Company* |
Product | Description | Indication |
Status |
| AUTOIMMUNE | ||||
Human Genome |
LymphoStat-B |
Belimumab; human monoclonal antibody that inhibits activity of B- lymphocyte stimulator |
Lupus |
Phase II trial in 449 patients demonstrated significantly reduced disease activity in those with serologically active disease(6/22) |
Targeted |
tgAAC94 |
Product using an adeno-associated viral vector to deliver a soluble TNF- alpha receptor protein |
Inflammatory arthritis |
Early data from Phase I/II trial indicated agent was safe and well tolerated; improvements vs. placebo also were seen (6/1) |
ZymoGenetics |
TACI-Ig |
Antagonist protein that binds to the TNF cytokines BLyS and APRIL |
Rheumatoid arthritis |
Phase Ib trial in 73 patients demonstrated tolerability and a biologic effect; efficacy trends also were seen (6/26) |
| CANCER | ||||
Allos |
Efaproxyn |
Efaproxiral; small molecule designed to sensitize hypoxic areas of tumors during radiation therapy |
Brain metastases from various cancers |
Retrospective data from Phase III REACH trial showed clinically meaningful survival and response rates in those sufficiently exposed to the drug (6/14) |
Ariad |
AP23573 |
Intravenously administered small-molecule mTOR inhibitor |
Metastatic and/or unresectable soft- tissue and bone sarcomas |
Phase II data showed that treatment more than doubled progression-free survival rates when compared to control data(ASCO) |
Abraxis |
Abraxane (FDA-approved) |
Paclitaxel protein-bound particles for injection; albumin-bound |
Late-stage non-small- cell lung cancer |
Phase II data showed improved antitumor benefits over the solvent-based taxane treatment; 50% of patients had either a complete or partial response (ASCO) |
Active Biotech |
Anyara |
Antibody linked to a toxin designed to stimulate immune system to target and kill cancer cells |
Advanced non-small-cell lung cancer; renal cell cancer; and pancreatic cancer |
Interim Phase I data showed a reproducible induction of the immunostimulatory cytokine interleukin-2 as a surrogate marker for T-lymphocyte activation (ASCO) |
Adherex |
ADH-1 |
Cadherin antagonist; small peptide, tumor/ vascular-targeting agent |
Advanced cancers |
Phase Ib data showed the drug was well tolerated in all five doses tested and demonstrated evidence of antitumor activity (ASCO) |
Adnexus |
CT-322 |
Agent based on AdNectin protein that blocks vascular endothelial growth factor receptor-2 |
Cancers |
Is starting a Phase I trial in patient (6/21) |
Adventrx |
CoFactor |
Form of folic acid designed to enhance the antitumor effects of 5-FU |
Metastatic colorectal cancer |
Began pivotal Phase III trial to evaluate use of drug in first-line combination treatment in 1,200 patients (6/28); pharmacokinetic study supported use of a two- hour administration (6/29) |
Adventrx |
CoFactor |
Form of folic acid designed to enhance the antitumor effects of 5-FU |
Metastatic colorectal cancer |
Monitors recommended continuation without modification of Phase IIb combination trial, based on data from 150 patients (6/26) |
Adventrx |
CoFactor |
Form of folic acid designed to enhance the antitumor effects of 5-FU |
Metastatic colorectal cancer |
Median overall survival was about 15.1 months in a Phase II trial in combination with 5-FU, vs. 11.7 months for those treated with 5- FU plus leucovorin (ASCO) |
AEterna |
AN-152 |
Cytotoxic conjugate that targets certain cancer cells that express LHRH receptors |
Gynecological and breast cancers |
Phase I data showed the compound has a good safety profile and no dose-limiting toxicities (ASCO) |
Amgen Inc. |
Aranesp |
Darbepoetin alfa, a recombinant erythropoietic protein |
Chemotherapy- induced anemia |
Phase IIIb data from 196 patients suggested Aranesp administered every three weeks with intravenous iron has the potential to enhance the effectiveness of in- creasing patient hemoglobin levels and reducing the need for red blood cell transfusions (ASCO) |
Amgen Inc. |
Panitumumab |
Fully human monoclonal antibody that targets the epidermal growth factor receptor |
Metastatic colorectal cancer |
Phase II data suggest that anti-tumor activity of panitumumab was independent of tumor EGFr expression levels (ASCO) |
Antigenics |
Oncophage |
Vitespen; personalized cancer vaccine based on heat-shock protein technology |
Kidney cancer |
New analysis from Phase III trial showed a clinically significant improvement in recurrence-free survival in a subgroup of better-prognosis patients (6/7) |
Antigenics |
Oncophage |
Vitespen; personalized cancer vaccine based on heat-shock protein technology |
Metastatic melanoma |
Phase III data showed that patients who received at least 10 days of vaccine experienced an extension in median survival of 29% vs. those who received physician's choice (ASCO) |
ArQule Inc. |
ARQ 501 |
Activated checkpoint therapy molecule designed to selectively kill cancer cells |
Advanced solid tumors |
Data from Phase Ib combination trials demonstrated favorable tolerability, pharmacokinetic and antitumor data (6/15) |
ArQule Inc. |
ARQ 501 |
Activated checkpoint therapy molecule designed to selectively kill cancer cells |
Pancreatic cancer |
Began Phase II trial to evaluate drug with gemcitabine in 60 to 70 patients (6/20) |
ArQule Inc. |
ARQ 501 |
Activated checkpoint therapy molecule designed to selectively kill cancer cells |
