Company* | Product |
Description | Indication |
Status (Date) |
| ||||
AUTOIMMUNE | ||||
Abbott |
Humira (FDA-approved) |
Adalimumab; fully human antibody designed to block TNF-alpha |
Psoriatic arthritis and ankylosing spondylitis |
Presented data from trials that showed benefit in each indication (6/15) |
Amgen |
Enbrel (FDA-approved) |
Etanercept; anti-tumor necrosis factor-alpha antibody |
Rheumatoid arthritis |
Two-year data from TEMPO trial showed Enbrel improved clinical remission at two years compared to methotrexate alone (6/10) |
Antisense |
ATL-1102 |
Second-generation inhibitor of very late-antigen-4 |
Multiple sclerosis |
Phase I trial showed drug appeared to be well tolerated, and the study produced a dose for Phase II development (6/8) |
Arakis Ltd.* (UK) |
AD 452 |
Single-isomer form of a drug marketed in a different indication |
Rheumatoid arthritis |
Began Phase IIa trial in 96 RA patients to study pharmacokinetics, safety and tolerability of a range of doses (6/8) |
Aspreva |
CellCept |
Mycophenolate mofetil; an immunosuppressant |
Myasthenia gravis |
Began Phase III trial that will include 136 patients in five countries to test safety and efficacy (6/7) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets and binds tumor necrosis factor-alpha |
Ankylosing spondylitis |
ASSERT trial demonstrated that drug improved signs and symptoms of the disease vs. placebo (6/14) |
Centocor Inc. |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets and binds tumor necrosis factor-alpha |
Rheumatoid arthritis |
Data from ASPIRE trial showed improved bone erosion scores vs. methotrexate alone in early RA patients (6/11) |
Centocor |
Remicade (FDA-approved) |
Infliximab; monoclonal antibody that targets and binds tumor necrosis factor-alpha |
Psoriatic arthritis |
Phase III IMPACT 2 trial showed improvements in both the arthritis and psoriasis associated with PA (6/10) |
Genentech Inc. (NYSE:DNA) |
Rituxan (FDA-approved) |
Rituximab; antibody that binds to the CD20 antigen on the surface of normal and malignant B cells |
Rheumatoid arthritis |
Published Phase IIa data showed a statistically significant benefit in combination group vs. methotrexate alone (6/16) |
Hemispherx |
Alferon N |
Purified mixture of natural alpha interferons |
Multiple sclerosis |
Began Phase IIa program to test safety and efficacy in 50 patients who discontinued other treatments (6/14) |
Neurogen |
NGD 2000-1 |
Oral C5a antagonist |
Rheumatoid arthritis |
Phase IIa trial failed to meet its primary endpoint, change in C-reactive protein, but fared better on secondary endpoints (6/15) |
CANCER | ||||
Advanced Viral |
AVR118 |
Peptide-nucleic acid complex with immunomodulatory properties |
Cachexia |
Phase I/II trial in cancer and AIDS patients showed an increase in weight, strength and fat percentage with all doses (ASCO) |
Aesgen Inc.* |
Saforis |
L-glutamine delivered with company's technology |
Oral mucositis in cancer patients |
Phase III trial showed significant reduction in severity and duration of condition in patients with breast and other cancers (ASCO) |
AEterna Zentaris Inc. (Canada; AEZS) and Keryx Biopharmaceuticals Inc. (KERX) |
Perifosine (KRX-0401) |
Orally active AKT inhibitor |
Advanced solid tumors |
Phase I trial demonstrated safety and tolerability, dose-limiting toxicity and evidence of antitumor activity (ASCO) |
Agennix Inc.* |
-- |
Oral recombinant human lactoferrin |
Metastatic cancers |
Data from two Phase I/II trials showed a statistically significant reduction in the average tumor growth rate (ASCO) |
Allos Therapeutics |
RSR13 (efaproxiral) |
Small molecule designed to sensitize hypoxic areas of tumors prior to radiation |
Brain metastases |
Retrospective Phase III data showed benefit in metastases from non- small-cell lung cancer; presented already-reported positive Phase III REACH trial data (ASCO) |
American BioSciences |
Abraxane |
Nanoparticle albuminbound taxane |
Advanced breast cancer and other solid tumors |
Phase II trial produced a response rate of 15% in advanced breast cancer; Phase I trial showed drug was well tolerated at high doses with weekly dosing (ASCO) |
Amgen |
Aranesp (FDA- approved) |
Darbepoetin alfa, a recombinant erythropoietic protein |
Anemia from chemotherapy |
Final data from three trials showed Aranesp every two weeks was comparable to weekly epoetin (Procrit); also, three-week dosing achieved target hemoglobin levels; trial showed drug could be useful in anemia in patients not on chemotherapy (ASCO) |
Amgen |
Panitumumab (formerly ABX-EGF) |
Fully human monoclonal antibody that targets the epidermal growth factor receptor |
Metastatic colorectal cancer |
Phase II trial demonstrated anti-tumor activity as a single agent in patients who had failed other treatments (ASCO) |
Angstrom Pharmaceuticals |
A6 |
Agent that targets the urokinase plasminogen- activator system |
Preventing relapse in ovarian cancer |
Began Phase II trial to assess safety in 48 to 60 asymptomatic women (6/14) |
AnorMed |
AMD3100 |
Designed to block receptor that triggers movement of stem cells out of bone marrow |
Stem cell transplantation in cancer patients |
Phase II trial in 10 multiple myeloma patients showed it helped patients undergo a tandem stem cell transplant procedure (ASCO) |
Antigenics Inc. |
Oncophage |
Personalized cancer vaccine based on heat-shock protein technology |
Metastatic melanoma |
Ten of 16 patients with residual melanoma post- surgery experienced disease stabilization (ASCO) |
Aphton |
G17DT |
Immunotherapy vaccine designed to induce antibodies that bind to both gastrin 17 and glygastrin 17 |
Various cancers |
