Company* | Product | Description | Indication | Status (Date) |
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CANCER |
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AEterna Laboratories Inc. (Canada; AELA) | Neovastat | Orally bioavailable; activates apoptosis of endothelial cells; also inhibits matrix metalloproteinase and vascular endothelial growth factor | Progressive multiple myeloma | Patient recruiting for a pivotal Phase II trial continues in about 35 investigative centers in Canada, the U.S. and Europe (5/8) |
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AEterna Laboratories Inc. (Canada; AELA) | Neovastat | Orally bioavailable; activates apoptosis of endothelial cells; also inhibits matrix metalloproteinase and vascular endothelial growth factor | Renal cell carcinoma | At ASCO, the company said patient recruitment in its Phase III trial is more than half complete (5/15) |
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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 | Phase II data presented at ASCO showed RSR13 in combination with radiation therapy demonstrated an overall response rate of 89% within the radiation therapy portal in the chest (5/14) |
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AltaRex Corp. (Canada; OTC BB: ALRXF; TSE:AXO) | BrevaRex MAb | Targets antigen, MUC1, and elicits cancer-killing B- and T-cell immune responses | Cancer | Phase I results demonstrated the antibody's ability to elicit cancer-killing B- and T-cell immune responses to the target antigen (5/7) |
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AltaRex Corp. (Canada; OTC BB: ALRXF; TSE:AXO) | OvaRex | Modified murine monoclonal antibody that binds to CA125 cancer antigen | Ovarian cancer | Phase II results presented at ASCO indicate the treatment can provide comparable efficacy to salvage chemotherapies, but without toxicities (5/14) |
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Amgen Inc. | Aranesp | Recombinant erythropoietic protein that stimulates production of oxygen-carrying red blood cells; an extended-release version of Epogen | Cancer-related conditions, including anemia and the need for transfusions | Phase III data presented at ASCO showed Aranesp could reduce red blood cell transfusions in patients receiving multicycle platinum-based chemotherapy regimens, treat chronic anemia of cancer in patients who are not receiving chemotherapy, and correct anemia associated with chemotherapy (5/13) |
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AnorMED Inc. (Canada; TSE:AOM) | ZD0473 | Platinum-based anticancer agent | Ovarian and small-cell lung cancer | Phase II data presented at ASCO showed the compound produced objective responses (5/15) |
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Antigenics Inc. | Oncophage | Cancer vaccine; uses heat shock proteins to activate cellular immune responses | Advanced melanoma and colon cancer | Phase II results presented at ASCO showed that five of 28 patients who were incurable with surgery responded favorably; another Phase II trial showed that half of the 29 patients treated generated anticolon cancer immunity (5/14) |
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Aphton Corp. | Anti-gastrin 17 immunogen | Administered with cisplatin and 5-FU | Metastatic stomach cancer | Phase II data presented at ASCO showed that two of the six evaluable patients had tumor volume shrinkage of more than 50% (5/15) |
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Aronex Pharmaceuticals Inc. (ARNX) | Annamycin | Liposomal anthracycline | Acute myeloid and lymphoid leukemia | Phase I results presented at ASCO showed two out of 21 patients achieved complete remission (5/15) |
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Aronex Pharmaceuticals Inc. (ARNX) | Atragen | Injectable liposomal formulation of all-trans retinoic acid (tretinoin) | Advanced renal cell cancer | Phase I data presented at ASCO of Atragen in combination with interferon-alpha showed two of 16 evaluable patients had partial remission in bone and lung; five patients had stable disease (5/14) |
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AVI BioPharma Inc. (AVII) | Oncomycin-NG | Neugene antisense cancer drug | Cancer | Company began a Phase I/II study (5/21) |
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Biomira Inc. (Canada; BIOM; TSE:BRA) | Theratope | Synthetic carbohydrate- based vaccine; mimic of cancer antigen si alyl-Tn plus carrier molecule KLH | Metastatic colorectal cancer | Phase II data presented at ASCO showed the median survival time was 14.2 months from the time of commencing the vaccine (5/14) |
