Hamlet BioPharma, the pharmaceutical company, specializing in the
development of drugs for cancer and infections, announces that Hamlet
BioPharma’s drug candidate Alpha1H has shown potent treatment
effects in patients with cancer of the urinary bladder. The final analysis
of the placebo-controlled, dose-escalation and repeated treatment
study parts, confirmed the strong treatment effects compared to
placebo. The Clinical study report is being completed for submission to
the FDA.
Clinical effects
Clinical effects of alpha1-oleate were quantified in patients with non-muscle invasive
bladder cancer, using a randomized, placebo-controlled study protocol. Patients were
treated by six intra-vesical instillations of alpha1-oleate (Alpha1H) and the treatment
response was defined relative to the placebo group. Responding patients were offered
a second round of treatment, consisting of six intravesical instillations.
A complete or partial tumor response was detected in >80% of the tumors in patients
treated with 8.5 mM of Alpha1H. Intravesical Alpha1H administrations triggered rapid,
dose-dependent tumor cell shedding and tumor fragmentation, consistent with the
reduction in tumor size. Alpha1H was taken up by tumor tissue and treatment
triggered rapid tumor cell apoptosis, during both treatment rounds.
Immune response confirmed
Alpha1H treatment has previously been shown to activate an immune response with
strong anti-tumor characteristics. This was confirmed in the study, with similar effects
as BCG treatment, underlining the potential of Alpha1H as a broadly acting anti-tumor
molecule.
Alpha1H treatment further inhibited the expression of cancer gene networks,
including bladder cancer genes and became more similar to healthy tissue. Drugrelated
side effects were not recorded, except for local irritation at the site of
instillation.
Clinical study report is being completed for submission to the FDA
These anti-tumor effects strongly support Alpha1H’s potential in patients, initially as
a neoadjuvant, targeting newly diagnosed tumors or recurrences, acknowledged by
the FDA (Food and Drug Administration, USA), by awarding Alpha1H Fast Track status
as a neoadjuvant for the treatment of bladder cancer.
The broad collaborative clinical network required for these studies is maintained
through long-standing collegial interactions. Technology for genome-wide analyses of
clinical samples is maintained by the scientists at Lund University.
For further information, please contact:
Ines Ambite, senior scientist, Lund University +46-762088958
Ines.Ambite@med.lu.se
Catharina Svanborg, CEO, +46-709 42 65 49
catharina.svanborg@hamletpharma.com
www.hamletbiopharma.com
