Company* (Symbol) | Product | Description | Indication | Status (Date) |
CANCER |
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Alfacell Corp. (OTC BB: ACEL) | Onconase | Cytotoxic ribonuclease; member of the superfamily of pancreatic ribonucleases | Unresectable malignant mesothelioma | Reported positive preliminary Phase III survival results vs. doxorubicin at the 36th annual meeting of the American Society of Clinical Oncology in New Orleans (ASCO) (5/23) |
Allos Therapeutics Inc. (ALTH) | RSR13 | Synthetic allosteric modifier of hemoglobin that noncovalently binds to hemoglobin, increasing oxygen delivery to hypoxic tissue | Newly diagnosed glioblastoma multiforme and brain metastases (separate trials) | Reported survival data for two Phase II trials combining RSR13 and cranial radiation therapy at ASCO (5/23) |
AltaRex Corp. (TSE:AXO) | BrevaRex MAb | Modified murine monoclonal antibody against the MUC1 cancer antigen | MUC1-positive cancer | Reported immunology data from Phase I trial at ASCO (5/22) |
AltaRex Corp. (TSE:AXO) (Canada) | OvaRex MAb | Modified murine monoclonal antibody that binds to CA125 cancer antigen | Ovarian cancer | Presented long-term follow-up data on patients who received the product during early clinical trials (5/22) |
Alza Corp. (NYSE:AZA) | Doxil | Liposomal formulation of doxorubicin | Ovarian cancer | Presented data from trial comparing Doxil to Hycamtin (topetecan; marketed by SmithKline Beecham plc [UK; NYSE:SBH]) (5/20) |
Antigenics Inc. (AGEN) | Oncophage | Cancer vaccine consisting of purified, patient-specific heat shock protein-peptide complexes | Renal cell carcinoma and gastric carcinoma (separate trials) | Presented data from Phase II trial comparing monotherapy to combination with interleukin-2 in renal cell carcinoma at ASCO (5/22) |
Antigenics Inc. (AGEN) | Oncophage | Cancer vaccine consisting of purified, patient-specific heat shock protein-peptide complexes | Gastric carcinoma | Presented data from Phase I/II trial at ASCO (5/22) |
Antisoma plc (UK; EASDAQ: ASOM) | Theragyn | Murine monoclonal antibody, HMFG1, and chemical linker that binds to yttrium-90; HMFG1 targets polymorphic epithelial mucin (PEM), an abnormal form of mucine produced by tumor cells of the epithelium | Ovarian cancer in remission | Antisoma temporarily delayed recruitment into Phase III study following preliminary review of unaudited information about a similar product suggesting a survival advantage for the control group (5/22); independent safety committee recommended that recruitment continue; company will discuss the matter with regulatory authorities (5/26) |
Aphton Corp. (APHT) | | Anti-gastrin therapeutic vaccine; neutralizes hormone G17 and Gly-extended G17 | Advanced pancreatic cancer | Presented data from Phase II trial at the annual meeting of the American Gastroenterological Society in San Diego (AGA) (5/25) |
Aphton Corp. (APHT) | | Anti-gastrin therapeutic vaccine; neutralizes hormone G17 and Gly-extended G17 | Colorectal and stomach cancers | Presented antibody response G17 and Gly-extended G17 |
Aronex Pharmaceuticals Inc. (ARNX) | Atragen | Liposomal formulation of tretinoin (all trans-retinoic acid) | Acute promyelocytic leukemia | Presented data from pivotal Phase II trial at ASCO (5/22) |
Aronex Pharmaceuticals Inc. (ARNX) | Atragen | Liposomal formulation of tretinoin (all trans-retinoic acid) | Advanced renal cell cancer | Presented data from ongoing Phase I/II trial combining Atragen and interferon-alpha at ASCO (5/23) |
Atrix Laboratories (ATRX) | | Slow-release formulation of leuprolide acetate; product is injected subcutaneously as a liquid, then solidifies and releases a predetermined dose of leuprolide | Advanced prostate cancer | Completed enrollment in Phase III trial (5/31) |
Avax Technologies Inc. (AVXT) | O-Vax | Haptenized autologous cell vaccine | Ovarian cancer | Presented data from ongoing Phase I/II trial at ASCO (5/22) |
Avax Technologies Inc. (AVXT) | L-Vax | Haptenized autologous cell vaccine | Acute myelogenous leukemia | Initiated Phase I/II study (5/15) |
Avax Technologies Inc.(AVXT) | M-Vax | Haptenized autologous cell vaccine | Metastatic melanoma | Presented 10-year follow-up data at ASCO (5/23) |
AVI Biopharma Inc. (AVII) | Avicine | Therapeutic vaccine that elicits an immune response to human chorionic gonadotropin hormone | Advanced colorectal cancer | Presented Phase II data at ASCO (5/19) |
Biomira Inc. (Canada; BIOM) | BLP25 | Vaccine incorporates a synthetic 25-amino-acid sequence of the MUC1 cancer mucin encapsulated in a synthetic liposomal delivery system | Non-small-cell lung cancer | Presented Phase I data at ASCO (5/22) |
Biomira Inc. (Canada; BIOM) | BLP25 (with dendritic cells) | Injection of dendritic cells incubated with BLP25, a synthetic 25-amino-acid sequence of the MUC1 cancer mucin encapsulated in a synthetic liposomal delivery system | Recurrent metastatic breast cancer | Presented data from Phase I trial (5/22) |
