Company (Country) |
Product |
Description |
Indication |
Status (Date)# |
|
Abbott and Bristol-Myers Squibb Co. |
Elotuzumab |
Targets a cell-surface glycoprotein that is present on multiple myeloma cells |
Multiple myeloma |
Interim Phase II data of elotuzumab plus lenalidomide and low-dose dexamethasone showed that 90% of 31 patients achieved an objective response (12/8) |
|
Aeterna Zentaris Inc. (Canada) and Keryx Biopharma-ceuticals Inc. |
Perifosine |
An oral Akt inhibitor |
Chronic lymphocytic leukemia and relapsed or refractory Hodgkin's lymphoma |
Phase II data showed it achieved objective response and a high rate of stable disease as a single-agent therapy in CLL and in combination with Nexavar in Hodgkin's lymphoma (12/7) |
|
Alder Biopharma-ceuticals Inc. |
ALD518 |
Interleukin-6-targeting antibody |
Advanced non-small-cell lung cancer |
Phase II data showed that 58% of advanced cancer patients with anemia experienced hemoglobin level increases from less than 11 g/dL to more than 12 g/dL vs. no patients experiencing that increase in the placebo arm at 12 weeks of treatment (12/8) |
|
Alexion Pharmaceuticals Inc. |
Samalizumab |
Humanized monoclonal antibody |
Advanced stage B-cell chronic lymphocytic leukemia or multiple myeloma |
Interim data from the first Phase I/II trial showed it was well tolerated at all doses studied, exhibited a dose-dependent biological and pharmacokinetic response and exhibited initial evidence of antitumor activity (12/7) |
|
Alexion Pharmaceuticals Inc. |
Soliris |
Eculizumab |
Paroxysmal nocturanl hemoglobinuria |
Long-term data showed that patients achieved survival comparable to that of an age- and gender-matched normal population when treated with Soliris (12/8) |
|
Allos Therapeutics Inc. |
Folotyn |
Pralatrexate injection |
Peripheral T-cell lymphoma |
Phase II data demonstrated the ability of Folotyn to achieve responses in patients in the second-line treatment setting (12/7) |
|
Amgen Inc. |
Nplate |
Romiplostim |
Adult chronic immune thrombocytopenic purpura |
Five-year, open-label extension study results showed platelet cells were safely maintained between 50,000 and 200,000 per microliter in a majority of patients for up to 277 weeks (12/7) |
|
Ariad Pharmaceutical Inc. |
AP24534 |
Ponatinib |
Chronic myelogenous leukemia |
About two-thirds of patients who were resistant to two or three receptor tyrosine kinase inhibitors had a major cytogenetic response, and half achieved a complete response (12/7) |
|
Array BioPharma Inc. |
ARRY-520 |
Kinesin spindle protein inhibitor |
Multiple myeloma |
Phase I data showed it was well tolerated and had encouraging results (12/7) |
|
Baxter Healthcare Corp. |
rVWF |
Recombinant von Willebrand factor |
von Willebrand disease |
Phase I data showed it may be safe and well tolerated (12/7) |
|
BioCryst Pharmaceuticals Inc. |
Forodesine |
Purine nucleoside phosphorylase inhibitor |
Chronic lymphocytic leukemia |
Phase II data confirmed clinical activity (12/7) |
|
Biovest International Inc. |
BiovaxID |
Personalized vaccine |
Non-Hodgkin's lymphoma |
Phase III data suggested that improved disease-free survival rates following administration with BiovaxID depend on an integral tumor protein fragment administered as part of each patient's vaccine (12/7) |
|
Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co. Ltd. (Japan) |
Sprycel |
Dasatinib |
Chronic myeloid leukemia |
An 18-month follow up from its Phase III trial of Sprycel vs. Gleevec was consistent with data at 12 months, showing Sprycel produced higher and faster rates of complete cytogenic response (12/7) |
|
Calistoga Pharmaceuticals Inc. |
CAL-101 |
Oral, delta-isoform-selective P13K inhibitor |
Hematologic malignancies |
Phase I data demonstrated the clinical potential of CAL-101 as a single agent and in combination with other standard-of-care therapies (12/7) |
|
Celator Pharmaceuticals Inc. |
CPX-351 |
Cytarabine: daunorubicin |
Acute myeloid leukemia |
Phase II data showed that elderly patients with newly diagnosed disease had a higher aplasia rate, a higher remission rate, lower mortality, improved median event-free survival and improved median overall survival than patients receiving conventional cytarabine and daunorubicin (12/8) |
|
Celgene Corp. |
Revlimid |
Lenalidomide |
Multiple myeloma; indolent non-Hodgkin's lymphoma; myelodysplastic syndromes |
Phase III data showed a 60% reduction in the risk of disease progression and a median time to progression of 42.3 months for Revlimid vs. 21.8 months for placebo; another trial showed a 50% reduction in the risk of disease progression, with median progression-free survival of 42 months vs. 24 months for placebo; in newly diagnosed patients, those 65 and older had an 85% two-year survival on low-dose and 72% on high dose, while those younger than 65 had 92% and 86%, respectively (12/7); Phase II data showed an average 58% overall response rate with Revlimid and low-dose dexamethasone plus rituximab, and a second study in relapsed or refractory patients showed an overall response rate of 76%; in myelodysplastic syndromes with a del(5q) chromosome abnormality, Phase III data showed the three-year overall survival rate was 56% |
