Investigator-Initiated Trial

NBM-BMX: Metastatic Uveal Melanoma (Phase 1b/2)

NBM-BMX: Glioblastoma (TW, Phase 1b/Expansion → Phase 2)

Novelwise Pharmaceutical is committed to carefully considering access to our investigational medicines through expanded access.

Expanded Access Policy

At NovelWise Pharmaceutical Corporation, we are committed to discovering and developing innovative therapies that have the potential to fundamentally improve the way patients are treated.
Our core philosophy is to identify and advance validated molecular targets or therapeutic approaches that show meaningful clinical potential but remain underexplored.
NovelWise aims to advance these innovative therapies through to clinical Proof-of-Concept and ultimately redefine standards of care for patients with serious diseases.

Our ultimate goal is to provide access to these therapies through marketing authorization. However, before our product candidates might be available through these means, NovelWise Pharmaceutical is committed to carefully considering access to our investigational medicines through expanded access.

There is no guarantee that every request will be fulfilled; however, each request will be given careful consideration by NovelWise Pharmaceutical  whose decisions are final. 

Please see more about NovelWise Pharmaceutical’s Expanded Access programs.

Criteria for Expanded Access Requests

General Criteria:
To be eligible for consideration under Expanded Access, patients should:

• Suffer from a serious or life-threatening disease or condition.
• Have received appropriate standard treatments without success, and have no comparable or satisfactory alternative therapy available.
• Be ineligible for participation in an ongoing clinical study of the investigational medicine, including due to geographic limitations.

For Treating Physicians
Requests for Expanded Access must be submitted by a qualified treating physician who:

• Is appropriately licensed and authorized to administer investigational drugs; and
• Agrees in writing to comply with:
• All applicable country-specific legal and regulatory requirements governing the use of investigational products under Expanded Access; and
• NovelWise requirements regarding medical criteria, safety reporting, drug handling and accountability, ongoing data collection, and protection of intellectual property.

For Patients

If you are a patient seeking information about access to an investigational medicine, please discuss this option directly with your treating physician.
Information about NovelWise’s ongoing or recruiting clinical trials can be found on www.clinicaltrials.gov by searching “NovelWise Pharmaceutical”.

Submitting a Request

Physicians requesting Expanded Access for their patients should submit a written request to:
expandedaccess@novelwisepharma.com

NovelWise will make best effort to acknowledge receipt of each request within five (5) business days.
Any Expanded Access or early-access programs provided by NovelWise will comply with all applicable laws and regulations in the respective country.

NovelWise may update or revise this Expanded Access Policy at any time.
Any modifications will be reflected on this webpage upon implementation.