Medical Access
to Investigational Medicines at
Intragel

About the program

Intragel is deeply committed to pioneering new standards in care and ensuring that our innovative medicines reach the patients who need them most. Each product we develop must first undergo rigorous clinical trials to determine its safety and efficacy. This ensures that any potential benefits surpass known risks before it becomes accessible to the wider public.

Obtaining regulatory approval for marketing is the most efficient and rapid way to provide access to new medicines to the greatest number of patients who may benefit. As result, the majority of Intragel resources are invested in clinical trials that expedite the approval of new or unapproved investigational treatments. These trials facilitate enhanced treatment opportunities for high-risk patient groups.

However, we understand that there are special circumstances when:

  • Existing treatment options are either inadequate or have been exhausted.
  • Clinical trial enrollment is impractical or not justified.
  • There’s a sufficient supply of the investigational medicine available to address the patient’s needs.

 

For these exceptional cases, treating physicians might seek access to Intragel’s investigational medicine before it has regulatory approval.

Such access, sometimes known as “expanded access”, “compassionate use”, or “early access”, is facilitated as long as it aligns with local legal regulations.

Intragel’s Medical Access program, using our innovative polymer-based Cisplatin loaded Gel (TumoCure), targets localized chemotherapy treatment. This injectable compound is offered to head and neck cancer patients who have exhausted other effective treatment avenues due to the ineffectiveness, intolerability, or inapplicability of standard treatments.

Eligibility for the Medical Access Program typically requires:

  • The patient has a life-threatening condition with no adequate therapeutic alternatives.
  • Ineligibility or inability to participate in ongoing clinical studies for the investigational treatment.
  • The investigational medicine is in active development
  • A favorable benefit-risk profile for the drug in the potential indication and patient demographic.
  • Assurance that the Medical Access program won’t jeopardize the medicine’s development or delay its clinical trials.
  • Compliance with local rules and protocols.

 

Intragel cannot approve any request that contradicts company policies, local laws, or potentially presents an unfavorable benefit/risk profile, as determined by our medical team.

Our Commitment

Every request for Medical Access will undergo a careful and thorough evaluation by Intragel’s medical experts. We ensure timely acknowledgment, typically within five business days. Once approved, the requesting physician must enter into an agreement with Intragel.

For Approved Requests

  • Medicines will be provided per local regulations.
  • Physicians must report any potential side effects or complications to both Intragel and necessary regulatory bodies.
  • The responsibility to obtain local ethics committee approval lies with the treating physician.

Important Considerations

Intragel is working hard to bring our treatments to patients as fast as possible with a goal to save lives. We are committed to ensuring that once a patient has started on the investigational medicine, they are guaranteed continuous supply until they/their physician deems it is time to stop treatment. 

Maintaining a safe demand-supply balance of any medicine is very delicate. At Intragel, we consistently oversee our stock of

investigational medicines. When possible, depending on the available supply, there might be opportunities to distribute limited amounts on an individual case basis. This decision is influenced by several factors, primarily ensuring that such allocations do not delay, impede or compromise the progression and conclusion of current or upcoming clinical trials, which aim for regulatory approval. Our goal through this method is to maximize access to the medicine for as many patients as possible.

Making a Request

Intragel is working hard to bring our treatments to patients as fast as possible with a goal to save lives. We are committed to ensuring that once a patient has started on the investigational medicine, they are guaranteed continuous supply until they/their Only the treating physician may submit requests for investigational medicines for a patient under a Medical Access program; Intragel cannot consider requests directly from a caregiver or a patient.

Physicians requesting access to investigational medicines can contact 
info@intra-gel.com
For details on current clinical trials, please refer to clinicaltrials.gov.

For patients interested in getting involved, please consult your physician.
deems it is time to stop treatment. 

Maintaining a safe demand-supply balance of any medicine is very delicate. At Intragel, we consistently oversee our stock of