Presented Phase III data showing statistically significant survival benefit as monotherapy in advanced pancreatic cancer patients who can't take chemotherapy; also presented Phase II combination studies in other cancers (ASCO) |
Ariad |
AP23573 |
Small molecule designed to inhibit cell-signaling protein mTOR |
Advanced solid tumors |
Phase I single-agent trials demonstrated antitumor activity in 50% of patients dosed daily and 17% of patients dosed weekly (ASCO); began single-agent Phase II trial in relapsed hematological cancers in up to 200 patients (6/15) |
Array |
ARRY-142886 (AZD6244) |
Selective, ATP non- competitive inhibitor of MEK 1/2 |
Advanced cancers |
Began Phase I trial to evaluate tolerability and pharmacokinetics, as well as indications of biological activity (6/14) |
Biogen |
Zevalin (FDA- approved) |
Ibritumomab tiuxetan; monoclonal antibody targeting CD20 combined with radioisotope |
Low-grade follicular lymphoma |
Phase II trial showed combination with Rituxan might produce high complete remission rates in previously untreated patients (ASCO); drug produced durable responses in 78 of 211 refractory patients with non- hodgkin's lymphoma (6/14) |
Biomira Inc. |
Theratope |
Vaccine combining mimic of cancer antigen sialyl-Tn and carrier molecule KLH |
Metastatic breast cancer |
Exploratory analysis of Phase III trial showed statistical significance in hormonal therapy subset of women (ASCO) |
CancerVax |
SAI-EGF |
Immunotherapeutic agent targeting the epidermal growth factor receptor |
Non-small-cell lung cancer |
Phase I/II data showed therapy was well tolerated, resulted in immune responses and may increase survival (ASCO) |
CancerVax |
Canvaxin |
Therapeutic whole-cell vaccine that expresses more than 20 antigens |
Stage IV melanoma |
Restrospective analysis of Phase II trial in 1,856 patients showed a significant improvement in overall survival (ASCO) |
Can-Fite Biopharma Ltd.* (Israel) |
CF101 |
Adenosine 3 receptor agonist |
Solid tumors |
Began Phase I trial to test safety, tolerability and clinical effects in combination with three different chemotherapy regimens (6/30) |
Celgene |
Thalomid (FDA-approved) |
Thalidomide |
Multiple myeloma and metastatic melanoma |
Phase III trial showed a statistically significant response increase in combination with dexamethasone vs. dexamethasone alone; Phase II trial with melphalan and prednisone also showed benefit; ongoing Phase II data with temozolomide for metastatic melanoma also were presented (ASCO) |
Cell Genesys |
GVAX |
Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF |
Acute myelogenous |
Presented encouraging follow- up data from Phase II trials in both AML and advanced hormone-refractory prostate cancer (ASCO) |
Cell Genesys |
CG7870 |
Oncolytic virus therapy |
Metastatic prostate |
Final Phase I/II data showed five of 23 patients (3 of 5 in highest dose groups) had reduced PSA levels (ASCO) |
Cell Genesys |
GVAX |
Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF |
Lung cancer |
Began Phase II trial in 100 patients with advanced-stage broncho-alveolar carcinoma, the second of two Phase IIs in lung cancer (6/28) |
Cell Genesys |
GVAX |
Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF |
Pancreatic cancer |
Phase II exploratory trial in 50 inoperable patients showed tolability with cyclophosphamide and trends toward improved outcomes (6/26) |
Cell Therapeutics |
CT-2106 |
A polyglutamate camptothecin |
Solid tumors |
Phase I data showed the drug was well tolerated and lacked certain toxicities typical of camptothecins (ASCO) |
Cell Therapeutics |
Xyotax |
Paclitaxel linked to biodegradable polyglutamate polymer |
Non-small-cell lung cancer |
Update on Phase III trial showed higher survival rates than in historical controls, thus extending the study (ASCO) |
Cell Therapeutics Inc. (CTIC) |
Trisenox (FDA- approved) |
Arsenic trioxide |
Late-stage multiple myeloma |
Phase II trial with vitamin C and melphalan produced responses in seven of 13 relapsed patients (6/14) |
Cell Therapeutics |
Trisenox (FDA- approved) |
Arsenic trioxide |
Myelodysplasia |
Phase II trial in 62 patients demonstrated activity in both low- and high-risk disease (ASCO); Phase II single-agent trial produced a hematologic response rate of 27% (6/10) |
Cel-Sci Corp. (AMEX:CVM) |
Multikine |
Mixture of human cyto- ines designed to stimulate an immune response |
Head and neck cancer |
Phase II data from 39 patients showed those on drug had more cancer cells killed and a 42% response rate (ASCO) |
ChemGenex Therapeutics |
Quinamed |
Amonafide dihydrochloride; topoisomerase II inhibitor |
Solid tumors |
Presented positive data from 32-patient study that used genotyping to determine dosing (ASCO) |
Chiron |
Proleukin |
Recombinant form of human interleukin-2 |
Non-Hodgkin's lymphoma |
Began Phase II trial with Rituxan to assess combination in first- time Rituxan patients (ASCO) |
Coley Pharmaceutical Group Inc.* |
ProMune (CPG 7909) |
Toll-like receptor 9 agonist |
Advanced non- small-cell lung cancer |
More objective tumor responses were seen with ProMune combination than with chemotherapy alone in Phase II trial (ASCO) |
Corixa |
Bexxar (FDA-approved) |
Radiotherapeutic combining tositumomab and iodine-131 |
Non-Hodgkin's lymphoma |
Two trials using Bexxar after chemotherapy produced complete responses in 80% to 83% of patients with advanced follicular B-cell NHL (ASCO) |
Cytogen |
Quadramet |
Samarium-153 lexidron injection; skeletal-targeting radiopharmaceutical |
Bone metastases and prostate cancer |
Data from three trials showed the agent may work synergistically with other approaches in metastases from various tumors (ASCO); 30- patient study showed survival benefit (p=0.02) in hormone- refractory prostate cancer (6/22) |