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British Biotech plc (UK; BBIOY) | Marimastat | Oral matrix metalloproteinase inhibitor | Non-small-cell lung cancer | Company said it will halt a Phase III trial, which failed to meet its primary endpoint in a gastric cancer trial (5/2) |
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British Biotech plc (UK; BBIOY) and ImmunoGen Inc. (IMGN) | BB-10901/ huN901-DM1 | Tumor-activated prodrug | Small-cell lung cancer | Companies started patient enrollment for a Phase I/II study (5/29) |
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Celgene Corp. | Revimid | Immunomodulatory drug to treat solid tumors | Multiple myeloma | Phase I/II results showed that more than 60% of the late-stage patients treated were responding or had their disease stabilized (5/8) |
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Celgene Corp. | Thalomid | Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha | Late-stage renal cell carcinoma | Company said it will pursue a major trial with time to disease progression and survival as endpoints (5/16) |
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Celgene Corp. | Thalomid | Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha | Metastatic colorectal cancer | Company will initiate a Phase II trial that will team Thalomid with Camptosar (irinotecan) and 5-fluorouracil/leucovorin regimen (5/17) |
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Cell Genesys Inc. | GVAX | Lung cancer vaccine | Lung cancer | Phase I/II data presented at ASCO showed three of 22 patients had a complete disappearance of metastatic tumors following treatment; one patient had a greater than 50% tumor reduction (5/14) |
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Cell Genesys Inc. | GVAX | Prostate cancer vaccine | Prostate cancer | Phase II results presented at ASCO showed that 55 patients who had failed hormone therapy showed a trend toward increased median time to progression, but another trial of 41 early stage patients showed that median time to progression had not been reached (5/15) |
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Cell Pathways Inc. (CLPA) | CP461 | Selective apoptotic antineoplastic drug | Advanced cancer | Phase I data presented at ASCO showed CP461 was rapidly absorbed and achieved, at certain doses, the plasma concentrations required to induce apoptosis (5/14) |
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Cel-Sci Corp. (AMEX:CVM) | Multikine | Immunotherapy drug; natural mixture of human cytokines, including interleukin-2 | Cervical cancer | Phase I trials will begin at the University of Maryland, focusing on women infected with both human papillomavirus and HIV (5/7) |
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Chiron Corp. | Proleukin | Recombinant form of human interleukin-2 | Metastatic renal cell carcinoma | Phase III results presented at ASCO showed the high-dose group had a tumor response of 25%, while the low-dose group had a response of 12%; two patients had a complete response and 10 achieved a partial response (5/14) |
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Cytran Inc.* | IM862 | Naturally occurring peptide administered as nose drops | Ovarian cancer | A Phase II trial will begin evaluating IM862 in combination with initial chemotherapy using paclitaxel and carboplatin (5/2) |
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EntreMed Inc. (ENMD) | Angiostatin | Subcutaneous antiangiogenic | Cancer | Phase I results presented at ASCO showed the drug was safe, has linear and predictable pharmacokinetics, and did not alter blood-clotting mechanisms (5/14) |
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EntreMed Inc. (ENMD) | Endostatin | Angiogenesis inhibitor | Tumors | Phase I data presented at ASCO showed the product had no serious side effects (5/15) |
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Enzon Inc. | PEG-paclitaxel | PEG-modified version of paclitaxel formulated for ease of administration | Advanced solid tumors and lymphomas | Company initiated a Phase I trial in up to 40 patients (5/7) |
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Genaera Corp. | Squalamine | Combination therapy with standard chemotherapy of carboplatin and paclitaxel | Non-small-cell lung cancer | Phase IIa data presented at ASCO showed, overall, that 27% of patients at all doses experienced an objective response (5/15) |
