From here: http://www.biocentury.com/dailynews/clinical/2014-01-29/progenics-falls-on-deaths-in-phase-ii-trial
Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) fell $1.70 (27%) to $4.50 on Wednesday after an abstract from the American Society of Clinical Oncology Genitourinary Cancers Symposium noted that two patients receiving IV PSMA ADC died due to sepsis in the Phase II PSMA ADC 2301 trial to treat metastatic castration-resistant prostate cancer (CRPC). The open-label, U.S. trial has enrolled 70 CRPC patients with progressive disease despite treatment with one or more taxane-containing chemotherapies. The trial also has an additional cohort of 35 chemotherapy-naïve patients who have progressed on hormonal therapies. The abstract, which includes safety data, is slated to be presented at the symposium on Thursday.
PSMA ADC is an antibody-drug conjugate (ADC) composed of a human mAb against prostate-specific membrane antigen (PSMA; FOLH1; GCPII) and monomethyl auristatin E (MMAE). The product uses ADC technology from Seattle Genetics Inc. (NASDAQ:SGEN), which was up $0.10 to $45.29.
From here: http://www.biocentury.com/dailynews/clinical/2014-01-29/kalobios-falls-after-dropping-kb003-for-asthma
KaloBios Pharmaceuticals Inc. (NASDAQ:KBIO) fell $1.45 (31%) to $3.20 in early after-hours trading on Wednesday after the company announced after market close that it discontinued development of KB003 for severe asthma. The decision came after IV KB003 every four weeks missed the primary endpoint of improving mean forced expiratory volume in 1 second (FEV1) from baseline to week 24 vs. placebo in a Phase II trial in the indication. The double-blind, international trial enrolled 160 patients with severe asthma inadequately controlled on corticosteroids. All patients received standard of care (SOC). The company said it will continue to analyze the data to determine next steps, if any, for KB003, a chimeric mAb against GM-CSF developed using Humaneered technology.
KaloBios also said it will now focus on developing KB001-A, a humanized antibody fragment against PcrV (V-antigen) on Pseudomonas aeruginosa in Phase II testing to treat cystic fibrosis in patients with P. aeruginosa lung infections, with data expected in 4Q14. The company is also developing KB004, a humanized mAb targeting EPH receptor A3 (EPHA3) receptor tyrosine kinase in Phase II testing to treat acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).
Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) fell $1.70 (27%) to $4.50 on Wednesday after an abstract from the American Society of Clinical Oncology Genitourinary Cancers Symposium noted that two patients receiving IV PSMA ADC died due to sepsis in the Phase II PSMA ADC 2301 trial to treat metastatic castration-resistant prostate cancer (CRPC). The open-label, U.S. trial has enrolled 70 CRPC patients with progressive disease despite treatment with one or more taxane-containing chemotherapies. The trial also has an additional cohort of 35 chemotherapy-naïve patients who have progressed on hormonal therapies. The abstract, which includes safety data, is slated to be presented at the symposium on Thursday.
PSMA ADC is an antibody-drug conjugate (ADC) composed of a human mAb against prostate-specific membrane antigen (PSMA; FOLH1; GCPII) and monomethyl auristatin E (MMAE). The product uses ADC technology from Seattle Genetics Inc. (NASDAQ:SGEN), which was up $0.10 to $45.29.From here: http://www.biocentury.com/dailynews/clinical/2014-01-29/kalobios-falls-after-dropping-kb003-for-asthma
KaloBios Pharmaceuticals Inc. (NASDAQ:KBIO) fell $1.45 (31%) to $3.20 in early after-hours trading on Wednesday after the company announced after market close that it discontinued development of KB003 for severe asthma. The decision came after IV KB003 every four weeks missed the primary endpoint of improving mean forced expiratory volume in 1 second (FEV1) from baseline to week 24 vs. placebo in a Phase II trial in the indication. The double-blind, international trial enrolled 160 patients with severe asthma inadequately controlled on corticosteroids. All patients received standard of care (SOC). The company said it will continue to analyze the data to determine next steps, if any, for KB003, a chimeric mAb against GM-CSF developed using Humaneered technology.
KaloBios also said it will now focus on developing KB001-A, a humanized antibody fragment against PcrV (V-antigen) on Pseudomonas aeruginosa in Phase II testing to treat cystic fibrosis in patients with P. aeruginosa lung infections, with data expected in 4Q14. The company is also developing KB004, a humanized mAb targeting EPH receptor A3 (EPHA3) receptor tyrosine kinase in Phase II testing to treat acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).
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