|
Celgene Corp. |
Pomalidomide |
IMiD compound |
Multiple myeloma |
Phase II data of pomalidomide plus low-dose dexamethasone showed an overall response rate of 42% and 39% in patients receiving the therapy for 21 and 28 days, respectively (12/8) |
|
Cell Therapeutics Inc. |
Pixuvri |
Pixantrone dimaleate |
Relapsed or refractory aggressive non-Hodgkin's lymphoma |
Phase III data showed continuous improvement in primary and secondary endpoints; complete response was 24% in the pixantrone arm vs. 7% in the comparator arm (12/7) |
|
ChemGenex Pharmaceuticals Ltd. (Australia) |
Omapro |
Omacetaxine mepesuccinate |
Chronic myeloid leukemia |
Clinical data showed it produced durable hematologic and cytogenetic responses in a significant proportion of chronic phase patients (12/7) |
|
Cytheris SA (France) |
CYT107 |
Recombinant human interleukin-7 |
Hematological malignancies |
Phase I data showed a median increase in CD4 T cells exhibiting a naive or central memory phenotype of 69% over baseline in eight evaluable post-transplant patients (12/8) |
|
Emergent BioSolutions Inc. |
TRU-016 |
Humanized anti-CD37 small modular immunopharmaceutical candidate |
B-cell malignancies |
Phase I data showed favorable response rates and it was generally well tolerated (12/7) |
|
EntreMed Inc. |
ENMD-2076 |
An Aurora A/angiogenic kinase inhibitor |
Relapsed/refractory multiple myeloma; relapsed/refractory leukemia |
Interim Phase I data showed it was well tolerated with three of nine evaluable patients showing stable disease and one achieving a partial response; data from 20 evaluable patients showed that daily administration was associated with reductions in bone marrow blast counts of 11%, 14% and 65% (12/8) |
|
Gentium SpA (Italy) |
Defibrotide |
A DNA-based drug |
Veno-occlusive disease |
Clinical data showed that patients who were not on dialysis or were not ventilator-dependent at study entry had a 41% complete response rate compared to a 23% response rate in patients who were (12/8) |
|
Geron Corp. |
GRNVAC1 |
An autologous dendritic cell vaccine targeting telomerase |
Acute myelogenous leukemia |
Phase II data said it may prolong remission duration in some patients with high-risk AML (12/7) |
|
HemaQuest Pharmaceuticals Inc. |
HQK-1001 |
An orally administered small chain fatty acid derivative |
Sickle cell disease and beta thalassemia |
Data showed the drug was well tolerated with significant drug-related adverse events in both trials (12/8) |
|
ImmunoGen Inc. |
IMGN901 |
Designed to target and kill cancer cells that express the CD56 antigen |
Multiple myeloma |
Phase I data were positive (12/7) |
|
Immunomedics Inc. |
Milatuzumab and veltuzumab |
A humanized anti-CD74 antibody and a humanized anti-CD20 antibody |
Non-Hodgkin's lymphoma |
Combination treatment resulted in therapeutic responses in heavily pretreated and Rituxan-refractory patients (12/7) |
|
Immunomedics Inc. |
Y-90 epratuzumab |
Yttrium-90 labeled epratuzumab |
Diffuse B-cell lymphoma |
Conslidation treatment with fractionated Y-90, after induction therapy with rituximab and CHOP chemotherapy, improved remission status of adult patients (12/7) |
|
Incyte Corp. |
INCB18424 |
A selective, oral JAK1 and JAK2 inhibitor |
Advanced polycythemia vera and essential thrombocythemia |
Phase II data showed long-term clinical activity, including reduction in spleen size, phelebotomy independence and improvement in blood counts lasting up to 27 months (12/7) |
|
MethylGene Inc. (Canada) |
MGCD0103 |
Mocetinostat |
Hodgkin lymphoma |
Phase II data showed a complete response for two out of 43 patients, partial response for 12 patients and durable disease for at least six months for one patient (12/7) |
|
Micromet Inc. |
MT103 |
Blinatumomab |
Acute lymphoblastic leukemia |
Phase II data demonstrated that it produced prolonged remissions in patients with ALL (12/7) |
|
Millennium (unit of Takeda Pharmaceutical Co. Ltd.) |
MLN4924 |
A small-molecule inhibitor of the NEDD8-activating enzyme |
Acute myeloid leukemia or high-grade myelodysplastic syndromes |
Phase I data showed that four patients achieved a complete response (12/8) |
|
Millennium Pharmaceuticals Inc. and Janssen-Cilag (Belgium) |
Velcade |
Bortezomib |
Relapsed multiple myeloma; relapsed or refractory follicular lymphoma |
