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new Hemispherx patent application..... Toll-like receptor 3 (TLR3) agonist.


Senior Member
you can read the patent application or download the PDF file here:


Here is the summary:

It is an objective of the invention to improve at least one physical symptom or at least the function or phenotype of dendritic cells in a subset of human patients having chronic fatigue syndrome and impaired physical performance using at least one or more different double-stranded ribonucleic acids (dsRNA) or other selective agonists of Toll-like receptor 3 (TLR3).

The effectiveness of treatment may be assessed by measuring the patient's physical performance (e.g., Karnofsky performance score, activities of daily living, exercise tolerance, vitality, or any combination thereof) before, during, and/or after treatment. No cognitive test or measurement of the 2?-5? oligoadenylate/RNase L pathway is required to assess treatment effectiveness. Virus replication in the patient or infection of the patient does not need to be measured for human herpes viruses (e.g., cytomegalovirus, Epstein-Barr virus, HHV-6).

In one aspect, the at least dsRNA or other TLR3 agonist is administered to a human patient in need of such treatment. A specifically configured or mismatched dsRNA is preferred, but other types of dsRNA may also be used. In particular, the specifically-configured dsRNA is a mismatched dsRNA. The dsRNA may be administered at a dosage of from about 10 to about 1200 mg/dose. This dosage may be administered once per week or month, or two or more doses per week or month. Each dose (e.g., from about 10 mg to about 1200 mg, from about 100 mg to about 800 mg, or from about 200 mg to about 400 mg) may be administered by intravenous infusion. Use of an effective amount of at least dsRNA or TLR3 agonist may be continued until one or more physical symptoms are improved as determined by, for example, Karnofsky performance score (KPF), activities of daily living (ADL), treadmill exercise, vitality, or any combination thereof. The effective amount required to obtain such improvement may be identical to or higher than the amount required for maintenance of the effect(s). For example, physical performance may be assessed before (to establish at least suitability for treatment, baseline performance, or both) and after treatment (to confirm effectiveness of treatment) by at least one or more numerical scores from standardized questions or instruments, treadmill exercise, or both. In particular, a patient with impaired physical performance on a treadmill may be selected by having a cardiac stress test or exercise tolerance test (ETT) value of less than 18 minutes, more preferably ETT less than or equal to nine minutes.

In some aspects, the at least dsRNA or TLR3 agonist is used with the proviso that at least the patient is not cognitively impaired by chronic cerebral dysfunction, cognitive ability of the patient (e.g., intelligence or memory) is not tested, the brain is not scanned by magnetic resonance imaging, the patient is not infected by specific viruses (e.g., CMV, EBV, and/or HHV-6), replication of specific viruses (e.g., CMV, EBV, and/or HHV-6) in the patient is not assayed, a change in the activity of the 2?-5? oligoadenylate/RNase L pathway in the patient is not measured, or any of the combinations thereof.

The dsRNA may act selectively through a TLR3 receptor. The function and phenotype of dendritic cells may be normalized in the treated patient. This may be used to diagnose a patient as in need of treatment or the efficacy of dsRNA or, alternatively, thereby to improve one or more physical symptoms of a patient afflicted by chronic fatigue syndrome. Use of the dsRNA may correct dendritic cell maturation abnormalities in the patient.

In another aspect, a medicament is provided as a pharmaceutical composition containing one or more different dsRNA or other TLR3 agonists. In particular, the dsRNA may be specifically configured, or more preferably mismatched. Optional components of the composition include excipients and a vehicle (e.g., saline buffer) as a single dose or a multi-dose package (e.g., an injection vial or vials), and instructions for their use. Processes for making and using the pharmaceutical composition (medicament) are also provided. For example, one or more different dsRNA may be formulated at a concentration from about 1 mg/mL to about 5 mg/mL (e.g., 200 mg dissolved in 80 mL or 400 mg dissolved in 160 mL) in physiological phosphate-buffered saline and stored at from 2 C. to 8 C. in a refrigerator under aseptic conditions.

Further aspects of the invention will be apparent from the following description of specific embodiments and the appended claims, and generalizations thereto.


now, somebody want to interpret this?