Advanced solid tumors |
Phase I trial with docetaxel demonstrated tolerability, favorable pharmacokinetics and signs of antitumor activity (ASCO) |
Array |
AZD6244 |
Selective MEK inhibitor |
Malignant melanoma |
Began Phase II trial that will compare drug to temozolomide in up to 180 patients with Stage III/IV melanoma (6/8) |
Ascenta |
AT-101 |
Oral, pan-Bcl-2 inhibitor; apoptotic agent |
Chronic lymphocytic leukemia |
Phase I data demonstrated early evidence of single-agent activity in treatment-naïve patients (ASCO) |
Bioenvision |
Evoltra (FDA-approved) |
Clofarabine; second-generation purine nucleoside analogue |
Acute myeloid leukemia |
Pivotal Phase II trial showed that the compound achieved a substantially higher overall complete response rate and a longer median survival than the current standard of care in elderly, high-risk patients (ASCO) |
Biogen Idec |
Zevalin |
Ibritumomab tiuxetan; |
Refractory and |
Data showed that patients experienced improved response and remission rates once treated with Zevalin (ASCO) |
Biovest |
BiovaxID |
Personalized vaccine; tumor antigen conjugated to KLH administered with GM-CSF |
Follicular |
Follow-up data from Phase II trial |
Cabrellis |
Calsed |
Synthetic, next-generation |
Small-cell |
The company started a Phase II |
Callisto |
Atiprimod |
Drug designed to inhibit VEGF and interleukin-6 |
Advanced solid tumors |
Three of four advanced carcinoid patients in Phase I trial had tumor regressions and improved symptoms (6/2) |
Celator |
CPX-1 |
Formulation of irinotecan and floxuridine |
Colorectal cancer |
Phase I data showed that of 23 evaluable patients, 15 had stable disease and two showed partial clinical responses (ASCO) |
Celgene Corp. |
Revlimid |
Lenalidomide; derivative of Thalomid (thalidomide) |
Multiple myeloma |
Phase III data showed an overall survival of 29.6 months and a median time to disease progression of 11.1 months in patients receiving Revlimid with dexamethasone, compared to those receive dexamethasone and placebo (20.2 months and 4.7 months, respectively); Phase III data indicated median overall survival had not been reached compared to 20.6 months with dexamethasone plus placebo (ASCO) |
Celldex |
EGFRvIII |
Epidermal growth factor receptor variant III peptide vaccine |
Glioblastoma |
Phase II data demonstrated minimal toxicity without evidence of autoimmunity, and generated both humoral and cellular responses against the EGFRvIII peptide (ASCO) |
Cell Genesys |
GVAX |
GM-CSF gene transduced allogeneic cellular immunotherapy |
Metastatic, hormone-refractory prostate cancer |
Antitumor activity was seen in 5 of 6 patients receiving GVAX and ipilimumab in a Phase I trial (ASCO) |
Cell Genesys |
GVAX |
GM-CSF gene transduced allogeneci cellular immunotherapy |
Chronic myelogenous leukemia |
Phase II data showed that adding GVAX to Gleevec reduced persistent leukemic disease in 10 of 19 patients (ASCO) |
Cell |
Xyotax |
Paclitaxel linked to a biodegradable polyglutamate polymer |
Non-small-cell lung cancer |
Phase III data showed that Xyotax had a significant impact on survival in women (ASCO) |
Cell |
CT-2106 |
A polyglutamate camptothecin |
Advanced solid tumors |
Phase I data showed that weekly dosing of CT- 106 for three weeks every 28 days resulted in a dose intensity similar to that seen with dosing once every 21 days (ASCO) |
ChemGenex |
Ceflatonin |
sHHT; homoharringtonine; apoptosis inducer |
Chronic myeloid leukemia |
Began Phase II/III trial to test the drug in up to 81 patients who have the T315I bcr-abl point mutation (6/13) |
CuraGen Corp. |
CR011-vcMMAE |
Fully human monoclonal, CR011, linked to the cell- killing drug MMAE |
Metastatic melanoma |
Began Phase I trial to evaluate safety, tolerability, pharmacokinetics and activity in patients with Stage III or IV disease (6/22) |
CuraGen Corp. |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Mesothelioma |
Began Phase II trial to evaluate responses and other endpoints in 24 patients who failed prior chemotherapy (6/20) |
CuraGen Corp. |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Advanced solid tumors |
Began Phase I trial to evaluate safety and tolerability with cisretinoic acid in up to 24 patients(6/14) |
CuraGen Corp. |
PXD101 |
Small-molecule histone deacetylase inhibitor |
Acute myelogenous leukemia |
Began open-label Phase II trial to evaluate drug in up to 55 patients (6/6) |
Cyclacel |
Seliciclib (CYC202) |
Oral molecule that targets cyclin dependent kinases |
Non-small-cell lung cancer |
Began Phase IIb APPRAISE trial to evaluate efficacy and safety in third-line treatment (6/29) |
Cyclacel |
Sapacitabine (CYC682) |
Orally available nucleoside analogue |
Advanced leukemias or myelodysplastic syndromes |
Began Phase I trial to evaluate dosing and pharmacodynamics in patients (6/15) |
Cytogen Corp. |
Quadramet (FDA-approved) |
Samarium-153 bound to a small- molecule, bone- seeking phosphonate |
Metastatic bone disease |
Presented data from various investigator-sponsored studies showing benefit in various indications and drug combinations (6/7) |
Cytogen Corp. |
Quadramet (FDA-approved) |
Samarium-153 bound to a small- molecule, bone-seeking phosphonate |
Relapsed multiple myeloma |
Data from ongoing Phase I trial with Velcade demonstrated tolerability and antitumor activity (6/19) |
Cytogen Corp. |
Quadramet |
