FDA approved Ferring's Adstiladrin for BCG Unresponsive NMIBC

3 months 1 week ago #61522 by Alan
Great news! Thanks.

DX 5/6/2008 TAG3 papillary tumor .5 CM in size. 2 TURBS followed by 6 instillations of BCG weekly with a second round of 6 after a 6 week wait.

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3 months 1 week ago - 3 months 1 week ago #61521 by joea73
On December 16, FDA approved nadofaragene firadenovec-vncg (Adstiladrin), a nonreplicating adenoviral vector–based gene therapy developed by Ferring Pharmaceutical Inc. of Switzerland of her US headquarter is located in New Jersey.  Adstiladrin(R) is for BCG Unresponsive  High risk Non-Muscle  Invasive Bladder Cancer (NMIBC).   High Risk NMIBC includes Ta/T1HG and CIS.  BCG Unresponsive means those who had recurrence after adequate BCG treatment.  5+ weeks induction + 2+weeks maintenance BCG treatment.   Note that for T1HG, patient's bladder is checked after the induction course and if it has recurrence it is considered BCG Unresponsive. In case of CIS, it is considered BCG Unresponsive if there is recurrence after the induction + at least one 2-3 weekly maintenance treatment.

Below is the summary of the result of the clinical trial (157 patients) which led to the FDA approval

Overall, 51% of enrolled patients receiving Adstiladrin achieved a complete response. The median duration of response was 9.7 months. About 46% of responding patients remained in complete response for at least 1 year.  

The most common adverse reactions associated with Adstiladrin included bladder discharge, fatigue, bladder spasm, urinary urgency, hematuria, chills, fever, and painful urination. Individuals who are immunosuppressed or immune-deficient should not come into contact with Ad

Adstiladrin is administered once every 3 months into the bladder via a urinary catheter.

Mechanism of Action 

Adstiladrin is a non-replicating adenovirus vector-based gene therapy containing the gene interferon alfa-2b. The vector enters the cells of the bladder wall, releasing the active gene. The internal gene/DNA machinery of the cells “picks up” the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach thereby turns the patient’s own bladder wall cells into interferon microfactories, enhancing the body’s natural defenses against the cancer.   ** from internet

Below are my understanding.  I think 80% are correct.  

The agent which kills cancer is high quantities of interferon alfa 2b protein.   Interferon alfa 2b protein had been used in combination with BCG for BCG Unresponsive until MERCK dropped Interferon alfa 2b protein manufacturing business.  

The agent interferon alfa 2b protein is delivered to bladder cancer cells in the form of the gene for interferon alfa protein.  Once it is delivered to a cancer cell, enzymes  in the cell  read the gene and produce interferon alfa 2b protein which invokes our immune system to kill cancer cells.

The vehicle to deliver high quantity of gene  for interferon alfa 2b protein is adeno virus which was engineeringly modified virus for common cold so it will not cause cold, and designed so it infects specifically cancer cells only and not healthy cells.  

Mechanism of Interferon alfa 2b  how it kills cancer cell ** from internet.

Interferon alfa is a type of medication called a biologic response modifier. It is a type of protein called a cytokine that works to increase the function of various components of the body's immune system. This protein is normally produced in the body but in small amounts. By increasing the levels of interferon, the immune system gets a kick-start, mounting an attack against the cancer cells, which are seen as foreign invaders. In addition, interferon-alpha is able to interfere with the cancer cell's ability to divide.



The following user(s) said Thank You: sara.anne, Alan

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