| Company* | Product | Description | Indication | Status |
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| CANCER |
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| AnorMED | ZD0473 | Platinum-based anticancer agent | Ovarian cancer | AstraZeneca is taking a second look at the design and timetable of the Phase III trial after new data showed a lower response rate among platinum-resistant ovarian cancer patients than previously reported (8/31) |
| Cell Pathways | CP461 | Selective apoptotic antineoplastic drug | Chronic lymphocytic leukemia | Company initiated three pilot Phase II studies of CP461 (8/6) |
| Cell Pathways | Aptosyn | Exisulind; small-molecule compound that augments apoptosis in precancerous cells | Prostate cancer; precancerous sporadic adenomatous polyps of the colon | Phase II/III results demonstrated that exisulind inhibited the rise of prostate-specific antigen levels in treated men overall and prolonged PSA doubling time in high-risk patients compared to placebo (8/9); clinical results showed that exisulind caused polyps to regress and reduced their further growth (8/27) |
| CollaGenex | COL-3 (Metastat) | An orally active angiogenesis inhibitor | HIV-related Kaposi's sarcoma | The consortium opened enrollment for a multicenter Phase II trial with 70 patients (8/2) |
| Cytran Inc.* | IM862 | Monotherapy; naturally occurring peptide administered as nose drops | AIDS-related Kaposi's sarcoma | IM862 did not meet its primary endpoint of reducing the size and number of tumors by itself (8/17) |
| Image-Guided | Cotara | Tumor necrosis therapy drug; radiolabeled monoclonal antibody that binds to the necrotic core of tumors and uses beta-radiation to kill tumors from the inside out | Brain cancer | Companies are co-sponsoring a Phase I/II pilot study of Cotara using IGN's Navigus Array multilumen intracranial catheter in patients with brain cancer (8/22) |
| Lorus | Virulizin | Non-toxic immunotherapy that recruits monocytes and macrophages to attack tumor cells | Pancreatic cancer | Company said its Phase III clinical protocol is expanding to include 350 patients (8/7) |
| MGI Pharma | MG98 | Second-generation mRNA inhibitor that inhibits methyltransferase | Renal cell carcinoma | Companies began Phase II trials(8/21) |
| Neoprobe | RIGScan | Humanized antibody fragment that targets the antigen produced by many solid tumor types | Colorectal cancer imaging tool | Company began patient enrollment in a clinical trial (8/8) |
| OxiGene Inc. | CA4P | Combrestatin compound that reduces blood flow | Tumors | Phase I trials showed the agent's ability to reduce blood flow to tumors (8/20) |
| Pharmacyclics | Xcytrin | Motexafin gadolinium injection | Glioblastoma multiforme | Company completed patient enrollment in a Phase II trial (8/2) |
| PhotoCure | Hexvix | Diagnostic using fluorescence cystoscopy | Bladder cancer | Phase II results were positive showing the Hexvix fluorescence cystoscopy was superior to standard white light cystoscopy in detecting bladder cancer (8/17) |
| Photogen | PH-10 | Topical drug; photo- dynamic agent that selectively reduces inflammation of the epidermis and decreases plaque thickness | Actinetic keratosis | Company began a Phase I study (8/27) |
| Prescient | Anhydrovin- | Analog of vinblastine (vinca alkaloid) | Solid tumors | Company completed a Phase I trial demonstrating the safety and tolerability of the compound (8/14) |
| Progen Industries | PI-88 | Anticancer therapeutic; sulfated oligosaccharide | Cancer | Company enrolled the first two patients in a Phase I/II trial conducted in the U.S. (8/2) |
| Ribozyme | Herzyme | An anti-human epidermal growth factor receptor Type II ribozyme | Breast and ovarian cancer | Company began a Phase I trial (8/29) |
| Seattle | SGN-15 | Monoclonal antibody drug conjugate | Non-small-cell lung cancer | Company began Phase II trials (8/21) |
| Vion | Triapine | Inhibitor of the enzyme ribonucleotide reductase | Advanced and metastatic cancers | Company began enrollment for a Phase I trial of Triapine in combination with the anticancer agent gemcitabine (8/2); company initiated a Phase II trial for patients with metastatic breast cancer (8/6) |
| CARDIOVASCULAR |
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| Avant Immuno- | CETi-1 | Cholesterol management vaccine | Low levels of high-density lipoprotein cholesterol | Company began a Phase II study in about 200 patients (8/16) |
| Cerus Corp. | Intercept Platelet System | A system to inactivate bacteria, viruses and other pathogens and white blood cells in platelets intended for transfusion | Thrombocytopenia | Companies completed Phase III trial, which showed effectiveness in treating and preventing bleeding during severe thrombocytopenia (8/17) |
| Corgentech Inc.* | E2F Decoy | Works to prevent occlusion in grafted veins | Peripheral bypass graft surgery | Company will initiate a Phase III trial in September (8/16) |
| CV Therapeutics | CVT-3146 | Selective, short-acting A2A adenosine receptor agonist | To increase coronary artery flow for use in cardiac perfusion imaging studies | Company began Phase II trials (8/21) |
| CV Therapeutics | Ranolazine | Part of pFOX (partial fatty acid oxidation) inhibitors | Chronic angina | Company said the last patient has completed treatment in a Phase III trial of 700 patients (8/8) |
| Genentech | TNKase | Tenecteplase; second- generation, single bolus recombinant plasminogen activator with greater specificity to fibrin than Genentech's first-generation tissue plasminogen activator (Activase) | Acute myocardial infarction | Trial results indicate that a combination of TNKase and the low-molecular-weight heparin Lovenox and a 12-hour infusion of ReoPro showed increased efficacy and safety (8/24) |
