Key Developments For Gentium S.p.A.
Gentium S.p.A. (GENT.O) (Consolidated Issue listed on NASDAQ Global Market)
Gentium S.p.A. Announces Appoints Interim CEO
Gentium S.p.A. announced the appointment of an interim Chief Executive Officer (CEO). The Company's Board has initiated a search for a new Chief Executive Officer to replace Dr. Laura Ferro and has appointed Dr. Khalid Islam as Interim CEO on a temporary and part-time basis.
Gentium S.p.A. Reports Top Line Results From Phase III Treatment Trial of Defibrotide for Severe Veno-Occlusive Disease
Gentium S.p.A. announced top-line results from a historically controlled, multicenter, open label, Phase III trial designed to evaluate the safety and efficacy of 25 mg/kg/day of Defibrotide for the treatment of severe veno-occlusive disease (sVOD) in hematopoietic stem cell transplant (SCT) patients. The results demonstrate strong trends in favor of the Defibrotide-treated patients for complete response and survival, but did not reach the protocol-specified levels of significance for the primary and secondary endpoints at 100 days. With regard to safety, adverse events were well balanced between the historical control and treatment arms. The primary endpoint of the trial was complete response at 100 days following SCT and utilized historical controls (patients who in the past received the best therapy and supportive care available at the time, but not Defibrotide) as a comparator. Secondary endpoints included survival rate at 100 days and six months post SCT. The historical control database was generated through a sequential, retrospective medical chart review, with final selection of the control group performed by an independent medical review committee (MRC).
Gentium S.p.A. Announces Director Resignations Following Communication Of CEO To Step Down
Gentium S.p.A. announced that five of the eight members of its Board of Directors have resigned, triggering the automatic termination of the entire Board of Directors under Italian law. The Company's Board of Statutory Auditors will promptly call an ordinary shareholders' meeting to appoint the new Board of Directors following determination of the proposed slates of candidates. This meeting is expected to be held in October 2009. On the basis of Italian law, the Board of Statutory Auditors has temporarily assumed responsibility for the ordinary administration of the Company. The Director resignations followed the communication to the Board of Directors by Dr. Laura Ferro, the Chairperson of the Board, President and CEO of Gentium, of her intention to step down as CEO of the Company. The resigning Directors, consisting of Gigliola Bertoglio, Luca Breveglieri, Marco Codella, Laura Ferro and Andrea Zambon, expressed differing reasons for their decisions. The reasons included dissatisfaction with the corporate governance and management of the Company and a sentiment that, once other Directors were resigning, the shareholders should again be given the opportunity to elect a new Board of Directors to make the important strategic decisions facing the Company at this time. The Board of Directors had been recently elected at the annual ordinary shareholders' meeting held on June 30, 2009, prior to Dr. Ferro's communication of her intention to step down as CEO.
Gentium S.p.A. Announces Preliminary Results From Phase 2/3 European Pediatric Prevention Trial for Veno-Occlusive Disease
Gentium S.p.A. announced preliminary unaudited top-line results from the Phase 2/3 European pediatric prevention clinical trial of Defibrotide. In this two-armed trial, patients were randomly assigned to receive Defibrotide. Patients in the prophylaxis arm received 25 mg/kg/day of Defibrotide in four divided doses beginning at the time of conditioning. Patients in the control arm, however, did not receive Defibrotide for Veno-Occlusive Disease (VOD) prophylactic measures. The primary endpoint of the study was development of VOD within 30 days post stem cell transplantation (SCT) based on the modified Seattle criteria. The results from this clinical trial demonstrated a 40% reduction in incidence of VOD within 30 days after SCT and achieved a statistical P-value of 0.0539, with a hazard ratio of 1.68 (95% confidence interval of 0.98-2.86), in the intent-to-treat analysis of 180 patients in the prophylaxis arm and 176 patients in the control arm. In addition, the analysis of data pursuant to the protocol (patients who completed 30 days in the study), which included 164 patients in the prophylaxis arm and 169 patients in the control arm, showed a 40% reduction rate of the incidence of VOD within 30 days and achieved a statistical P-value of 0.0366, with a hazard ratio of 1.78 (95% confidence interval of 1.03-3.08). The data also demonstrated the excellent safety profile of Defibrotide showing no difference in adverse events between the prophylaxis and control arms.
Gentium S.p.A. Provides Phase II/III Pediatric Prevention Trial
Gentium S.p.A. provided an update regarding the Phase II/III pediatric prevention trial. There has been continued progress with the Company’s Phase II/III European trial for Defibriotide evaluating the prevention of veno-occlusive disease (VOD) in pediatric patients. During the second quarter the Company announced results from an independent Data Safety and Monitoring Board (DSMB) review which concluded there were no significant safety concerns, the prophylactic treatment arm (Defibrotide) and the control arm (no drug) were well balanced, and there was no evidence of clinical futility in the trial. However, the DSMB did recommend increasing the total patient enrollment to 360 patients, 180 in each arm. Gentium continues to enroll patients per the DSMB’s recommendation and currently there are 352 out of 360 total patients enrolled in the trial. Additionally, the Company has announced that following discussions with the EMEA, there is the possibility of an accelerated review for Defibrotide in this indication.