Biomira Inc. (Canada; BIOM) | Theratope | Synthetic carbohydrate-based vaccine (mimic of cancer antigen sialyl-Tn plus carrier molecule KLH) | Metastatic breast cancer | Data Safety Monitoring Board recommended continuation of Phase III based on data from the first 300 patients who have completed at least the first 12 weeks of therapy (5/17) |
BioNumerik Pharmaceuticals Inc.* | BNP1350 | Karenitecin; silicon-containing camptothecin-like agent | Advanced solid tumors | Presented Phase I data at ASCO (5/22) |
BioNumerik Pharmaceuticals Inc.* | MDAM | Antifolate (gamma-methylene-10 deazaaminopterin) delivered via infusion (future trials will use oral version) | Advanced solid tumors | Presented data from Phase I and pharmacokinetic trial (5/22) |
BioTransplant Inc. (BTRN) | MEDI-507 antibody and AlloMune Cancer System | Mixed chimerism approach whereby patients are prepared for a bone-marrow or stem-cell transplant with a combination of low-dose chemotherapy and antibodies against T cells; incorporates MEDI-507, a humanized monoclonal antibody against CD2 antigen receptor found on T cells and natural killer cells | Bone marrow transplants in patients with blood or bone marrow cancers | Presented preliminary results of six-patient trial at Transplant 2000, the annual meeting of the American Society of Transplant Physicians and the American Society of Transplant Surgeons in Chicago (5/15) |
Celgene Corp. (CELG) | Thalomid (FDA-approved) | Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha | Multiple myeloma | Presented data from 169-patient trial at ASCO (5/24) |
Celgene Corp. (CELG) | Thalomid (FDA-approved) | Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha | Myeloma or Waldenstrom's-macroglobulinemia | Presented data from trial combining low-dose Thalomid and biaxin and dexamethasone at ASCO (5/24) |
Celgene Corp. (CELG) | Thalomid (FDA-approved) | Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha | Progressive metastatic renal cell carcinoma | Presented data from 15-patient trial at ASCO (5/24) |
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 (GM-CSF) | Pancreatic cancer | Presented Phase I data at ASCO (5/20) |
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 (GM-CSF) | Prostate cancer | Presented additional Phase I/II data at ASCO (5/20) |
Cell Pathways Inc. (CLPA) | Aptosyn | Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase | Post-prostatectomy men at risk of prostate cancer recurrence | Presented positive data from Phase II/III trial at the annual meeting of the American Urological Association in Atlanta (5/1) |
Cell Pathways Inc. (CLPA) | Aptosyn | Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase | Familial adenomatous polyposis | Presented positive data from Phase III trial and open-label extension at the annual meeting of the American Gastroenterological Association in San Diego (5/23) |
Celltech Group (UK; NYSE:CLL) and American Home Products Corp. (NYSE: AHP) | Mylotarg (FDA-approved) | Gemtuzumab ozogamicin; humanized recombinant antibody targeting CD33+(leukemic) cells; linked to anticancer antibiotic called calicheamicin, isolated from a bacterium in caliche clay | Advanced leukemia | Reported pooled data from three Phase II trials at ASCO (5/21) |
CollaGenex Pharmaceuticals Inc. (CGPI) | Metastat | Orally administered inhibitor of matrix metalloproteinases | Kaposi's sarcoma | Presented Phase I data at the 4th International AIDS Malignancy Conference in Bethesda, Md. (5/18) |
EntreMed Inc. (ENMD) | Endostatin | Naturally occurring fragment of collagen XVIII angiogenesis inhibitor | Cancer | EntreMed responded to media reports of poor patient response in Phase I trials; the company said it would not comment on individual patient responses, but also said there have been no serious adverse events and that a number of measures provided early evidence of biological activity (5/12) |
Genentech Inc. (NYSE:DNA) | | Recombinant humanized monoclonal antibody to vascular endothelial growth factor (rhuMAb-VEGF) | Advanced metastatic colorectal cancer | Presented data from Phase II trial of anti-VEGF in combination with with 5-fluorouracil/leucovorin at ASCO (5/21) |
Genentech Inc. (NYSE:DNA) | | Recombinant humanized monoclonal antibody to vascular endothelial growth factor (rhuMAb-VEGF) | Metastatic breast cancer | Presented data from Phase II trial of anti-VEGF in combination with various chemotherapy agents at ASCO (5/23) |
Genentech Inc. (NYSE:DNA) | | Recombinant humanized monoclonal antibody to vascular endothelial growth factor (rhuMAb-VEGF) | Non-small-cell lung cancer | Presented data from open-label Phase II trial in which six of 66 treated patients experienced sudden, serious pulmonary hemorrhage, resulting in four deaths (5/23) |
