ADJUREX™ – Alternative Cancer Treatment and Adjunct IVM Pretreatment

ADJUREX™

ADJUREX™: A Standalone Alternative Cancer Treatment and also as an adjunct IVM Pretreatment for Increased Ivermectin Sustained Efficacy.

ADJUREX™ is a precision-formulated advanced Rectal treatment option with THC-HS (Hemisuccinate) Pro-drug as its primary cannabinoid formulation. Formulated to provide systemic cannabinoid exposure with a minimized psychoactive burden, compared with conventional THC delivery.

Primary function of this treatment is as a cannabinoid-based adjunct alternative with demonstrated pharmacodynamic effects on cellular signalling, metabolism and treatment response.

ADJUREX™ has also exhibited to be an effective pharmacokinetic pretreatment strategy, for IVM protocols. ADJUREX™ successfully demonstrated systemic cannabinoid exposure before ivermectin administration. The central pharmacokinetic functions as a pretreatment that can alter CYP3A/CYP3A4-mediated ivermectin metabolism, potentially reducing ivermectin metabolic clearance and increasing systemic ivermectin exposure and the amount of drug subsequently available for tissue distribution.

Following the nightly suppository pretreatment interval, ivermectin is administered at normal intervals as prescribed and separately.

The objective is not simply to administer more ivermectin. It is to effectively alter the metabolic environment before ivermectin administration, which in effect can produce greater systemic exposure from a controlled ivermectin dose.

Two Potential Therapeutic Roles

1. Pharmacokinetic Pretreatment

The primary ADJUREX™ strategy is sequential:

ADJUREX™ administration

→ systemic cannabinoid exposure

→ potential modification of CYP3A/CYP3A4 activity

→ altered ivermectin metabolism and clearance

→ increased ivermectin systemic exposure (AUC)

→ potentially greater ivermectin availability for tissue distribution

Under this hypothesis, ADJUREX™ functions as a pretreatment rather than as an ivermectin-containing medicine.

ADJUREX™ does not contain ivermectin.

Any numerical estimate of increased ivermectin exposure—including a proposed increase of up to 143%—should be regarded as a hypothesis or experimental target unless and until that magnitude has been demonstrated in appropriately controlled pharmacokinetic studies.

2. Potential Independent Cannabinoid Activity

ADJUREX™ When administered independently of ivermectin, exhibits THC and related cannabinoids interactions with cannabinoid receptors and multiple intracellular signalling, metabolic and cellular-stress pathways. These biological effects create a systemic exposure produced by ADJUREX™ demonstrating effective pharmacological activity on its own.

This means ADJUREX™ should not necessarily be viewed solely as a mechanism for modifying ivermectin pharmacokinetics. But as broader research model:

ADJUREX™

→ systemic cannabinoid exposure

→ cannabinoid-receptor and intracellular signalling effects

→ potential biological effects independent of ivermectin

plus, when used sequentially with ivermectin:

ADJUREX™ pretreatment

→ potential alteration of ivermectin pharmacokinetics

→ increased systemic ivermectin exposure

Evidence that ADJUREX™ increases ivermectin exposure would not establish that ADJUREX™ itself treats cancer. Likewise, evidence of independent cannabinoid biological activity would not automatically establish clinical anticancer efficacy.

Standardized Administration

ADJUREX™ is designed for administration nightly on 30-day protocols before separately administered ivermectin when being used as part of the proposed pharmacokinetic pretreatment protocol. Because cannabinoid exposure and drug interactions can vary substantially according to formulation, dose, route of administration, timing, patient physiology and concurrently administered medicines, the proposed ADJUREX™–ivermectin interaction should not be assumed to be reproducible using conventional cannabis products.

Different cannabinoid products, routes of administration, doses, timing intervals and ivermectin doses could produce substantially different pharmacokinetic and safety profiles. The nightly interval is therefore an integral part of the protocol rather than a timing recommendation that should be independently shortened, extended or modified.

Clinical Status and Appropriate Use

The pharmacokinetic, pharmacodynamic, safety and therapeutic base described for ADJUREX™ still require appropriate clinical validation for efficacy, an optimal dosing protocol, or a defined magnitude of drug interaction can be established.

ADJUREX™ therefore can not presently be represented as a proven cancer treatment or as a clinically established alternative to standard oncology treatment.

Warning: ADJUREX™ should not be used to delay, discontinue, reduce or modify chemotherapy, radiation therapy, surgery, immunotherapy, targeted therapy, hormonal therapy, supportive care or other treatment recommended by a qualified oncology team.

Any clinical consideration of ADJUREX™, whether alone or in conjunction with another compound, should involve appropriate medical oversight so that potential drug interactions, treatment timing, organ function, adverse effects and overall treatment objectives can be evaluated and monitored.