CLINICAL TRIALS PROFILE FOR VALCHLOR

All Clinical Trials for Valchlor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02296164 ↗	Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma	Completed	Actelion		2014-11-12	The Valchlor PROVe study is a multi-center, prospective, observational, US-based drug study that longitudinally follows patients with Mycosis Fungoides Cutaneous T-cell Lymphoma (MF-CTCL) who are receiving therapy with Valchlor. Patients will be followed prospectively for a maximum of 2 years from the date of signed informed consent (enrollment) until end of study. Continuation in the study is not contingent on continuation of Valchlor.
NCT02296164 ↗	Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma	Completed	Helsinn Therapeutics (U.S.), Inc		2014-11-12	The Valchlor PROVe study is a multi-center, prospective, observational, US-based drug study that longitudinally follows patients with Mycosis Fungoides Cutaneous T-cell Lymphoma (MF-CTCL) who are receiving therapy with Valchlor. Patients will be followed prospectively for a maximum of 2 years from the date of signed informed consent (enrollment) until end of study. Continuation in the study is not contingent on continuation of Valchlor.
NCT02881749 ↗	Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides	Unknown status	Actelion	Phase 2	2016-09-01	The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose TSEBT (12 Gy total) over a period of two weeks. After a 30 day observation period and confirmation that their disease stage has been downgraded to IA or IB, subjects will use Valchlor as a maintenance therapy over the course of one year. The efficacy of Valchlor as a maintenance drug will be followed clinically through Modified Severity Weight Assessment Tool (mSWAT) and percent body surface area measurements (%BSA). Furthermore, subjects will be followed histopathologically through skin biopsies performed at the screening visit, immediately after observation period, one month after the start of the maintenance period, and twelve months after the start of the maintenance period (4 biopsies total).
NCT02881749 ↗	Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides	Unknown status	Thomas Jefferson University	Phase 2	2016-09-01	The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose TSEBT (12 Gy total) over a period of two weeks. After a 30 day observation period and confirmation that their disease stage has been downgraded to IA or IB, subjects will use Valchlor as a maintenance therapy over the course of one year. The efficacy of Valchlor as a maintenance drug will be followed clinically through Modified Severity Weight Assessment Tool (mSWAT) and percent body surface area measurements (%BSA). Furthermore, subjects will be followed histopathologically through skin biopsies performed at the screening visit, immediately after observation period, one month after the start of the maintenance period, and twelve months after the start of the maintenance period (4 biopsies total).
NCT02968446 ↗	Effect of Vitamin D After Application With Valchlor	Unknown status	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Early Phase 1	2016-11-17	The purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system. An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown. Inflammation is the body's physical response to infection, injury, or long term disease. Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the body. This study will look at product use, testing skin irritation in healthy volunteers and seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could one day help doctors prescribe Vitamin D to patients with long term disease to relieve their symptoms.
NCT02968446 ↗	Effect of Vitamin D After Application With Valchlor	Unknown status	National Institutes of Health (NIH)	Early Phase 1	2016-11-17	The purpose of this research study is to evaluate the effects of an oral Vitamin D on the body's immune system. An interest has been growing because studies have shown that Vitamin D may reduce inflammation and harmful effects in the body, however, the best dose for Vitamin D is still unknown. Inflammation is the body's physical response to infection, injury, or long term disease. Pain, redness, heat, and sometimes loss of function are all signs of inflammation in the body. This study will look at product use, testing skin irritation in healthy volunteers and seeing how Vitamin D may help stop or reduce inflammation and skin irritation, which could one day help doctors prescribe Vitamin D to patients with long term disease to relieve their symptoms.

Clinical Trial Conditions for Valchlor

Condition Name

Condition Name for Valchlor
Intervention	Trials
Mycosis Fungoides	5
Cutaneous T-cell Lymphoma	2
Cutaneous T-Cell Lymphoma/Mycosis Fungoides	1
Folliculotropic Mycosis Fungoides	1

Condition MeSH

Condition MeSH for Valchlor
Intervention	Trials
Mycoses	6
Mycosis Fungoides	6
Lymphoma, T-Cell, Cutaneous	4
Lymphoma, T-Cell	3

Clinical Trial Locations for Valchlor

Trials by Country

Trials by Country for Valchlor
Location	Trials
United States	25
Netherlands	1

Trials by US State

Trials by US State for Valchlor
Location	Trials
New York	3
Pennsylvania	2
Ohio	2
Florida	2
South Carolina	1

Clinical Trial Progress for Valchlor

Clinical Trial Phase

Clinical Trial Phase for Valchlor
Clinical Trial Phase	Trials
Phase 2	5
N/A	1
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for Valchlor
Clinical Trial Phase	Trials
Recruiting	3
Unknown status	2
Completed	2

Clinical Trial Sponsors for Valchlor

Sponsor Name

Sponsor Name for Valchlor
Sponsor	Trials
Actelion	4
Case Comprehensive Cancer Center	1
University Hospitals Cleveland Medical Center	1

Sponsor Type

Sponsor Type for Valchlor
Sponsor	Trials
Other	8
Industry	7
NIH	2

VALCHLOR: Clinical Trials, Market Analysis, and Projections

Introduction

VALCHLOR (mechlorethamine gel) is a topical alkylating agent used primarily for the treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL). Here, we will delve into the recent clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Efficacy and Safety of VALCHLOR

VALCHLOR was evaluated in a randomized, multicenter, observer-blinded, 12-month noninferiority trial involving 260 patients with MF-CTCL. The trial compared VALCHLOR gel to compounded mechlorethamine. The primary endpoint was the Composite Assessment of Index Lesion Severity (CAILS) score, and the secondary endpoint was the Severity Weighted Assessment Tool (SWAT) score.