Genentech Inc. (NYSE:DNA) | Herceptin (FDA-approved) | Trastuzumab; humanized monoclonal antibody to HERs growth factor receptor | Metastatic, HER2+breast cancer (front-line therapy) | Presented Phase II results for Herceptin as a single agent at ASCO (5/23) |
Genta Inc. (GNTA) | Genasense (G3139) | Antisense compound; synthetic DNA strands that bind to mRNA for the bcl2 gene (proto-oncogene) | Advanced cancer | Presented Phase I data from trial of combination therapy with Taxol (paclitaxel) at ASCO (5/23) |
Genta Inc. (GNTA) | Genasense (G3139) | Antisense compound; synthetic DNA strands that bind to mRNA for the bcl2 gene (proto-oncogene) | Advanced prostate cancer | Presented Phase I results from trial of combination therapy with mitoxantrone at ASCO (5/24) |
Genta Inc. (GNTA) | Genasense (G3139) | Antisense compound; synthetic DNA strands that bind to mRNA for the bcl2 gene (proto-oncogene) | Advanced breast cancer | Presented interim Phase I/II data of combination trial with Taxotere (docetaxel) at ASCO (5/22) |
Genzyme Molecular Oncology (GZMO) | | Therapeutic vaccine that uses dendritic cells and combines melanoma tumor antigens (Mela-A/MART-1 and gp100) in a gene-based vaccine | Melanoma | Reported preliminary data from Phase I/II trial at ASCO (5/22) |
Hoffmann-La Roche Inc. (unit of Roche Group; Switzerland) | Ro-31-7453 | Oral cell-cycle inhibitor (inhibits proliferation and prompts apoptosis) | Various cancers | Presented Phase I data at ASCO (5/23) |
Idec Pharmaceuticals Corp. (IDPH) | Zevalin (IDEC-Y2B8) | Ibritumomab tiuxetan; murine monoclonal antibody that targets CD20 antigen, conjugated to yttrium 90 radioisotope | Non-Hodgkin's lymphoma | Presented data from four studies at ASCO: a biodistribution and dosimetry study, a Phase III study in chemotherapy-resistant patients, an infection-risk analysis, and a blood analysis for the bcl-2 cancer marker; the interim Phase III results showed a response rate for chemotherapy-resistant patients (77%) that was nearly identical to that observed for chemotherapy-sensitive patients (81%) (5/23) |
ImClone Systems Inc. (IMCL) | IMC-C225 | Chimeric monoclonal antibody targeting epidermal growth factor receptor | Refractory or relapsed head and neck carcioma | Presented data on 12 patients treated with C225 and cisplatin (5/22) |
ImClone Systems Inc. (IMCL) | IMC-C225 | Chimeric monoclonal antibody targeting epidermal growth factor receptor | Refractory colorectal carcinoma | Presented data on six patients treated with C225 and irinotecan (5/22) |
ImClone Systems Inc. (IMCL) | IMC-C225 | Chimeric monoclonal anti-body targeting epidermal growth factor receptor | Locally advanced squamous-cell head and neck cancer | Presented follow-up data of Phase Ib/IIa trial of C225 in combination with radiation (5/23) |
Immuno Designed Molecules SA (France) and Medarex Inc. (MEDX) | IDM-1 | Antibody-based cell drug comprised of MAK (mono-cytes-derived activated killer) cells associated with MDX-210, a bispecific anti-HER2/neu antibody | Ovarian cancer | Presented Phase II results at ASCO (5/22) |
Immunomedics Inc. (IMMU) | | Epratuzumab; humanized monoclonal antibody that targets the CD22 receptor on mature and malignant B lymphocytes | Non-Hodgkin's lymphoma | Presented analysis of ongoing Phase II trial at ASCO (5/23) |
IntraBiotics Pharmaceuticals Inc. (IBPI) | Protegrin IB-367 Rinse | Synthetically derived analogue of naturally occurring protegrins | Oral mucositis associated with chemotherapy | Initiated enrollment in Phase III trial (5/4) |
Introgen Therapeutics Inc.* and Aventis Pharmaceuticals (France; NYSE:AVE) | RPR/INGN 201 | Gene therapy using the p53 tumor suppressor gene delivered via an adenoviral vector | Non-small-cell lung cancer | Presented interim Phase II data of therapy in combination with radiation at ASCO (5/21) |
Introgen Therapeutics Inc.* and Aventis Pharmaceuticals (France; NYSE:AVE) | RPR/INGN 201 | Gene therapy using the p53 tumor suppressor gene delivered via an adenoviral vector | Various cancers | Presented Phase I and II data at ASCO (5/21 and 5/23) |
Isis Pharmaceuticals (ISIP) and Novartis AG (Switzerland; NYSE:NVS) | Isis 3521 | Antisense inhibitor of protein kinase C-alpha | Non-small-cell lung cancer | Presented data at ASCO from ongoing Phase I/II trial of Isis 3521 in combination with carboplatin and paclitaxel (5/22) |
Isis Pharmaceuticals (ISIP) | Isis 2503 | Antisense inhibitor of H-ras | Advanced cancer | Reported data at ASCO from Phase I trial of Isis 2503 in combination with gemcitabine |