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Genentech Inc. (NYSE:DNA) | Rituxan | Rituximab; genetically engineered chimeric pan B monoclonal antibody that targets CD20 antigen on B-cell surface | Chronic lymphocytic leukemia | Phase II results presented at ASCO showed an overall response rate of 90% when patients were treated with Rituxan in combination with fludarabine (5/15) |
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Genentech Inc. (NYSE:DNA) | Rituxan | Rituximab; genetically engineered chimeric pan B monoclonal antibody that targets CD20 antigen on B-cell surface | Low-grade non-Hodgkin's lymphoma | Clinical data presented at ASCO showed a 47% objective response rate in patients receiving Rituxan alone (5/15) |
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Genta Inc. | Genasense | Antisense compound geared toward blocking the production of Bcl-2 | Prostate cancer | Clinical results presented at ASCO showed antitumor activity when Genasense and Taxotere were used in combination (5/14) |
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ImClone Systems | IMC-C225 | Designed to target and block the epidermal growth factor receptor | Pancreatic cancer | Phase II trials presented at ASCO showed the combination of the compound with gemcitabine produced a one-year survival rate of 32.5% (5/14) |
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ImClone Systems | IMC-C225 | Designed to target and block the epidermal growth factor receptor | Head and neck cancer | Phase II results presented at ASCO showed the combination of IMC-C225 and cisplatin can produce major responses (5/14) |
Immunex Corp. (IMNX) and Abgenix Inc. (ABGX) | ABX-EGF | Fully human monoclonal antibody | Kidney cancer | Phase I data presented at ASCO showed the product was well tolerated; the companies initiated a Phase II study (5/15) |
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Immunex Corp. (IMNX) | Novantrone | Mitoxantrone for injection concentrate | Prostate cancer | Data in patients who have failed radiation therapy or surgery demonstrated the drug improved prostate-specific antigen test results (5/18) |
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ImmunoGen Inc. (IMGN) | huC242-SM1/ SB-408075 | Tumor-activated prodrug | Colorectal, pancreatic and non-small-cell lung cancers | Company began enrollment for a third Phase I/II trial (5/8); Phase I data presented at ASCO showed antitumor activity (5/14) |
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Inspire Pharmaceuticals Inc. (ISPH) | INS316 Diagnostic | Diagnostic inhaled solution | Lung cancer diagnosis | Company initiated its Phase III program (5/10) |
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IntraBiotics Pharmaceuticals Inc. (IBPI) | Protegrin IB-367 Rinse | Synthetically derived analogue of naturally occurring protegrins | Prevention of oral mucositis in patients undergoing high-dose chemotherapy | Phase III final results presented at ASCO indicated the company would have to conduct a repeat Phase III trial due to a third-party vendor error that caused patients to receive incorrect bottles (5/14) |
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Introgen Therapeutics Inc. (INGN) | INGN 201 | Adenoviral p53 gene therapy candidate | Cancer | Biosafety data indicated the vector used is genetically stable; data was presented at ASCO (5/14); Phase II lung cancer results presented at ASCO showed that 12 of 19 patients had complete or partial responses at the injected site; Phase I ovarian cancer results showed up to a 17-fold increase in the percent of tumor cells expressing p53 protein (5/15) |
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Isis Pharmaceuticals Inc. (ISIP) | ISIS 3521 | Antisense protein kinase C-alpha inhibitor that binds to an mRNA sequence specific to PKC-alpha | Non-small-cell lung cancer | Phase I/II data presented at ASCO showed prolonged survival and time to progression of disease, and robust overall response rates (5/14) |
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Ligand Pharmaceuticals Inc. (LGND) | Targretin | Bexarotene capsules; synthetic retinoid analogue that selectively activates retinoid X receptors | Advanced renal cell cancer | Phase I/II results presented at ASCO showed the optimal dose was 400 mg/m2/day (5/15) |
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Ligand Pharmaceuticals Inc. (LGND) | Targretin | Bexarotene capsules; synthetic retinoid analogue that selectively activates retinoid X receptors | Non-small-cell lung cancer | Phase I/II results presented at ASCO suggest Targretin administered in combination with chemotherapy may prolong survival in patients (5/16) |