• Response Rates: The trial showed a 60% overall response rate for patients receiving VALCHLOR gel, with 45% achieving a partial response and 14% achieving a complete response. This was noninferior to compounded mechlorethamine[1].

• SWAT Score: Using the SWAT score, 50% of patients receiving VALCHLOR achieved an overall response, with 43% partial responses and 7% complete responses[1].

Comparative Studies with HyBryte

Recent studies have compared VALCHLOR with HyBryte (synthetic hypericin) in the treatment of CTCL. These studies were designed to assess the efficacy and safety of both treatments.

• Efficacy Comparison: In a comparative study, 60% of patients treated with HyBryte achieved a ≥50% improvement in their modified CAILS (mCAILS) score after 12 weeks, compared to only 20% of patients treated with VALCHLOR. HyBryte also showed a more rapid and robust treatment response[2][4].

• Safety Profile: HyBryte demonstrated a more favorable safety profile, with all patients tolerating the treatment well and no adverse events reported. In contrast, 60% of VALCHLOR-treated patients experienced at least one adverse event, including rashes, application site sensitivity, and allergic contact dermatitis[2][4].

Market Analysis

Current Market Position

VALCHLOR is currently protected by six US patents, with the earliest estimated generic entry date based on patent exclusivity. However, various factors can influence the timing of generic entry, including new patent filings, patent extensions, and early generic licensing[5].

• Sales and Revenue: While specific global sales figures for VALCHLOR are not publicly available, the drug's market position is influenced by its efficacy, safety profile, and the presence of alternative treatments like HyBryte.

Competitive Landscape

The introduction of HyBryte as a potential competitor has significant implications for VALCHLOR's market share. HyBryte's superior efficacy and safety profile in recent clinical trials could lead to a shift in treatment preferences among clinicians and patients.

• Market Share: The comparative studies suggest that HyBryte may capture a significant portion of the CTCL treatment market, potentially reducing VALCHLOR's market share. However, the final impact will depend on the outcomes of ongoing and future clinical trials, particularly the confirmatory Phase 3 FLASH2 trial for HyBryte[2][4].

Projections and Future Outlook

Clinical Trial Pipeline

The upcoming confirmatory Phase 3 FLASH2 trial for HyBryte is expected to initiate before the end of 2024 and will provide further clarity on its efficacy and safety compared to VALCHLOR. This trial will be crucial in determining the long-term market dynamics between these two treatments[4].

• Regulatory Approvals: The FDA and EMA have indicated that a second successful Phase 3 trial is required for HyBryte to gain marketing approval. A positive outcome in the FLASH2 trial could significantly impact VALCHLOR's market position[4].

Generic Entry

The potential for generic entry of VALCHLOR is a critical factor in its future market projections. Generic versions could enter the market once the patent exclusivity period ends, which is estimated based on the current patent landscape. This could further erode VALCHLOR's market share and revenue[5].

Key Takeaways

• Efficacy and Safety: VALCHLOR has demonstrated efficacy in treating MF-CTCL, but recent comparative studies suggest HyBryte may offer superior efficacy and a better safety profile.
• Market Competition: The introduction of HyBryte is likely to impact VALCHLOR's market share, with the outcome of the Phase 3 FLASH2 trial being a key determinant.
• Regulatory and Patent Landscape: The timing of generic entry and the outcomes of ongoing clinical trials will significantly influence VALCHLOR's future market position.

FAQs

What is the current efficacy of VALCHLOR in treating MF-CTCL?

VALCHLOR has shown a 60% overall response rate in patients with MF-CTCL, with 45% achieving a partial response and 14% achieving a complete response[1].

How does HyBryte compare to VALCHLOR in clinical trials?

HyBryte has demonstrated a more rapid and robust treatment response, with 60% of patients achieving a ≥50% improvement in their mCAILS score after 12 weeks, compared to 20% for VALCHLOR. HyBryte also has a more favorable safety profile[2][4].

What is the expected timeline for the Phase 3 FLASH2 trial of HyBryte?

The Phase 3 FLASH2 trial for HyBryte is expected to initiate before the end of 2024, with topline results anticipated in the second half of 2026[4].

When can generic versions of VALCHLOR be expected?

The earliest estimated generic entry date for VALCHLOR is based on the expiration of its patent exclusivity, but the actual timing can be influenced by various factors including new patent filings and early generic licensing[5].

How might the introduction of HyBryte affect VALCHLOR's market share?

The introduction of HyBryte, with its superior efficacy and safety profile, is likely to capture a significant portion of the CTCL treatment market, potentially reducing VALCHLOR's market share[2][4].

Sources

1. VALCHLOR HCP Website - Efficacy of VALCHLOR® (mechlorethamine) gel
2. Zacks Small-Cap Research - Soligenix, Inc. (SNGX-NASDAQ) Current Price and Valuation
3. PR Newswire - HyBryte™ Clinical Results Demonstrate Continued Improvement Post-Treatment
4. Soligenix, Inc. - Positive Clinical Results from a Comparative Study Evaluating HyBryte™ Against Valchlor®
5. DrugPatentWatch - VALCHLOR Drug Patent Profile