# Laminar Pharma Announces "Last Patient, Last Visit" in LAM561 Phase 2b/3 Trial for Newly Diagnosed Glioblastoma Patients

- Link: https://www.thailand-business-news.com/pr-news/laminar-pharma-announces-last-patient-last-visit-in-lam561-phase-2b-3-trial-for-newly-diagnosed-glioblastoma-patients
- Published: 2026-07-24T08:30:00+07:00
- Author: PR Newswire

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PALMA DE MALLORCA, Spain, July 24, 2026 /PRNewswire/ — Laminar Pharma, a leader 
in the development of innovative therapies based on a novel membrane lipid therapy
approach, today announced that the last patient has completed their last visit (
LPLV) in the company’s Phase 2b/3 clinical trial of its lead asset, LAM561, in patients
with newly diagnosed glioblastoma. This milestone marks the conclusion of the active
clinical monitoring phase of the trial "LAM561 With RT and TMZ for Adults with Glioblastoma"(
NCT04250922) which evaluates LAM561 in combination with standard of care (SoC). 
The company expects to report topline results from this study during the second 
quarter of 2027.

Achieving LPLV represents a key operational step as the trial progresses through
the data lock and the highly anticipated overall survival (OS) analysis, triggered
once 90 OS events were reached.

This development follows the interim unblinded data announced in March 2025, after
the Independent Data Monitoring Committee (IDMC) recommendation in late 2024 for
the study to be unblinded and continue without modification. At that time, Laminar
Pharma reported a potential clinically relevant improvement in progression-free 
survival (PFS) for MGMT-methylated patients receiving LAM561 plus SoC compared to
the placebo control group. Laminar Pharma’s commitment to international ethical 
principles for post-trial access and continued patient care is demonstrated by the
continuation of LAM561 treatment for patients who were experiencing clinical benefit
according to their treating physicians, who prescribed continuing treatment beyond
study completion through a compassionate use program that will be available for 
these patients until marketing authorization is granted. The safety profile observed
throughout the trial remained consistent with prior studies, with the combination
of LAM561 and SoC proving well-tolerated among the 144 enrolled patients.

"Reaching the ‘last patient, last visit’ is a milestone for Laminar Pharma and brings
us one step closer to our goal of delivering a much-needed therapy to patients battling
one the most aggressive forms of brain cancer", said Dr. Pablo Escribà, CEO of Laminar
Pharma. "We extend our deepest gratitude to the patients, their families, and the
clinical investigators and healthcare personnel who have made this trial possible."

Laminar’s LAM561 Phase 2b/3 trial is an international, multicenter, randomized, 
double-blind (until interim analysis completion), placebo-controlled clinical trial
designed to assess the efficacy and safety of LAM561 in combination with radiotherapy
and temozolomide in patients with newly diagnosed, IDH-wildtype glioblastoma. The
study consisted of two randomized (1:1) arms between LAM561+SoC and placebo+SoC.
The primary efficacy endpoint will be overall survival, along with PFS using the
Response Assessment in Neuro-Oncology (RANO) criteria.

**About Glioblastoma**

Glioblastoma (GBM) is the most common primary malignant brain tumor and accounts
for nearly 50 percent of all gliomas and approximately 25 percent of all primary
brain and CNS malignant tumors. The incidence of GBM in Europe is currently above
25,000 new cases each year, rising to over 100,000 cases per year worldwide. The
prognosis for GBM patients is very poor, with a median survival time of about 14.5
months despite optimum chemo-radiation treatment. About 15% of patients survive 
two years after diagnosis and approximately 4% survive for five or more years. In
this scenario, there is a desperate need for novel treatment alternatives that provide
safe and more efficacious clinical outcomes.

**About LAM561**

LAM561 (2-hydroxyoleic acid –2-OHOA, idroxioleic acid sodium) is a synthetic derivative
of oleic acid and Laminar’s most advanced product under development, which is taken
orally. This drug regulates the composition of the plasma membrane in cancer cells,
reducing the activity of membrane-associated signaling proteins that are known to
promote tumor growth and affecting tumors in the brain. LAM561 is currently being
evaluated in a phase 2b/3 trial and has shown promising preliminary clinical activity
in the treatment of aggressive brain tumors, including glioblastoma (Lopez et al.,
2023).

**About Laminar Pharma**

Laminar Pharmaceuticals S.A. (Laminar) is a Spanish biotechnological company created
in 2006, committed to translational health research for the rational design and 
development of drugs to treat oncological and other pathologies. Its treatments 
are formulated as synthetic fatty acids considered "First-in-class Health Solutions"
based on a novel technology, Melitherapy (MLT or Membrane Lipid Therapy). Laminar
controls all processes, from the rational design of molecules to the clinical trials
that lead to the launch of a new drug, with constant investment in R&D and high-
quality standards. It is currently headquartered in Mallorca (Spain) with a subsidiary
in Massachusetts (US).

_Forward-Looking Statements:_ _The development and commercialization of medicines
involve a high degree of risk, and only a small number of research and development
programs result in the commercialization of a product. This text contains forward-
looking statements. These statements do not relate strictly to historical or current
facts and may be accompanied by words such as "anticipate," "believe," "conceivably,""
could," "estimate," "expect," "may," "potential," "possible," "will," and other 
words of similar meaning. The results of clinical trials may not be indicative of
the full results or the results of later-stage clinical trials and do not guarantee
regulatory approval._

**References**:

Lopez, J., Lai-Kwon, J., Molife, R. et al. A Phase 1/2A trial of idroxioleic acid:
first-in-class sphingolipid regulator and glioma cell autophagy inducer with antitumor
activity in refractory glioma. Br J Cancer 129, 811–818 (2023).

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