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Matrix Pharmaceutical Inc. (MATX) | IntraDose Injectable Gel | Biodegradable gel containing cisplatin and epinephrine | Squamous cell carcinoma of the head and neck | Phase III data presented at ASCO showed a response rate of 29% (5/15) |
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Matrix Pharmaceutical Inc. (MATX) | Tezacitabine | Nucleoside analogue that irreversibly inhibits ribonucleotide reductase and terminates DNA chain elongation | Cancer | Phase I data presented at ASCO showed a combination of tezacitabine and fluorouracil demonstrated antitumor activity at tolerable doses (5/14) |
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Maxim Pharmaceuticals Inc. (MAXM) | Ceplene | Histamine dihydrochloride; an adjuvant to interleukin-2 | Metastatic renal cell carcinoma | Phase II results presented at ASCO showed Ceplene in combination with interferon-alpha and interleukin-2 resulted in a median survival of an intent-to-treat basis of 16.3 months (5/14) |
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MetaPhore Pharmaceuticals | M40403 | Enzyme mimetic compound | Advanced skin and end-stage kidney cancers | Company initiated a Phase I study (5/31) |
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MGI Pharma Inc. (MOGN) | MGI-114 | Irofulven; hydroxymethyl- acylfulvene | Recurrent malignant glioma | Company initiated a Phase II trial, which will include up to 27 patients (5/4) |
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MGI Pharma Inc. (MOGN) | MGI-114 | Irofulven; hydroxymethyl- acylfulvene | Advanced, metastatic soft tissue sarcoma | Company initiated a Phase II trial of irofulven as a single-agent treatment (5/7) |
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MGI Pharma Inc. (MOGN) | MGI-114 | Irofulven; hydroxymethyl- acylfulvene | Ovarian cancer | Phase II data presented at ASCO showed that seven of 38 patients demonstrated objective responses and 13 had stable disease (5/14) |
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MGI Pharma Inc. (MOGN) | Salagen | Tablets; pilocarpine | Head and neck cancer | Phase III data presented at ASCO showed use of Salagen resulted in a statistically significant improvement of salivary flow vs. placebo (5/17) |
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NeoRx Corp. | STR | Skeletal targeted radiotherapy | Multiple myeloma | Phase I/II data showed that 32 of 75 evaluable patients are in complete remission (5/7) |
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Northwest Biotherapeutics | DCVax- Prostate | Dendritic cell-based immunotherapy | Prostate cancer | Phase I/II data show that immune tolerance in elderly patients can be overcome safely with DCVax (5/8) |
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Onyx Pharmaceuticals Inc. (ONXX) | CI-1042 (ONYX-015) | Administered via hepatic artery infusion; tumor-selective, modified adenovirus that has been genetically engineered to replicate in and kill cancer cells that have dysfunctional p53 | Colorectal cancer liver metastases | Phase I/II data presented at ASCO showed the product was well tolerated and, at the highest dose, had prolonged survival when compared to the lowest dose (5/14) |
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Onyx Pharmaceuticals Inc. (ONXX) | CI-1042 (ONYX-015) | Administered via hepatic artery infusion; tumor-selective, modified adenovirus that has been genetic-ally engineered to replicate in and kill cancer cells that have dysfunctional p53 | Premalignant oral dysplasia | Phase II data presented at ASCO showed the product was well tolerated and may cause resolution of dysplasia in some patients (5/15) |
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OSI Pharmaceuticals (OSIP), Genentech Inc. (NYSE:DNA) and F. Hoffmann- La Roche Ltd. (Switzerland) | Tarceva | Inhibitor of the epidermal growth factor receptor tyrosine kinase | Non-small-cell lung cancer | Phase II data presented at ASCO showed one complete response and eight partial responses out of 57 evaluable patients; data also indicated a one-year survival rate of 48% (5/14) |
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Peregrine Pharmaceuticals Inc. (PPHM) | Cotara | Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with I-131 | Biliary system and pancreatic cancers | Company opened a Phase I trial (5/8) |
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Peregrine Pharmaceuticals Inc. (PPHM) | Cotara | Tumor necrosis therapy; chimeric monoclonal antibody that targets DNA-associated histone antigens, labeled with I-131 | Brain cancer | Phase II data presented at ASCO showed the overall median time to progression was 13.9 weeks (5/15) |
