PMB is making significant strides with its unique complex natural marine based biologic product, Immune-12, which could revolutionize the treatment landscape for these aggressive brain tumors. The genesis for PMB and Immune-12 was the lengthy experience the principles of the company had with a proprietary complex biologic product, derived from specific marine-sourced ingredients.
A nutritional supplement was originally called TBL-12 and has many devoted and long-term customers who attribute a variety of positive health benefits to the product. In addition, the product was evaluated in a clinical study under IND 105,543. This IND was submitted to the FDA on November 14, 2008, and the initial study under the IND was considered safe to proceed on December 12, 2008. TBL-12 was designated as an Orphan Drug (OOD 12-3686) for the treatment of multiple myeloma by the FDA on May 14, 2012. When the product was granted the OOD for treatment of patients with multiple myeloma, a name change to SeaCare was implemented to differentiate from the version available outside the United States.
While general positive health benefit is a meaningful outcome for customers taking SeaCare as a nutritional supplement, a subset of customers has attributed anti-cancer activity to SeaCare. Since the reported outcomes of individual patients are difficult to interpret, and the purported clinical effects may be attributed to various causes, the frequency and consistency of these reports over the past few years have prompted further investigation.
As the evidence of meaningful clinical results is collected, PMB has determined that a high-dose strength of the biologic product should be evaluated in clinical studies. As such, a clinical strength of the biologic product, herein referred to as Immune12, has been produced.
Mechanism of Action
What sets this Immune12 product apart is its novel mechanism of action. Unlike traditional treatments, it supports the immune system and helps the body target specific pathways involved in tumor growth and resistance, offering a new approach to combating these formidable cancers. The precision of this mechanism holds promise for not only efficacy but also reduced side effects, which is a crucial consideration in cancer treatment.
Clinical Trials and Efficacy
As PMB prepares to submit a formal IND application to the FDA for approval to begin clinical trials, the preliminary data is compelling. Immune12 has shown significant efficacy, with cases showing complete tumor elimination or substantial reduction in tumor size, as well as improved survival rates among a group of patients treated with this complex biologic product. These extraordinary results offer a beacon of hope for patients with GBM and DIPG, conditions known for their limited options and poor prognosis
Another remarkable aspect of Immune12 is its exceptional safety profile. Early studies have shown no demonstrated toxicity and only minimal side effects, making it well tolerated and suitable for long term use. This outstanding safety profile positions Immune12 as a viable treatment option for a wider range of patients, including those who may not be candidates for more aggressive therapies.
Impact and Future Potential
The potential impact of PMB’s product, Immune12, extends well beyond GBM and DIPG, as PMB has also achieved noteworthy success in treating other challenging conditions. Thes promising results could pave the way for further research into marine-derived compounds and their application in tackling other hard to treat cancers. With its innovative approach, PMB is poised to be at the forefront of a new era in cancer therapy.