Ligand Pharmaceuticals Inc. (LGND) | Panretin Gel (FDA-approved) | Alitretinoin 0.1% (topical); chemically synthesized version of 9-cis-retinoic acid (derived from vitamin A) | AIDS-related Kaposi's sarcoma | Presented positive long-term Phase III data at the National Cancer Institute's Fourth International AIDS Malignancy Conference in Bethesda, Md. (5/17) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin Gel | Bexarotene 1%; topical therapy based on synthetic retinoid that selectively activates retinoid X receptors | Early-stage cutaneous T-cell lymphoma | Two abstracts summarizing results of two open-label studies were published in the 4/00 edition of The Journal of Investigative Dermatology and were presented at the 61st annual meeting of the Society for Investigative Dermatology in Chicago (SID) (5/9) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin Capsules (FDA-approved) | Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors; oral formulation | Cutaneous T-cell lymphoma | Presented positive Phase II/III data at ASCO (5/23) |
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 | Phase II results were published in the ASCO meeting's abstracts book (5/23) |
Lorus Therapeutics Inc. (Canada; LORFF) | GTI-2040 | Antisense anticancer therapeutic | Cancer | Company reported Phase I/II trial is progressing according to plan (5/23) |
Matrix Pharmaceutical Inc. (MATX) | IntraDose Injectable Gel | Biodegradable gel containing cisplatin and epinephrine (intratumoral injection) | Head and neck cancer | Presented positive results from two independent Phase III trials at ASCO; an NDA is expected by the end of the year (5/23) |
Matrix Pharmaceutical Inc. (MATX) | IntraDose Injectable Gel | Biodegradable gel containing cisplatin and epinephrine (intratumoral injection) | Primary liver cancer | Presented updated interim results from ongoing Phase II trial at ASCO (5/22) |
Maxim Pharmaceuticals (MAXM) | Maxamine | Histamine dihydrochloride; H2 receptor agonist | Stage IV malignant melanoma | Presented positive results from U.S. Phase III trial using Maxamine in combination with interleukin-2 (5/2) |
MGI Pharma Inc. (MOGN) | Irofulven | Hydroxymethylacyfulvene; lead compound from acylfulvene family | Advanced pancreatic cancer for which gemcitabine has failed | Released Phase II data at ASCO (5/22) |
Millennium Pharmaceuticals Inc. (MLNM) | LDP-341 | Small-molecule proteasome inhibitor | Various cancers | Reported data from two ongoing Phase I trials at ASCO (5/23) |
NeoRx Corp. (NERX) | Skeletal Targeted Radiotherapy | Small-molecule carrier of the radionuclide holmium-166, designed to deliver radiation therapy selectively to the disease site | Multiple myeloma | Reported Phae I/II data at ASCO (5/22) |
Onyx Pharmaceuticals Inc. (ONXX) and Warner-Lambert Co. (WLA) | CI-1042 (ONYX-015) | Genetically engineered adenovirus that replicates in and kills tumor cells deficient in p53 tumor-suppressor gene product | Liver metastases of colorectal cancer | Reported data from Phase I/II trial combining CI-1042 and 5-fluororacil/leucovorin at ASCO (5/24) |
Onyx Pharmaceuticals Inc. (ONXX) and Warner-Lambert Co. (WLA) | CI-1042 (ONYX-015) | Genetically engineered adenovirus that replicates in and kills tumor cells deficient in p53 tumor-suppressor gene product | Refractory cancer | Reported data from Phase I doseescalation trial (5/24) |
Neurobiological Technologies Inc. (NTII) | Xerecept | Synthetic preparation of the natural human peptide corticotropin-releasing factor | Peritumoral brain edema | Presented data from Phase II trial at the annual meeting of the American Academy of Neurology meeting in San Diego (5/9) |
Pharmacyclics Inc. (PCYC) | Xcytrin | Motexafin gadolinium; intravenously delivered radiation sensitizer | Brain metastases | Presented positive data from lead-in portion of Phase III trial at ASCO (5/22) |
PharmaMar (Spain)* | ET-743 | Ecteinascidin; compound obtained from the tunicate Ecteinascidia turbinata | Soft-tissue sarcomas | Presented preliminary results from Phase II trials at ASCO (5/23) |
Praecis Pharmaceuticals Inc. (PRCS) and Amgen Inc. (AMGN) | Abarelix-depot-M | Synthetically modified peptide that acts as a gonadotropin-releasing hormone antagonist | Prostate cancer | Presented positive data from two Phase III trials at ASCO; NDA filing expected by year-end (5/23) |
Progenics Pharmaceuticals Inc. (PGNX) and Bristol-Myers Squibb Co. (NYSE:BMY) | GMK vaccine | Cancer vaccine; induces antibodies to GM2 ganlioside cancer antigen on melanoma cells | Melanoma | The Eastern Cooperative Oncology Group (a site in the Phase III study) performed an unplanned early analysis on a subset of patients and found the relapse-free and overall survival rates for patients receiving the vaccine were lower than for patients receiving high-dose alpha interferon; the trial is fully enrolled and the company will continue to analyze data as it becomes available (5/26) |
Protarga Inc.* | Taxoprexin | Synthetic small molecule made by linking paclitaxel to the natural fatty acid DHA (docosahexanoic acid) | Progressive metastatic disease representing a variety of tumor types | Presented preliminary results of Phase I trial at ASCO (5/21) |
Protein Design Labs Inc. (PDLI) | | SMART (humanized) monoclonal antibody that binds to an HLA-DR determinant found on many pre-B and B-cell lymphomas | Relapsed 1D10-positive non-Hodgkin's B-cell lymphoma | Presented preliminary results from ongoing Phase I trial at ASCO (5/22) |