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Pharmacyclics Inc. (PCYC) | Xcytrin | Injection therapy; motexafin gadolinium | Glioblastoma multiforme | Phase I results presented at ASCO showed median survival to date was 17.3 months (5/14) |
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SciClone Pharmaceuticals Inc. (SCLN) | Zadaxin | Immune system enhancer; synthetic immunostimulant peptide | Hepatocellular carcinoma | Company initiated a Phase II trial of Zadaxin in combination with transarterial chemoembolization (5/14) |
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Telik Inc. (TELK) | TLK286 | Small-molecule candidate that targets tumors that overexpress GST P1-1 | Refractory cancers | Phase I data presented at ASCO indicate the compound is well tolerated over a range of doses (5/14); company initiated a Phase II trial (5/29) |
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Therion Biologics* | Vaccinia-CEA and Alvac-CEA | Vaccines | Late-stage metastatic cancers | Phase I/II data presented at ASCO showed five of nine patients treated with sequential vaccinations of the two products showed increased immune response and also remained alive two years out compared to zero long-term survivors in other treatment groups (5/15) |
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Titan Pharmaceuticals Inc. (AMEX:TTP) | TriGem | Anti-idiotypic monoclonal antibody-based vaccine; mimics GD2 antigen present on many types of cancer cells | Stage III melanoma | Phase II data presented at ASCO suggest TriGem provides a therapeutic benefit both as a single agent and in combination with alpha-interferon (5/14) |
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Vical Inc. (VICL) | Allovectin-7 | DNA lipid complex containing the human gene encoding the | Late-stage metastatic melanoma | Phase II data presented at ASCO showed a reduction in total tumor burden of 50% or more in 14.8% of the evaluable patients (5/14) |
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Vion | Triapine | Inhibitor of the enzyme ribonucleotide reductase | Cancer | Company initiated a Phase I trial (5/10); Phase I data presented at ASCO showed Triapine was well tolerated and showed evidence of antitumor activity (5/15) |
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Vion | VNP20009 | First-generation Tapet vector administered by intratumoral injection | Cancer | Phase I data presented at ASCO showed the product was well tolerated (5/14) |
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Wilex AG | WX-G250 | Monoclonal antibody that recognizes an antigen predominantly expressed on renal cancer cells | Renal cell carcinoma | Phase I data presented at ASCO showed the product to be safe and well tolerated (5/15) |
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YM BioSciences | Tesmilifene | Combination therapy with doxorubicin | Metastatic breast cancer | Phase III data presented at ASCO showed patients receiving the combination therapy lived about 50% longer than those receiving doxorubicin alone (5/17) |
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CARDIOVASCULAR |
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Actelion Ltd. (Switzerland; SWX:ATLN) and Genentech Inc. (NYSE:DNA) | Tracleer | Bosentan; endothelin receptor antagonist | Pulmonary arterial hypertension | Phase III results indicated a statistically significant greater walking distance in treated patients (5/2) |
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Alliance Pharmaceutical Corp. (ALLP) | LiquiVent | Perflubron; an oxygen-carrying liquid drug; intrapulmonary agent | Acute respiratory distress syndrome | Company is abandoning studies because LiquiVent failed to meet its primary and secondary endpoints in a Phase II/III study (5/22) |
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Avant Immunotherapeutics Inc. (AVAN) | TP10 | Complement inhibitor | Infants undergoing cardiac surgery | Company began treating patients in the second of its Phase IIb trials (5/10) |
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Carrington Laboratories Inc. (CARN) | Manapol | Powder at 160 mg per day | Moderate hyper- cholesterolemia | Data from an open-label study showed that LDL cholesterol levels were lowered by 9.8% after three weeks of treatment (5/18) |
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ConjuChem Inc. (Canada; TSE:CJC) | DAC-TI | Designed to prevent localized blood clotting | Blood clots | Company completed enrollment in a Phase I trial conducted in kidney dialysis patients (5/17) |