| CENTRAL NERVOUS SYSTEM |
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| MedImmune Inc. (MEDI) | Vitaxin | Antibody that has the potential to inhibit the growth of new blood vessels by binding to a specific integrin | Rheumatoid arthritis | Company began dosing patients in a Phase I trial (8/6) |
| DIABETES |
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| Amylin | AC2993 | Synthetic exendin-4 | Type II diabetes | Phase II data showed a statistically significant reduction in the incidence of nausea when a target dose was achieved with gradual dose titration (8/10) |
| Chrysalis | Chrysalin | Synthetically manufactured peptide | Diabetic ulcers | The drug appeared to be well tolerated, with no drug-related adverse effects in a Phase I/II trial (8/21) |
| Forest | Memantine | Orally available neuroprotective agent that appears to restore damaged nerve cells and block excitatory signals by modulating the N-methyl D-aspartate (NMDA) receptor on cell membranes | Diabetic neuropathy | Company will start a second pivotal trial in the U.S.; the first one was conducted by Neurobiological Technologies Inc. (8/2) |
| Metabasis | | A drug that is the first in a new class that acts to reduce the overproduction of glucose by the liver | Type II diabetes | Company initiated a Phase I trial (8/1) |
| Organo- | Vitrix | Living dermal replacement | Diabetic foot ulcers | Company initiated a clinical study with 20 patients (8/7) |
INFECTION | ||||
| Antex | Helivax | Oral vaccine produced using Nutriment Signal Transduction technology, which regulates bacterial growth | Gastrointestinal infections and disease caused by Heliobacter pylori | Phase Ib results showed the vaccine to be safe and immunogenic (8/22) |
| A-Viral A/S | AV-1101 | A new generation of drug to treat HIV/AIDS | AIDS | Company enrolled the first six patients in a Phase II trial (8/29**) |
| BioCryst | RWJ- | Oral small-molecule drug | Viral influenza | Company is preparing to complete a Phase III trial in the U.S.; the trial was delayed because the FDA imposed more monitoring requirements (8/13) |
| Cerus Corp. | Intercept Plasma System | Based on Helinx technology that inactivates viruses, bacteria and parasites in blood | Infectious diseases resulting from plasma transfusions | A Phase IIIb trial has resulted in supportive data of safety and therapeutic effectiveness of the system, which protects against infectious diseases (8/17) |
| OraPharma | OC-1012 | Topical drug | Prevention of mucositis | Company started a Phase I trial in patients undergoing bone marrow transplants (8/27) |
| Samaritan | Anticort | Procaine-based drug that has demonstrated cortisol-lowering properties | HIV infection | Company completed a Phase Ib/IIa trial (8/17) |
| Tanox Inc. | TNX-355 | Monoclonal antibody designed to bind to the CD4 receptor on host cell surfaces | HIV | Company began enrollment in a Phase I trial (8/1) |
| The Immune | Remune | HIV-1 immunogen | HIV | Company said it is dropping a pivotal trial, but said a previously reported failed Phase II trial in Spain was actually a success, hitting its primary endpoint (8/30) |
| Trimeris Inc. | T-20 | A fusion inhibitor | HIV | Both Phase III trials are fully enrolled (8/9) |
| MISCELLANEOUS |
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| Avigen Inc. | Coagulin-B | Coagulin-B is delivered via infusion into the hepatic artery using Avigen's adeno-associated virus vector containing the Factor IX gene | Hemophilia B | The first patient was treated in a second Phase I trial (8/16) |
| Biopure | Hemopure | Blood oxygenator; hemoglobin glutamer-250 (bovine) | Orthopedic surgery | Phase III results showed the Hemopure group avoided any blood transfusions during a six-week period, meeting the primary safety and efficacy endpoints (8/27) |
| Cambridge | CAT-152 | Human anti-TGD-beta 2 monoclonal antibody | To prevent excessive post-operative scarring in glaucoma patients | Phase II results showed the product was safe and well tolerated (8/22) |
| Cellegy | Tostrelle | Transdermal testosterone gel product | Female sexual dysfunction | Company completed a second Phase I/II trial of Tostrelle (8/29) |
| Immunex | Enbrel | Tumor necrosis factor-inhibiting drug | Psoriasis | Clinical results were positive with 30% of patients achieving a 75% improvement in the Psoriasis Area and Severity Index after 12 weeks (8/21) |
| Inspire | INS37217 | Respiratory nasal spray | Sinusitis | The company initiated a Phase I trial (8/14) |
| InterMune | Actimmune | A gamma interferon therapy | Idiopathic pulmonary fibrosis | Company completed enrollment in a Phase III trial (8/21) |
| Micrologix | MBI | Bactolysin compound (cationic peptide) | Acne | Company completed enrollment of 75 patients for its Phase II trial (8/2) |
| Photogen | PH-10 | Photoactive agent used with laser light | Plaque psoriasis | Trial results showed patients experienced significant reduction of plaque thickness with a single administration of PH-10 (8/8) |
| RxKinetix | RK-0202 | Developed using Rx-Kinetix's ProGelz polymer drug delivery system | Bone marrow and stem cell transplant | Company initiated a Phase Ib trial (8/8) |
| Stressgen | HspE7 | Immunotherapeutic; recombinant fusion product composed of heat shock protein 65 from Mycobacterium bovis BCG and the protein E7 | Anal dysplasia caused by human papillomavirus | Company completed patient enrollment in its Phase III trial two months ahead of schedule (8/1) |
| Vivus Inc. | Alista | Topical formulation of alprostadil | Female sexual dysfunction | Company completed patient dosing in a Phase II study (8/23) |
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| 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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