RE:RE:RE:RE:RE:RE:New Press Release - Theratechnologies' Sudocetaxel Zendusortide ASCO 2024 Presentation Demonstrates Signs of Long-Term Efficacy and Manageable Safety Profile in Patients with Solid Tumors As they have FDA Fast Track, do you think there is any leniency at the FDA for amending the trial (with a partner who has experience) to add Ga68 without having to start the trial from scratch?
if there is, then that's the pitch to a partner however I just wonder if they could get one without the need to give up the entire platform; or most of the upside.
jfm1330 wrote: The strong scientific rationale was there from the beginning. A company with real financial means and stong scientific people would have integrated it in their clinical protocol from the beginning. I agree that now it's too late for that. It could be implemented just if they end up having good enough results and a great partner. Again, it's like F4 and F8 for tesamorelin, they had these enhanced formulations since 2011, but they came close to bankruptcy shortly after that, had no money to push them forward, and ended up doing it 10 years later when they had money and clinical and IP goals to justify it.
Mannequin wrote: The cannot start a Ga68 trial without evidence. Coupling a clinical trial with Ga-68 (Gallium-68) involves using this radioisotope in conjunction with a PET scan to enhance the imaging and diagnostic capabilities within the trial. Here’s an overview of what this would entail and its feasibility:
What it Entails
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Radiotracer Development: Ga-68 can be linked to specific molecules or peptides that target certain cancer cells or tumor markers. For example, Ga-68 can be used to label peptides that target receptors expressed on cancer cells, such as somatostatin receptors in neuroendocrine tumors (Ga-68 DOTATATE) or PSMA in prostate cancer (Ga-68 PSMA).
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PET Imaging: Patients in the trial would undergo PET scans using the Ga-68-labeled radiotracer. The Ga-68 emits positrons, which are detected by the PET scanner to create detailed images of the tumor’s location, size, and metabolic activity.
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Enhanced Monitoring: The high-resolution images provided by Ga-68 PET scans can help in monitoring the disease’s progression, response to the investigational drug, and any changes in tumor activity. This can provide more precise data on how the treatment is affecting the tumor over time.
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Safety and Feasibility: Incorporating Ga-68 PET imaging into a clinical trial requires coordination between radiology and oncology departments, access to a cyclotron (to produce Ga-68), and the ability to safely administer the radiotracer to patients. The trial protocol would need to include safety measures for handling radioactive materials and ensuring patient safety.
Feasibility
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Regulatory Approval: Any changes to the trial protocol, including the addition of Ga-68 PET imaging, would need to be approved by regulatory bodies and ethics committees. This involves demonstrating that the use of Ga-68 is safe and provides significant clinical benefit.
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Clinical Justification: There needs to be a strong scientific rationale for using Ga-68 PET imaging in the trial. This might include evidence that the imaging can provide crucial information about the tumor’s response to the investigational drug that cannot be obtained through other methods.
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Logistics and Infrastructure: Implementing Ga-68 PET imaging requires appropriate infrastructure, including access to PET scanners and facilities capable of producing and handling Ga-68. This might limit the trial to specific centers equipped with these resources.
Potential Benefits
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Improved Patient Selection: Ga-68 PET imaging can help identify patients who are more likely to benefit from the investigational treatment by detecting specific tumor markers.
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Enhanced Monitoring: The detailed imaging can provide better insights into how the tumor is responding to treatment, potentially allowing for more precise adjustments to the therapy.
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Early Detection of Response: Ga-68 PET scans can detect metabolic changes in the tumor earlier than conventional imaging, providing an early indication of whether the treatment is effective.
Conclusion
Incorporating Ga-68 PET imaging into a clinical trial is feasible and can offer significant benefits in terms of patient monitoring and treatment evaluation. However, it requires careful planning, regulatory approval, and appropriate infrastructure. If these challenges can be addressed, Ga-68 PET imaging could enhance the trial's ability to assess the efficacy and safety of the investigational drug.