Cytokinetics |
SB-743921 |
Small-molecule inhibitor of kinesin spindle protein |
Advanced solid tumors |
Phase I trials showed the agent might be well tolerated in that patient group (ASCO) |
Dendreon |
APC8024 |
Immunotherapy; vaccine that targets tumors expressing the HER2/neu marker |
Metastatic solid tumors |
Phase I trial demonstrated a statistically significant T-cell immune response in patients with HER2/neu-positive cancers (ASCO) |
DUSA |
Levulan (FDA- approved) |
Photodynamic therapy |
High-grade dysplasia within Barrett's esophagus |
Began pilot Phase II trial to gather information on new endoscopic light delivery system (6/8) |
Exelixis |
XL999 |
Spectrum selective kinase inhibitor, targeting receptor tyrosine kinases |
Cancers |
Filed IND for Phase I trial to test safety, tolerability, pharmaco-kinetics and biological activity in patients (6/29) |
Exelixis |
XL119 |
Becatecarin; small-molecule cancer compound |
Bile duct cancer |
Began Phase III trial vs. chemotherapy in up to 600 patients to assess survival (6/23) |
Exelixis |
XL647 |
Oral compound targeting multiple receptor tyrosine kinases |
Solid tumors |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in patients for whom there is no alternative therapy (6/3) |
Epimmune |
EP-2101 |
Immunotherapy; multi-pitope vaccine |
Cancers |
Results from 10 patients in Phase I/II trial showed it was safe and well tolerated, and induced a multi-epitope response (ASCO) |
Genaera |
Squalamine |
Anti-angiogenesis agent; vascular endothelial growth factor inhibitor |
Non-small-cell lung cancer |
Updated Phase IIb data showed drug with chemotherapy was well tolerated and produced a 72% overall response rate (ASCO) |
Genentech Inc. (NYSE:DNA) |
Avastin (FDA- approved) |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Metastatic pancreatic and colorectal cancer |
Among presentations was a Phase II trial with gemcitabine showing one-year survival of 54% in pancreatic cancer and a survival benefit in Phase II trial with 5-FU/leucovorin in colorectal cancer (ASCO) |
Genentech Inc. (NYSE:DNA) and OSI Pharmaceuticals Inc. (OSIP) |
Tarceva and Avastin (FDA- approved) |
Erlotinib HCl; small- molecule HER1/EGFR inhibitor; and bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Metastatic renal- cell carcinoma and non-small- cell lung cancer |
Phase II trial in metastatic kidney cancer showed 12 of 58 patients had an objective response to the combination and 38 a minor response; clinical benefit also was seen in Phase I/II NSCLC trial; (ASCO) |
Genentech Inc. (NYSE:DNA) and OSI Pharmaceuticals Inc. (OSIP) |
Tarceva |
Erlotinib HCl; small-molecule HER1/EGFR inhibitor |
Advanced non-small-cell lung and other cancers |
Phase III trial in NSCLC showed a 42.5% improvement in median survival and 41% in one-year survival vs. placebo; Tarceva did not improve on standard chemotherapy in advanced lung cancer (ASCO) |
Genentech Inc. (NYSE:DNA) and Biogen Idec Inc. (BIIB) |
Rituxan (FDA- approved) |
Rituximab; antibody that binds to the CD20 antigen on normal and malignant B cells |
Non-Hodgkin's lymphoma |
Phase III trial in 824 patients demonstrated a significant improvement in time to treatment failure, the primary endpoint; Phase III maintenance trial with chemotherapy showed significant improvement in progression-free survival (ASCO) |
Genentech Inc. (NYSE:DNA) |
Herceptin (FDA-approved) |
Trastuzumab; monoclonal antibody against HER2/neu protein |
HER2-positive metastatic breast cancer |
Presented data showing trend of improved survival in study with paclitaxel and carboplatin, and presented 50 other studies of various treatment regimens (ASCO) |
Genmab |
HuMax-CD20 |
Human antibody that binds to the CD20 antigen |
Chronic lymphocytic leukemia |
Began Phase I/II dose- escalation trial to measure responses in 32 patients with relapsed or refractory CLL (6/21) |
GenVec |
TNFerade |
Adenovector with TNF- alpha gene and a radiation- responsive promoter |
Locally advanced prostate cancer |
Presented promising survival data from Phase II trial in combination with standard therapy in unresectable disease (ASCO) |
Genzyme |
Thyrogen (FDA-approved) |
Thyrotropin alfa for injection; a recombinant human thyroid- stimulating hormone |
Thyroid tumors |
Trial in 63 patients showed agent was as effective for remnant ablation as thyroid hormone withdrawal, with reduced side effects (6/16) |
Geron |
-- |
Telomerase therapeutic vaccine that uses ex vivo dendritic-cell technology |
Metastatic prostate cancer |
Phase I/II trial showed 19 of 20 patients generated telomerase-specific cytotoxic T cells, without any side effects (ASCO) |
Gloucester Pharmaceuticals |
FK228 |
Depsipeptide; bicyclic peptide, histone deacetylase inhibitor |
T-cell lymphomas |
Presented encouraging data on tolerability and responses from ongoing Phase II trial (ASCO) |
GTx |
Acapodene (toremifene citrate) |
Small-molecule non- steroidal selective estrogen receptor modulator |
Side effects of androgen-deprivation therapy |
Phase II trial showed product was well tolerated and reduced bone mineral density better than placebo (ASCO) |
GTx |
Acapodene (toremifene citrate) |
Small-molecule non- steroidal selective estrogen receptor modulator |
Prostate cancer |
Phase II trial in men demonstrated tolerability and the reduction of disease in those with high-grade prostatic intraepithelial neoplasia (6/2) |
Human |
HGS-ETR1 |
Agonistic human mono- clonal antibody to TRAIL receptor-1 |
Cancers |
Phase I trials demonstrated safety and tolerability, as well as biological activity (ASCO) |
ILEX |
Campath (FDA- approved) |
Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces |
B-cell chronic lymphocytic leukemia |