Samarium-153 bound to a small-molecule, bone- seeking phosphonate |
Multiple myeloma and progressive hormone-refractory prostate cancer |
Phase I interim results indicate the combination of Quadramet and bortezomib was well tolerated and demonstrated antitumor activity; Phase II data of the drug with docetaxel showed it was well tolerated, provided pain palliation and had promising response rates (ASCO) |
Cytokinetics |
Ispinesib (SB-715992) |
Small-molecule inhibitor of kinesin spindle protein |
Metastatic colorectal cancer; breast cancer |
Phase II data showed it did not produce an objective response rate on the two schedules evaluated; Phase I data showed a partial response in one patient with breast cancer (ASCO) |
Cytokinetics |
SB-743921 |
Small-molecule kinesin spindle protein inhibitor |
Non-Hodgkin's lymphoma, Hodgkin's disease and multiple myeloma |
Phase I data showed a median half-life of 29 hours and disease stabilization in seven patients (ASCO) |
Dendreon |
Provenge |
Immunotherapy that uses a recombinant form of the prostatic acid phosphatase antigen |
Advanced prostate cancer |
Phase III D9901 trial in men with androgen- independent disease demonstrated a survival benefit vs. placebo; a BLA filing is planned (6/29) |
Exelixis Inc. |
XL880 |
Small-molecule inhibitor of receptor tyrosine kinases, including MET and VEGFR |
Papillary renal cell carcinoma |
Began Phase II trial to evaluate responses, safety, tolerability and certain efficacy measures in up to34 patients (6/28) |
Favrille Inc. |
FAV-201 |
Recombinant, patient- specific, T-cell receptor- based immunotherapy |
T-cell lymphoma |
Is starting a Phase I/II trial to evaluate safety and biologic activity in 30 patients (6/15) |
Gemin X |
GX15-070 |
Small-molecule inhibitor of bcl-2 proteins |
Refractory solid tumors and lymphomas |
Phase I data showed the compound generally was well tolerated at doses resulting in biological activity (ASCO) |
Genentech |
Avastin |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Advanced |
Phase III trial of drug with gemcitabine as a first- ine treatment was stopped due to not meeting its primary endpoint of overall survival (6/27) |
Genentech |
Avastin (FDA-approved) |
Bevacizumab; antibody designed to inhibit vascular endothelial growth factor |
Recurrent or refractory non-small- cell lung cancer |
Phase II data suggested that the addition of Avastin to either Tarceva or chemotherapy improved progression-free survival compared to chemotherapy alone (ASCO) |
Genta Inc. |
Genasense |
Oblimersen sodium; inhibits function of bcl-2 protein |
Chronic lymphocytic leukemia |
Phase III data showed the therapy induced remissions that were associated with elimination of minimal residual disease (ASCO) |
GlobeImmune |
GI-4000 |
Molecular immunogen directed against mutated Ras proteins |
Pancreatic cancer |
Began Phase II trial to evaluate recurrence-free survival in combination with gemcitabine after surgery vs. placebo (6/8) |
Gloucester |
Depsipeptide (FK228) |
Histone deacetylase inhibitor |
Cutaneous T-cell lymphoma |
Pivotal data showed a 36% overall response rate among 28 evaluable patients (ASCO) |
GPC Biotech |
Satraplatin |
Oral platinum compound |
Hormone- refractory prostate cancer |
Monitors recommended Phase III SPARC trial continue as planned; no safety issues were seen (6/8) |
GPC Biotech |
Satraplatin |
Oral platinum compound |
Advanced solid tumors |
Phase I data showed the drug was well tolerated in patients with liver impairment and reduced kidney function (ASCO) |
GTx Inc. |
Acapodene |
Toremifene citrate; small- molecule non-steroidal selective estrogen receptor modulator |
Prostate cancer |
Interim analysis from Phase III ADT trial showed positive results on lipid parameters (6/22) |
GTx Inc. |
Acapodene |
Toremifene citrate; small-molecule non-steroidal selective estrogen receptor modulator |
Prostate cancer |
Phase III data showed Acapodene in an 80-mg dose increased bone mineral density in patients on androgen deprivation therapy (ASCO) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Non-small-cell lung cancer |
Phase II data showed a median survival of 10 months in patients receiving Erbitux with chemo- therapy, and nine months in patients receiving chemotherapy followed by Erbitux (ASCO) |
Immunomedics |
131I-labetuzumab |
Radiolabeled antibody against the carcino- embryonic antigen |
Metastatic colorectal cancer |
Data from 12 patients in Phase II trial demonstrated safety and tolerability (ASCO) |
Immunomedics |
Epratuzumab |
Humanized anti-CD20 monoclonal antibody |
Non-Hodgkin's lymphoma |
Phase I/II data demonstrated an overall objective response rate of 43%, with 17% of patients having a complete response; in follicular lymphoma, the overall response rate was 44%, with a complete response rate of 22% (ASCO) |
Introgen |
Advexin |
Adenoviral vector containing the p53 tumor-suppressor gene |
Recurrent squamous cell carcinoma of the head and neck |
Phase II trials helped identify a set of prognostic indicators associated with high response rates and increased survival, including abnormal p53 function (ASCO) |
Keryx Bio- |
Perifosine |
Oral agent that modulates AKT and other signal transduction pathways |
Advanced renal cell carcinoma |
Clinical data showed that three of seven patients had a partial response, and an additional two patients achieved long-term stable disease (ASCO) |
