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5-Amino Levulinic Acid · 1 trial · 5 indications
The response will be clinically evaluated three weeks after PDT treatment. It will be defined as complete, partial, stable or progressive disease by modified RECIST criteria.
| Arm | Type | Description |
|---|---|---|
| To evaluate the clinical efficacy of image guided photodynamic therapy to manage HGD-OPML | EXPERIMENTAL | The participants will take 5-ALA in oral solution (20 mg/kg BW 5-ALA HCl) 2 to 4 hours prior to undergoing image guided SITOS based PDT treatment. PDT treatment will use a total light dose of 100 J/cm\^2 of 635 nm light (red light) delivered from a laser at an irradiance of approximately 50 mW/cm\^2 at the tissue surface. Participants will be admitted for 48 hours to monitor toxicity profile evaluation. The lesion response will be evaluated and the PDT treatment will be repeated, if required, once in every 3 weeks with a maximum of up to three sessions. The clinical responses will be evaluated during the clinical visits. If the patient shows complete clinical response in less than three sessions of PDT, the PDT will be stopped and the patients will be followed up every 3 months, for one year. If there is lack of complete response or relapse of the lesions during the follow up, the patients will be advised to undergo surgical excision. |
| Name | Type | Description |
|---|---|---|
| 5-Amino Levulinic Acid | DRUG | 5-ALA (Gleolan) orally (20 mg/kg BW 5-ALA HCl) 2 to 4 hours prior to undergoing image-guided SITOS-based PDT treatment |
Subject Inclusion Criteria 1. One grossly visible OPML, with histopathologically confirmed diagnosis of moderate, severe, and carcinoma in situ measuring ≥ 10 mm in diameter. 2. Willing and available for follow-up for at least one year and at prerequisite time intervals. 3. All patients above the a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Pfizer Inc. | PFE | 1 | PHASE1 | TG4001, Avelumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Oncolytics Biotech Inc. | ONCY | 1 | PHASE1 | Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen |
| TScan Therapeutics, Inc. | TCRX | 1 | PHASE1 | TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101 |
5-Amino Levulinic Acid is an investigational small molecule being studied for use in oral cancer, including premalignant and malignant oral lesions. It is being evaluated as a low-cost screening tool and for image-guided photodynamic therapy (PDT) of conditions such as oral leukoplakia, oral lichen planus, and oral squamous cell carcinoma.
5-Amino Levulinic Acid is a photosensitizing agent used in photodynamic therapy. It is a precursor that leads to the accumulation of protoporphyrin IX in target cells, which, when activated by light, produces reactive oxygen species to destroy abnormal cells. This mechanism is being studied for imaging and treating oral lesions.
5-Amino Levulinic Acid is being developed by National Healthcare Corp. (ticker: NHC). The company is conducting a Phase 2 clinical trial to evaluate the drug for oral cancer screening and photodynamic therapy.
5-Amino Levulinic Acid is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is a single-arm, uncontrolled study that is not yet recruiting participants.
5-Amino Levulinic Acid is being studied in one Phase 2 trial, NCT06876038, titled 'Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions.' The trial, enrolling 65 participants in India, is not yet recruiting and is open to adults aged 18 and older.