Replies to post #252719 on Innovation Pharmaceuticals Inc (IPIX)

[Jhawker]

As you know a Dr can do what they want regarding off label they just have to answer to the patient the lawyers and the insurance companies and not always in that order!

[Snowy_Owl]

Areader, thank you for your recent comments as I find them most informative.

I'm writing this in the hope that others like you will come forward and share their professional and personal skills and opinions.

I'm also a senior medical director for an insurance company.

[frrol]

Your insights are valuable. The physicians in my family say the same things re: off-label and reimbursements (which have a big impact on potential drug revenue).

[JTORENCE]

Areader does the patient/family have to sign-off that they understand the possibilities of using an off label drug??

[farrell90]

Many of the recent advances in cancer therapy have been in identifying mutations in the cancer cells and directing therapy based on the mutation and not the origin of the cancer.

This paradigm shows the short coming of FDA programs which approve drugs based on the origin and cell type of the cancer and not the cancers genome and mutations associated with the development of malignancy.

It is now routine for oncologists to send the patient's cancer cells to identify these mutations. Research has identified drugs which are effective against particular mutations which in the past not recognized for that cancers of that organ or cell type.

In a nut shell this is the basis of what has been called targeted or precision cancer therapy. This therapy has become standard for many cancers. Off label prescribing to treat the patients' cancers is an essential part of this concept and if the therapies are shown to be beneficial they will be covered by insurance.The problem for patients who have failed standard treatments is it may be impossible to show efficacy of the precision treatments because the decisions for approval and coverage are based on cell type and not the mutations, but with time these targeted therapies are being covered more frequently.

ASCO and other professional groups are working to solve these problems which may hamper the use of the best treatment for cancer patients.

The bottom line for IPIX and Brilacidin OM is, if approved, the treatment of oral mucositis will eventually be covered for all cancer patients where this it commonly occurs as well as other entities such as bone marrow transplant patients who develop oral mucositis associated with graft versus host disease.

References:

https://www.mycancergenome.org/content/molecular-medicine/overview-of-targeted-therapies-for-cancer/

https://www.cancertherapyadvisor.com/general-oncology/cancer-off-label-prescription-moving-targeted-therapies-risk/article/814117/3/

https://www.cancer.gov/about-cancer/treatment/types/targeted-therapies/targeted-therapies-fact-sheet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2758710/

GLTA, Farrell

[Empiricst1]

Thanks, Areader, the more quality med input the better.

[loanranger]

Please dumb it down for me...yes or no.
Are you saying that people can expect doctors to prescribe B-OM as a preventative for any patients who might be susceptible to OM as a result of scheduled chemo/radiation treatment for whatever cancer they might have if the drug is approved to treat OM in HNC patients?

Thanks.