-7 to be safe (8/1) |
Vion Pharmaceuticals Inc. (VION) | TAPET bacterial vector | Tumor amplified protein expression therapy; Salmon- ella vector consisting of highly attenuated bacteria that preferentially replicate in tumors | Advanced cancer | Initiated a Phase I intravenous trial at Beth Israel Deaconess Medical Center; study is expected to enroll 20 to 30 patients (8/25) |
Xcyte Therapies Inc.* | Xcellerated T cells | Patient blood is collected and the T cells are stimulated to increase 100- fold and are injected into the patient; process uses anti-CD3 and anti-CD28 monoclonal antibodies covalently attached to superparamagnetic microbeads (designed to mimic antigenpresenting cells); the complexes activate T cells and the microbeads are then removed | Metastasized kidney cancer | Initiated a clinical study in 20 patients at the University of Calif., Los Angeles (8/2) |
CARDIOVASCULAR |
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Aquasearch Inc. (OTCBB:AQSE) | AstaFactor (astaxanthin) | Oral astaxanthin-rich algae extract | Coronary heart disease | Initiated a randomized, double-blind trial evaluating 100 patients (8/22) |
Centocor Inc. (subsidiary of Johnson & Johnson [NYSE:JNJ]) and Eli Lilly and Co. (NYSE:LLY) | ReoPro (FDA- approved) | Abciximab; a multirecep tor monoclonal antibody inhibitor of glycoprotein IIb/IIIa (alpha V beta 3) and MAC-1 plasty or bypass) | Unstable angina and non-ST eleva- tion myocardial infarction when a coronary intervention (angioed at 458 sites worldwide; data is not planned | Presented results of a Phase III trial showing ReoPro didn't provide a statistically significant benefit over placebo; the trial was double-blind, randomized and placebo-controlled and conduct from the GUSTO IV ACS (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndrome) trial were presented at the 22nd meeting of the European Society of Cardiology in Amsterdam (8/28) |
Genentech Inc. (NYSE:DNA) | TNKase (FDA- approved) | Tenecteplase; second-generation, single-bolus recombinant plasminogen activator with greater specificity to fibrin than Genentech's first- generation tissue plasminogen activator (Activase) | Heart attack | Reported one-year follow-up data at the 22nd annual congress of the European Society of Cardiology in Amsterdam; results were from ASSENT II trial (Assessment of the Safety and Efficacy of a New Thrombolytic agent) (8/29) |
GenVec Inc.* | BioBypass | Angiogenic gene therapy that delivers vascular endothelial growth factor 121 | Peripheral vascular disease | Began a double-blind, placebocontrolled Phase II trial in 100 patients with ischemic leg pain who are not candidates for other procedures (8/10) |
Myogen Inc.* | Enoximone | Phosphodiesterase (type III) inhibitor; oral formulation | Heart disease | Published findings that low doses of enoximone improve exercise ability of patients with heart failure in a double-blind, placebo- controlled study; data were published in the Journal of the American College of Cardiology (8/23) |
United Therapeutics Corp. (UTHR) | Uniprost | Subcutaneous prostacyclin therapy; stable structural analogue of prostacyclin | Pulmonary hypertension | Presented data from Phase III trial at the 22nd meeting of the European Society of Cardiology in Amsterdam (8/28) |
CENTRAL NERVOUS SYSTEM |
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| Guilford Pharmaceuticals Inc. (GLFD) and Amgen Inc. (AMGN) |
Neuroimmunophilin ligands | Orally-active drugs shown to cross the blood-brain barrier in order to induce nerve growth | Parkinson's disease | Commenced a Phase II trial to evaluate safety and efficacy; trial is double-blind, randomized and placebo-controlled (8/7) |
Repligen Corp. (RGEN) | Secretin | Synthetic porcine secretin | Autism | Presented study results showing changes in the metabolic profiles in autistic children treated with secretin; data were reported at the World Congress of Pediatric Gastroenterology in Boston (8/9) |
Sepacor Inc. (SEPR) | (S)-zopiclone | Single-isomer version of zopiclone, a non-benzodiazepine, rapid-acting hypnotic | Insomnia | Completed enrollment in 400 patient efficacy trial; Phase III studies slated to begin in third quarter (8/28) |
INFECTION |
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| Amrad Corp. Ltd. (Australia; ASX:AMC) |
AM365 | Inhibitor of viral replication | Hepatitis B | Completed a Phase I trial showing a specificity for Hepatitis B virus by the drug and selectivity for the virus rather than the host (8/30) |
