VPHM Announces positive Phase II results for CMV antiviral;
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>>>>VPHM Avg Down 2nd BUY $10-10.10
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ViroPharma Announces Positive Phase 2 Results Demonstrating That Maribavir Significantly Reduces CMV Reactivation Wednesday March 29, 8:17 pm ET - Data Suggest That Maribavir May Alter Current CMV Prevention Strategies for Bone Marrow Transplant Patients - - Company to Host Conference Call to Discuss Clinical Results at 9:00 AM ET Tomorrow -
EXTON, Pa., March 29 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) today announced positive preliminary results from a Phase 2 study with maribavir, an oral antiviral drug candidate currently being developed to inhibit cytomegalovirus (CMV) reactivation in transplant patients. The data from this study demonstrate that prophylaxis with maribavir displays strong antiviral activity, as measured by significant reduction in the rate of reactivation of CMV in recipients of allogeneic stem cell (bone marrow) transplants, and that administration of maribavir for up to 12 weeks has a favorable tolerability profile in this very sick patient population. The full data set will be presented at a future medical meeting.
"We could not have hoped for better results, as these data show that treatment with maribavir dramatically reduces the incidence of CMV reactivation in these very sick patients. In fact, the only cases of CMV disease in this trial occurred in the placebo group -- there were no cases of CMV disease in subjects who received maribavir," commented Colin Broom, ViroPharma's chief scientific officer. "These results could potentially change the current treatment paradigm in which transplant physicians usually wait until CMV can be detected in the blood, indicating that the virus is multiplying, before initiating treatment. If untreated, there is a high risk that the virus will continue to replicate and lead to potentially lethal CMV disease. The reason physicians are reluctant to use currently available therapies as prophylaxis, particularly in stem cell transplant, is the toxicities associated with available therapies, particularly bone marrow or kidney toxicities. These data from our Phase 2 study suggest that maribavir could be used as prophylaxis to prevent CMV infection and thus prevent CMV disease."
"With these new data now in hand, we can move forward toward pivotal Phase 3 studies," added Broom. "Our plan is to meet with the FDA as soon as possible to discuss the data and reach agreement on the Phase 3 program. Our goal is to initiate a pivotal Phase 3 study in allogeneic stem cell transplant patients mid-year and a subsequent Phase 3 study in solid organ transplant patients by year end."
Study Design
The maribavir Phase 2 clinical trial was a randomized, double blind, placebo-controlled, dose-ranging study at 13 transplant centers across the U.S. involving CMV seropositive subjects who have undergone allogeneic stem cell transplantation. A total of 111 subjects were randomized 3:1 to receive maribavir or placebo in each of three ascending dose groups (100 mg BID, 400 mg QD, 400 mg BID). All subjects were monitored frequently for CMV infection, and if CMV was detected, study drug (maribavir or placebo) was discontinued and the subject was managed according to current standards of care at each transplant center, including starting pre-emptive anti-CMV treatment at the discretion of the investigator.
The objectives of this study included an evaluation of the safety and tolerability of maribavir administered orally for up to 12 weeks, and an evaluation of the prophylactic activity of maribavir in preventing CMV reactivation in CMV seropositive recipients of allogeneic stem cell transplants. The term 'prophylaxis' in this setting refers to therapy given to subjects starting before there is any evidence of CMV replication, to prevent CMV infection and in turn prevent CMV disease.
Antiviral activity of maribavir as measured by reductions in CMV reactivation
Available preliminary data from this Phase 2 clinical study includes all data for subjects through at least 12 weeks after enrollment, and indicated the following:
* In an intent-to-treat analysis of the first 100 days post-transplant, the number of subjects who required pre-emptive anti-CMV therapy was statistically significantly reduced (p = 0.051 to 0.001) in each of the maribavir groups compared to the placebo group (57% for placebo vs. 15%, 30%, and 15% for maribavir 100 mg BID, 400 mg QD, and 400 mg BID, respectively).
* Separate analyses of the incidence of CMV infection as measured by different CMV assays such as CMV pp65 antigenemia or plasma CMV DNA PCR were consistent in showing fewer CMV infections in each of the maribavir groups compared to placebo. In most cases, the reduction in rates of infection between patients in the maribavir groups and placebo were statistically significant.
* There were no cases of CMV disease in any of the maribavir groups, whereas CMV disease was reported in three subjects (11%) in the placebo group.
* There have been no reports of late CMV disease (after the 100 day post-transplant period), although patient follow-up remains ongoing for some subjects in the study.
Tolerability of maribavir
Administration of maribavir for up to 12 weeks had a favorable tolerability profile in this study in this very sick patient population. The incidence of most adverse events occurred at similar rates in maribavir and placebo groups.
* Consistent with prior clinical studies, the most notable adverse events that appeared to be associated with maribavir were taste disturbance and nausea.
* In contrast to a prior Phase 1 study in HIV-infected subjects, skin rash was reported at similar rates in maribavir and placebo groups in this study, and thus did not appear to be associated with maribavir administration.
* Preliminary analyses of laboratory data did not identify any notable differences between maribavir groups and placebo. In particular, there was no adverse impact on neutrophil count or other hematologic parameters. |
