Glioblastoma (GBM)
Program: ARKA-101 (GLA)
ARKA-101 explores a lipid-based investigational approach using Gamma-Linolenic Acid (GLA) delivered locally. The program is being studied for its potential role in addressing difficult-to-treat glioblastoma.
What is ARKA-101?
ARKA-101 is an investigational lipid-based approach centered on gamma-linolenic acid (GLA; 18:3 n-6). GLA is a naturally occurring fatty acid that has been studied for its potential effects on tumor cells. Our program is exploring local delivery of GLA directly to the tumor site following surgical resection of glioblastoma.
We understand you may be seeking options for yourself or a loved one. This site provides educational information about our investigational research. ARKA-101 is not currently available as an approved treatment. We encourage you to discuss all treatment options with your medical team. If you'd like to learn more about our research or connect your physician with our team, please reach out through our contact form.
How it may work
Proposed mechanism of action (based on research observations)
Tumor Cell Vulnerability
Research suggests tumor cells may have altered lipid metabolism that makes them potentially vulnerable to certain lipid-based interventions.
Lipid Peroxidation
Studies have observed lipid peroxidation phenomena in tumor cells exposed to GLA, which may contribute to cellular effects.
Apoptosis Signaling
Research has documented activation of apoptosis (programmed cell death) pathways in laboratory studies.
Local Delivery
Direct administration to the tumor site is being explored to achieve local concentrations while minimizing systemic exposure.
Information presented represents historical observations and preclinical research. Results may not be generalizable and do not predict future clinical outcomes.
Administration Concept
The investigational approach involves local administration via a reservoir placed during standard surgical tumor resection. The concept involves outpatient daily dosing for approximately 7–10 days, allowing patients to return home between administrations.
Surgery + Reservoir
Placement
10
Daily Local Administration
up
Monitoring + Standard Care
Evidence Summary
Laboratory studies using cell cultures have observed selective effects on glioma tumor cell lines compared to normal brain cells.
FAQs for Patients & Caregivers
Common questions about our investigational program
No. ARKA-101 is investigational and has not been approved by the FDA or any regulatory authority for clinical use. It is currently in the IND-enabling stage of development.
ARKA-101 is not currently available as an approved therapy. It is not offered outside of properly conducted clinical trials, which have not yet begun.
Open-label refers to a study design where both the patient and physician know what treatment is being given. This is in contrast to blinded or placebo-controlled studies. Historical open-label observations have limitations compared to randomized controlled trials.
Clinical trials, once initiated, would involve careful screening of participants, informed consent,administration according to a defined protocol, and close monitoring. Specific trial designs have not been finalized pending regulatory discussions.
Preclinical studies are designed to understand potential toxicities. Any clinical investigation would include careful safety monitoring and informed consent processes.
Healthcare providers can request additional information through our contact form. We can provide scientific background, preclinical data summaries, and discuss the development program under appropriate confidentiality agreements.
Publicly, we share high-level summaries of our research approach and published findings. More detailed data packages, including protocol synopses and study reports, may be available to qualified parties under non-disclosure agreements.
The investigational program is focused on patients with glioblastoma multiforme (GBM). The approach involves local delivery following surgical resection.
Standard care for GBM typically includes surgery, radiation, and chemotherapy. ARKA-101 represents an investigational approach using local lipid-based delivery that would potentially be used alongside standard care, not as a replacement.
You can reach us through the contact form on this website or by emailing undurti@gmail.com. We respond to all inquiries, though detailed scientific discussions may require appropriate confidentiality agreements.
Important Notice: ARKA-101 is investigational and not approved by the FDA or any regulatory authority. It is not available as an approved treatment option.
Want to learn more?
Request our information deck or connect with our team to discuss the GBM program.