Brain Tumor News!
Note: The comments under each article title are the opinion of our president, Al Musella, DPM,
and do not reflect official policy of the Musella Foundation!
02/21/24
Promising Pathway Act Open House in Washington, DC This Tuesday!
We are planning to introduce version 2.0 of the Promising Pathway Act sometime next week. This open house is for patient advocates to hear about the act and to network with other groups. If you are in the area, we need people to show up to let them know we support this bill! Note: A previous version of the invitation had the wrong date. It is Feb 27, 2024.
02/21/24
Sonodynamic Therapy Webinar added to website! Sonodynamic therapy is one of my favorite new treatments. It is very elegant in how it works to noninvasively target cancer cells while minimizing damage to the normal cells. Early results look very good. Keep in mind the first few patients presented had a low dose and few treatments. It will get better and better as they learn how best to use it!
We have the ability to speed up the process of making this available - it is a matter of money - but in this case a lot of money. So as the speaker mentions in the talk, if you have any interest and ability to make either a large ($1-5 million) donation or investment in the company, contact me!
02/20/24
Webinar on Sonodynamic Therapy For Brain Tumors this Wednesday 2/21/24! Sonodynamic therapy is an exciting, non-invasive experimental treatment for brain tumors. I think it will be shown to be a breakthrough and will significantly impact this disease. This webinar is at a different date and time than usual - we wanted to get it to you as soon as possible!
02/11/24
Webinar on Sonodynamic Therapy For Brain Tumors this Wednesday!
Sonodynamic therapy is an exciting, non-invasive experimental treatment for brain tumors. I think it will be shown to be a breakthrough and will significantly impact this disease. This webinar is at a different date and time than usual - we wanted to get it to you as soon as possible!
02/09/24
Brain cancer a thing of the past? It's far too premature to determine the efficacy of this treatment, as it has not yet been tested in animals or humans. Experience has shown that many treatments effective in lab settings fail in human clinical trials. The purpose of sharing this article is to highlight the development process of a new lab-proven treatment. The next steps typically involve further lab research, animal testing, and the challenging task of securing funding for human trials. Recently, we were approached for a grant to support an early-stage brain tumor treatment, which required a staggering $1 million per patient. Unfortunately, we had to decline due to financial constraints. The plan was to treat approximately 250 patients in total over the next decade before seeking FDA approval, a venture that no one is eager to invest $250 million in, given the risks and the potential to become obsolete by the time approval is granted.
I advocate for the Promising Pathway Act, which offers a more feasible approach. If the drug proves to be highly effective, it could undergo a small phase 1/2 trial with about 25 patients for an estimated $25 million, potentially receiving conditional FDA approval within three years. This would allow the drug to be accessible sooner, with continued research over eight years and costs covered by insurance or out-of-pocket payments. This method not only makes fundraising more manageable but also enables setting a reasonable price for the treatment, recovering the investment without the need for exorbitant pricing. This approach addresses the financial challenges of bringing new treatments to market.
02/06/24
Northwest Biotherapeutics Moves From Optimization of Flaskworks Prototype to Fabrication of GMP-Compliant Units For Installation, Validation and Final Testing Prior to Regulatory Certification This announcement heralds significant progress in the realm of personalized medical treatments, a field historically challenged by the dual hurdles of scaling production and managing costs effectively. The bespoke nature of custom-made therapies, while groundbreaking, has led to exorbitant prices and a notable scarcity, compelling physicians to allocate these life-saving treatments to only the most critically ill patients. The traditional method of meticulously crafting each treatment individually is far from efficient.
However, Northwest Bio's recent breakthrough introduces a game-changing solution. They have developed a machine capable of automating this intricate process, enabling the simultaneous creation of vaccines for multiple patients. Remarkably, this innovation also eliminates the need for the sterile environments mandated by manual production methods. This advancement is poised to significantly streamline the production of DCVAX, when it receives approval, meeting any level of demand with newfound ease.
02/03/24
Copayment Assistance Program update! We increased our income guidelines - see the website for details but for a family of 4, we now allow up to $156,000 in income! We also take into account if you will make less money due to the tumor.
02/02/24
Australian government steps in to fund experimental brain cancer drug
Stories like this ignite my frustration. The video highlights a young Australian girl battling DIPG (Diffuse Intrinsic Pontine Glioma) who has shown remarkable progress. Her treatment involves a combination of drugs, including ONC-201, for which her family has incurred expenses exceeding $100,000. Fortunately, the Australian government has decided to cover the costs moving forward. The demand for this drug is global, as it has demonstrated potential to significantly extend survival rates and, in some cases, produce miraculous outcomes in a condition where such results are exceedingly rare. The family is also experimenting with other drugs, although specifics are not disclosed.
In the United States, access to such treatment combinations outside of clinical trials, which include a placebo group, is virtually non-existent. The urgency for ONC-201's approval cannot be overstated. This underscores my dedication to advocating for the Promising Pathway Act. Passage of this act would not only facilitate access to drugs like ONC-201 but also establish a learning system to expedite the evaluation of drug combinations and optimize their application. Meanwhile, the grim reality is that DIPG claims the life of approximately one child almost every day in the USA.
02/02/24
Press Release
IB awarded a $100,000 grant by the Musella Foundation
We awarded a $100,000 grant to get this expanded access program for oral gallium maltolate launched. I will let you know when it opens. We helped fund the early work on this drug and early results look good. If interested in trying to get access, send an email to eap@imagingbiometrics.com and tell them a little about your case and ask if you may qualify for the program and to get on the waiting list. Our grant only covers PART of the costs of this program - and enabled getting it opened. Patients will be charged a portion of the costs. If any other organizations want to help fund the full program to make it free to patients, contact me! We are working on creating a fund to help offset these cost - will let you know details when ready!
02/01/24
Musella Foundation's Copayment Assistance Program Reaches a Monumental Milestone!
A Note on Our Funding Allocation and Program Impact
In light of some questions raised about the allocation of our resources, we wish to clarify the financial structure underpinning our Copayment Assistance Program. It is imperative to understand that the funds designated for this program are specifically allocated for this purpose and cannot be diverted to other uses.
When generous donors contribute to the Musella Foundation, they have the option to direct their donation towards specific programs or to allow the Foundation to allocate it where it is most needed. Similarly, grants received by our organization are earmarked for particular initiatives, in accordance with the stipulations set forth in each grant agreement. This ensures that our financial resources are used effectively and in alignment with our donors' and grantors' intentions.
It's important to underscore that the funds allocated for the Copayment Assistance Program do not detract from our other critical initiatives. On the contrary, this program plays a vital role in our broader mission by bringing more patients and their families into the Musella Foundation family. It enhances our patient navigation, educational outreach, advocacy, and research funding efforts by ensuring that more individuals can access the treatments they need without the added stress of financial burden.
Our commitment to transparency and accountability is paramount. We remain dedicated to maximizing the impact of every donation and grant, supporting the brain tumor community through comprehensive programs that address both immediate needs and long-term research goals.
01/29/24
Conditional Approval for Human Drugs This article talks about conditional approval of drugs - like what we are trying to do with the Promising Pathway Act. A quick update on the Promising Pathway Act: we are working on version 2.0 of the act, to address the critics. It should be introduced to Congress in Febuary or March. When it does, we will need everyone to write letters again. I will let you kmow!