Ribozyme Pharmaceuticals Inc. (RZYM) and Chiron Corp. | Angiozyme | Synthetic ribozyme targeting mRNA of the Flt-1 receptor for vascular endothelial growth factor; subcutaneously delivered anti-angiogenic | Cancer | Presented data from single-dose Phase I trials (5/23) |
SafeScience Inc. (SAFS) | GBC-590 | Carbohydrate lectin inhibitor that competitively binds to unique lectins on cancer cells and disrupts the metastatic process | Refractory or relapsing carcinoma of the pancreas | Received institutional review board approval for a Phase II open-label trial (5/3) |
Sugen (wholly owned subsidiary of Pharmacia Corp. [NYSE: PHA]) | SU5416 | Angiogenesis inhibitor; small-molecule inhibitor of tyrosine kinase Flk-1/KDR receptor (to which vascular endothelial growth factor binds, thus activating angiogenesis) | Untreated metastatic colorectal cancer | Presented preliminary data from Phase I/II trial combining SU5416 and 5-fluorouracil/lecovorin (5/23) |
SuperGen Inc. (SUPG) | Rubitecan | Oral chemotherapy compound in the camptothecin class | Refractory pancreatic cancer | Presented Phase II data at ASCO (5/23) |
SuperGen Inc. (SUPG) | Rubitecan | Oral chemotherapy compound in the camptothecin | Various refractory tumors | Presented data from two Phase I trials at ASCO (5/23) |
Targeted Genetics Corp. (TGEN) | tgDCC-E1A | Cancer therapeutic that uses a cationic lipid formulation of DC-cholesterol to deliver the E1A gene to tumor cells | Recurrent head and neck squamous cell carcinoma | Presented Phase II trial data at ASCO (5/22) |
Targeted Genetics Corp. (TGEN) | tgDCC-E1A | Cancer therapeutic that uses a cationic lipid formulation of DC-cholesterol to deliver the E1A gene to tumor cells | Ovarian cancer | Presented data from Phase I trial combining tgDCC-E1A and paclitaxel/cisplatin (5/22) |
Therion Biologics Corp.* | Prostvac | Therapeutic vaccine comprised of a recombinant vaccinia virus engineered to express human prostate specific antigen | Advanced prostate cancer | Phase I data was published in 5/00 issue of Clinical Cancer Research (5/11) |
Transgene | VV-MUC1-IL2 (France; TRGNY) | Cancer vaccine that contains the genes for the MUC1 cancer antigen and interleukin-2; delivered via vaccina vector | Progressive prostate cancer | Presented Phase I data at the annual meeting of the American Urological Association in Atlanta (5/2) |
Vical Inc. (VICL) | Allovectin-7 | DNA/lipid complex containing the human gene encoding the HLA-B7 antigen; intra-tumoral injection | Late-stage metastatic melanoma | Presented positive interim data from ongoing Phase II registration trial at ASCO (5/21) |
Vical Inc. (VICL) | Allovectin-7 | DNA/lipid complex containing the human gene encoding the HLA-B7 antigen; intra-tumoral injection | Metastatic melanoma | Independent Drug Safety Review Board recommended that Phase II and III registration trials continue (5/12) |
Vical Inc. (VICL) | Leuvectin | Gene encoding interleukin-2 (complexed with lipid) administered by direct intratumoral injection | Renal cell carcinoma | Presented interim Phase II data at ASCO (5/21) |
Vion Pharmaceuticals Inc. (VION) | Triapine | Ribonucleotide reductase inhibitor (inhibits DNA synthesis); intravenous administration | Various cancers | Completed one Phase I trial and started another (5/18) |
Xenova Group plc (UK;XNVA) | XR9576 | P-glycoprotein pump inihibitor that restores the sensitivity of multi-drug resistant cancer cells to specific cytotoxic drugs | Cancer | Completed Phase IIa drug-interaction study combining XR9576 and doxorubicin; reported interim data (5/11) |
CARDIOVASCULAR |
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Actelion Ltd. (Switzerland; SWX New Market:ATLN) | Bosentan | Orally active dual endothelin receptor antagonist; interferes with binding of endothelin To ETa and ETb receptors | Pulmonary hypertension | Reported positive Phase III trial results (5/2) |
Avant ImmunoTherapeutics (AVAN) | TP10 | Soluble form of complement receptor 1 (CR1), designed to inhibit complement proteins | Infants undergoing cardiac surgery | Presented data from Phase I/II trial at the Society of Cardiovascular Anesthesiologists Annual Meeting in Orlando, Fla. (5/10) |
Centocor Inc. (subsidiary of Johnson & Johnson; NYSE:JNJ) and Eli Lilly and Co. (NYSE:LLY) | ReoPro (FDA-approved) | Chimeric monoclonal antibody fragment to GPIIb/IIIa platelet receptor (abciximab) | Patients undergoing primary stenting | Presented positive six-month data from ADMIRAL study (Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-term-Follow-up); presentation was made at the Paris Course on Revascularization (5/26) |
Centocor Inc. (subsidiary of Johnson & Johnson; NYSE:JNJ) and Eli Lilly and Co. (NYSE:LLY) | ReoPro (FDA-approved) | Chimeric monoclonal anti-body fragment to GPIIb/IIIa platelet receptor (abciximab) | Unstable angina | Completed enrollment in Phase III IV-ACS trial (Global Use of Strategies to Open Occluded Arteries in Acute Coronary Syndromes) (5/4) |
