CLINICAL TRIALS PROFILE FOR PROLEUKIN

All Clinical Trials for PROLEUKIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000825 ↗	The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1998-05-01	The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system. IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.
NCT00000889 ↗	A Study to Evaluate the Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1997-10-01	To demonstrate the safety and tolerability of subcutaneously administered interleukin-2 (IL-2) plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cells/mm3 or more. To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus antiretroviral therapy relative to antiretroviral therapy alone. IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.
NCT00000909 ↗	A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	The purpose of this study is to evaluate the safety and tolerability of giving interleukin-2 (IL-2) alone to HIV-positive patients with CD4 cell counts greater than 350 cells/mm3 who do not wish to receive anti-HIV (antiretroviral) therapy. This study will also determine if IL-2 given alone can increase CD4 cell counts or decrease the level of HIV in the blood. IL-2 (a protein found in the blood that helps boost the immune system) can result in increases in CD4 cell count (immune system cells that fight infection). IL-2 is normally given in combination with antiretroviral therapy to treat HIV infection; however, some HIV patients do not wish to take antiretrovirals. This study asks if it is safe and effective to take IL-2 alone to treat HIV infection.
NCT00000948 ↗	Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1998-02-01	The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system. IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.
NCT00000949 ↗	A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV. There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood (viral burden).

Clinical Trial Conditions for PROLEUKIN

Condition Name

Condition Name for PROLEUKIN
Intervention	Trials
Melanoma	21
Metastatic Melanoma	18
HIV Infections	13
Neuroblastoma	7

Condition MeSH

Condition MeSH for PROLEUKIN
Intervention	Trials
Melanoma	46
Neoplasms	18
Leukemia	17
HIV Infections	16

Clinical Trial Locations for PROLEUKIN

Trials by Country

Trials by Country for PROLEUKIN
Location	Trials
United States	418
Canada	29
Australia	25
United Kingdom	13
France	11

Trials by US State

Trials by US State for PROLEUKIN
Location	Trials
Texas	40
California	29
Maryland	25
New York	21
Washington	18

Clinical Trial Progress for PROLEUKIN

Clinical Trial Phase

Clinical Trial Phase for PROLEUKIN
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	17
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for PROLEUKIN
Clinical Trial Phase	Trials
Completed	67
Active, not recruiting	28
Terminated	28

Clinical Trial Sponsors for PROLEUKIN

Sponsor Name

Sponsor Name for PROLEUKIN
Sponsor	Trials
National Cancer Institute (NCI)	62
M.D. Anderson Cancer Center	27
National Institute of Allergy and Infectious Diseases (NIAID)	14

Sponsor Type

Sponsor Type for PROLEUKIN
Sponsor	Trials
Other	199
NIH	79
Industry	58

PROLEUKIN Market Analysis and Financial Projection

Proleukin: Clinical Trials, Market Analysis, and Projections

Introduction to Proleukin

Proleukin, also known as aldesleukin, is a recombinant form of interleukin-2 (IL-2), a cytokine that promotes the growth and activity of T cells, which are crucial for the immune system. It is currently licensed for the treatment of metastatic renal cell carcinoma and metastatic melanoma in various countries[1].

Clinical Trials Update

MIROCALS Trial for ALS

One of the recent and notable clinical trials involving Proleukin is the MIROCALS trial. This phase 2b randomized placebo-controlled trial investigated the efficacy and safety of low-dose interleukin-2 (ld IL-2) in controlling neuro-inflammation in newly diagnosed patients with amyotrophic lateral sclerosis (ALS). The trial results indicated that the treatment was well tolerated, with adverse events mostly mild to moderate and occurring across both active treatment and placebo arms. This trial presents positive news for ALS patients, for whom there is currently no effective treatment[1].

Iovance Biotherapeutics Trials

Iovance Biotherapeutics has been actively involved in clinical trials using Proleukin in conjunction with other therapies. For instance, the IOV-COM-202 trial has shown promising results for lifileucel (a form of tumor-infiltrating lymphocyte or TIL therapy) in combination with nivolumab and relatlimab in patients with frontline advanced melanoma. The trial demonstrated an unprecedented rate, depth, and durability of responses, including a 30% confirmed complete response rate and a differentiated safety profile[3].

In another trial, the TILVANCE-301 phase 3 confirmatory trial, lifileucel is being investigated in combination with pembrolizumab in frontline advanced melanoma. This trial aims to support accelerated and full U.S. approvals of lifileucel in combination with pembrolizumab and full approval of lifileucel in post-anti-PD-1 melanoma[4].

Non-Small Cell Lung Cancer (NSCLC) Trials

Iovance is also conducting trials in NSCLC, particularly the IOV-LUN-202 registrational phase 2 trial, which is exploring the use of lifileucel in post-anti-PD-1 NSCLC. The FDA has provided positive regulatory feedback on the proposed potency matrix and trial design, suggesting potential for accelerated approval in 2027[3].

