ARGEA for Patients

Who arginine deprivation can be considered for

The therapy targets tumours that have lost ASS1 or OTC. The list below shows tumour types where this loss is frequent. It is a starting point, not a promise: a biopsy stain tells whether your particular tumour is affected.

MesotheliomaASS1 loss in a majority. Phase III evidence with a related enzyme.

Hepatocellular carcinomaASS1 loss common. Phase II data with ADI-PEG 20.

MelanomaASS1 frequently silenced. Early trials with ADI-PEG 20.

Pancreatic cancerASS1 loss in a substantial share. Combination with gemcitabine planned.

SarcomaASS1 loss in most soft-tissue sarcomas. Clinical programme with ADI-PEG 20.

Prostate cancerASS1 and OTC loss described. Laboratory data with arginase.

Breast cancerSubsets, including triple-negative. One observed case with NGA-8000.

Lung cancerSmall-cell and some non-small-cell tumours. One observed case with NGA-8000.

Gastric and colorectalLaboratory data with arginase; one colorectal case observed.

Bladder and ovarianASS1 loss described in subsets.

GlioblastomaCombination with temozolomide and radiation planned.

LeukaemiaAML and CLL. Phase II data with ADI-PEG 20; one CLL case observed with NGA-8000.

Conditions for treatment

DiagnosisA confirmed cancer diagnosis with histology. Any stage can be reviewed; in practice most enquiries concern stage III and IV disease or recurrence.

Standard therapyExhausted, declined after proper counselling, or ongoing and suitable for combination. We do not treat instead of a standard therapy that is working.

General conditionAble to attend weekly visits and tolerate a six-month course. Liver and kidney function sufficient to handle the enzyme and its products.

Tumour statusASS1 or OTC loss confirmed by immunohistochemistry where tissue is available. Where it is not, the decision rests on tumour type and the oncologist's judgement.

ConsentCapacity to understand the disclosure and give informed consent, or a legal representative who can.

Who is not treated

Pregnancy or breastfeedingArginine is essential for the foetus and infant.

Urea-cycle disordersPatients who cannot make their own arginine would be harmed.

Severe organ failureAdvanced liver or kidney insufficiency, uncontrolled heart failure.

Uncontrolled infectionArginine is involved in immune and wound responses; active sepsis or large open wounds exclude treatment until resolved.

Severely reduced conditionWhere a six-month course is not realistic, we say so, and we say why.

Week by week

BEFORE

Enquiry and records

You send a short description through the enquiry form. We reply within five working days and ask for records through a secure channel: reports, histology, recent labs, latest imaging. Nothing is decided yet.

WEEK −3

Eligibility review

Physicians matched to your tumour type and language review your case. Where tissue exists, ASS1 and OTC are stained. You receive a written outcome: a recommendation, further questions, or a decline with reasons.

WEEK −2

Disclosure and consent

A personal consultation, in person or by video, covering mechanism, evidence, risks, alternatives and costs, with your oncologist involved if you wish. You receive the information sheet, consent form and binding cost overview. You take the time you need.

WEEK 0

Baseline and first dose

Blood tests including arginine, tumour markers, blood count, liver and kidney function; imaging if not recent. First administration of NGA-8000, followed by observation. Arginine is measured again within days to confirm it has fallen below target.

WEEKS 1–7

Weekly doses

One visit per week. Short check, administration, observation. Blood tests every two to four weeks. Many patients notice fatigue in the first weeks; it usually settles.

WEEK 8

First review

Imaging, tumour markers, arginine level, your own account of how you feel. Decision together with your oncologist: continue, add a combined therapy, adjust, or stop.

WEEKS 9–15

Second block

Weekly doses continue. This is the window where combinations are most often added. Visits can sometimes be scheduled closer to home for parts of this phase, depending on your situation.

WEEK 16

Second review

Same assessment as week 8. If the tumour is not responding, we stop. If it is, the final block begins.

WEEKS 17–23

Third block

Weekly doses. Monitoring continues. Planning for what follows begins with your oncologist.

WEEK 24

Final review

Full assessment and a written summary for your oncologist. Depending on the course: end of treatment, a pause with monitoring, or, where it makes sense, an extension agreed case by case.

What a weekly visit looks like

Check-inBlood pressure, weight, temperature, a few questions about the past week: energy, appetite, sleep, any new symptoms.

Blood drawEvery two to four weeks, before the dose. Arginine, blood count, liver and kidney values, tumour markers on schedule.

AdministrationThe enzyme is given by injection or short infusion. The administration itself takes minutes.

ObservationYou stay for observation afterwards, longer at the first doses. Then you go home or back to your accommodation.

Between visitsNormal life, within what your condition allows. A contact number for questions and for anything unusual.