CV Therapeutics Inc. (CVTX) | CVT-510 | Selective adenosine A1 receptor antagonist | Paroxysmal supraventricular tachycardia | Completed first segment of Phase II program, which provides support to move into Phase III (5/16) |
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 | Chronic venous ulcers | Reported preliminary results from Phase II trial (5/23) |
Protherics plc (UK; LSE:PTI) | | Angiotensin vaccine | Hypertension | Completed Phase I trials (5/10) |
United Therapeutics Corp. (UTHR) | Uniprost | Subcutaneous prostacyclin therapy; stable structural analogue of prostacyclin | Pulmonary hypertension | Filed with the FDA to commence a clinical study to investigate the safety of transitioning pulmonary hypertension patients from Flolan (marketed by Glaxo Wellcome) to Uniprost (5/8) |
CENTRAL NERVOUS SYSTEM |
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Alza Corp. (NYSE:AZA) and Johnson & Johnson (NYSE: JNJ) | Concerta | Extended-release formulation of methylphenidate hydrochloride | Children with attention deficit disorder/attention deficit hyperactivity disorder | Presented blinded, randomized trial data at the American Academy of Neurology's 52nd annual meeting in San Diego (5/4) |
Gliatech Inc. (GLIA) | Perceptin | Selective antagonist of histamine H3 receptor | Adults with attention deficit hyper-activity disorder | Initiated enrollment in Phase II trial (5/23) |
NicOx SA (France; Nouveau Marche: NICOX) and AstraZeneca plc (UK; NYSE:AZN) | HCT-3012 | Nitic oxide-releasing non-steroidal anti-inflammatory drug; derivative of naproxen designed to have reduced gastric toxicity | Pain and inflammation | AstraZeneca initiated Phase I trial (5/19) |
DIABETES |
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Aradigm Corp. (ARDM) and Novo Nordisk A/S (Denmark) | AERx system | Insulin delivered via fine aerosol mists that are deposited deep into the lung; handheld electronic inhaler guides patient to breathe correctly and consistently | Type I diabetes | Company confirmed Phase I study results disclosed in an abstract published by the American Diabetes Association and reported by investment analysts (5/18) |
Generex Biotechnology Corp. (Canada; GNBT) | | Oral insulin aerosolized liquid formulation administered as a fine spray into the mouth via small device that looks like an asthma inhaler | Diabetes | Initiated long-term Phase II trials (5/10) |
Neurobiological Technologies Inc. (OTC BB:NTII) and Merz+Co. GmbH (Germany) | 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 neuropathic pain | Presented trial data at the annual meeting of the American Academy of Neurology in San Diego (5/4) |
Questcor Pharmaceuticals Inc. (AMEX: QSC) and Shire Pharmaceuticals | Emitasol | Intranasal formulation of metoclopramide | Diabetic gastroparesis | Completed enrollment and treatment in clinical trial (5/18) |
INFECTION |
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Avant Immuno-Therapeutics Inc. (AVAN) and SmithKline Beecham plc (NYSE:SBH) | | Two-dose oral rotavirus attenuated vaccine derived from a naturally occurring isolate found in children | Prevention of rotavirus gastroenteritis disease in young children | Reported results of second-year surveillance extension of Phase II trial (5/4) |
BioChem Pharma Inc. (BCHE) | Zeffix (FDA-approved) | Lamivudine; nucleoside analogue (oral) | Chronic hepatitis B infection | Reported positive data at the 35th annual meeting of the European Association for the Study of the Liver in Rotterdam, the Netherlands (EASL) (5/1) |
Cubist Pharmaceuticals Inc. (CBST) | Cidecin | Daptomycin for injection; lipopeptide antibiotic | Serious Grampositive infections | Presented data from two ongoing Phase II trials at the 10th European Congress of Microbiology and Infectious Diseases in Stockholm (5/31); separate presentation discussed results of using daptomycin for two patients with Leuconostoc species bacteremia in recipients of bone-marrow transplants (5/31) |
Enzon Inc. (ENZN) and Schering-Plough Corp. (NYSE: SGP) | Pegintron and Rebetol | Long-acting dosage form of Intron A (recombinant interferon alfa-2b) conjugated to polyethylene glycol; combination therapy with Rebetol (ribavirin; synthetic nucleoside with antiviral activity; oral) | Chronic hepatitis C and compensated liver disease | Presented data from Phase II openlabel, randomized, active controlled study at EASL; formally presented positive Phase III data reported earlier (5/1) |
The Immune Response Corp. (IMNR) and Agouron Pharmaceuticals Inc. (subsidiary of Warner-Lambert Co. [NYSE: WLA]) | Remune | Envelope-depleted, inactiveated AIDS virus (emulsified with adjuvant); therapeutic vaccine | HIV infection | Initiated pivotal trial of Remune in combination with antiretroviral therapy (5/10) |
