10K is out
STILL LOOKING FOR MONEY TO MOVE FORWARD, BUT PROCEEDING ON THE WORK TO GET TRIALS STARTED.
Overview of key events of the year ended September 30, 2017
During 2016-17, the Company had been positioning its product, NovaDerm, to enter clinical trials to gain FDA product approval. Having secured Orphan Designation for NovaDerm, we completed the necessary independent research and executed several key supply and manufacturing contracts to pave the way toward a pre-IND meeting with the FDA. The IND is an investigational new drug application filed in order to receive permission from the FDA to enter into the clinical trial process. Our pre-IND meeting with the Agency was very successful and clearly defined some additional requirements we needed to begin the clinical trials and the agreed upon protocols we needed to perform the trials. It was further agreed that the trials would initially cover 3 patients and then would be extended to 7 additional patients. If approved, NovaDerm® will be the first and only autologous, cultured skin substitute product allowed for medical use on burns requiring grafting.
We estimated that the completion of the IND and the clinical trials would take approximately 12-18 months and cost in the range of $3.5 -$4.5 million. In addition to the completion of the IND, the only other significant gating item to entering the clinical trials is funding.
On December 26, 2016, Dr. Joseph Rubinfeld, one of the original Board Members, unexpectantly passed away. On August 7, 2017, Dr. Craig Eagle, also an original Board Member resigned to pursue other interests. The Company is grateful to these two gentlemen for their support and contributions during the past seven years.
These two board positions remain open anticipating requests of Board representation from potential investors.
The following is a review of the major milestones achieved during the year:
1. Our contract laboratory completed the laboratory portion of their analytical research services and we received their final report. This was a lengthy process in which we identified certain potential product improvements that we continue to evaluate internally. The final research report was a crucial part of our FDA submissions for an Orphan Designation and Pre-IND (Investigational New Drug).
2. We filed our annual report for our Orphan Designation, as a biologic, with the Office of Orphan Products Development of the FDA for the treatment of burns requiring skin grafting with NovaDerm®. The Orphan Designation granted is for “treatment of patients with deep-partial or full-thickness thermal burns requiring grafting”. The FDA's Orphan designation is granted to promote the development of unmet clinical needs with new therapies for rare diseases and disorders. Orphan Product terminology is applied to Orphan designated products proven safe and effective, and the approved Orphan Product entitles the product, up to seven years of US market exclusivity. In addition, there are other financial benefits along with the FDA’s support during the approval process.
3. We are following through on the results of our FDA pre-IND meeting. During the Pre-IND meeting The Agency addressed our questions and provided guidance on our planned NovaDerm® development pathway going forward. It was agreed that Bovine TYPE 1 hide collagen scaffolds from Pure Med Farma, LLC (a related company) would satisfy American Society of Testing and Materials testing to fulfill current ASTM Type I requirements. We are working closely with Pure Med Farma to ensure this testing complies.
4. We have continued to work on finalizing the IND as funds allow. An IND application is the document filed with the FDA to request permission to proceed with clinical trials. This application includes the candidate product's research, chemistry, manufacturing controls and processes, pre-clinical safety, clinical trial protocols, and more.
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Our Business Moving Forward In 2018
The company’s major objective for 2018 remains to secure the required funding to finalize some additional requirements of the IND application, and begin the clinical trials. It is estimated that the cost to finalize the IND will be approximately 1.5 million dollars, and the cost to complete Phase 1 of the clinical trial will be approximately 2 million dollars. As previously reported, our goal in obtaining this funding has been to minimize shareholders' dilution as much as possible. Consequently, we are primarily pursuing financing through the issuance of a debt instrument and international licensing agreements.
We have worked with a number of potential investors and continue to pursue the necessary funding based on our stated objectives. It has taken longer to raise the funds than originally estimated; however, we remain confident that our goal is achievable. In the interim, the officers and related parties intend to continue to fund the Company’s essential operating costs.
We have begun the preliminary planning for the clinical trials to the extent we are able, considering funding constraints. As previously reported, we have chosen a CRO to assist in our IND submission and conducting the trials. Clinical site selection and patient recruitment should be somewhat simpler than other clinical trials, as we are limited in site selection to the 150 burn centers qualified to treat catastrophic burns. In addition, the surgical protocol will be similar to the grafting procedures currently in use at those facilities. NovaDerm® should thus require minimal physician training.
The initial trials are planned to begin with a total of ten subjects with an Initial Data Safety Monitoring Board (DSMB) review of safety on the first three subjects once they have reached 6 months follow-up. We do not intend to interrupt our trial waiting for the DSMB report.
Our management is considering various possibilities and approaches to obtaining clinical trial materials and manufacturing. While no final decision has been made, management’s approach is to set up the trials so as to allow for a seamless transition into commercial production upon approval.