Interim safety update was positive from Phase III trial comparing drug to chlorambucil in patients with progressive disease (ASCO) |
ILEX |
ILX-651 |
Next-generation synthetic pentapeptide analogue of dolastatin |
Hormone- refractory cancer |
Began Phase II trial in 40 patients whose disease has progressed after Taxotere treatment (6/17) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Advanced head and neck cancer and other cancers |
Phase III trial with high-dose radiation met endpoints of locoregional control and survival in head and neck cancer; presented data from four combination trials in colorectal cancer; two Phase II combination trials in non- small-cell lung cancer showed benefit vs. chemotherapy alone; two Merck KGaA-sponsored studies in advanced squamous- cell carcinoma of the head and neck had a disease control rate of 45.6% and 69.8% (ASCO) |
ImClone |
IMC-BEC2 |
Cancer vaccine; anti- idiotypic monoclonal antibody that mimics GD3 |
Small-cell lung cancer |
Two-year Phase III trial did not demonstrate a survival benefit (ASCO) |
Immunomedics |
CEA-Cide (labetuzmab) |
Humanized antibody against carcinoembryonic antigen, labeled with 90-yttrium |
Advanced colorectal and pancreatic cancers |
Phase I studies in each cancer showed tumor targeting, accept- able normal organ radiation doses and a maximum dose (6/21) |
Immunomedics |
Epratuzumab |
Humanized anti-CD22 monoclonal antibody |
Aggressive non- Hodgkin's lymphoma |
Pilot study with Rituxan and CHOP regimen and Phase II with Rituxan showed promising activity; also reported on Phase I/II trial on radiolabeled form of drug (ASCO) |
Inex |
Onco TCS |
Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology |
Aggressive non- Hodgkin's lymphoma |
Follow-up Phase II data showed a complete response rate of 91% (62 of 68) in first-line treatment as part of chemotherapy regimen (ASCO) |
Introgen |
INGN 241 |
Agent containing the tumor- suppressor gene Mda-7/IL-24 |
Solid tumors |
Final data from Phase I trial demonstrated clinical and biological activity (6/7) |
Introgen |
Advexin |
Adenoviral vector containing the p53 tumor-suppressor gene |
Cancers |
Presented data from 445 patients in 14 trials showing safety, tolerability and activity as a single agent and in combination trials (6/3 and ASCO) |
Keryx Bio- pharmaceuticals |
KRX-0401 (perifosine) |
Oral AKT inhibitor |
Non-small-cell lung cancer |
Began Phase II trial to test safety and efficacy of single- gent treatment in progressed disease (6/10) |
Kosan |
KOS-862 |
Epothilone D |
Colorectal and prostate cancers |
Roche and Kosan stopped development in colorectal cancer due to toxicities seen in Phase II trial; they plan a Phase II trial in prostate cancer (6/22) |
Kosan |
17-AAG |
17-allylamino-17-demeth- oxy-geldanamycin; inhibits heat-shock protein 90 |
Solid tumors |
Presented data from four Phase I or II trials; drug was well tolerated (ASCO) |
Kudos |
AQ4N |
Hypoxic cell-activated antitumor therapy |
Advanced esophageal carcinoma |
Interim Phase I results showed AQ4N to be well tolerated with a favorable pharmacokinetic profile (ASCO) |
Ligand |
Avinza (FDA-approved) |
Extended-release morphine |
Chronic pain in cancer patients |
Long-term, open-label trial demonstrated pain control with acceptable tolerability (ASCO) |
Ligand |
Targretin (FDA- approved) |
Bexarotene capsules |
Non-small-cell lung cancer |
Phase II trial with chemotherapy regimen showed improved event-free survival vs. historical controls; other trials showed tolerability and some activity (ASCO) |
Maxim |
Ceplene |
Histamine dihydrochloride in combination with interleukin-2 |
Metastatic melanoma |
Published 36-month follow-up data from M01 Phase III trial demonstrated statistically significant survival improvement vs. IL-2 alone (6/4) |
Medarex |
MDX-070 |
Fully human antibody to prostate-specific membrane antigen |
Prostate cancer |
Began Phase II trial in up to 30 patients with hormone-refractory disease (6/23) |
Medarex |
MDX-010 |
Fully human antibody against human CTLA-4 |
Metastatic melanoma |
Overall response rate in Phase II trial with dacarbazine was 17.1%, or six of 35 patients (ASCO) |
MediciNova |
MN-029 |
Vascular targeting agent |
Solid tumors |
Plans to begin Phase I trial testing safety and tolerability (6/24) |
MedImmune |
Ethyol (FDA- approved) |
Amifostine; cytoprotective agent |
Dry mouth in radiation therapy patients |
Phase III trial in 303 head and neck cancer patients showed drug reduced dry mouth, and that two years after treatment patients still produced saliva (ASCO) |
Merix Bioscience |
-- |
RNA-loaded autologous dendritic-cell vaccine | Kidney cancer |
Began Phase I/II trial in newly diagnosed patients with metastatic disease (6/8) |
MGI |
Aloxi (FDA-approved) |
Palonosetron hydrochloride injection; a 5-HT3 receptor antagonist |
Nausea in patients undergoing chemotherapy |
Presented various postmarketing and other data showing benefit (ASCO); presented summary data from various trials showing positive efficacy and quality-of- life results (6/25) |
MGI Pharma |
Irofulven |
Hydroxymethylacylfulvene; compound from acylfulvenes family |
Solid tumors |
Phase II data from trials in three cancers demonstrated antitumor activity alone and in combination regimens (ASCO) |
Millennium Pharmaceuticals |
MLN2704 |
Monoclonal antibody (MLN591) directed at PSA conjugated to DM1 |
Hormone- refractory prostate cancer |
Phase I trial in metastatic disease showed it was well tolerated and produced antitumor activity (ASCO) |
Millennium Pharmaceuticals |
Velcade (FDA-approved) |
Bortezomib; proteasome inhibitor |
Relapsed multiple myeloma and non-small- ell lung cancer |
