AMIPurdue Past Development Projects
(an AMIPurdue spinout, Delaware Corporation)
Scar Mitigation & Wound Healing
Alyssa Panitch, Biomedical Engineering Department
Proteoglycans (PGs) are a class of molecules found primarily in the extra cellular matrix which serve a wide variety of biological functions. One of the known functions of PGs is to regulate collagen fibrillogensis which is an important component for proper wound healing. Supplementation of PGs to wounds has been investigated, but since naturally derived PGs are very expensive ($1,000’s/gram) to isolate, their use in a clinical application is severely limited. As a result, there is great demand for a means of inexpensive synthesis of PGs.
Researchers at Purdue University have engineered a solution which is comprised of a collagen binding peptide conjugated to glycosaminoglycans. Depending on the specific combination, a number of synthetic proteoglycan’s mimic a unique biological function which can be manufactured cost effectively ($100’s/gram). Development projects using two distinct synthetic proteoglycan compounds are underway. The first uses a synthetic proteoglycan compound to enhance healing and inhibit surface scarring which often results from surgical incisions or injury repair. The second synthetic proteoglycan compound is targeted as an antithrombotic agent for use in addressing thrombosis and restenosis associated with balloon angioplasty.
AMIPurdue funded this technology development, starting in September, 2008 in the belief that the application and resulting platform products would be regulated by the FDA as a device. In mid-2010 AMIPurdue submitted a “Request for Designation” to the FDA, which subsequently determined that this product would be regulated as a drug. This decision by the FDA eliminated the opportunity for AMIPurdue to conduct a Non-Significant Risk (NSR) clinical study. Ongoing commercialization efforts are being pursued by Glytrix Inc., efforts which are being led by the faculty inventor and the original team of scientific founders. Their efforts are being backed by a professional management team. Glytrix holds an option to the IP portfolio and is currently seeking an initial round of Series “A” funding.
Drug Reformulation
Stephen Byrn and Daniel Smith, Industrial and Physical Pharmacy Department
Formulation of Active Pharmaceutical Ingredients (API) is an integral part of drug development and AMIPurdue has financed formulation efforts targeted toward producing a mechanism to deliver the correct amount of API to the body. This Drug Reformulation project focused on discovering a formulation known as ER-ODT, or an “Extended Release – Oral Disintegrating Tablet”. ER-ODT formulation is especially beneficial for a number of diseases such as Alzheimer’s, Parkinson’s, Diabetic Gastroparesis, Gastroesophageal Reflux Disease, and Schizophrenia, since they are accompanied by symptoms of dysphagia (difficulty in swallowing). Furthermore, a majority of patients suffering from these diseases typically require help in taking their medication. A once-a-day formulation instead of multiple doses per day (2 – 3) with a quick dissolve mode of action is a highly desirable product formulation. Several drugs aimed at treatment of the aforementioned diseases are currently under investigation for an ER-ODT formulation.
Efforts to discover an appropriate co-crystal for several currently available drug formulations to serve as the basis for an ER-ODT formulation were not successful. A number of co-crystal formulations were discovered by Purdue researchers; however the performance characteristics of these co-crystals did not meet the minimum requirements necessary for the marketing of a new proprietary drug formulation.
OccuTack
Babak Ziaie, Electrical and Computer Engineering
Glaucoma is a disease caused by increased intraocular pressure (IOP), which typically results from either a malformation or malfunction of the eye’s drainage structures. If left untreated, an elevated IOP causes irreversible damage to the optic nerve and retinal fibers resulting in a progressive, permanent loss of vision. However, early detection and treatment can slow, or even halt the progression of the disease.
OccuTack is an intraocular pressure monitoring system comprised of a minimally invasive intraocular sensor, a specially designed implantation tool, and an externally hand-held output reader & recorder. The use of the OccuTack system would allow a clinician to implant (or remove) the sensor in a 5-10 minutes out-patient procedure in a physician’s office. By pressing a button, patients can perform a measurement of their intraocular pressure. The IOP data is automatically also saved for later review by a clinician. The use of the OccuTack system will revolutionize care for glaucoma patients as well as high-risk patients through close monitoring of intraocular pressure without necessitating complicated and highly invasive surgical procedures.
While the OccuTack project achieved several key technology development milestones, in attempting to recruit potential industry partners, a concern was expressed regarding the inability to eventually receive reimbursement for a minimally-invasive diagnostic device. Without the prospect for CMS or private insurance reimbursement, and without an industry partner, AMIPurdue returned this technology to Purdue University.
Electrochemical Biosensor
Stephen Beaudoin, Chemical Engineering Department
Breast cancer remains a primary cause of death for women in Western countries. It is estimated that 1 in 8 women in the U.S. will develop breast cancer over the course of their lifetime and that the overall mortality rate from breast cancer is 1 in 33. There are significant limitations involving existing diagnostic procedures for detecting the presence of breast cancer cells.
IUPUI School of Medicine collaborators have identified a biomarker for breast cancer and the Purdue Chemical Engineering Department has developed an immunoassay test based upon impendence biosensor technology which will provide clinicians with “real time” determination of the presence of cancer cells within 10 -15 minutes. The immunoassay is highly specific, thus reduces test errors and which can potentially be used in other forms of cancer diagnostics. AMIPurdue has funded the further development of the technology with the expectation that a commercial assay can be developed using a Purdue-developed device and the IUPUI biomarker.
Through in-depth investigation into the intellectual property for this project, a standard practice employed by AMIPurdue for every supported project, it was determined that another competing technology was filed a year prior to the Purdue disclosure. All efforts to work around the prior art was unsuccessful and therefore AMIPurdue was forced to cancel the project.
Electrochemically-Oriented Collagen Matrix
Ozan Akkus, Biomedical Engineering Department
The most common clinical practice for soft tissue repair is the use of naturally derived mesh, primarily consisting of biologically derived collagen. Compared to synthetic meshes, collagen-containing meshes offer higher biocompatibility and tissue integration, yet they lack uniformity involving their mechanical properties.
Researchers at Purdue University have developed an electrochemically oriented collagen matrix (ELAC) having uniform mechanical properties which can be tailored to specific applications. As such, this industry scalable process can be utilized to produce biocompatible meshes having superior properties to currently available options while offering higher biocompatibility and tissue integration, as well as the appropriate mechanical strength and uniformity. The targeted clinical applications of the ELAC mesh are hernia repair, rotator cuff repair, and dermal wound healing. Additionally, ELAC bundles may represent an inexpensive method for fabricating biocompatible aligned structures for peripheral nerve regeneration. AMIPurdue funded the development of the scale-up of the manufacturing process for ELAC in order to launch its laboratory-to-beside commercialization.
This project achieved several scientific milestones however the manufacturing process was determined to be still in its infancy and not yet scalable. AMIPurdue has requested additional research to be completed. If further research efforts are successful, AMIPurdue will consider proceeding with further commercialization support.