Ribozyme Pharmaceuticals Inc. (RZYM) and Eli Lilly and Co. (NYSE:LLY) | LY 466700 (formerly Heptazyme) | Synthetic ribozyme designed to selectively cut hepatitis C virus RNA and inhibit viral replication | Chronic hepatitis C infection | Completed single-dose safety trial and initiated new trial to measure HCV viral RNA levels in treated patients (5/10) |
StressGen Biotechnologies (Canada; TSE: SSB) | HspE7 | Recombinant fusion product composed of heat shock protein 65 (Hsp65) from Myco-bacterium bovis BCG and the protein E7, derived from the human papillomavirus | Human papilloma-virus infection | Reported data from Phase I trial at ASCO (5/22) |
VaxGen Inc. (VXGN) | AIDSVAX | Bivalent vaccine composed of recombinant gp 120 (envelope protein) from two strains of HIV-1 that are prevalent in the Americas, Western Europe and Australia | Prevention of HIV infection and AIDS | Two Phase III trials received third consecutive positive review from independent Data and Safety Monitoring Board; additionally, the company noted that 96% of trial volunteers continued to participate in Phase III trials, a significantly higher rate than expected (5/3) |
MISCELLANEOUS |
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Anika Therapeutics Inc. (ANIK) | Orthovisc | High-molecular weight naturally derived form of hyaluronic acid | Osteoarthritis of the knee | Product did not show sufficient efficacy to support the filing of a premarket application with the FDA (5/30) |
Ares-Serono International SA (Switzerland) | Rebif | Recombinant interferon beta-1a | Relapsing-remitting multiple sclerosis | Presented long-term results from PRISMS study (Prevention of Relapses and disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) at the 52nd annual meeting of the American Academy of Neurology in San Diego (AAN); data indicate the product can delay progression of MS if patients are treated early (5/1) |
Biogen Inc. (BGEN) | Avonex (FDA-approved) | Recombinant inerferon beta-1a | Patients at risk for Presented data from the Phase III CHAMPS study (Controlled High Risk Subjects Avonex Multiple sclerosis Prevention Study) at AAN; trial was stopped early (2/00) when interim analysis indicated positive results (5/2) |
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Celgene Corp. (CELG) | Thalomid (FDA-approved) | Thalidomide; thought to act by modulating levels of tumor necrosis factor-alpha | Moderate to severe ulcerative colitis | Reported interim results of an open-label pilot study (5/25) |
Centocor Inc. (subsidiary of Johnson & Johnson; NYSE:JNJ) | Remicade (FDA-approved) | Infliximab; chimeric monoclonal antibody to tumor necrosis factor-alpha | Crohn's disease | Presented positive data from multiple studies at the Digestive Diseases Week meeting in San Diego (DDW); data showed the product can reduce or eliminate the need for steroids for many patients (5/24) |
Chiron Corp. (CHIR) and Berlex Laboratories Inc. (unit of Schering AG; Germany) | Betaseron for SC Injection (FDA-approved) | Recombinant human interferon beta-1b | Secondary progressive multiple sclerosis | In European trial -- but not in North American trial -- the product achieved statistical significance in the primary endpoint of delay of disability progression; Berlex said data suggest patients with more advanced disease seem less likely to respond, a factor that may have contributed to the North American disappointment; data were presented at AAN (5/1) |
Genzyme General (GENZ) | Fabrazyme | Afgalsidase beta for injection; enzyme replacement Therapy | Fabry's disease | Based on preliminary analysis of Phase III trial data, Genzyme is completing BLA and initiated prelaunch activities (5/2) |
Immtech International Inc. (IMMT) | DB-289 | Orally administered, more stable molecule based on Pentamidine (marketed by Fujisawa Healthcare [Japan]) | Pneumocystis carinii pneumonia and Trypanosomisis | Manufacturing completed for Phase I trials scheduled for third quarter (5/31) |
Immunex Corp. (IMNX) | Nuvance | A recombinant human version of a naturally occurring protein thought to act by binding to interleukin-4, a protein presesnt in asthmatic lungs | Asthma | Immunex released preliminary analysis of Phase III results; Nuvance failed to achieve statistical significance in a weekly measure of efficacy (but did meet other endpoints); Immunex is continuing development (5/25) |
Inhale Therapeutic Systems Inc. (INHL) and Biogen Inc. (BGEN) | Inhaleable Avonex | Use of Inhale's Inhance powder delivery technology to administer interferon beta-1a | Multiple sclerosis | Biogen initiated Phase I trials (4/18) |
Inhale Therapeutic Systems Inc. (INHL) | | Albuterol sulfate delivered using the PulmoSphere particle processing technology | Asthma | Reported data from Phase I trial (5/16) |
InKine Pharmaceutical Company Inc. (INKP) | CBP-1011 | Tablet formulation of orally available steroid | Idiopathic thrombocytopenic purpura | Completed a trial comparing bioavailability of tablet formulation to capsule formulation (currently in Phase III trials) (5/31) |
