AMINEX THERAPEUTICS, INC.
is
Changing the way we fight Cancer
 

















PRODUCT PIPELINE

PRODUCT DEVELOPMENT STRATEGY

We find ourselves in a unique and enviable position for a biotechnology company. Aminex Therapeutics, Inc. is developing its PBT™ small molecule cancer treatment based on its patented technology. This breakthrough therapeutic approach, based on an optimized drug molecule, triggers a discriminating immune system response that can target tumors without affecting normal tissues. In the results so far, it has demonstrated a high level of efficacy in mice and domestic cats. Upon successful completion of the trials, we will target the $46 billion cancer chemotherapeutics market. Just as importantly, we seek to find cures for specific cancers for which there are no remedies and patients have very sub-optimal treatment choices. The Company has completed its initial R&D phase and is looking to raise capital to complete Phase I/II and Phase II human trials. With the goal of sale or licensing to a Big Pharma company in the foreseeable future, Aminex’s end game is clearly in sight. We aim to continue our capital-efficient, virtual company strategy to maximize returns for our investors without the need to build expensive infrastructure or headcount.

Aminex Therapeutics, Inc.’s goal is to develop Polyamine-Based Therapy (PBT) for eventual introduction into clinical oncology practice. We expect that this first-in-class therapeutic approach will be broadly active against many tumor types but due to strong biological rationale we will direct PBT's use towards Head and Neck Squamous Cell Carcinoma, Prostate Cancer and Colorectal Cancer indications. Skin cancers including squamous cell carcinoma and melanoma are known to be highly immunogenic. The human prostate gland synthesizes and accumulates very high levels of polyamines and was shown to have the highest concentration of spermine of any human organ. The enzyme involved in the rate-limiting step in the production of polyamines, ornithine decarboxylase (ODC) has been shown to be elevated in cancerous prostate tissue in comparison to paired benign tissue samples. DFMO plus the antiiflammatory agent sulindac have recently been shown to prevent the re-occurrences of colon polyps.

DEVELOPMENT PROFILE




The Company’s goal is to translate this dramatic preclinical approach into the oncology clinical setting by focusing on filing an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) by the end of 2011. With the animal proof-of-concept testing already in-hand, together with results expected from collaborations with academic scientists, this will enable the choice of cancer indication most likely to benefit by our PBT™ approach.

Quick equity return aligns with quick entry into human trials. Aminex’s technology is based on the discovery, optimization and early development efforts provided by MediQuest Therapeutics. Over a decade of scientific validation has gone into proving the feasibility of the PBT™ approach for cancer. The next step for Aminex is to file an IND with the FDA for Phase I clinical trials. As you know, Phase I trials are typically performed on healthy patients with the goal of establishing a drug’s safety. If a candidate compound passes this milestone, it can move on to Phase II, where efficacy becomes the major focus.

Because Aminex is seeking approval for the use of PBT™ in late-stage drug-resistant cancers, it will likely be safety tested on people who have a life-ending form of the disease. Therefore, PBT™ has the unusual opportunity to demonstrate not only safety in Phase I, but efficacy. Following completion of its preclinical toxicology studies in rats and dogs in 2011, Aminex will be poised to enter its Phase I trial by 1Q2012. Inclusion criteria for this Phase I study will include measurements ensuring these solid tumor patients have a functioning immune system, thereby, increasing the likelihood of patient benefit in this trial.





Aminex - It's what's next!

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