Kosan |
KOS-862 |
Epothilone D, a polyketide |
HER-2 metastatic breast cancer |
Phase Ib data showed antitumor activity in three of 13 patients who received KOS-862 with Herceptin (ASCO) |
Kosan |
KOS-1584 |
Epothilone drug candidate |
Advanced solid tumors |
Phase I data showed there was no dose-limiting toxicity; one patient had a 13% tumor shrinkage (ASCO) |
Ligand |
Targretin (FDA-approved) |
Bexarotene capsules; selective retinoid X receptor modulator |
Non-small-cell lung cancer |
Data showed the benefit of Targretin added to chemotherapy in a first-line setting and as monotherapy in a third-line setting (ASCO) |
Lorus |
GTI-2040 |
Antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase |
Myelodysplastic syndromes and acute myeloid leukemia |
Is starting a study to evaluate the drug as a single agent in patients with high-grade MDS and AML (6/19) |
Medarex Inc. |
MDX-010 |
Ipilimumab; fully human antibody against CTLA-4, a molecule on T cells |
Metastatic melanoma |
Is starting a registrational trial under an FDA SPA to evaluate drug as part of regimen in first- line treatment in 500 patients (6/19) |
Medarex Inc. |
MDX-010 |
Ipilimumab; fully human antibody against CTLA-4, a molecule on T cells |
Resected Stage IIIc or Stage IV melanoma |
Interim data based on median follow-up of 12 months of extended dosing indicated the treatment regimen generally was well tolerated in 25 patients, and all patients had survived to date (ASCO) |
MediciNova |
MN-029 |
Vascular-targeting agent |
Solid tumors |
Phase I data showed MN-029 significantly reduced tumor blood flow at doses that were well tolerated (ASCO) |
MGI Pharma |
Dacogen (FDA-approved) |
Decitabine for injection; a hypomethylating agent |
Myelodysplastic syndromes |
Company completed enrollment in its multicenter Phase II alternate-dosing trial; Phase III data showed an overall response rate of 21% (ASCO) |
MGI Pharma |
Aloxi |
Palonosetron hydrochloride injection; a 5-HT3 receptor antagonist |
Germ cell tumors |
Phase II data showed drug with dexamethasone was well tolerated, and three-dose regimen provided comparable or better protection from nausea and emesis than standard five-day ondansetron-based regimen (ASCO) |
Microbix |
-- |
Angiostatic cocktail; combination of two approved drugs, a protein urokinase and a small molecule |
Solid tumors |
Encouraging data were seen in a Phase I trial (6/27) |
Micromet Inc. |
MT103 (MEDI-538) |
Single-chain, bispecific antibody derivative targeting the CD19 antigen |
Relapsed non- Hodgkin's lymphoma |
Data from 19 patients in ongoing Phase I trial showed encouraging pharmacokinetic and response data (6/19) |
Millennium |
Velcade (FDA-approved) |
Bortezomib; proteasome inhibitor |
Multiple myeloma |
Phase I/II trial showed drug plus melphalan and prednisone was significantly superior to those agents alone in treating elderly patients with newly diagnosed MM (6/21) |
Millennium |
Velcade |
Bortezomib; proteasome inhibitor |
Non-small-cell lung cancer |
Phase II data showed a median survival of 11 months for patients treated with Velcade (ASCO) |
Molecular |
Azedra (formerly Ultratrace MIBG) |
Radiopharmaceutical designed to maximize delivery of MIBG molecules |
Neuroendocrine tumors |
Began Phase I trial to evaluate safety, tolerability and pharmaco-kinetics in adult patients (6/22) |
Morphotek |
MORAb-003 |
Monoclonal antibody that targets the folate receptor alpha |
Ovarian cancer |
Began Phase II trial to evaluate agent alone and in combinations in patients experiencing their first relapse (6/8) |
NeoPharm |
IL13-PE38QQR |
Cintredekin besudotox; agent designed to deliver bacterial cytotoxic PE38 |
Glioblastoma multiforme |
Monitors in Phase III PRECISE trial recommended continuation to the final efficacy anlaysis, meaning efficacy was not proved early (6/22) |
Nereus |
NPI-2358 |
Small-molecule tumor vascular disrupting agent |
Solid tumors |
Began Phase I single-agent trial to evaluate safety, tolerability, pharmacokinetics and responses in 35 patients (6/7) |
Novacea Inc. |
DN-101 |
Formulation of calcitriol, the biologically active form of Vitamin D |
Non-small-cell lung cancer |
Phase I/II trial with Taxotere in second-line treatment showed a response rate of 6.6% in 61 patients (6/8) |
NovaRx Corp.* |
Lucanix |
Therapeutic vaccine consisting of four NSCLC cell lines |
Non-small-cell lung cancer |
Phase II data demonstrated two-year survival more than four times that of those treated with the standard of care (ASCO) |
Oncolytics |
Reolysin |
Intratumorally delivered formulation of the human reovirus |
Advanced cancers |
Interim data from Phase I trial showed virus- ediated tumor responses (ASCO) |
Onyx |
Nexavar (FDA-approved) |
Sorafenib; RAF kinase and VEGF inhibitor |
Advanced kidney cancer |
Phase III data demonstrated longer overall survival than placebo patients, 19.3 months vs. 15.9 months (ASCO) |
OSI |
Tarceva (FDA-approved) |
Erlotinib; small-molecule HER1/EGFR inhibitor |
Lung cancer |
Data showed Tarceva may be used earlier to treat lung cancer and in certain patients viewed as less responsive to therapy with EGFR inhibitors, and in the treatment of additional cancers (ASCO) |
OSI |
Tarceva (FDA-approved) |
Erlotinib; small-molecule HER1/EGFR inhibitor |
Head and neck cancer; squamous cell carcinoma; non-small-cell lung cancer |
