Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

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

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

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

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

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

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)

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:

* Privately held.

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

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

ND = Not disclosed.

AAN = 52nd Annual Meeting of the American Academy of Neurology in San Diego.

ASCO = 36th annual meeting of the American Society of Clinical Oncology in New Orleans.

ARVO = 2000 annual meeting of the Association for Research in Vision and Ophthalmology in Ft. Lauderdale, Fla.

DDW = Digestive Diseases Week 2000 in San Diego.

EASL = European Association for the Study of the Liver meeting in Rotterdam, the Netherlands.

SID = 61st annual meeting of the Society for Investigative Dermatology in Chicago.

No Comments