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Endovasc Ltd. Inc. (OTC BB:ENDV) | Liprostin | A vasodilator and stimulator for new | Critical limb ischemia | Company said it will bypass Phase II trials and move directly into Phase III with Liprostin, if the FDA gives its approval (5/7) |
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ICOS Corp. (ICOS) and Texas Biotechnology Corp. (AMEX:TXB) | Sitaxsentan | Oral endothelin A receptor antagonist | Pulmonary hypertension | Companies began recruiting patients in a pivotal Phase II/III trial (5/30) |
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CENTRAL NERVOUS SYSTEM |
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Durect Corp. | DUROS sufentanil | Approved opioid that uses the DUROS osmotic delivery system to deliver sufentanil | Chronic pain | Company completed a Phase II program evaluating a continuous dose of sufentanil (5/11) |
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Nouvel Pharma Inc. (unit of Neo-Pharma Production AB; Sweden)* | Duodopa | A liquid gel preparation of levodopa/carbidopa and administration via intra- duodenal infusion to the small intestine | Parkinson's disease | Company began a Phase III trial, which is scheduled to complete in late 2001 (5/4) |
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Pozen Inc. | MT-400 | Combines an approved triptan drug with an approved long-acting, nonsteroidal anti-inflammatory agent | Migraine | Phase II results showed that MT-400 was significantly better than placebo with the primary endpoint of sustained pain relief, as well as the secondary endpoints (5/21) |
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Serono SA (Switzerland; NYSE:SRA) | Rebif | Recombinant interferon beta-1a | Relapsing- remitting multiple sclerosis | In a 677-patient study, Rebif was shown to give patients a 90% greater chance of remaining relapse-free compared to patients treated with Biogen Inc.'s Avonex (5/8) |
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Titan Pharmaceuticals Inc. (AMEX:TTP) | Spheramine | Cell therapy product that uses human retinal pigmented epithelial cells that secrete dopamine | Parkinson's disease | Phase I/II results showed improvement in motor function and quality of life in all patients treated, with no safety concerns or significant adverse events (5/10) |
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DIABETES |
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Sangstat Inc. | Thymoglobulin | Anti-thymocyte globulin, rabbit; organ rejection therapeutic | Diabetes caused by organ rejection | Data showed the therapeutic produced a lower incidence of diabetes, infection and hepatitis C than when it was used in combination with steroids (5/10) |
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INFECTION |
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AnorMED Inc. (Canada; TSE:AOM) | AMD-3100 | Inhibits the binding action of HIV with the CXCR4 chemokine co-receptor | HIV | Company said it is discontinuing its Phase Ia/IIb trial due in part to abnormal cardiac activity observed in two patients (5/29) |
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Avant Therapeutics Inc. (AVAN) | Peru-15 | Oral vaccine that deploys a live, attenuated mutant of V. cholerae O1 biotype El Tor | Cholera | Phase IIb results showed 100% protection against moderate to severe diarrhea associated with the disease (5/8) |
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BioMedicines Inc.* | ¿ | Omega interferon | Chronic hepatitis C | Company completed enrollment in a Phase II trial (5/16) |
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Enzon Inc. (ENZN) | PEG-intron | Peginterferon alfa-2b injections | Chronic hepatitis C | Studies of PEG-Intron used in combination with Rebetol showed that 35% had a virologic response after 24 weeks of treatment (5/22) |
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Hemispherx Biopharma Inc. (AMEX:HEB) | Antiviral | Uses HAART (highly active antiretroviral therapy) | HIV | Company began a Phase IIb trial (5/10) |
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ID Biomedical Corp. (Canada)* | ¿ | Intranasal flu vaccine | Flu | Company initiated a Phase I trial (5/22) |
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Immtech International Inc. (IMMT) | DB289 | Oral, anti-infective | Pneumocystis carinii pneumonia and Trypano- somiasis | Company completed a Phase I trial, which showed the drug was safe at all dose levels (5/23) |
