Noveome is developing an investigational non-cellular drug, called ST266.
ST266 is ‘investigational’ as it is not approved by the U.S. Food and Drug Administration (FDA) at this time. In our clinical trials we are looking to see if ST266 issafe and effective in humans.
ST266 contains hundreds of biologically active proteins and other biologic factors crucial to cellular healing and modulating inflammation. These biologically active proteins and factors are delivered in physiological concentrations that have been shown to be well-tolerated with proven biological activity in preclinical and clinical studies.
Unlike genetically engineered cellular products, ST266 is made by our proprietary method of culturing amnion cells that are harvested from full term placenta that is normally discarded after birth. These cells produce many of the biologic factors found in amniotic fluid that promote healing, restore nerve damage, and are anti-inflammatory.
Study of ST266 Given by Intranasal Delivery in Subjects With Ocular Hypertension
Protocol Number: ST266-IOPHTN-101, enrolling
A dose-escalating phase 1 open-label safety study of ST266 given by non-invasive intranasal trans-cribriform delivery in subjects with increased intraocular pressure without evidence of glaucomatous damage.
Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act) document.
Male or Female, Ages 20-75 years.
Must have mildly elevated intraocular pressure (IOP) without evidence of glaucomatous damage.
IOP ≤ 28 mmHg and at least one (1) IOP measurement > 21 mmHg.
Normal visual fields (VF) both Swedish Interactive Threshold Algorithm – Short-wavelength Automated Perimetry (SITA-SWAP) and 24-2 VF spaced at least six (6) months apart.
Normal Ocular Coherence Tomography (OCT) (of macula and nerve fiber layer) spaced at least six (6) months apart.
Gonioscopy open to at least scleral spur with normal iris configuration.
Normal baseline neuro-cognitive testing.
Normal baseline Magnetic Resonance Imaging (MRI), including expected age-related changes, performed with and without contrast.
Baseline Lumbar Puncture within normal limits.
Women of Child Bearing Potential (WOCBP) who are pregnant or lactating or who will not abstain from sexual activity for 14 days prior to Visit 1, and willing to remain so through 30 days following completion of the subject’s first menstrual cycle following the End of Treatment (EOT) Visit. Alternatively, a WOCBP who will not remain abstinent must have been using one of the following acceptable methods of birth control for the times specified:
IUD in place for at least three (3) months prior to Visit 1 until completion of the subject’s first menstrual cycle following the EOT Visit.
Barrier method (condom or diaphragm) with spermicide for at least three (3) months prior to Visit 1 through completion of the subject’s first menstrual cycle following the EOT Visit.
Stable hormonal contraceptive for at least three (3) months prior to Visit 1 through completion of the subject’s first menstrual cycle following the EOT Visit. NOTE: For Depo-Provera injection contraceptives, the statement regarding first menstrual cycle following administration of the study product is not applicable as females receiving this form of contraception will not have menses.
In a monogamous relationship with a surgically sterilized (i.e., vasectomized) partner at least six (6) months prior to Visit 1.
Have undergone one of the following sterilization procedures at least six (6) months prior to Visit 1: Bilateral tubal ligation, Hysterectomy, Hysterectomy with unilateral or bilateral oophorectomy, Bilateral oophorectomy.
Unwillingness to submit a urine pregnancy test at screening if of childbearing potential.
Male subjects who refuse to use one of the following birth control methods:
Abstinence from the time of consent and through the duration of their participation in the protocol
Barrier method (condom or diaphragm) with spermicide from time of consent through the duration of their participation in the protocol
Surgical sterilization (vasectomy) at least 6 months prior to consent.
IOP greater than 29 mmHg in either eye.
Patients with high risk factors of ocular hypertension as identified by the Principal Investigator who may benefit from earlier treatment will be excluded: family history of primary open angle glaucoma (POAG), thinner central corneas (<540 microns), and low ocular perfusion pressure with a cup to disk ratio >8.
Evidence of Angle closure.
One (1) abnormal VF within one (1) year of screening exam.
Recent laser or incisional glaucoma surgery.
Subjects who are currently taking glaucoma medications. Subject who can safely stop taking these medications during washout period (4-6 weeks) may be considered.
Intranasal polyp or any head and/or neck neoplasm.
History of or evidence on physical examination including endoscopy of sinus or nasal pathology, nasal passage obstruction, chronic sinus infections, or severe seasonal allergies.
Currently using medications given intranasally.
Subject is taking any anticoagulant medication such as heparin, low molecular weight heparin, Coumadin, or antiplatelet agents including low dose aspirin.
History of stroke or Trans-Ischemic Attack (TIA) within the past five (5) years.
Neuro-cognitively impaired as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Subjects who have participated in an investigational product trial within the past 30 days.
Subjects who refuse any part of the protocol assessments.
ST266 Eye Drops for the Treatment of Persistent Corneal Epithelial Defects
Protocol Number: ST266-PED-201, open and enrolling
A phase 2 open label trial of ST266 eye drops in the treatment of persistent corneal epithelial defects (PED).
Subjects with a PED present for at least seven (7) days.
The defect may be of any size and must be measurable by slit lamp.
In the Investigator’s opinion, the defect is persistent i.e., the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
The original defect to the cornea must be hard to heal and be a result of any injury, infection, disease or surgery to the eye.
Subjects who are currently being treated with cenegermin.
Subject who requires treatment with autologous serum eyedrops throughout the duration of the trial. If, in the opinion of the investigator, autologous serum eyedrop treatment can be safely stopped, subject may be included in the clinical trial.
Subject who requires treatment with other amnion products throughout the duration of the trial. If, in the opinion of the investigator, the amniotic product treatment can be safely stopped, subject may be included in the clinical trial.
Subject who requires treatment with amniotic membrane throughout the duration of the trial. If the amniotic membrane can be safely stopped, the subject may be included in the clinical trial. Note: The amniotic membrane must be removed at least one (1) day prior to the baseline visit.
Subject has had an uncontrolled lid or ocular infection.
History of alkali burns of the cornea.
The circumference affected by limbal blood vessel ischemia is greater than 75 percent of the circumference.
Subjects with severe lid abnormalities contributory to the persistence of the PED such as the inability to close the lids.
Subjects who have a history of AIDS or HIV.
10. Treatment with systemic corticosteroids (equivalent to >10 mg/day of prednisone) or immunosuppressive (including Plaquenil) or chemotherapeutic agents within 7 days prior to Day 1, or likely to receive one of these therapies during study participation.
Subjects who have participated in a clinical trial within 30 days prior to Day 1.
Subjects with more than one distinct PED in the study eye.
Subjects with bullous keratopathy.
Subjects with corneal perforation or impending corneal perforation.
For subjects with bilateral PEDs, only the eye with the larger PED should be entered in to the study. The non-study eye will receive standard of care treatment and will be observed throughout the trial.
Female subjects who are pregnant or breastfeeding. Female subjects who are neither postmenopausal nor surgically sterile require a negative urine pregnancy test on Day 1 visit.
Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren’s ulceration.