Market Analysis

Market Growth and Segmentation

The global Proleukin market is anticipated to grow at a considerable Compound Annual Growth Rate (CAGR) during the forecast period from 2023 to 2031. This growth is driven by several factors, including the rising prevalence of cancer, particularly among the geriatric population. Kidney cancer, for which Proleukin is used, is a significant contributor to this market growth[5].

The market is segmented based on product forms (injection, powder, and others) and applications (hospital and pharmacy). Geographically, the market covers North America, Europe, Asia-Pacific, and the Rest of the World[5].

Key Players and Strategic Initiatives

Key players in the Proleukin market include Clinigen Limited and Iovance Biotherapeutics. In a significant move, Iovance acquired worldwide rights to Proleukin from Clinigen Limited, which is expected to benefit Iovance through immediate and future revenue, securing the IL-2 supply chain, and reducing costs associated with TIL therapies[4].

Strategic initiatives such as new product launches, mergers and acquisitions, and business expansions are also driving market growth. For example, Clinigen Group plc acquired the US rights to Proleukin from Novartis for up to $210 million in cash in 2019[5].

Market Projections

Revenue and Expansion

The Proleukin market is projected to experience robust growth due to the increasing demand for cancer treatments. The market size is expected to expand significantly from 2023 to 2031, driven by the rising incidence of cancers such as kidney cancer and melanoma[5].

Iovance's acquisition of Proleukin rights is expected to contribute to this growth, with the company anticipating immediate and future revenue from the transaction. The deal includes an upfront payment, milestone payments, and double-digit global sales royalties, which will further bolster the market[4].

Geographical Outlook

Geographically, the market is expected to grow across all major regions, with North America, Europe, and Asia-Pacific being key contributors. The increasing prevalence of cancer and the availability of advanced healthcare facilities in these regions are expected to drive the demand for Proleukin[5].

Challenges and Opportunities

Regulatory Environment

The regulatory environment plays a crucial role in the growth of the Proleukin market. Positive regulatory feedback, such as the FDA's support for Iovance's trial designs, is essential for the approval and subsequent market expansion of Proleukin-based treatments[3].

Patient Selection and Safety

Careful patient selection is mandatory prior to the administration of Proleukin, as patients with more favorable performance status respond better to the treatment. The drug is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the Proleukin formulation[1].

Emerging Applications

The MIROCALS trial and other research initiatives suggest potential new applications for Proleukin beyond its current indications, such as in neuro-inflammatory diseases like ALS. These emerging applications could further expand the market for Proleukin[1].

Key Takeaways

• Clinical Trials: Proleukin is being investigated in various clinical trials, including the MIROCALS trial for ALS and Iovance's trials for advanced melanoma and NSCLC.
• Market Growth: The global Proleukin market is expected to grow significantly due to the rising prevalence of cancer and strategic initiatives by key players.
• Geographical Expansion: The market is anticipated to grow across North America, Europe, Asia-Pacific, and other regions.
• Regulatory Support: Positive regulatory feedback is crucial for the approval and market expansion of Proleukin-based treatments.
• Emerging Applications: Potential new applications, such as in neuro-inflammatory diseases, could further expand the market.

FAQs

What is Proleukin used for?

Proleukin (aldesleukin) is used for the treatment of adults with metastatic renal cell carcinoma and metastatic melanoma. It is also being investigated for other applications, including neuro-inflammatory diseases like ALS[1].

Who are the key players in the Proleukin market?

Key players include Clinigen Limited and Iovance Biotherapeutics. Iovance recently acquired worldwide rights to Proleukin from Clinigen Limited[4].

What are the potential new applications of Proleukin?

Besides its current indications, Proleukin is being explored for use in neuro-inflammatory diseases such as ALS, as seen in the MIROCALS trial[1].

What drives the growth of the Proleukin market?

The growth is driven by the rising prevalence of cancer, particularly among the geriatric population, and strategic initiatives such as new product launches and acquisitions[5].

What are the regulatory considerations for Proleukin?

Careful patient selection is mandatory, and the drug is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the Proleukin formulation. Positive regulatory feedback is essential for market expansion[1].

Sources

1. Clinigen Limited, "Clinigen notes results from the MIROCALS trial investigating low dose Proleukin® (aldesleukin) in patients with amyotrophic lateral sclerosis," Biospace, December 8, 2022.
2. Market Research Intellect, "Global Proleukin Manufacturers Profiles, Market Size | Share | Scope," Market Research Intellect, December 2024.
3. Iovance Biotherapeutics, "Iovance Biotherapeutics Reports Financial Results and Corporate Updates," Iovance Biotherapeutics, November 7, 2024.
4. Iovance Biotherapeutics, "Iovance Biotherapeutics Provides Corporate, Clinical, and Regulatory Updates," Iovance Biotherapeutics, January 23, 2023.
5. ResearchAndMarkets.com, "Global Proleukin Market Report to 2027 - Players Include Chiron and Prometheus Laboratories," Business Wire, May 31, 2022.