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Maxim Pharmaceuticals Inc. (MAXM) | Ceplene | Histamine dihydrochloride | Hepatitis C | Phase II results of Ceplene in combination with interferon-alpha showed that 5% of patients discontinued treatment due to adverse events, compared to 14% of patients treated with interferon-alpha alone (5/21) |
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Nabi (NABI) | StaphVAX | Injection; staphylococcus aureus conjugate vaccine | Staphylococcus aureus blood infections | Company initiated a trial to evaluate a booster dose of Nabi StaphVAX (5/17) |
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The Immune Response Corp. (IMNR) | Remune | HIV-1 Immunogen | HIV | Preliminary interim Phase II data show Remune to induce both alloand HIV-specific cell-mediated immune responses (5/21) |
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Versicor Inc. | V-Glycopeptide | Dalbavancin; a novel antibiotic | Skin and soft tissue infections | Company started a Phase II study (5/22) |
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XTL Biopharmaceuticals Ltd. (Israel; LSE:XTL) | XTL-001 | Consists of two fully human monoclonal antibodies that recognize different areas of the virus and a range of viral serotypes | Chronic hepatitis B | Company began a Phase II study of XTL-001 in combination with lamivudine (5/16) |
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MISCELLANEOUS |
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Advanced Tissue Sciences Inc. (ATIS) | NouriCel | Human tissue-engineered skin | Facial wrinkles | Data indicated that nine of 14 patients had visible improvements in at least one of four areas (5/14) |
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Alkermes Inc. (ALKS) and Janssen Pharmaceutical Products LP | Risperdal | A long-lasting injectable form of Risperdal, using Alkermes' Medisorb technology | Schizophrenia | Results suggest the formulation provides relief without the need to take daily medication (5/2) |
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Alkermes Inc. (ALKS) and Serono SA (Switzerland; NYSE:SRA) | rhFSH | Long-acting formulation of recombinant human follicle stimulating hormone | Infertility | Companies completed a Phase I trial and intend to proceed with clinical development (5/16) |
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Apex Bioscience Inc.* | VTR-PHP | Pyridoxalated hemoglobin polyoxyethylene conjugate | Nitric oxide-induced shock | Company initiated a Phase III trial (5/24) |
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AtheroGenics Inc. (AGIX) | AGI-1067 | Oral agent; anti-inflammatory compound with antioxidant properties | Restenosis after angioplasty | Preliminary Phase II results showed that six months after angioplasty, patients who received AGI-1067 had statistically significant greater luminal diameters of their coronary arteries than patients in the placebo group (5/21) |
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Biogen Inc. (BGEN) and Elan Corp. plc (Ireland) | Antegren | Humanized monoclonal antibody | Crohn's disease | Phase II data indicated a statistically significant difference in clinical response between the drug and placebo groups (5/23) |
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BioMarin Pharmaceutical Inc. (BMRN), Glyco Biomedical Ltd. (OTC BB:GLYK; TSE: GBL) and Genzyme General (GENZ) | Aldurazyme | Recombinant human alpha-L-iduronidase enzyme replacement therapy | Mucopoly- saccharidosis-I | Data indicated significantly decreased liver and spleen size in all patients after one year of therapy; results also showed reduced levels of urinary carbohydrates and improvements in range of motion and physical function (5/10) |
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Biopure Corp. (BPUR) | Hemopure | An oxygen therapeutic; hemoglobin glutamer-250 (bovine) | Orthopedic surgery | Phase III results showed Hemopure eliminated the need for red blood cell transfusion in patients undergoing elective orthopedic surgery (5/8) |
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Cambridge Antibody Technology Group plc (UK; CATG; LSE:CAT) | CAT-152 | Human anti-TGD-beta2 monoclonal antibody | Prevention of scarring after eye surgery | Phase I/II data showed that patients treated with CAT-152 at the time of surgery had significantly lower intraocular pressure (5/8) |
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Centaur Pharmaceuticals | CPI-1189 | Oral drug that | Dementia | Centaur said it obtained proof of concept in its dementia trials, showing the drug protects brain cells and improves cognitive function (5/15) |
