Lexington-Based NX Development Corp (NXDC) Announces Baptist Health Lexington is First Hospital in Kentucky to Use Breakthrough Imaging Agent for Brain Tumor Visualization

Dr. Christian Ramsey first neurosurgeon in state to use Gleolan™ for enhanced visualization of high-grade gliomas/glioblastoma

Lexington, Kentucky | October 3, 2019 — NX Development Corp (NXDC), a life sciences company based in Lexington, KY, today announced Baptist Health Lexington is the first hospital in state to use its flagship product Gleolan™ (aminolevulinic acid HCl).
Gleolan was approved for use in the United States by the Food and Drug Administration in 2017. Gleolan is known as an “visualizing agent” that is dosed orally 2-4 hours before the induction of anesthesia to help neurosurgeons see certain types of malignant brain tumors known as high-grade gliomas.

These life-threatening and rare glioma tumors, with glioblastoma being the most common and difficult to manage, generally have serious consequences and infiltrate into brain tissue which makes the tumors difficult to remove, or “resect”. Maximizing a safe resection is the primary goal of surgery and, along with chemotherapy and radiation, represents front-line therapy. This imaging agent improves visualization and the ability to achieve a more complete resection.

Surgical field under white light

Surgical field under white light

Surgical field with blue filter and fluorescing tissue

Surgical field  with blue filter and fluorescing tissue

Photos courtesy of Prof. Dr. Walter Stummer, University of Münster, Fermany

During surgery using Gleolan, the neurosurgeon views the brain through a special blue light filter on the surgical microscope. Under this blue light, the active substance in Gleolan, aminolevulinic acid (ALA) is converted to a fluorescent compound that causes tumor cells to fluoresce a red-violet color while non-cancerous brain cells appear blue. This procedure, known as fluorescence guided surgery, may allow the neurosurgeon to safely remove more of the tumor tissue. Prior to Gleolan, this surgery would be performed under white light alone, making it difficult to differentiate malignant and non-malignant tissue.

Dr. Christian Ramsey of Baptist Health Lexington performed the first fluorescence-guided neurosurgery in the state last fall, using Gleolan in conjunction with blue light. “It is great to be the first to have a technology that allows us to maximize more complete resections for these very challenging tumors,“ he says.

Baptist Health Lexington, a Joint Commission-accredited Comprehensive Stroke Center, has the largest private neurosurgical program in central and eastern Kentucky with five neurosurgeons, one neurointerventional radiologist, one pain management specialist and three providers trained in minimally invasive interventional procedures used to repair problems such as aneurysms, arteriovenous malformations and perform brain clot removal to stop a
stroke. Baptist provides a full range of neurosurgical services including surgical and Cyberknife non-invasive radiosurgery neuro-oncology services for brain and spinal cord tumors; vascular minimally invasive and surgical services; highly advanced neuroimaging capabilities; computer- assisted neurosurgical operating room technologies, pain management services and comprehensive spine surgical services including minimally –invasive spine surgery through complex, multi-level spine surgery.
“We are thrilled to announce the use of Gleolan at Baptist Health Lexington, a cutting edge medical center in close proximity to our corporate offices,” said Alan Ezrin, Ph.D., co-founder and CEO of NXDC. “We expect Gleolan to become the standard of care in neurosurgery for suspected high grade gliomas with over 100 participating centers and nearly 400 surgeons trained in its use nationwide. This drug, albeit more recent to the US, has been in medical practice in over 40 other countries with a safety profile observed in over 70,000 patients.”

For more information on neurosurgery at Baptist Health Lexington, please visit https://www.baptisthealth.com/Pages/services/neuroscience-and-stroke.

For more information on Gleolan, please visit www.gleolan.com or email customersupport@nxdevcorp.com.

Please refer to Important Safety Information and Full Prescribing Information here.

