Further study details as provided by KaloBios Pharmaceuticals:
Primary Outcome Measures:
Phase 1: Determine a possible maximum tolerated dose (MTD) [ Time Frame: Once weekly for the first three weeks of study treatment ] [ Designated as safety issue: Yes ]
Phase 2: To characterize preliminary clinical activity based on the International Working Group (IWG) criteria specific to the hematologic malignancy [ Time Frame: Evaluations at designated timepoints ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Phase 1: Examine clinical activity [ Time Frame: Evaluations at designated timepoints ] [ Designated as safety issue: No ]
Phase 1/2: Safety and Tolerability [ Time Frame: Duration of study participation ] [ Designated as safety issue: Yes ]
Phase 1/2: Pharmacokinetic profile [ Time Frame: Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles ] [ Designated as safety issue: No ]
Phase 1/2: Assess immunogenicity [ Time Frame: Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Es werden also im Juli 2016 Daten zur Phase 2 Studie erwartet. Die Firma hat auch noch KB003 in der Pipeline und will hier auch in kürze mit Phase 1 beginnen.
offizielle Shareholderinfos von der Webseite:
Share Related Items
Market Cap. (Mil) $ 20.85
Shares Out (Mil) 32.99
Float (Mil) 28.45
Derzeitiger Bargeldbestand laut letztem Quartalsbericht:
ca. 32 MIO USD
Benötigtes jährliches Kapital für die weitere Entwicklung und Studienarbeit:
ca. 10 MIO
ir.kalobios.com/...cfm?filingID=1558370-15-866&CIK=1293310
D.H.:
Die haben mehr als das 1,5 fache an Cash in der Kasse als die derzeitige Marktkapitalisierung. Die nächsten 2-3 Jahre der Entwicklungsarbeit sind finanziert.
ca. 25 % der Aktien liegen in institutioneller Hand.