Phase III confirmatory trial showed statistically significant benefits in survival and time to disease progression vs. high- dose dexamethasone; data were presented from two investigator- sponsored trials; also presented promising Phase II data in non- small-cell lung cancer (ASCO) |
NeoPharm |
LEP-ETU |
Liposomal formulation of paclitaxel |
Advanced cancers |
Phase I trial provided preliminary evidence of improved safety and tolerability (ASCO) |
NeoPharm |
LE-SN38 |
Liposomal formulation of the active metabolite of irinotecan |
Advanced cancers |
Patients were safely treated in a Phase I trial that used pharmaco- genomics in dosing (ASCO) |
NeoRx |
Skeletal Targeted Radiotherapy |
Bone-targeting molecule DOTMP with radioactive substance holmium-166 |
Multiple myeloma |
Phase II dosimetry trial showed positive trends in both patient response and safety (ASCO) |
OncoGenex Technologies Inc.* (Canada) and Isis Pharmaceuticals Inc. (ISIS) |
OGX-011 |
Second-generation anti- sense agent designed to inhibit the production of clusterin |
Prostate cancer |
Phase I trial showed drug was well tolerated, achieved concentration in target tissue and produced a 91% dose-dependent down-regulation of clusterin (ASCO) |
Onyx Pharmaceuticals Inc. (ONXX) and Bayer Pharmaceuticals Corp. |
BAY 43-9006 |
RAF kinase and VEGF inhibitor |
Advanced renal- cell carcinoma and malignant melanoma |
Phase II single-agent trial showed responses in 89 of 106 patients who were assessed at 12 weeks; also presented encouraging Phase l/II data on combination therapy in advanced malignant melanoma (ASCO) |
OSI |
Aptosyn (exisulind) |
Small molecule that augments apoptosis in precancerous cells |
Advanced non- small-cell lung cancer |
Phase III trial in combination with Taxotere did not meet primary endpoint of improving overall survival; also missed secondary endpoints (6/11) |
Pharmacyclics |
Xcytrin |
Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis |
Non-Hodgkin's lymphoma |
Began Phase II trial to study efficacy and safety in 35 to 40 patients with low-grade NHL who relapsed after Rituxan therapy (6/16) |
Pharmacyclics Inc. (PCYC) |
Xcytrin |
Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis |
Advanced refractory tumors |
Preliminary Phase I data of drug and Taxotere showed four of seven patients achieved a partial response (ASCO) |
PharmaMar |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Cancers |
Gained approval to begin Phase II trials in the U.S. in multiple myeloma and prostate cancer (6/22) |
PharmaMar |
Kahalalide F |
Peptides isolated from the Hawaiian mollusk, Elysia rufescens |
Advanced prostate cancer |
Phase I trial of the product demonstrated safety (ASCO) |
PharmaMar |
Yondelis |
Trabectedin; ET-743; derived from the sea squirt Ecteinascidia turbinata |
Various cancers |
Data showed activity in sarcomas, tolerability and activity in refractory ovarian cancer, and activity in recurrent endometrial carcinoma (ASCO) |
Point |
Talabostat (PT-100) |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Metastatic melanoma and chronic lymphocytic leukemia |
Began Phase II trial in up to 54 melanoma patients in combination with cisplatin (6/17); began Phase II trial with Rituxan in up to 54 CLL patients (6/22); began Phase II single-agent trial in advanced melanoma (6/30) |
Point |
Talabostat (PT-100) |
Small molecule designed to stimulate proliferation of hematopoietic progenitor cells |
Solid tumors |
Phase I data suggested drug can accelerate neutrophil recovery in patients receiving myelosuppressive chemotherapy (ASCO) |
Procyon |
PCK3145 |
Synthetic peptide analogue of prostate secretory protein |
Metastatic prostate cancer |
Final Phase IIa results in 16 pat- ients with hormone-refractory disease confirmed safety, tolerability and preliminary efficacy at all dose levels tested (ASCO) |
Pro-Pharmaceuticals Inc. (AMEX:PRW) |
Davanat |
Carbohydrate compound designed for targeted delivery |
Advanced solid tumors |
Interim tolerability data from Phase I trial in combination with 5-FU were positive (6/23) |
Regeneron |
VEGF Trap |
Intravenous product designed to block vascular endothelial growth factor |
Advanced solid tumors |
Phase I trial showed it can bind VEGF in patients and was well tolerated (ASCO) |
Seattle |
SGN-15 |
Antibody-drug conjugate that provides targeting to doxorubicin |
Non-small-cell lung cancer |
Phase II trial in 62 refractory patients showed improved survival with Taxotere vs. Taxotere alone, 7.3 months to 5.9 months (ASCO) |
Sonus |
Tocosol Paclitaxel |
Formulation of paclitaxel using Sonus' delivery system |
Various cancers |
Presented ongoing results from Phase IIa trials in three tumor types showing tolerability and encouraging efficacy data (ASCO) |
Spectrum Pharmaceuticals |
EOquin |
Anticancer agent |
Superficial bladder cancer |
Additional data from single- gent Phase I trial demonstrated safety and complete response in eight of 10 patients (6/24) |
Sunesis |
SNS-595 |
Small-molecule cell- cycle modulator designed to induce apoptosis |
Cancers |
Began Phase I trial in patients with advanced disease to examine safety, tolerability, pharmacokinetics and dosing (6/28) |
SuperGen |
Dacogen |
Decitabine for injection |
Myelodysplastic syndromes |
Phase I trial with carboplatin in advanced solid tumors confirmed feasibility of the combination (ASCO) |
SuperGen |
Nipent (FDA- approved) |
Pentostatin for injection |
Leukemias and lymphomas |
Presented data from three combination trials showing treatment was active, well tolerated and did not increase toxicity (ASCO) |
Telik |
Telcyta |
Small-molecule tumor- activated drug designed to induce apoptosis |
Non-small-cell lung cancer |
Began Phase II trial with carboplatin and paclitaxel in the front- line treatment of Stage IIIb or IV disease (6/30) |