InSite Vision Inc. (AMEX:ISV) and Pharmacia Corp. (NYSE: PHA) | ISV-205 | Diclofenac (non-steroidal anti-inflammatory drug) formulated in InSite's DuraSite sustained-release delivery vehicle; inhibits TIGR protein | Reduction of intraocular pressure in first-degree relatives of glaucoma patients | Presented Phase II data at the annual meeting of the Association for Research in Vision and Ophthalmology in Ft. Lauderdale, Fla. (ARVO) (5/2) |
InSite Vision Inc. (AMEX:ISV) | ISV-615 | Topical eyedrop formulation containing batimastat, a metalloproteinase inhibitor; anti-angiogenic | Retinal degeneration | Presented previously released data at ARVO (5/2) |
Isotechnika Inc. (Canada; CDNX: ISA) | ISAtx247 | Immunosuppressive | Prevention of organ transplant rejection | Completed Phase Ia trials (5/17) |
KS Biomedix plc (UK; LSE:KSB) | CBF-BS2 | Small molecule | Rheumatoid arthritis | Released more detailed analysis of Phase II trial (5/22) |
La Jolla Pharmaceutical Co. (LJPC) | LJP 394 | Molecule (toleragen) that binds to surface of B cells and shuts off production of antibodies to double-stranded DNA | Lupus | Reported additional positive results from Phase II/III trial (5/3) |
Ligand Pharmaceuticals Inc. (LGND) | Ontak (FDA-approved) | Denileukin difitox; fusion protein consisting of fragment of diphtheria toxin genetically fused to interleukin-2; targets IL-2 receptors on the surface of malignant cells and some normal lymphocytes, leading to the death of those cells | Severe psoriasis | Presented Phase II data at 61st annual meeting of the Society for Investigative Dermatology in Chicago (results also published in 4/00 issue of The Journal of Investigative Dermatology) (5/11) |
Ligand Pharmaceuticals Inc. (LGND) | Targretin Capsules (FDA-approved) | Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors; oral formulation | Moderate to severe plaque psoriasis | Presented Phase II data at the SID meeting; data was published in the 4/00 edition of the Journal of Investigative Dermatology (5/9) |
Millennium Pharmaceuticals Inc. (MLNM) | LDP-02 | Humanized monoclonal antibody against alpha-4 beta-7, an integrin on inflammatory cells that causes the cells to adhere to the gastrointestinal tract | Ulcerative colitis | Presented Phase I/II data at DDW (5/24) |
MoliChem Medicines Inc.* | Molil901 | Duramycin, 2622U90; polycyclic peptide delivered via aerosol; fosters mucus clearance | Cystic fibrosis | Completed Phase I trial (5/19) |
NPS Pharmaceuticals Inc. (NPSP) | | Recombinant human parathyroid hormone (l-84) | Osteoporosis | The University of San Francisco initiated a trial combining the hormone and alendronate (supplied by Merck & Co. Inc. [NYSE: MRK]) (5/18) |
PathoGenesis Corp. (PGNS) | Tobi (FDA-Approved) | Tobramycin solution for inhalation | Cystic fibrosis patients with mild lung disease | Initiated open-label Phase IV trial (5/30) |
Pharmacyclics Inc. (PCYC) | Optrin | Motexafin lutetium; water-soluble photodynamic drug activated by 732 nm light | Age-related macular degeneration | Presented preliminary results of Phase II study at ARVO (5/3) |
QLT PhotoTheraputics Inc. (Canada; QLTI) and CIBA Vision (unit of Novartis AG [Switzerland; NYSE:NVS]) | Visudyne (FDA-approved) | Verteporfin for injection; photodynamic theapy activated by specially designed laser that produces low-level, non-thermal 689 nm light | Age-related macular degeneration | Presented data from multiple clinical trials at ARVO (5/3) |
Vysis Inc. (VYSI) and Genentech Inc. (NYSE:DNA) | PathVysion HER2 test kit | Test for HER2 gene amplification using fluorescence in situ hybridization (FISH) method | Identification of HER2-positive metastatic breast cancer with potential to response to Genentech's Herceptin therapy | Reported results of retrospective study comparing FISH method to immunohistochemical technique at ASCO (5/23) |
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; 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 |
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ND = Not disclosed. |
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AAN = 52nd Annual Meeting of the American Academy of Neurology in San Diego. |
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ASCO = 36th annual meeting of the American Society of Clinical Oncology in New Orleans. |
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ARVO = 2000 annual meeting of the Association for Research in Vision and Ophthalmology in Ft. Lauderdale, Fla. |
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DDW = Digestive Diseases Week 2000 in San Diego. |
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EASL = European Association for the Study of the Liver meeting in Rotterdam, the Netherlands. |
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SID = 61st annual meeting of the Society for Investigative Dermatology in Chicago. |