What is measured, and why

Arginine levelThe proof that the enzyme is working. Target below 10 µmol/L. A rising level means antibodies, a missed dose or a dosing problem, and is acted on immediately.

Tumour markersCEA, CA 15-3, CA 19-9, PSA, LDH or others depending on your cancer. Measured at baseline and every four weeks. Often the first sign of response, usually before imaging changes.

ImagingCT, MRI or PET as appropriate, at baseline and at weeks 8, 16 and 24. The decisive measure of tumour size.

Safety labsBlood count, liver enzymes, kidney function, ammonia where indicated. Every two to four weeks.

Circulating tumour cellsOptional. A blood test that counts cancer cells in circulation; a falling count supports response. Offered where the tumour type makes it informative.

YouHow you feel is data. Fatigue, appetite, pain and sleep are recorded at every visit and weigh in every review.

Side effects to expect

CommonFatigue in the first weeks, injection-site reactions, mild nausea, rash. Usually mild and settling.

Watched in bloodLiver enzymes, blood count, blood pressure. Checked every two to four weeks; dose or schedule adjusted if needed.

RareAllergic reaction to the enzyme, which is why the first doses are observed. Antibodies that neutralise the enzyme; detected by a rising arginine level and acted on at once.

What the price covers

The full 24-week course costs EUR 250,000. Health insurers do not cover unlicensed individual treatment, in any country we know of, so the therapy is self-funded. The price is billed in three blocks of eight weeks, one third before each block, and every patient receives a binding written quote before consent.

Eligibility reviewReview of your records, ASS1/OTC staining where tissue is available, written outcome.

BEFORE CONSENT

Consultation and disclosurePersonal consultation, information documents, coordination with your oncologist.

BEFORE CONSENT

Enzyme, per blockNGA-8000 for eight weekly doses. One third of the course price per block, not the whole course up front.

PER BLOCK

Administration and visitsWeekly visits, administration, observation, nursing, contact line.

PER BLOCK

MonitoringLaboratory tests on schedule; imaging at weeks 8, 16 and 24 where not done by your own oncologist.

AS INCURRED

Combined therapiesChemotherapy, immunotherapy or radiation are prescribed and billed by your oncologist, and may be covered by your insurance as standard care.

SEPARATE

If treatment stops earlyYou pay for blocks started, not for the whole course. A decision to stop at week 8 or 16 ends further charges; the remaining two thirds or one third are never due.

Travel and stayNot included. We help with planning; you book and pay directly.

PaymentIn euros, per block, in advance, by bank transfer. A written receipt for every payment, which some insurers accept for partial reimbursement of monitoring costs.

Living with the therapy

DietNo special diet. The enzyme removes arginine faster than food can replace it, so you eat normally and keep your strength. Eat well: protein, vegetables, enough calories. Losing weight is not a goal.

SupplementsStop L-arginine, L-citrulline and L-ornithine supplements, and pre-workout or "nitric oxide" products; they work against the therapy. Tell us about every other supplement. Most are fine.

ExerciseEncouraged, within your limits. Walking daily is the single most useful thing most patients can do during the course.

WorkMany patients continue to work, especially from the second block onward. The first weeks may be tiring.

Travel and stayTreatment takes place at partner clinics in Georgia, the United Arab Emirates and Hong Kong. Which one is proposed to you depends on your tumour type, your language and where you live, and is agreed after the eligibility review. For the first block most patients stay nearby. From the second block, parts of the schedule can sometimes be arranged closer to home.

Other medicinesKeep taking them. Bring a complete list. Interactions with the enzyme are not expected, but your oncologist and the treating physicians check.

AlcoholLittle or none. Your liver is doing extra work.

How ARGEA works with your own doctors

Your treating oncologist knows your case and your history. We want them involved from the first conversation, and we send them every result.

Before consentWe invite your oncologist to the disclosure consultation and provide a clinical summary written for physicians.

During treatmentLab results and review summaries go to your oncologist after every block, or more often if they ask. Combined therapies are their decision and their prescription.

If they advise againstWe take that seriously. We will talk to them, and if the concern stands, we will tell you so plainly. We do not treat against a treating oncologist's considered advice without a second opinion.

After treatmentA full written summary for your records and theirs, including every value measured.

For relatives and partners

A six-month course is carried by more than one person. Partners, children and friends are welcome at consultations and visits, and the questions they ask are often the ones the patient has not dared to.

We will tell you the same things we tell the patient, in the same words, with the patient's permission. If you are enquiring on behalf of someone who cannot, say so in the form; we will explain what we need to proceed.

TipIf you are enquiring for a relative in a hurry, read the questions and answers first; most of what you will be asked is there.

Everything you need to decide