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Centocor Inc. | Remicade | Infliximab; chimeric monoclonal antibody to tumor necrosis factor- alpha | Crohn's disease | Data from a 573-patient trial demonstrated prolonged remissions in patients with moderate to severe Crohn's disease (5/21) |
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Cephalon Inc. | Provigil | Modafinil tablets | Depression | Two pilot studies indicated that Provigil tablets reduce fatigue and sleepiness in clinically depressed patients (5/10) |
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Dynavax Technologies | Amb a-1 | Immunostimulatory oligo- deoxyribonucleotide conjugate | Ragweed allergies | Company started a Phase I/II trial (5/22) |
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Genzyme General (GENZ) | Fabrazyme | Agalsidase beta enzyme replacement therapy | Fabry disease | Phase III extension study data demonstrated the product's ability to clear the lipid globo- triaosylceramide from a range of cell types in organs affected by Fabry disease (5/29) |
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InKine Pharmaceuticals Co. Inc. (INKP) | Colirest | Oral steroid molecule; Fc receptor technology | Crohn's disease | Phase II results demonstrated a response rate after two months of therapy of 82%; the data also indicated a 64% remission rate (5/21) |
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Inspire Pharmaceuticals | INS365 Ophthalmic and INS37217 Ophthalmic | P2Y(2) receptor agonist; second-generation P2Y(2) agonist designed to enhance the lung's innate mucosal hydration and mucociliary clearance mechanisms | Dry eye disease and retinal detachment | Company presented positive Phase II results of INS365 and launched a Phase I/II trial of INS-37217 to treat retinal detachment (5/3) |
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Lilly ICOS LLC | Cialis | A PDE5 inhibitor | Erectile dysfunction | Clinical results indicated that Cialis improved men's ability to achieve erections 24 hours after taking the drug (5/1) |
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Neurocrine Biosciences Inc. (NBIX) | NBI-34060 | Type I GABA, a receptor agonist; chemically distinct from benzodiazepines | Transient and chronic insomnia | Company completed enrollment in its Phase II trials (5/10) |
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NexMed Inc. (NEXM) | Femprox | Topical treatment | Female sexual arousal disorder | Company initiated a Phase II study (5/21) |
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Orphan Medical Inc. (ORPH) | Xyrem | Sodium oxybate; oral solution | Narcolepsy | Open-label trial indicated that Xyrem produced an overall improvement in both the quality and the integration of sleep (5/28) |
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Palatin Technologies Inc. (AMEX:PTN) | PT-141 | Synthetic modification of PT-14, an analogue of a naturally occurring peptide hormone called alpha M.S.H. | Erectile dysfunction | Palatin completed a Phase I study in 56 volunteers; a maximum tolerated dose was not established (5/31) |
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TheraMed Inc. (subsidiary of | ErythroMax | Red blood cell-enhancing therapeutic which replaces 2,3 DPG with Inositol Hexaphosphate | Infection, cardiovascular and cerebrovascular conditions | Company will begin a Phase I trial (5/17) |
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Transkaryotic Therapies Inc. (TKTX) | Replagal | Agalsidase alfa enzyme replacement therapy | Fabry disease | Phase II data indicated Replagal therapy reduced cardiac mass and corrected the metabolic defect of Fabry disease; the therapy also appeared safe and well tolerated (5/18) |
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Vivus Inc. (VVUS) | Alista | Topical formulation of alprostadil | Female sexual arousal disorder | Clinical results demonstrated the safety of a single dose applied topically (5/22) |
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XOMA Ltd. | Xanelim | Efalizumab | Psoriasis | Xanelim hit its primary endpoint of achieving a 75% or greater improvement in Psoriasis Area and Severity Index scores over placebo in two Phase III trials (5/24) |
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Notes: | ||||
* Denotes privately held company. | ||||
ASCO = The 37th Annual Meeting of the American Society for Clinical Oncology. | ||||
Unless otherwise noted, shares are traded on the Nasdaq market. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange | ||||
NEXT WEEK: Non-U.S. clinical trials and FDA actions in May. |
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