On November 11, 2022 The HAMLET Pharma reported that drug candidates has remarkable effects and continues to show great promise for the prevention and treatment of cancer (Press release, HAMLET Pharma, NOV 11, 2022, View Source;utm_medium=rss&utm_campaign=hamlet-pharma-q1-interim-report-july-2022-september-2022 [SID1234623845]). Alpha1H kills tumor cell efficiently and attacks tumor tissue in patients with bladder cancer. A unique mechanism of action permits Alpha1H to target the tumor without damaging healthy bladder tissue. In bladder cancer patients, the tumor responds by releasing large numbers of tumor cells and tumor fragment into the urine, which is an efficient way of removing tumor tissue without causing a toxic effect. These positive findings suggest that Alpha1H can be used liberally to treat different types of cancer in the future.
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During the first quarter of the new fiscal year, Hamlet Pharma has strengthened the clinical trial program for stand-alone use of Alpha1H in bladder cancer patients, continued the collaboration with Neurochase Ltd for the treatment of brain tumors with Alpha1H and, in collaboration with external partners, intensified the development of BAMLET as a drug candidate.
After a successful dose-finding study with positive clinical effects, the clinical program is aimed at defining the optimal treatment regimen. We are currently testing the effects of repeated treatment using a five times higher dose of Alpha1H compared to placebo. The patients will receive two rounds of treatment and the clinical outcome will be compared to the placebo group and to patients receiving one round of treatment. The dialogue with the US (FDA) and European (EMA) authorities has, with the help of experienced consultant organizations, been intensified during this first quarter.
The ongoing collaboration with Neurochase Ltd will explore Alpha1H for brain tumor therapy, where a novel drug delivery technology and methods to treat tumors in the central nervous system with Alpha1H will be developed. The work includes technology development and testing of the new device with Alpha1H in an animal study. The goal is to provide adequate materials and data to prepare for the first clinical study for this indication.
BAMLET, with strong tumoricidal effects, is the third member of the HAMLET family of compounds. In the first quarter, we have continued the development of BAMLET as a drug candidate, primarily in colon cancer. In an animal study in mice we have found that daily, long-term treatment with BAMLET in the drinking water inhibits tumor development and increases long-term survival, compared to mice not receiving BAMLET. The frequency of polyps and the polyp size was reduced already after eight weeks and with continued treatment. The mice remained symptom-free and survived significantly longer than control mice. Hamlet Pharma has also initiated discussions regarding the manufacturing of BAMLET for future clinical studies with external partners.
The stable financial position enables Hamlet Pharma to secure the development of the projects in the Hamlet Pharma portfolio. Hamlet Pharma is committed to improving the treatment options for cancer patients, initially patients with bladder cancer, where there is a significant unmet medical need for new therapies.
Catharina Svanborg and Martin Erixon
Chairperson of the Board and CMO, and CEO, respectively, of Hamlet Pharma AB
Significant events during the first quarter
Q1
On August 2, 2022, Hamlet Pharma published "Full speed ahead! – Hamlet Pharma adapts the clinical trial program for stand-alone use". Hamlet Pharma highlights the development of the clinical protocol in bladder cancer with Alpha 1H. The company has decided to interrupt the combination study where Alpha1H was used together with a chemotherapy drug. There was no evidence of a therapeutic advantage and the patients experienced side effects, which were not seen with Alpha1H alone. It was also announced that Hamlet Pharma is taking one more step towards the design of the Phase III clinical trial protocol by adding a second treatment round after the completion of the first round of treatment in the ongoing study. These decisions strengthen Hamlet Pharma’s position as a company developing drug candidates with a more beneficial profile than traditional chemotherapeutic drugs.
On August 9, 2022, Hamlet Pharma published "Hamlet Pharma receives a new rapid approval in the Czech Republic". Hamlet Pharma announced the rapid approval of Hamlet Pharma’s application to amend the clinical trial of Alpha1H in bladder cancer by the Czech regulatory authorities. This important new part of the ongoing study is now ready to start.
On September 29, 2022, Hamlet Pharma presented at the Nordic Life Science Days, a pharmaceutical and biotechnology conference held in Malmö. The title of the presentation was "High precision cancer treatment with low side effects".
Significant events after the first quarter
On October 2022, Catharina Svanborg attended the 17th Annual Peptide Therapeutics Symposium held at the Salk Institute in La Jolla, California and presented the Hamlet project to leaders in the field of peptide drug development. The title of the presentation was "A new approach to Cancer Therapy with Documented Clinical Effects".
On November 3, 2022, the annual report for the fiscal year 2021/2022 was published. It can be found on our updated homepage or on spotlight Stock Market’s home page.
On November 9, Hamlet Pharma published ‘’BAMLET in the drinking water; protection against intestinal cancer and potent beneficial health effects’’. We show that daily, long-term treatment with BAMLET in the drinking water inhibits intestinal tumor development in mice genetically susceptible to intestinal tumors, compared to mice not receiving BAMLET. The frequency of tumors and the tumor size was reduced already after short-term BAMLET treatment but with continued treatment, the mice remained symptom-free and survived significantly longer than control mice. BAMLET treatment also protected the mice from extra-intestinal manifestations of disease. These findings are conceptually important, as they suggest that local treatment of the intestine, by supplying BAMLET in the drinking water, can affect cancer development as well as disease states in other organs, suggesting a systemic as well as a local effect.
The findings highlight the beneficial properties of BAMLET and a broad range of effects affecting health and disease.
The period in summary
FIRST QUARTER (JUL 1, 2022-SEP 30, 2022)
– Net sales for the quarter totaled KSEK 0 (0)
– Other operating income totaled KSEK 0 (3,927)
– Loss before tax amounted to KSEK -5,618 (-2,048)
– Loss after tax amounted to KSEK -5,618 (-2,048)
– Loss per share* was SEK -0.0508 (-0.0188), and SEK -0.0491 after dilution
– On September 30, 2022, the equity/assets ratio** was 94.0 (88.7) %
Amounts in parentheses above and below indicate the corresponding value in the preceding year.
* Profit/loss after tax for the period divided by 110,529,666 (108,761,179) and 114,472,907, respectively, where 110,529,666 is the number of shares outstanding on September 30, 2022, and 114,472,907 will be the number of shares if the subscription warrants issued by the Company are exercised. The comparative figure in parentheses was the number of shares on September 30, 2021.