Telik |
Telcyta |
Small-molecule tumor-activated drug designed to induce apoptosis |
Ovarian and non-small-cell lung cancers |
Presented results from three Phase II combination trials showing encouraging response rates in refractory patients (ASCO) |
Therion Biologics Corp.* |
Panvac-VF |
Vaccine designed to stimulate the immune system to target and destroy cells expressing CEA and mucin-1 |
Metastatic pancreatic cancer |
Began pivotal Phase III trial to test survival in 250 patients in whom gemcitabine is ineffective (6/21) |
Therion Biologics Corp.* |
Panvac-VF |
Vaccine designed to stimulate the immune system to target and destroy cells expressing CEA and mucin-1 |
Advanced pancreatic cancer |
Phase I trial showed survival of at least 5.3 months vs. an expected three months; additional safety data also were reported; and CEA-VF/ Tricom Phase I trial showed median survival of 7.9 months (ASCO) |
Threshold Pharmaceuticals |
Glufosamide |
Isophosphoramide mustard linked to beta-D-glucose |
Breast and colon cancers |
Antitumor activity was seen in Phase II trials in both indications (ASCO) |
Titan |
Pivanex |
Agent designed to inhibit histone deacetylases class of enzymes |
Non-small-cell lung cancer |
Discontinued Phase IIb study in combination with docetaxel after interim safety analysis found significant safety issues (6/21) |
Transgene |
MVA-Muc1- IL2 vaccine |
Product using the MVA virus to carry and express two antigens found in HPV 16 |
Prostate and non-small-cell lung cancers |
Vaccination produced increases in PSA doubling time in Phase II prostate cancer trial; seven of 18 NSCLC patients responded in Phase II trial (ASCO) |
U.S. Oncology |
Abraxane |
Nanoparticle albumin-bound paclitaxel |
Metastatic breast cancer |
Trial showed a 15% overall response rate and tolerability in 106 patients (ASCO) |
VasGene |
Veglin |
Antisense oligonucleotide that binds VEGF |
Various cancers |
Phase I trial showed the drug was safe and demonstrated clinical activity (ASCO) |
Vical |
Allovectin-7 |
DNA plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and ß2 microglobulin |
Metastatic melanoma |
Phase II trial testing high doses in 127 refractory patients showed a response rate of 10.2%, as well as tolerability (ASCO) |
Vion |
Cloretazine (VNP40101M) |
Sulfonyl hydrazine DNA alkylating agent |
Leukemia |
Phase I trial in combination with cytosine arabinoside data in 34 patients produced positive results (ASCO) |
Vion |
Cloretazine (VNP40101M) |
Sulfonyl hydrazine DNA alkylating agent |
Cancer |
Initial Phase I data on 23 patients showed it was well tolerated and showed effect, but did not produce clinical responses (ASCO) |
Vion |
Cloretazine (VNP40101M) |
Sulfonyl hydrazine DNA alkylating agent |
Brain cancer |
Began Phase II trial to assess the activity and toxicity in adult patients with recurrent gliomas (6/1) |
Wilex |
Rencarex (WX-G250) |
Chimeric monoclonal IgG1 antibody that binds to the MN cell-surface antigen |
Renal-cell carcinoma |
Began pivotal Phase III ARISER trial in 612 patients in Europe and the U.S. as an adjuvant therapy in clear-cell RCC (6/15) |
Xanthus |
Symadex (C-1311) |
Next-generation product based on mitoxantrone, from the imidazoacri-dinone family |
Advanced solid tumors |
Began Phase I trial in 15-20 patients to assess pharmacokinetics and dosing (6/15) |
Xcyte |
Xcellerated T Cells |
T cells from patient stimulated to carry out immune functions |
Various cancers |
Positive data were seen in Phase I/II trials in chronic lymphocytic leukemia, multiple myeloma and prostate cancer (ASCO) |
Xenova |
Tariquidar |
P-glycoprotein membrane inhibitor |
Solid tumors in children |
NCI investigators presented Phase I data indicating the drug was well tolerated in children (ASCO) |
CARDIOVASCULAR | ||||
Archemix |
ARC183 |
Anti-thrombin aptamer |
Anticoagulant |
Filed IND for Phase I trial for potential use in coronary artery bypass graft surgery (6/30) |
Cerus |
Intercept Blood System |
Pathogen-inactivation system for red blood cells that uses the compound S-303 |
Blood transfusions |
Independent analysis of Phase III trial showed no statistically significant differences in respiratory adverse events between test and control groups (6/16) |
Corgentech |
E2F Decoy (edifoligide) |
Oligonucleotide designed to inactivate the cell-cycle transcription factor E2F |
Coronary artery bypass graft failure |
Monitors in final review said Phase III PREVENT IV CABG trial could continue as planned (6/24) |
CoTherix |
Ventavis |
Iiloprost inhalation solution; prostacyclin analogue |
Pulmonary arterial hypertension |
Began Phase II STEP trial in combination with Tracleer in 60 patients (6/15) |
Dyax Corp. |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein |
Hereditary angioedema |
Phase II EDEMA1 trial met primary endpoint of improving symptoms of acute attacks of HAE within four hours of treatment (6/14) |
Emisphere |
-- |
Oral heparin formulated with Eligen delivery technology |
Thrombolytic agent |
Began trial to select appropriate oral dosing for late-stage clinical trials (6/16) |
Endovasc |
Liprostin |
Liposome-encapsulated form of prostaglandin E1 |
Peripheral vascular disease |
Data from first 28 patients in Phase II trial showed improvements in endpoints related to walking distance (6/9) |
Millennium Pharmaceuticals |
Integrilin (FDA- approved) |
Eptifibide; glycoprotein IIb-IIIa inhibitor |
Acute coronary syndrome |
Began Phase IIIb EARLY ACS trial in up to 10,500 patients worldwide to assess the benefit in high-risk patients experiencing non-ST-segment elevation ACS (6/1) |
Nabi Bio- pharmaceuticals |
PhosLo |
Calcium acetate |
