Aposense ML-10 in Oncology: A Window to the Biological Effect of Therapy

In current clinical practice, the efficacy of cancer treatment is assessed by following tumor size with anatomical imaging (CT scan or MRI). However, these changes are typically observed only weeks or months after treatment.

If treatment is ineffective, the patient may lose the opportunity for alternative, potentially more effective therapy. The patient may also be unnecessarily exposed to the treatment's side effects, which can be severe, while potentially significant healthcare resources are utilized inefficiently.

Induction of cell death, primarily by apoptosis, is the goal of most anti-cancer treatments, including chemotherapy and radiation therapy. Cell death is a key component of the biological response of the tumor to effect treatment, and marks the beginning of the physiological process of tumor mass reduction following treatment. It may be detected within days, or even hours, from initiation of effective treatment.

Imaging of apoptosis may therefore provide early assessment of the biological effect of treatment in the individual patient and tumor, to aid clinicians in making earlier decisions.


 

Aposense Takes Up the Tumor Challenge

The Aposense molecular probe [18-F]-ML-10 is now in phase II clinical trials for early imaging of tumor mass reduction following anti-cancer therapy, with an initial focus on response of metastatic brain tumors to radiotherapy. Approximately 170,000 cancer patients develop brain metastases annually, representing approximately 24% of patients who die from cancer. Metastasis to the brain is the most common intracranial tumor in adults and the most feared complication of systemic cancer. Early diagnosis and aggressive treatment of brain metastasis may result in remission of brain symptoms and may enhance the quality of the patient's life and prolong survival.


 The ML-10 and its analogue compounds were studied in pre-clinical tumor models of six different tumor types, each treated with a range of different therapies. In all studies, the Aposense® probes demonstrated the capability to clearly detect the apoptotic effect of anti-cancer treatment within several days, as well as dose-response relationship and correlation tumor mass-reduction and survival.

 

[18F]-ML-10 is an investigational agent, not yet approved for use outside clinical trials