GelTex Pharmaceuticals Inc. (GELX) | GT160-246 | Non-antibiotic toxin binding polymer | Clostridium difficile colitis | Completed a double-blind, placebo-controlled, randomized study of three doses in 24 normal Volunteers (8/22) |
InterMune Pharmaceuticals Inc. (ITMN) | Actimmune (aerosolized) | Interferon gamma-1b; aerosolized formulation | Pulmonary multidrug- resistant tuberculosis | Commenced enrollment for a Phase III trial evaluating safety and efficacy of aerosolized Actimmune (8/1) |
Interneuron Pharmaceuticals Inc. (IPIC) | PRO 2000 Gel | Microbicide designed to provide protection against HIV infection and other sexually transmitted diseases | Prevention of HIV infection and other sexually transmitted diseases | Enrolled the first HIV patients into a government-sponsored Phase I/II safety study (8/17) |
OXO Chemie Inc. (subsidiary of OXO Chemie AG; Switzerland) | WF10 | Macrophage regulation drug containing proprietary chlorite | Late-stage HIV disease | Completed enrollment in Phase III trial (8/8) |
PathoGenesis Corp. (PGNS) | TOBI (FDA- approved) | Tobramycin solution for inhalation | Bronchiectasis | Published study in the American Journal of Respiratory and Critical Care Medicine of a double-blind, placebo-controlled, randomized study of 74 patients (8/24) |
PathoGenesis Corp. (PGNS) | TOBI (FDA- approved) | Tobramycin solution for inhalation | Ventilator- associated pneumonia | Initiated enrollment in a Phase I open-label study (8/29) |
Triangle Pharmaceuticals Inc. (VIRS) | Coactinon | Emivirine; non-nucleoside reverse transcriptase inhibitor | HIV infection | Company said it would continue development following FDA's 12/99 notification that additional Phase III studies would be required; Triangle plans to enroll an additional 280 patients in the Phase III study, MKC-401, in which Coactinon is being evaluated in combination with d4T (stavudine) and Coviracil (8/10) |
Vical Inc. (VICL), Aventis Pasteur (unit of Aventis SA [France; NYSE:AVE]) and the U.S. Navy | MuStDO 5 | Multigene vaccine incorporating five genes for Plasmodium falciparum antigens, plus a naked DNA agent encoding granulocyte macrophage colony stimulating factor, an immune stimulant | Prevention of infection with the malaria parasite, Plasmodium falciparum | Initiated a clinical trial to test the safety, immunogenicity and protective efficacy; trial is a Phase II dose-escalation study (8/22) |
MISCELLANEOUS |
Alza Corp. (NYSE:AZA) |
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Ditropan XL (FDA- approved) | Once-daily formulation of oxybutinin | Overactive bladder | Cleveland Clinic researchers presented positive clinical data showing the drug improved quality of life with fewer discontinuations due to adverse events than conventional oxybutinin; results were presented at the International Continence Society's 30th annual meeting in Tampere, Finland (8/31) |
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Alexion Pharmaceuticals Inc. (ALXN) | 5G1.1 | Monoclonal antibody that inhibits the fifth component of the complement cascade | Rheumatoid arthritis | Completed patient enrollment in a multicenter, double-blind, randomized, placebo-controlled Phase II trial; trial involves 200 patients (8/24) |
Angiotech Pharmaceuticals Inc. (ANPI) | Topical Paclitaxel Gel | Yew tree-derived semisynthetic taxoid; inhibits abnormal skin cell growth, inflammatory cell response and angiogenesis | Psoriasis | Announced results of two Phase I trials conducted at Harvard University and the University of British Columbia (8/22) |
BioTime Inc. (AMEX:BTX) | PentaLyte | Pentastarch-based physiologically balanced blood plasma volume expander | To expand blood plasma volume | Completed a Phase I trial (8/30) |
Idec Pharmaceuticals Corp. (IDPH) | Clenoliximab (IDEC-151) | Primatized, non-depleting, anti-CD4 monoclonal antibody believed to regulate helper T-cell function | Rheumatoid arthritis | Began a multicenter, double- blind, randomized, placebo-controlled study evaluating multiple doses of the agent used in combination with methotrexate (8/7) |
Novavax Inc. (AMEX:NOX) | Androsorb | Topical cream formulation containing nanosome- encapsulated testosterone | Testosterone deficiency | Began enrolling post-menopausal women in a Phase I study assessing the safety of Androsorb (8/10) |
Symbollon Corp. (SYMBA) | IoGen | Molecular iodine | Fibrocystic breast disease | Company announced preliminary results of a Phase II trial (8/16) |
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; CDNX = Canadian Venture Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange |
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ND = Not disclosed |
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