Data support earlier reports of encouraging antitumor activity for Tarceva in combination with chemotherapy (ASCO) |
Oxigene Inc. |
CA4P |
Combretastatin A4P; vascular disrupting agent |
Anaplastic thyroid carcinoma |
Phase II data showed stabilized disease in one patient and a partial response in a second patient (ASCO) |
Oxxon |
Hi-8 MEL |
Plasmid DNA vaccine expressing epitopes from five melanoma antigens, followed by a viral vector expressing those epitopes |
Non-resectable melanoma |
Phase II data showed the vaccine met its endpoints, demonstrating it was well tolerated and had clinical benefit in HLA-A2-positive patients (ASCO) |
PDL |
Volociximab (M200) |
Chimeric monoclonal antibody that blocks the alpha5-beta1 receptor; anti-angiogenic agent |
Metastatic renal cell carcinoma, adenocarcinoma of the pancreas and melanoma |
Phase II data showed volociximab appeared to be well tolerated and may inhibit tumor angiogenesis regardless of the pro-angiogenic growth factors that promote tumor growth (ASCO) |
Pharmion |
Thalidomide (FDA-approved) |
Celgene Corp.'s thalidomide |
Multiple myeloma |
Data demonstrated that the addition of thalidomide to standard therapy improved overall survival in newly diagnosed patients (ASCO) |
Pharmion |
Vidaza |
Azacitidine for injection; believed to have demethylation and cytotoxic actions |
Myelodysplastic syndromes; acute myelogenous leukemia |
Phase I/II data demonstrated an overall response rate of 30% among 13 patients who completed one course of treatment (ASCO) |
Seattle |
SGN-40 |
Humanized monoclonal antibody that targets the CD40 antigen |
Non-Hodgkin's lymphoma |
Phase I data showed SGN-40 induced objective responses in five patients and was well tolerated at doses up to 8 mg/kg (ASCO) |
Sunesis |
SNS-595 |
Small-molecule cell-cycle modulator designed to induce apoptosis |
Advanced solid malignancies |
Phase I data showed the therapy exhibited clinical activity across a variety of tumor types among end-stage refractory patient populations; it was well tolerated (ASCO) |
Therion |
Panvac-VF |
Vaccine designed to stimulate the immune system to destroy cells expressing CEA and mucin-1 |
Advanced pancreatic cancer |
Phase III trial did not meet endpoint of improving survival vs. palliative chemotherapy or best supportive care; a BLA filing no longer was planned (6/28) |
Threshold |
Glufosfamide |
Small molecule targeting abnormal glucose metabolism |
Metastatic pancreatic cancer |
Monitors for pivotal Phase III trial recommended continuation of the study to completion (6/1) |
Vion |
Cloretazine |
Sulfonylhydrazine DNA alkylating agent |
Acute myelogenous leukemia |
Phase II data showed a 50% overall response rate in the 44 de novo AML patients; cloretazine was well tolerated (ASCO) |
Xanthus |
Symadex (C-1311) |
Next-generation product based on the existing cancer drug mitoxantrone |
Advanced solid tumors |
Phase I data showed it was well tolerated (ASCO) |
Xanthus |
Xanafide |
Salt formulation of the cancer compound amonafide |
Secondary acute myeloid leukemia |
An independent data safety monitoring board has recommended continuation of a Phase II trial (ASCO) |
YM BioSciences |
Tesmilifene |
Small molecule designed to augment the activity of chemotherapy agents |
Metastatic breast cancer |
Began Phase II trial to evaluate the effect of adding the drug to Taxotere therapy in up to 39 women (6/5); monitors for pivotal Phase III trial said trial should continue as planned (6/26) |
Ziopharm |
ZIO-101 |
Organic arsenic agent |
Acute myelogenous leukemia; solid tumors |
An anti-leukemia effect was seen in 4 of 8 patients in Phase I trial in AML: interim data from Phase I trial in solid tumors showed clinical benefit in 6 of 24 patients (ASCO) |
Ziopharm |
ZIO-201 |
Isophosphoramide mustard; alkylating agent |
Sarcoma |
Phase I data showed bladder and central nervous system toxicity seen with ifosfamide was not evident with ZIO-201 (ASCO) |
ZymoGenetics |
IL-21 |
Interleukin-21 |
Stage IV metastatic melanoma; renal-cell carcinoma |
Phase I data displayed a satisfactory toxicity profile and exhibited preliminary evidence of antitumor activity (ASCO) |
| CARDIOVASCULAR | ||||
Actelion Ltd. |
Clazosentan |
Intravenous endothelin receptor antagonist |
Vasospasm subsequent to subarachnoid hemorrhage |
Phase IIb CONSCIOUS-1 trial demonstrated statistical significance on the primary endpoint of reducing cerebral vasospasm, but that did not translate into an overall clinical benefit (6/19) |
Alexion |
Pexelizumab |
Monoclonal antibody fragment; terminal complement inhibitor |
Heart attack |
Phase III APEX-AMI trial did not reduce with statistical significance mortality at 30 days following primary percutaneous coronary intervention or angioplasty (6/28) |
Alexion |
Soliris (eculizumab) |
Humanized monoclonal antibody designed to block complement protein C5 |
Paroxysmal nocturnal hemoglobinuria |
Six-month interim data from Phase III SHEPHERD trial showed positive safety and efficacy data (6/12) |
Amgen Inc. |
Aranesp |
Darbepoetin alfa, a recombinant erythropoietic protein |
Heart failure and anemia |
Data from Phase II trials showed drug effectively raised hemoglobin and may decrease the risk of heart failure hospitalization and mortality (6/19) |
Amorcyte |
-- |
Cell therapy |
Cardiovascular disease |