Control of blood phosphorus in end-stage renal disease |
Began Phase IV PRECISE trial to evaluate drug with the statin Lipitor in about 150 patients (6/10) |
Nuvelo |
Alfimeprase |
Modified fibrolase delivered via catheter; thrombolytic agent |
Acute peripheral arterial occlusion |
Phase II trial showed drug re- stored blood flow in four hours or less, as well as a dose response (6/28) |
Nuvelo |
Alfimeprase |
Modified fibrolase delivered via catheter; thrombolytic agent |
Venous catheter occlusion |
Monitors recommended Phase II trial continue in the two highest dose groups after looking at data from 48 patients (6/9) |
Nuvelo |
Alfimeprase |
Modified fibrolase delivered via catheter; thrombolytic agent |
Chronic peripheral arterial occlusion |
Preliminary data from 87 patients in Phase II trial showed a clear ose response, as well as safety and tolerability (6/5) |
Synthetic |
Oxycyte |
Perfluorocarbon-based blood substitute and therapeutic oxygen carrier |
Blood substitute |
Phase I safety trial supported move into Phase II development (6/14) |
CENTRAL NERVOUS SYSTEM | ||||
Acadia |
ACP-103 |
Small-molecule, 5-HT2A inverse agonist |
Parkinson's disease |
Phase Ib/IIa trial in 12 patients demonstrated safety and tolerability (6/29) |
Amgen |
GDNF |
Glial cell line-derived neurotrophic factor |
Parkinson's disease |
Phase II trial in 34 patients with advanced disease failed to meet primary endpoint of improving symptoms at six months (6/28) |
Axonyx |
Phenserine |
Inhibitor of acetylcholin- esterase and beta-amyloid precursor protein |
Alzheimer's disease |
Began second Phase III trial to evaluate safety and efficacy of two doses in mild to moderate AD patients treated for six months (6/16) |
Delex |
AeroLEF |
Aerosolized liposome- encapsulated fentanyl |
Pain following knee surgery |
Preliminary Phase IIa results were called encouraging (6/9) |
Guilford Pharmaceuticals |
Aquavan injection |
Water-soluble prodrug of propofol |
Sedation |
Confirmatory Phase II trial in 64 colonoscopy patients showed rapid onset and recovery without serious adverse effects (6/17) |
Orphan |
Xyrem (FDA- approved) |
Sodium oxybate oral solution |
Fibromyalgia |
Began trial to evaluate drug for treating symptoms of fibromyalgia in 150 patients (6/30) |
Orphan |
Xyrem (FDA- approved) |
Sodium oxybate oral solution |
Excessive daytime sleepiness |
Presented statistically significant results from 228-patient trial in EDS associated with narcolepsy (6/9) |
Pain |
Remoxy |
Capsule formulation of oxycodone, designed to be abuse-resistant |
Pain |
Head-to-head study vs. oxycodone in human volunteers showed Remoxy was significantly less abusable (6/29) |
Repligen |
RG2133 |
Prodrug of uridine, which acts on cell metabolism |
Bipolar disorder and major depression |
Phase I trial showed the drug appeared to be safe, did not induce mania, and provided early evidence of a clinical effect (6/10) |
Rinat |
RI 624 |
Humanized monoclonal antibody that inhibits nerve growth factor |
Pain |
Began a Phase I trial to test safety (6/23) |
Sepracor |
Estorra |
Eszopiclone tablets |
Insomnia |
Presented six posters describing positive results on sleep in elderly and non-elderly patients (6/8); new data from Phase III analysis howed improved sleep maintenance regardless of WASO levels (6/10) |
Titan |
Probuphine |
Buprenorphine formulated with Titan's ProNeura delivery system |
Opiate addiction |
Presented data from 12-patient pilot trial showing maintenance of benefit after switch from buprenorphine therapy to Probuphine (6/3) |
Vela |
VPI-013 |
Combination 5-HT(1A) receptor agonist, serotonin reuptake inhibitor and sigma receptor agonist |
Depression |
Began trial to test efficacy and safety in patients with major depressive disorder (6/29) |
Xenova Group |
TA-CD |
Vaccine designed to produce anti-cocaine antibodies |
Cocaine addiction |
The vaccine showed promise in a number of areas in Phase II trials involving 22 cocaine users (6/14) |
DIABETES | ||||
Amylin |
Exenatide |
Incretin mimetic; synthetic exendin-4 |
Type II diabetes |
Data from two of three pivotal studies showed significant lowering of blood sugar levels in patients unable to lower glucose levels with common oral regimens (6/5) |
BioStratum Inc.* |
Pyridorin |
Small molecule designed to inhibit formation of glycation end-products |
Diabetic kidney disease |
Phase IIa and IIb trials showed positive effects on creatinine levels and demonstrated safety and tolerability (6/7) |
Emisphere Technologies |
-- |
Oral insulin tablet that uses company's Eligen technology |
Type II diabetes |
13-patient trial showed a positive impact on glycemic control and tolerability (6/7) |
Generex |
Oralin |
Oral insulin spray formulation |
Type I diabetes |
Presented positive pharmac-kinetic data and results vs. s.c. regular insulin in two trials (6/8) |
Nektar |
Exubera |
Product that uses Nektar's inhaler and powdered insulin formulation |
Type II diabetes |
Pfizer Inc. and Aventis SA presented two-year open-label data showing sustained glycemic control and pulmonary function (6/7) |
INFECTION | ||||
Cubist |
Cubicin (FDA- approved) |
Daptomycin for injection |
Complicated skin and skin- tructure infections |
Published data from two pivotal Phase III trials showed statistical significance for safety and efficacy vs. comparator agent (6/16) |
Dynavax |
AIC |
Anti-allergy immunotherapy |
Ragweed allergy |
Phase I trial in 24 children demonstrated tolerability (6/24) |
Indevus Pharmaceuticals |
Aminocandin |
Fungicidal agent from the echinocandins class |
Fungal infections |
Phase I trial showed drug was well tolerated in healthy volunteers and demonstrated prolonged antifungal activity (6/9) |
Inhibitex |
Veronate |