About Baptist Health

Baptist Health Lexington, a 391-bed acute care hospital, has been designated a Magnet® hospital for nursing excellence three times by the American Nurses Credentialing Center. The hospital also was named to the Becker Healthcare 2016 and 2019 lists of “100 great hospitals in America” and received the Healthgrades Outstanding Patient Experience Award in 2018 and 2019. A long-time leader in innovative approaches to treat heart disease and related conditions, Baptist Health Lexington holds many nationally

recognized cardiac accreditations including American Heart Association Cardiovascular Center of Excellence. The Cancer Center offers a full range of services, from chemotherapy and radiation therapy to genetic counseling, and is accredited with commendation by the American College of Surgeons’ Commission on Cancer. The hospital’s family-centered obstetrics program delivers close to 4,000 babies a year. Other specialized, comprehensive patient service areas include orthopedics, neuroscience, women’s services and digestive health.

About NX Development Corp (NXDC)

NXDC is a life science company dedicated to the commercial launch of Gleolan in the U.S. as a real-time imaging agent allowing surgeons to clearly visualize brain tumors during surgery. The use of Gleolan to visualize real-time brain tumor tissue has become a standard-of-care in other countries and is intended to help enhance the upfront management of patients with glioblastoma. NXDC is wholly-owned subsidiary of photonamic GmbH & Co. KG (Head office: Pinneberg, Germany; “PHN”). PHN is the licensor of GleolanTM (aminolevulinic acid HCl (ALA)) to NXDC. The companies share a decade-long working relationship and are wholly-owned by SBI Holdings Inc. (Tokyo, Japan).

About Gleolan

Gleolan is an FDA-approved optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. Because of its unique mechanism-of-action, Gleolan may allow neurosurgeons to see malignant tissue during surgery under blue light that they may not see under standard white light.

Important Safety Information

Contraindications:

Do not use Gleolan in patients with:

  • Hypersensitivity to aminolevulinic acid (ALA) or porphyrins
  • Acute or chronic types of porphyria

Warnings and Precautions:

Due to the risk of phototoxic reactions, do not administer phototoxic drugs for 24 hours during the perioperative period. Reduce exposure to sunlight or room lights for 48 hours after administration of Gleolan.
Errors may occur with the use of Gleolan for intraoperative visualization of malignant glioma, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of tumor in patients with glioma. Fluorescence may be seen in areas of inflammation or metastases from other tumor types.
Hypersensitivity reactions, including serious hypersensitivity reactions have occurred; these reactions include anaphylactic shock, swelling, and urticaria. Always have cardiopulmonary resuscitation personnel and equipment readily available and monitor all patients for hypersensitivity reactions.

Adverse Reactions:

Adverse reactions occurring in >1% of patients in the week following surgery were pyrexia, hypotension, nausea, and vomiting.

Nervous system disorders occurred in 29% of patients within the first week after surgery and events occurring in >1% of patients included: aphasia (8%), hemiparesis (7.8%), hemianopsia (3.2%), headache (2.7%), seizure (1.9%), hemiplegia (1.9%), monoparesis (1.3%) and hypoesthesia (1.1%). Brain edema occurred in <1% of patients in the first 6 weeks after surgery. In a randomized clinical trial, the numbers of serious neurologic adverse events in the post operative period were higher in patients randomized to the ALA fluorescence arm compared to the control arm. An imbalance was notable for the adverse events aphasia, ataxia, convulsion and hemianopsia and is likely related to the higher amount of brain resection performed in the ALA arm. At longer follow up periods, the numbers between the two arms appeared similar.

Worsening of >= 2 Common Toxicity Criteria grades in alanine aminotransferase and gamma- glutamyl transferase occurred in 15.8% and 11.6% of patients, respectively, within the first week after surgery. Absolute levels ranged from 2 times to greater than 10 times the upper limit of normal for each parameter. At 6 weeks, these measurements remained elevated in 2.9% and 7.5% of patients, respectively. There were no cases of liver failure.

Drug-Drug Interactions:

See information under Warnings and Precautions regarding phototoxic reactions. Please see Full Prescribing Information

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