e
dose escalation trial in patients with advanced hematologic
malignancies. Patients are dosed for 21 days on a 28-day cycle. A
minimum of three patients are treated at each dose level. The study
is divided into two arms, one for treatment of leukemia patients
and the other for treatment of patients with lymphoma and myeloma.
For the leukemia arm of the study, patients are currently being
treated at the tenth dose level, 250 mg twice daily. For the
lymphoma and myeloma arm, patients are currently being treated at
the sixth dose level, 150 mg twice daily.
Positive Safety and Tolerability Data: The goal of the Phase I
study is to establish the safety, tolerability and pharmacokinetics
of the drug. Thus far, 104 one-month cycles of AVN944 have been
initiated in 46 patients and the compound is well tolerated.
Pharmacokinetics measurements indicate dose proportional plasma
levels of AVN944 during treatment and sustained plasma
concentrations at the dose levels tested thus far.
Early Activity Indicators: This Phase I study is designed to
evaluate several pharmacodynamic and efficacy-related endpoints.
Upon entering the trial, all patients have refractory, progressive
disease and have failed all prior therapies. Thus far, 18 of 39
evaluable patients (46%) showed stabilized disease after one cycle
of treatment with AVN944. These include patients with both leukemia
and multiple myeloma. Patients who have achieved stable disease
following completion of a one-month treatment cycle with AVN944, as
determined by the clinical investigator, may be advanced to a
subsequent cycle.
In the multiple myeloma cohort 60% of the patients have achieved
stabilized disease after one month. Two of these patients completed
five months of treatment and two others completed one full year of
treatment. One AML patient has completed 8 monthly cycles of
treatment.
Positive Dose Dependent Biomarker Data: The AvalonRx(R) platform
has identified selected biomarkers from pati
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Page: 1 2 3 4 5 6 Related medicine technology :1.
Avalon Updates the AVN944 Phase I Hematologic Malignancies Trial2.
Avalon Pharmaceuticals to Present at the American Association for
Cancer Research 2007 Annual Meeting3.
BioSante Pharmaceuticals Announces New Findings for Potential Bird
Flu Vaccine4.
Portola Pharmaceuticals Announces Positive Data from a Phase II
Study of its Factor Xa Inhibitor at the XXI Congress of the
International Society on Thrombosis and Haemostasis5.
Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for
Oral Oleoyl-estrone6.
Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging
Growth Opportunities Conference7.
Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin
Emerging Growth Conference8.
EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin
Emerging Growth Opportunities Conference9.
Pro-Pharmaceuticals Updates Progress of Clinical Trials &
Davanat 505 (b)(2) Filings10.
Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III
Data with Rifamycin MMX in Infectious Diarrhea11.
Portola Pharmaceuticals Announces Positive Phase II EXPERT Results
and Additional Oral and Poster Presentations at the XXI Congress of
the International Society on Thrombosis and Haemostasis (ISTH)