Data from a 222-patient study comparing subcutaneous vs. intravenous administration showed the efficacy was similar in both administrations with one-year overall survival of 72.6% in the subcutaneous group and 76.7% in the intravenous group (12/7); Phase III data of Velcade and rituximab showed an improvement in progression-free survival and prolonged the time to next therapy over rituximab alone (12/9) |
|
Novartis Pharmaceutical Corp. |
LBH589 |
Panobinostat |
Hodgkin lymphoma |
Pivotal Phase II data showed that it demonstrated substantial disease control and tumor reduction in pretreated patients who had relapsed or become refractory after an autologous stem cell transplant (12/7) |
|
Novartis Pharmaceutical Corp. |
Tasigna |
Nilotinib |
Chronic myeloid leukemia |
Phase III data showed that patients treated with a 300 mg dose twice daily had a lower incidence of progression to accelerated phase and blast crisis, compared to Gleevec 400 mg once daily (12/7) |
|
Onconova Therapeutics Inc. |
Estybon |
ON 01910 Na |
Acute myeloid leukemia |
Data from 48 higher risk patients who failed or became resistant to previous drug treatments showed they had increases in overall survival when treated with Estybon (12/7) |
|
Onyx Pharmaceuticals Inc. |
Carfilzomib |
Next-generation proteasome inhibitor |
Multiple myeloma |
Phase IIb data demonstrated that in a subset analysis of 128 patients refractory to Velcade showed an overall response rate of 19% (12/8) |
|
Pharmacyclics Inc. |
PCI-32765 |
Btk-selective inhibitor |
Chronic lymphocytic leukemia; B cell malignancies |
Phase I data of 54 patients showed it was well tolerated (12/7); Phase Ia study showed an overall response rate of 45%, with the highest response rates in mantle cell lymphoma (78%) and chronic/small lymphocytic leukemia (56%) (12/8) |
|
PharmaMar SA (Spain) |
Aplidin |
Plitidepsin |
Peripheral T-cell lymphoma |
Phase II data showed it was effective and safe, with two full responses and four partial responses in the 32 patients treated (12/8) |
|
PolyMedix Inc. |
PMX-60056 |
A synthetic, small molecule designed to reverse the anticoagulant activity of heparin and low-molecular-weight heparin |
For use during cardiac surgery |
Phase Ib/II data showed clinicians can accurately predict a single reversing dose of the drug that will safely and effectively neutralize the anticoagulation effects of heparin (12/8) |
|
Roche AG |
GA101 |
Monoclonal antibody |
Relapsed and refractory non-Hodgkin's lymphoma |
Phase II data showed that a third of patients who had tried three previous therapies responded (12/7) |
|
S*BIO Pte. Ltd. (Singapore) |
SB1518 |
JAK2 inhibitor |
Symptomatic myelofibrosis and enlarged spleens |
Phase I and II data indicated clinical efficacy and good tolerability (12/7) |
|
S*BIO Pte. Ltd. (Singapore) |
SB939 |
Oral histone deacetylase inhibitor |
Advanced hematologic malignancies |
Phase I data showed tolerability and safety (12/8) |
|
Seattle Genetics Inc. |
SGN-35 |
Brentuximab vendotin |
Relapsed Hodgkin's lymphoma; systemic anaplastic large cell lymphoma |
Data showed that in 102 patients who had been failed by a median of 3.5 prior treatments, almost all patients, or 94%, achieved some sort of tumor reduction, and a third went into complete remission (12/7); Phase IIb data showed a 97% tumor volume reduction, an 86% objective response and a 53% complete response (12/8) |
|
Spectrum Pharmaceuticals Inc. |
Zevalin |
Ibritumomab tiuxetan |
Indolent follicular non-Hodgkin's lymphoma; advanced B-cell lymphoma |
Phase III data showed that patients treated with a single-dose infusion of Zevalin after partial or complete response to first-line chemotherapy had a nearly three-year advantage in median progression-free survival compared to patients treated with chemotherapy alone or chemotherapy plus Rituxan (12/7); results showed non-myeloablative allogeneic transplant can provide prolonged remissions, and that its use is safe, feasible and can lead to early objective responses and prolonged disease control in certain patients (12/8) |
|
Stemline Therapeutics Inc. |
SL-401 |
A cancer stem cell-targeting agent |
Acute myeloid leukemia and myelodysplastic syndromes |
Phase I data showed efficacy at tolerable doses (12/8) |
|
Synta Pharmaceuticals Corp. |
STA-9090 |
A small-molecule Hsp90 inhibitor |
Acute myeloid leukemia |
Phase I/II trial showed early signs of clinical activity, including instances of long-term disease control (12/8) |
|
Telik Inc. |
Telintra |
Ezatiostat hydrochloride |
Myelodysplastic syndromes |
Phase II data showed a significant response rate among various patient groups (12/7) |
|
YM BioSciences Inc. (Canada) |
CYT387 |
JAK1/JAK2 inhibitor |
Myelofibrosis |
Interim Phase I/II data showed an overall response rate of 62% (12/7) |
|
Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. # The date indicated refers to the BioWorld Today issue in which the news item can be found. |