Clinical Trials

Inclusion Criteria:

• Provide written IRB-approved informed consent in accordance with institutional guidelines.
• Be ≥ 18 years of age on the day of signing the informed consent, and able and willing to comply with all trial procedures.
• Have histologically documented HPV-6- and/or HPV-11-positive respiratory papilloma or documentation of low-risk positive HPV using a Sponsor approved HPV-6/11 type-specific assay.
• Have a requirement for frequent RRP intervention in order to remove or resect respiratory papilloma, as defined as at least two RRP surgical (including laser) interventions in the year prior to and including Day 0.
• Must be an appropriate candidate for upcoming surgical intervention as per Investigator judgment and RRP Staging Assessment score.
• Have adequate bone marrow, hepatic, and renal function as defined by:
  • ANC (Absolute Neutrophil Count) ≥ 1000 cells/mm^3;
  • platelets ≥ 50,000/mm^3;
  • hemoglobin ≥ 9 g/dL; concentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN);
  • AST and ALT within 1.5 x ULN;
  • serum creatinine ≤ 1.5 x ULN.
• Agree that during the trial, male participants will not father a child, and female participants cannot be or become pregnant if they are of child-bearing potential. Subjects must meet one of the below requirements:
  • Be of non-childbearing potential (≥ 12 months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone [FSH], if not on hormone replacement);
  • Be surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females);
  • Agree to use one highly effective or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and at least through week 12 after last dose. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception;
  • Agree to abstinence from penile-vaginal intercourse, when this is the subject’s preferred and usual lifestyle.

Exclusion Criteria:

Subjects must not:

• Receive therapy directed toward RRP disease (other than surgery or ablation) including but not limited to anti-virals (including cidofovir), radiation, chemotherapy, anti-angiogenic therapy (including bevacizumab), prophylactic HPV vaccination (including Gardasil) as therapeutic intervention, or therapy with an experimental agent within 3 months prior to Day 0.
• Have ongoing or recent (within one year) evidence of autoimmune disease that required treatment with systemic immunosuppressive treatments, with the exception of: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment.
• Have a diagnosis of immunodeficiency or treatment with systemic immunosuppressive therapy within 28 days prior to the first dose of trial treatment, including systemic corticosteroids.
• Have a high risk of bleeding or require the use of anti-coagulants for management of a known bleeding diathesis.
• Receive any live virus vaccine within 4 weeks prior to first dose of trial treatment or any non-live vaccine within two weeks prior to the first dose of trial treatment.
• Have a history of clinically significant, medically unstable disease which, in the judgment of the Investigator, would jeopardize the safety of the subject, interfere with trial assessments or endpoint evaluation, or otherwise impact the validity of the trial results. This may include chronic renal failure; myocardial ischemia or infarction; New York Heart Association (NYHA) class III/ IV cardiac disease); any cardiac pre-excitation syndromes (such as Wolff-Parkinson-White; cardiomyopathy, or clinically significant arrhythmias); current malignancy with the exception of treated basal or squamous cell skin cancers, prostate cancer, or carcinoma of the cervix in situ; HIV, which may impact the ability to mount an immune response to the study therapy; or drug or alcohol dependence.
• Have fewer than two acceptable sites available for IM injection considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:
  • Tattoos, keloids or hypertrophic scars located within 2 cm of intended treatment site;
  • Cardioverter-defibrillator or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist);
  • Metal implants or implantable medical device within the intended treatment site.
• Be imprisoned, or compulsory detainment (involuntary incarceration) for treatment of either a psychiatric or physical (i.e., infectious disease) illness.
• Be pregnant or currently breastfeeding.
• As determined by the Investigator, have any medical or psychological or non-medical condition that might interfere with the subject’s ability to participate or affect the safety of the subject.