LEXINGTON, KY |GlobeNewswire| April 15, 2021 — NX Development Corp. (NXDC), a life-sciences company wholly owned by photonamic GmbH & Co. KG., today announced that Tracy Jerome “T.J.” Stalvey has been named Vice President of Clinical Operations.
Mr. Stalvey brings over 20 years of clinical operations and medical affairs experience to NXDC. Prior to joining NXDC, he consulted with pharmaceutical, biotechnology, and device companies and had multiple successful regulatory filing experiences, including NDA and 505(b)(2) development. His experience spans the startup, small and large pharma environments, working on location in Africa, Asia, Australia, Europe, North and South America.
In his new role, Mr. Stalvey will have direct responsibility and oversight for Phase I-III clinical trial planning and initiating new development programs. Mr. Stalvey will oversee Medical Affairs at NXDC, including field education and medical information for of NXDC’s flagship product, Gleolan (aminolevulinic acid HCl). Gleolan is currently indicated in the United States for patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery.
“With his wealth of experience in start-up, small and large pharma environments, TJ will be an integral asset in building the supplemental indications of Gleolan at NXDC,” said Alan M. Ezrin, Ph.D., co-founder and CEO of NXDC. “We welcome him to the team at a very exciting period of growth as we continue to invest in our future by bringing top talent into the organization.”
For more information on NX Development Corp, please visit www.nxdevcorp.com. For more information on Gleolan, please visit www.gleolan.com or email firstname.lastname@example.org. Please refer to Full Prescribing Information here.
About NX Development Corp. (NXDC)
NXDC is a privately held life science company dedicated to the commercialization of Gleolan in the U.S. The company was acquired in 2018 by photonamic (PHN) GmbH & Co. KG. (Pinneberg, Germany). PHN is wholly owned by SBI ALApharma (Hong Kong) a subsidiary of SBI Holdings, Inc. (Tokyo , Japan)
US INDICATION AND IMPORTANT SAFETY INFORMATION
Gleolan is an FDA-approved optical imaging agent indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan helps neurosurgeons see malignant tissue in real time during surgery and is provided orally 20mg/kg, 2-4 hours prior to glioma surgery. During operation, the surgeon utilizes a modified surgical microscope with a specific blue light filter for the visualization of red-violet fluorescence.
Important Safety Information
Do not use Gleolan in patients with:
- Hypersensitivity to the active substance
- 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 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.
See information under Warnings and Precautions regarding phototoxic reactions.
Please see Full Prescribing Information