Began Phase I trial to assess safety and the effect of stem cell dose on clinical endpoints following administration after myocardial infarction (6/5) |
Cardium |
Generex (Ad5FGF-4) |
Alferminogene tadenovec; angiogenic agent |
Heart disease |
Meta-analysis from AGENT trial run by Schering AG showed a statistically significant reduction in anginal severity and subgroup improvements in other endpoints (6/5) |
Cytokinetics |
CK-1827452 |
Cardiac myosin activator |
Heart failure |
Phase I trial in healthy volunteers demonstrated statistically significant improvements in indices of cardiac function (6/29) |
DeCode |
DG041 |
Selective antagonist of the EP3 receptor for PGE2 |
Peripheral artery disease |
Began Phase IIa trial to examine safety, tolerability, dosing and the effect on platelet function and certain biomarkers (6/22) |
Myogen Inc. |
Darusentan |
Type-A selective endothelin receptor |
Resistant hypertension |
Began Phase III DORADO trial to evaluate effectiveness in reducing systolic blood pressure in 352 patients (6/5) |
NovaCardia |
KW-3902 |
Adenosine A1 receptor antagonist |
Congestive heart failure |
Data from Phase II trial showed significant diuretic activity and increased hourly urine volume in patients refractory to diuretics (6/19) |
Speedel Group |
SPP100 (Rasilez) |
Oral renin inhibitor |
Hypertension in diabetics |
Phase III trial demonstrated efficacy as a monotherapy and with ramipril, an ACE inhibitor (6/13) |
Vasogen Inc. |
Celacade |
Immune-modulation therapy; delivers oxidative stress to a patient's cells |
Advanced chronic heart failure |
Phase III ACCLAIM trial in 2,414 patients did not meet primary endpoint of reducing the risk of death and cardiovascular hospitalization; benefit was seen in a patient subset (6/26) |
| CENTRAL NERVOUS SYSTEM | ||||
Alexza |
AZ-001 |
Prochlorperazine delivered by company's aerosolized system |
Migraine |
Began Phase IIb trial to evaluate headache pain relief at 2 hours post-dose and other endpoints in 400 patients (6/6) |
Anesiva Inc. |
4975 |
Non-opioid, VR1 agonist that acts as a C-neuron anesthetic |
Pain |
Phase II trial in patients who had knee surgery showed a statistic- ally significant reduction in pain (6/14) |
Athenagen |
GTS-21 (DMBX-A) |
Oral, alpha-7 nicotinic acetylcholine receptor agonist |
Schizophrenia |
Proof-of-concept study demonstrated cognition enhancement activity (6/15) |
Arena |
APD125 |
Selective inverse agonist for 5-HT2A receptors |
Insomnia |
Phase I trial demonstrated safety, tolerability and improved sleep parameters (6/21) |
Avera |
Gantacurium chloride |
Non-depolarizing, ultra-short- acting neuromuscular blocker |
For use in general anesthesia |
Phase II trial in 230 patients met its primary endpoint, achieving greater than 90% acceptable intubations at 60 seconds after injection (6/27) |
Celtic |
TA-CD |
Immunotherapy vaccine |
Cocaine addiction |
Phase IIa trial provided encouraging data on the vaccine's utility; Phase IIb trial showed positive trends but not statistically significant abstinence vs. placebo (6/21) |
Cephalon Inc. |
Gabitril (FDA-approved) |
Tiagabine hydrochloride; selective GABA reuptake inhibitor |
Generalized anxiety disorder |
Phase III trial did not reach statistical significance on the primary study endpoints (6/27) |
Cortex |
CX717 |
Ampakine analogue; designed to improve brain cell signaling |
For use in those with restricted sleep |
A simulated night-shift work study showed drug did not enhance cognitive performance vs. placebo (6/21) |
Cypress |
Mirtazapine |
Tetracyclic antidepressant |
Obstructive sleep apnea |
Phase IIa trials of mirtazapine with another approved drug did not support continued development (6/27) |
MediciNova |
MN-305 |
Selective serotonin 5-HT1A receptor agonist |
Generalized anxiety disorder |
Phase II/III trial in 416 patients showed trends for improvement in efficacy outcomes but not statistical significance (6/11) |
Elite |
ELI-154 |
Once-daily oxycodone agent |
Pain |
Phase I trial demonstrated the agent had favorable pharmacokinetic properties (6/27) |
NeurogesX |
Transacin (NGX-4010) |
High-concentration trans-capsaicin dermal patch |
Postherpetic neuralgia |
Is starting a second, confirmatory Phase III trial in the U.S. and Canada (6/13) |
Pozen Inc. |
Trexima (MT400) |
Single-tablet combination of sumatriptan (5-T1B/1D agonist) and naproxen |
Migraine |
Trials showed drug provided superior pain-free results vs. either drug alone or placebo; another trial showed improved migraine- associated neck pain and sinus pain/pressure (6/26) |
Predix |
PRX-00023 |
5-HT1A agonist |
Generalized anxiety disorder |
Phase II trial in 21 patients showed significantly reduced symptoms and tolerability (6/13) |
Predix |
PRX-07034 |
Serotonin 5-HT6 antagonist |
Obesity and cognitive impairment |
Began Phase I trial to evaluate safety, tolerability, and pharmaco- kinetics in 18 healthy volunteers (6/7) |
Sangamo |
SB-509 |
Plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor, designed to up-regulate the VEGF-A gene |
Diabetic neuropathy |
Phase Ib trial showed tolerability and improvements in pain and neurologic effects (6/12) |
Transition |
AZD-103 |
Scyllo-cyclohexanehexol |
Alzheimer's disease |
Began Phase I trial following the release of promising preclinical data (6/12) |
Vanda |
VEC-162 |
Melatonin agonist |
Insomnia |
Phase II trial in 37 healthy subjects showed a statistically significant shift in circadian rhythm; other positive data also were seen (6/23) |
