DNKO LLC has joined forces with the Musella Foundation to raise funds for preclinical glioblastoma studies and new clinical trials for brain tumor patients. DNKO was co-founded by David Needham PhD, DSc and Katherine (Onk) Hammer. Kate is a patient advocate and was the care partner to her late father who died of Glioblastoma, and David is a drug delivery expert with patents in cancer treatments. Together they have formed a "people before profits" organization that focuses on "health" and "care" when designing and implementing anti-cancer treatments, focused initially on primary brain cancer.

---

---

Our first treatment that is closest to the clinic, pairs Laser Interstitial Thermal Therapy (LITT) with David's invention of a Low-Temperature-Sensitive Liposomal Doxorubicin (LTSL-Dox), that has shown cures in both preclinical(¹ and in clinical studies of other human cancers: Recurrent Chest Wall² and a subgroup in Primary Liver Cancer³. LITT is Standard of Care for glioma, radiation necrosis, brain metastases and, especially, recurrent GBM. As an ablation technology, it achieves a cytoreductive effect via heat-induced killing. However, as reported by deGroot et al⁴ , the median overall survival (OS) following a LITT procedure was still only 9.73 months for newly diagnosed patients and 8.97 months for recurrent patients. For newly diagnosed patients receiving post-LITT chemo/radiation Median OS was 16.14 months.

Thus, our thinking is that, with a modified, lower temperature, and therefore more safe LITT procedure, we can gently warm the infiltrated penumbra of the tumor site, that is notoriously inaccessible by surgical resection and is not reached by LITT. Using temperatures of just 41.5°C (106.7°F), that do not damage normal cells but release the doxorubicin from i.v. injected LTSL-Dox into the tumor cells that binds to every cell's DNA, throughout the warmed region^5,6, we will offer a minimally invasive approach which targets the brain tumor regions that normally drive recurrence and death in Glioblastoma patients.

Our overall Vision is therefore that brain cancer patients will have access to a clinically more effective treatment that, when tested, may even be curative for the right sized and LITT-heatable tumors. Our driving Mission is to bring existing and proven technology to the brain cancer community, uniting like-minded clinicians to evaluate it, test it, and, if it shows promise, bring it as soon as possible to their patients.

With the initial $50k received from the Musella Foundation, we will begin our preclinical studies allowing us to optimize our approach with our collaborators at Dartmouth Center for Comparative Medicine and Research. Upon obtaining study results in a matter of only a few months, we will then make a decision with our lead clinicians as to if we need to move forward with either a canine clinical study (treating dogs with pre-existing brain tumors) or move directly into a humans with a Phase 1 in recurrent GBM patients this Fall (2024). While we have a current supply of the drug for the Phase 1 trial, if the results look safe and promising, we will need to produce a new batch of the LTSL-Dox to ensure adequate drug supply for future, expanded, clinical studies.

We need to raise about another $2,275,000 to complete pre-clinical testing, manufacture the Liposomes and complete the planned 12 patient phase 1 trial for recurrent Glioblastoma patients.

References cited:

1. Needham, D., et al., A new temperature-sensitive liposome for use with mild hyperthermia: Characterization and testing in a human tumor xenograft model. Cancer Research, 2000. 60(5): p. 1197-1201.
2. Zagar, T.M., et al., Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer. International Journal of Hyperthermia, 2014. 30(5): p. 285-294.
3. Lencioni, R. and D. Cioni, RFA plus lyso-thermosensitive liposomal doxorubicin: in search of the optimal approach to cure intermediate-size hepatocellular carcinoma. Hepat Oncol, 2016. 3(3): p. 193-200.
4. de Groot, J.F., et al., Efficacy of laser interstitial thermal therapy (LITT) for newly diagnosed and recurrent IDH wild-type glioblastoma. Neuro-Oncology Advances, 2022. 4(1).
5. Kong, G., et al., Efficacy of liposomes and hyperthermia in a human tumor xenograft model: Importance of triggered drug release. Cancer Research, 2000. 60(24): p. 6950-6957.
6. Manzoor, A.A., et al., Overcoming Limitations in Nanoparticle Drug Delivery: Triggered, Intravascular Release to Improve Drug Penetration into Tumors. Cancer Research, 2012. 72(21): p. 5566-5575.

---

Please donate by using the form on the right or if you would like to donate cryptocurrency, stocks or other ways, click HERE but be sure to mention the donation is for the DNKO project. You can also send a check made out to "Musella Foundation" with "DNKO Project" in the memo and mail to: 1100 Peninsula Blvd, Hewlett, NY 11557. Call us at 888-295-4740 if you have any problems or questions!
Encourage family and friends to donate! Donations are tax deductible to the full extent of the law and 100% of the donations made that menion the DNKO project will go to this project!