Antibody-based immune globulin |
S. aureus infections in infants |
Began pivotal Phase III trial to prevent hospital-associated infections in very-low-birth-weight infants (6/30) |
InterMune |
Infergen (FDA-approved) |
Interferon alfacon-1 |
Hepatitis C |
Began Phase III DIRECT trial to evaluate the safety and efficacy with ribavirin in 510 HCV non-responder patients (6/15) |
IntraBiotics Pharmaceuticals |
Iseganan |
Antimicobial peptide; a protegrin |
Ventilator- associated pneumonia |
Stopped pivotal study after monitors saw increased mortality and disease in the drug group (6/23) |
Nabi Bio- pharmaceuticals |
StaphVAX |
Staphylococcus aureus polysaccharide conjugate vaccine |
S. aureus infections |
Began additional studies of the vaccine to include cardiovascular and orthopedic surgery patients (6/22) |
Panacos Pharmaceuticals |
PA-457 |
Small-molecule drug from new class named maturation inhibitors |
HIV |
Phase I trial in healthy volunteers showed tolerability; company began multiple-dose safety trial (6/1) |
Peninsula Pharmaceuticals Inc.* |
Doripenem (S-4661) |
Agent from the carbapenem class of beta-lactam antibiotics |
Hospital- acquired pneumonia |
Began pivotal Phase III trial comparing safety and efficacy to piperacillin/tazobactam; it is the fifth pivotal trial of the drug (6/10) |
Spherics Inc.* |
Spherazole |
Oral itraconazole that incorporates Spherics' bioadhesive technology |
Fungal infections |
Began Phase I trial to evaluate the potential of the delivery technology (6/14) |
Valeant Pharmaceuticals |
Viramidine |
Oral nucleoside analogue |
Hepatitis C |
Began second of two Phase III trials in conjunction with a pegylated interferon; the VISER2 trial will enroll about 1,000 patients (6/14) |
Vertex |
VX-950 |
Oral protease inhibitor |
Hepatitis C |
Began Phase I trial to assess safety, tolerability and pharmacokinetics of escalating single doses in healthy volunteers (6/8) |
Vical Inc. |
-- |
Plasmid DNA-based anthrax vaccine |
Anthrax infection |
Beginning Phase I trial, which is being supported by the National Institute of Allergy and Infectious Diseases (6/1) |
ViroPharma |
HCV-086 |
Antiviral compound from new chemical series |
Hepatitis C |
Began trial in 96 patients to eval- uate antiviral activity, safety and pharmacokinetics of ascending doses (6/8) |
MISCELLANEOUS | ||||
Advanced |
Ferumoxytol |
Intravenously administered, bioavailable iron |
Iron replacement |
Began a Phase III trial in anemic chronic kidney disease patients who are on hemodialysis (6/16) |
BioMarin |
Aryplase |
Enzyme-replacement therapy |
Mucopoly- saccharidosis-VI |
Phase III trial in 39 patients demonstrated a statistically significant improvment in endurance, the primary endpoint, and that it was well tolerated in general (6/3) |
BioSante Pharmaceuticals |
LibiGel |
Transdermal testosterone gel |
Female sexual dysfunction |
Phase II trial in 46 patients demonstrated no safety concerns; efficacy data were being analyzed (6/23) |
CollaGenex Pharmaceuticals |
Col-101 (Periostat MR) |
Modified-release formulation of doxycycline |
Rosacea |
Began two Phase III trials with up to 264 patients each to assess benefit over 16 treatment weeks (6/15) |
Genaera Corp. |
Squalamine |
Anti-angiogenesis agent; VEGF inhibitor |
Wet age-related macular degeneration |
Began a second Phase II trial to assess safety and efficacy over two years in 100 patients (6/16) |
Inflazyme Pharmaceuticals |
IPL512,602 |
Leukocyte-selective anti-inflammatory agent |
Asthma |
Phase IIa trial failed to meet the primary endpoint vs. placebo in improving FEV1; no more development was expected (6/18) |
Inspire Pharmaceuticals |
Diquafosol tetrasodium |
Ophthalmic solution |
Dry eye |
Began Phase III trial in 500 patients, as called for following FDA approval letter in December 2003 (6/2) |
Nastech Pharmaceutical |
PYY3-36 Nasal Spray |
High-affinity Y2 receptor agonist |
Obesity |
Phase Ic study showed the product reduced caloric intake, led to weight loss and was safe and well tolerated (6/29) |
NitroMed Inc. (NTMD) and Merck & Co. Inc. |
-- |
Nitric oxide-enhancing COX-2 inhibitor |
Pain, inflammation and other conditions |
Merck moved the product into Phase II testing (6/22) |
Nymox Pharmaceuticals Corp. (NYMX) |
NX-1207 |
Investigational drug for BPH |
Benign prostatic hyperplasia |
Phase I/II trial in 20 men showed improved symptom scores and shrinkage in prostate size (6/24) |
Palatin Technologies Inc. (AMEX:PTN) |
PT-141 |
Intranasally delivered melanocortin agonist |
Erectile dysfunction |
Trial showed co-administration of PT-141 and Viagra was more efficacious than Viagra alone (6/8) |
Serono SA (Switzerland; NYSE:SRA) |
Serostim (FDA- approved) |
Somatropin for injection |
HIV-associated adipose redistribution syndrome |
Began trial in 300 patients to assess benefit in reducing excess visceral fat accumulation (6/1) |
Targeted Genetics Corp. (TGEN) |
tgAAVCF |
Gene therapy that uses an adeno-associated virus vector to deliver the CFTR gene directly into the lungs |
Cystic fibrosis |
Monitors of a Phase IIb trial recommended the trial continue as planned; the trial includes 100 patients (6/23) |
Tercica Inc. |
-- |
Recombinant human insulin- like growth factor-1 |
Short stature caused by IGF deficiency |
Phase III trial in 65 children demonstrated a statistically significant increase in growth rate, the primary endpoint, and an acceptable safety profile (6/16) |
Notes: | ||||
* Privately held | ||||
ASCO = Data reported at American Society of Clinical Oncology meeting, held June 5-8 in New Orleans. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; ASX = Australian Stock Exchange; CSE = Copenhagen Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. |