WEX |
Tectin |
Tetrodotoxin; non-narcotic agent |
Pain |
Is starting a Phase I trial to assess pharmacokinetics in healthy volunteers (6/12) |
| DIABETES | ||||
Amylin |
Byetta (FDA-approved) |
Exenatide; incretin mimetic |
Type II diabetes |
Two-year data showed sustained improvements in blood sugar control and reduced body weight in those not achieving blood sugar control on common oral medications; also, reduced glucose levels were seen in those who had used a thiazolidinedione (6/10) |
Amylin |
LAR Byetta |
Long-acting form of the approved drug exenatide, an incretin mimetic |
Type II diabetes |
86% of patients using the higher of two doses of the once- weekly formulation achieved recommended levels of glucose control (6/10) |
Incyte Corp. |
INCB13739 |
Small-molecule inhibitor of 11beta-HSD1 |
Type II diabetes |
Began Phase I trial to evaluate safety and pharmacokinetics in healthy volunteers (6/7) |
Isis |
ISIS 113715 |
Antisense inhibitor of protein tyrosine phosphatase (PTP-1B) |
Type II diabetes |
Phase II single-agent trial showed statistically significant improvement in multiple measures of glucose control (6/13) |
Metabolex |
Metaglidasen |
Insulin sensitizer; selective PPAR-gamma modulator |
Type II diabetes |
Began Phase II/III trial to evaluate drug vs. Actos (a TZD) in 400 insulin-taking patients (6/10) |
Novocell Inc.* |
-- |
Encapsulated primary human islet allografts |
Type I diabetes |
Data from first two patients in Phase I/II trial showed evidence of encapsulated islet function (6/12) |
OSI Pharmaceuticals Inc. (OSIP) |
PSN9301 |
Dipeptidyl peptidase-IV inhibitor |
Type II diabetes |
Phase IIa study showed reduced blood glucose levels; agent generally was well tolerated, with no episodes of hypoglycemia (6/12) |
Phenomix |
PHX1149 |
Oral inhibitor of the serine protease DPP4 |
Type II diabetes |
Began Phase II trial that will evaluate post-meal glucose levels and other endpoints in 150 patients (6/8) |
| INFECTION | ||||
Anadys |
ANA975 |
Oral prodrug of isatoribine, a Toll-Like receptor-7 agonist |
Hepatitis C |
Suspended dosing in Phase Ib trial pending additional analysis of recently seen toxicology studies in animals (6/26) |
Chimerix Inc* |
CMX001 |
Oral antiviral drug candidate |
Smallpox infection |
Is starting Phase I trial to evaluate safety in healthy volunteers (6/26) |
Hollis-Eden |
Neumune |
Immune-regulating hormone |
Hospital-acquired infections |
Began Phase I/II trial to evaluate safety in patients at high risk of developing infections (6/8) |
MedImmune |
-- |
Intranasal H5N1 influenza vaccine based on the company's live, attenuated technology |
Avian influenza virus |
The National Institutes of Health began a Phase I trial to evaluate the safety and immunogenicity in 20 volunteers (6/15) |
Nventa Bio- |
HspE7 |
Fusion therapeutic vaccine |
Human papillomavirus- related diseases |
Phase I/II trial in 15 HIV-positive patients demonstrated encouraging tolerability and efficacy data (6/15) |
Panacos |
Bevirimat (PA-457) |
Small-molecule maturation inhibitor designed to block a step in processing of the HIV Gag protein |
HIV |
Began Phase IIb trial to evaluate viral reduction loads vs. placebo when added to other drugs in resistant patients (6/12) monotherapy study showed lack of rapid emergence of resistance to drug (6/14) |
Peregrine |
Bavituximab (formerly Tarvacin) |
Anti-phosphotidylserine immunotherapeutic |
Hepatitis C |
Agent showed evidence of antiviral activity and of a prolonged effect in Phase Ia study (6/7) |
The Immune Response Corp. (OTC BB:IMNR) |
IR103 |
Co-formulation of its virus- ased Remune therapy and Amplivax, a TLR-9 agonist adjuvant |
HIV |
Phase II trial demonstrated safety and enhanced immunomodulatory effects vs. Remune (6/26) |
Vical Inc. |
-- |
Vaccine encoding two surface proteins of the West Nile virus |
West Nile virus |
Phase I trial showed safety and tolerability and produced WNV- specific antibody responses in all 11 healthy volunteers (6/1) |
| MISCELLANEOUS | ||||
Acceleron |
ACE-011 |
Protein therapeutic based on the activin receptor IIa |
Bone loss |
Began Phase I trial to evaluate safety, tolerability and pharma- cokinetics in healthy post-meno- pausal women (6/21) |
Acologix |
AC-100 |
Synthetic peptide derived from protein produced by bone and dental cells |
Dentin formation |
Phase II trial in 35 patients demonstrated product stimulated the formation of new dentin when applied to tooth defects (6/29) |
Acuity |
Bevasiranib (Cand5) |
Small interfering RNA therapeutic designed to shutdown VEGF |
Wet age-related macular degeneration |
Initial data from Phase II C.A.R.E trial showed the agent appeared safe and showed clinical evidence of efficacy (6/1) |
Advanced |
Ferumoxytol |
Intravenously administered bioavailable iron |
Iron replacement in anemic chronic kidney disease |
Monitors in Phase III trial identified no safety concerns and recommended continuation without modification (6/14) |
Altus |
ALTU-238 |
Long-acting, crystalline formulation of recombinant human growth hormone |
Growth hormone deficiency |
Phase II trial in adult patients showed tolerability and provided dosing information (6/23) |
Anacor |
AN0128 |
Topical anti-inflammatory agent |
Atopic dermatitis |
Phase IIa trial in 103 patients demonstrated safety and showed efficacy trends (6/15) |
