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Clinical Study

Our technology has been validated in study after study and we continue to pursue active research to further new formulation development and confirm benefit in disease indices where we can have a positive impact.

NEO100 Meningioma Trial

NeOnc’s research has shown that NEO100 can have an impact on Meningioma tumors, tumors that develop on the membranes that surround the brain and spinal cord. More than 170,000 people are diagnosed with meningioma each year in the United States and it is the most common type of brain tumor. NeOnc has already completed a framework and protocol to begin a clinical trial to develop the data needed for FDA approval of NEO100 for use in treating this disease. 

Background

A meningioma is a primary central nervous system (CNS) tumor. They usually develop in the brain or spinal cord. Overall, meningiomas are the most common type of primary brain tumor. 

Meningiomas account for 40% of primary brain tumors. In 2023, an estimated 42,260 people will be diagnosed with meningioma. Incidence rates of meningioma increase with age, with most cases diagnosed in adults aged 65 and older. The 5-year relative survival rate for malignant meningioma is 67% and the 10-year relative survival rate for malignant meningioma is 60%.

Treatment and survival rate for meningiomas depend on the size and grde of the tumor(s). Meningiomas are generally graded as follows:

  • Grade I meningiomas are low-grade tumors and are the most common. This means the tumor cells grow slowly.
  • Grade II atypical meningiomas are mid-grade tumors. This means the tumors have a higher chance of coming back after being removed. The subtypes include choroid and clear cell meningioma.
  • Grade III, or high-grade anaplastic meningiomas are malignant (cancerous). This means they are fast-growing tumors. The subtypes include papillary and rhabdoid meningioma.

The first treatment for a malignant meningioma is surgery, if possible. The goal of surgery is to obtain tissue to determine the tumor type and to remove as much tumor as possible without causing more symptoms for the person.

Most people with atypical and anaplastic meningiomas receive further treatments.

After surgery, radiation is often recommended to delay the return of grade II and III meningiomas. Treatments may also include chemotherapy, or clinical trials. 

The most common therapeutics used for the chemotherapeutic treatment of meningiomas include Hydroxyurea, Interferon-alfa 2B, and Sandostatin.

 

Protocol

The NEO100 Meningioma study will be a multi-site, Phase 2 clinical trial as an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma.  There will be up to 30 patients enrolled in this study to have 29 evaluable patients.  NEO100 will be self-administered four times daily on a 28-day treatment cycle for up to twelve cycles, until disease progression or death, whichever occurs first.  Following the completion of cycle twelve, the patients who received receiving benefit will be given the option to continue receiving compassionate use treatment with NEO100.

The inclusion criteria for the study will be limited to patients who:

  • Have histologically confirmed WHO Grade II or III meningioma that is residual, progressive, or recurrent following at least minimally safe resection and radiation therapy. Metastatic meningiomas are allowed.
  • Are on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.
  • Have failed maximal safe resection and radiation therapy.
  • Have a tumor that is not>30 mm (length x width) and must not be multifocal
  • Have recovered to grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include, but are not limited to alopecia, laboratory values listed per inclusion criteria, and lymphopenia).
  • Are ≥ 12 years of age.
  • Have an ECOG performance status of 0-2 or KPS ≥ 60.
  • Have an expected survival of at least three months.
  • Must be willing to provide blood samples for pharmacokinetic study (to assess proper administration of NEO100).
  • Have adequate organ and marrow function.
  • Have had an MRI (or CT if MRI contraindicated) within 14 days prior to the start of the study drug. Their corticosteroid dose must be stable or decreasing for at least 5 days prior to the scan. If steroids are added or the steroid dose is increased between the date of the screening scan and the start of treatment, a new baseline scan is required.
  • Agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), if female patients of child-bearing potential or male patients, for 30 days prior to the first administration of study drug, for the duration of study participation, and for 90 days following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • If female, must not be breastfeeding.
  • Have the ability to understand, and be willing to comply with scheduled visits, treatment schedules, laboratory testing, and other requirements of the study as confirmed by signing a written informed consent document.