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Mechlorethamine

Generic Name
Mechlorethamine
Brand Names
Valchlor, Ledaga
Drug Type
Small Molecule
Chemical Formula
C5H11Cl2N
CAS Number
51-75-2
Unique Ingredient Identifier
50D9XSG0VR
Background

A vesicant and necrotizing irritant destructive to mucous membranes, mechlorethamine is an alkylating drug. It was formerly used as a war gas. The hydrochloride is used as an antineoplastic in Hodgkin's disease and lymphomas. It causes severe gastrointestinal and bone marrow damage.

The FDA granted marketing approval for the orphan drug Valchlor (mechlorethamine) gel on August 23, 2013 for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Each tube of Valchlor contains 0.016% of mechlorethamine which is equivalent to 0.02% mechlorethamine HCl.

Indication

For the palliative treatment of Hodgkin's disease (Stages III and IV), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, polycythemia vera, mycosis fungoides, and bronchogenic carcinoma. Also for the palliative treatment of metastatic carcinoma resulting in effusion.

Associated Conditions
Bronchogenic Carcinoma, Chronic Lymphocytic Leukemia, Hodgkins Disease (HD), Lymphoma, Diffuse, Mycosis Fungoides (MF), Polycythemia Vera (PV), Stage I Mycosis Fungoides, Malignant effusion
Clinical Trials
Related News

Long-Term Study Shows PET-Guided Treatment Success in Early-Stage Hodgkin Lymphoma

The RAPID trial's 16-year follow-up data demonstrates that patients with early-stage classic Hodgkin lymphoma who achieve PET-negative status after three cycles of ABVD chemotherapy can safely avoid radiation therapy without compromising survival. This landmark finding, along with new data on bleomycin omission and novel combination therapies, represents a significant advancement in treatment de-escalation strategies.

HyBryte Shows Sustained Improvement in CTCL Lesions Post-Treatment

• Soligenix's HyBryte demonstrated continued improvement in cutaneous T-cell lymphoma (CTCL) lesions even after treatment cessation. • A comparative study showed a statistically significant improvement in plaque lesion response with HyBryte versus Valchlor at week 16 (p=0.006). • HyBryte was well-tolerated, with no related adverse events, contrasting with Valchlor, which had a 60% related adverse event rate. • Soligenix plans to initiate a confirmatory Phase 3 trial (FLASH2) to further evaluate HyBryte's efficacy and safety in CTCL patients.

Soligenix's HyBryte Enrolls First Patients in Phase 3 CTCL Trial

• Soligenix initiates patient enrollment for the confirmatory Phase 3 FLASH2 trial of HyBryte for cutaneous T-cell lymphoma (CTCL). • The FLASH2 trial builds upon previous positive Phase 3 results, aiming to demonstrate HyBryte's efficacy with an extended 18-week treatment period. • HyBryte, a novel photodynamic therapy, has shown a promising safety profile and efficacy in early-stage CTCL, offering a new treatment option. • Interim analysis of the FLASH2 study is anticipated in early 2026, with periodic updates on the trial's progress expected in 2025.

Soligenix to Initiate Phase 3 Trial of HyBryte for Cutaneous T Cell Lymphoma

• Soligenix is set to begin a Phase 3 trial (FLASH2) of HyBryte for cutaneous T cell lymphoma (CTCL) treatment before the end of 2024, mirroring the design of the previous FLASH trial. • Recent data presented at EORTC highlighted HyBryte's effectiveness and favorable safety profile compared to Valchlor in treating CTCL, alongside minimal systemic exposure. • Soligenix has partnered with Sterling Pharma Solutions to enhance the manufacturing process for synthetic hypericin, aiming to reduce production costs for HyBryte. • Anticipated topline results from the FLASH2 trial are expected in the second half of 2026, marking a significant milestone in HyBryte's development for CTCL.

HyBryte™ Shows Improved Response Rates in Cutaneous T-Cell Lymphoma with Extended Treatment

• Soligenix's HyBryte™ (synthetic hypericin) demonstrates improved response rates in cutaneous T-cell lymphoma (CTCL) with extended treatment and increased light doses. • Presentations at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting highlight the utility of longer treatment times with HyBryte™. • Studies show HyBryte™ has minimal systemic exposure and is relatively efficacious and tolerable compared to Valchlor® in CTCL treatment. • A second Phase 3 trial, FLASH2, is expected to begin before the end of 2024, building on positive results from the initial FLASH study.
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