Arena |
Lorcaserin hydrochloride (APD356) |
Stimulator of the 5-HT2C serotonin receptor |
Weight loss |
Phase IIb trial in 469 obese patients showed a statistically significant average weight loss and other improvements vs. placebo (6/12) |
Athenagen |
ATG002 |
Topical nicotinic acetylcholine receptor agonist |
Diabetic foot ulcers |
Is starting a Phase I/II trial of the agent (6/21) |
Auxilium |
AA2600 |
Testosterone replacement transmucosal film agent |
Hypogonadism |
Began pivotal Phase III trial to evaluate safety and efficacy in 240 patients (6/29) |
Auxilium |
AA4500 |
Injectable enzyme product |
Dupuytren's disease |
Pivotal trial in 35 patients demontrated statistical significance vs. placebo (6/21) |
Auxilium |
Testim (FDA-approved) |
Topical 1% testosterone gel |
Hypogonadism in diabetics |
Phase IV trial showed a statistically significant improvement in testosterone levels and in other endpoints (6/15) |
CombinatoRx |
CRx-102 |
Agent containing a low dose of the steroid prednisolone with dipyridamole |
Osteoarthritis of the hand |
Phase II trial showed a statistically significant improvement in pain relief vs. placebo, as well as improvements in other clinical measures (6/22) |
CombinatoRx |
CRx- 150 |
Agent containing low doses of amoxapine and dipyridamole |
Periodontitis |
Drug failed to reduce C-reactive protein in the chronic inflammatory phase, the primary endpoint of the Phase II trial; CRP was reduced in the acute inflammatory phase (6/7) |
Cytomedix |
AutoloGel |
Platelet releasate therapy system |
Diabetic foot ulcers |
Trial showed significantly more wounds healed in AutoloGel arm than in control gel arm (6/28) |
DeCode |
CEP-1347 |
Small-molecule inhibitor of stress-activated protein kinase pathway |
Asthma |
Phase II trial in 160 patients demonstated improvements in (Icceland; DCGN) some parameters of lung function (6/26) |
Debiopharm |
Sanvar |
Synthetic octapeptide analogue of the somatostatin hormone |
Esophageal variceal bleeding |
Began Phase III trial to evaluate drug in 85 patients with acute EVB secondary to portal hypertension (6/1) |
Genaera |
Evizon(squalamine) |
Anti-angiogenesis agent; vascular endothelial growth factor inhibitor |
Wet age-related macular degeneration |
Began Phase II trial to evaluate safety and efficacy of the drug at higher doses in up to 140 patients (6/26) |
Genentech |
Lucentis |
Ranibizumab; humanized antibody fragment designed tobind and inhibit VEGF-A |
Wet age-related macular degeneration |
Phase IIIb study of a quarterly dosing regimen met its primary endpoint by preventing vision loss at 12 months (6/2) |
Indevus |
Pagoclone |
Non-benzodiazepine, selective GABA-A receptor agonist |
Premature ejaculation |
Began Phase II trial that will evaluate the efficacy of various doses in 100 patients (6/23) |
Indevus |
Sanctura XR |
Once-daily formulation of the approved product Sanctura |
Overactive bladder |
Phase III trials met their primary endpoints, as well as secondary endpoints (6/15) |
Keryx Bio- |
Zerenex |
Inorganic, iron-based phosphate binder |
Hyper-phosphatemia |
Phase II trial in 111 patients with end-stage renal disease showed statistically significant reductions in serum phosphorous (6/29) |
Manhattan |
OE |
Oral, synthetic form of Oleoyl-estrone |
Obesity |
Began Phase IIa trial to evaluate safety, preliminary efficacy and pharmacokinetics in 100 obese adult subjects (6/29) |
Nastech |
PTH1-34 |
Intranasal formulation of a fragment of naturally occurring human parathyroid hormone |
Osteoporosis |
Phase I trial showed comparable exposure levels to the approved subcutaneous product, Forteo, in elderly subjects (6/26) |
NPS |
Preos |
Recombinant human parathyroid hormone |
Osteoporosis |
Company discontinued development of product in the U.S., after FDA said another trial would be needed (6/12) |
Nymox |
NX-1207 |
Investigational agent for BPH |
Benign prostatic hyperplasia |
Review of data from ongoing Phase II trial revealed no safety concerns (6/27) |
OSI |
Macugen (FDA-approved) |
Pegaptanib injection; pegylated anti-VEGF aptamer |
Neovascular age- elated macular degeneration |
Began Phase IV LEVEL trial to explore safety and efficacy of the drug as a maintenance therapy in up to 1,000 patients (6/26) |
OSI |
Macugen (FDA-approved) |
Pegaptanib injection; pegylated anti-VEGF aptamer |
Macular edema |
Phase II trial showed better visual acuity outcomes in patients with macular edema due to central retinal vein occlusion vs. placebo (6/1) |
Savient |
Puricase |
Polyethylene glycol conjugate of uricase |
Gout |
Began GOUT 1, the first of two Phase III trials; each will evaluate the drug vs. placebo in 100 patients (6/14); presented positive data from Phase II trials (6/22) |
Sound |
SPI-1005 |
Oral agent containing a selenium-based mimic of the enzyme glutathione peroxidase |
Hearing loss |
Began Phase I trial to evaluate safety and pharmacokinetics in 32 healthy volunteers (6/12) |
| Notes: | ||||
| * Privately held. | ||||
| ASCO = Data were released at the American Society of Clinical Oncology meeting, which was held June 2-6 in Atlanta. | ||||
| BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment. | ||||
| Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
| AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OSE = Osaka Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
