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. Drug-related 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