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November 10, 2014 Issue

The Most Powerful Name In Corporate News and Information


Oxysterol Compounds for Bone Formation Stimulation



Farhad Parhami
Founder & President

MAX BioPharma Inc.

Interview conducted by:
Lynn Fosse, Senior Editor, CEOCFO Magazine,
Published – November 10, 2014


CEOCFO: Dr. Parhami, it has been almost two years since we spoke; would you tell us what is happening now at MAX BioPharma?

Dr. Parhami: It has been a year of tremendous activity and a lot of momentum in the company. I think the highlight of the past year and a half has been our success in licensing one of our important technologies to a global commercialization partner that has now signed up with us and will be responsible for the future development of a drug candidate that we had discovered for use in stimulating localized bone formation. If you recall from our previous discussion one of the important programs at MAX BioPharma has been working with our platform technology of novel, small molecule oxysterol compounds to stimulate bone formation. Bone formation is a very important topic because as the population ages we have seen more and more incidents of osteoporosis and osteoporotic fractures and this is a debilitating and often fatal disease that is the end of life for a lot of otherwise active elderly people. The way to treat osteoporosis has now been fully recognized to require not just slowing down bone resorption but also stimulating the body’s ability to reform the bone that has been lost and that is exactly what we have been trying to do with our technology, first developing it for localized administration for fracture healing. Some bones when they break cannot heal properly; there are orthopedic procedures such as spine fusion for example that require stimulation of bone formation in the spine between different vertebrae to give stability and so on and so forth. That was our first focus and because of a lot of positive proof of concept data that we provided we were able to form this new partnership with our commercialization partner. That has been great for us and has created value for the company while validating our proprietary technology.


CEOCFO: How does it work and what will be the next steps?

Dr. Parhami: What we found is that the small molecule that is an “oxysterol” is able to stimulate bone formation so you implant it locally in the fractured bone for example. The way it works is that it targets those stem cells that develop into bone-forming cells, which are called osteoblasts and stimulates them to make bone. We showed this in vitro first in cells that grew in dishes and then we were able to demonstrate this in models of rats and rabbits, cranial defect healing and spine fusion. The next steps are going to be translating all of that into human clinical trials and eventually commercializing the drug for public use.


CEOCFO: Is the concept of growing bones a new one?

Dr. Parhami: As far as biologics go for stimulation of bone formation, first let us consider localized stimulation, there has been a drug called Infuse or Bone Morphogenetic Protein 2, which is a potent bone-forming agent and has been adopted by orthopedic surgeons and neurosurgeons who perform bone surgeries and bone fracture repairs and it works very well except that it is very expensive, and during the past five years it has shown a lot of complications in patients that have received this product. Unfortunately there is nothing else out there except for autologous bone, which is when the surgeon takes bone from the hip or another site and puts it into an area that requires bone formation which is a painful procedure and it adds to the length of surgery and complications. The only alternative to autologous bone has been this Bone Morphogenetic Protein and our oxysterol drug compound is going to be an alternative to Bone Morphogenetic Protein. It is going to be safer and much less expensive product, we hope, than what is currently available. In terms of systemic bone formation for example in intervention with osteoporosis, unfortunately there is only one drug out there that is FDA approved by the name of Forteo®, that stimulates bone formation but unfortunately it can only be given for eighteen to twenty-four months. It is given to frail elderly people and patients with severe osteoporosis that have no other choice but receiving this drug. It is extremely expensive and requires daily injections for the two-year period and many times it does not work. I know of many patients, including my own mother, that have been on this drug and it has not benefitted them (in fact my mother fell and broke her hip after having been on Forteo for 2 years). There are a few other clinical candidates that are in clinical trials mainly one by Amgen which have shown good data so far but works through a completely different mechanism of action than the drugs that we are developing. Our second main success in the past year and a half has been the design and synthesis of bone stimulating oxysterols that are bone targeted so we can give them systemically in a patient and make these molecules home to bone and perform their action which is stimulation of bone formation in the bone. This is a big step in terms of the next phase of our osteoporosis program.


CEOCFO: How are you able to measure this long-term?

Dr. Parhami: That is exactly what needs to be studied. There have been the recent observations about bisphosphonates and how they are affecting bone after long-term usage. As a result of all the studies that are now coming out we understand that by using bisphosphonates too long, the bone that has formed after several years does not have the same quality as normal healthy bone and it is more brittle and much more susceptible to fractures. Whether or not the compounds that we are forming are going to have similar effects long-term, we are going to have to study as soon as we can put these molecules in patients in clinical trials and following them up. However going back to the mechanism of action of oxysterols vs. bisphosphonates we can make an educated guess that because of the very different mechanism of action of oxysterols, we will not see the same types of complications that bisphosphonates have created namely osteonecrosis of the jaw and this increased fracture of the femur and others. Going back to your question these are the things that we have to study long-term and you cannot extrapolate from an animal when you are talking about what is going to happen in humans ten or twenty years down the road after receiving a drug.


CEOCFO: What else is happening at MAX BioPharma?

Dr. Parhami: Recently because of our successes we have had to increase our team members. MAX BioPharma now has seven members that are composed of full-time research scientists and business development personnel. We have had to increase our size in the California Nano Systems Institute (CNSI), which has an incubator for startup companies that license technology out of UCLA. This has been a blessing for us to be able to remain on UCLA campus where we have a lot of access to great minds and a lot of great technology and yet pursue our R&D efforts. We have also increased our facility by two times and that is great. I foresee that we are going to have to move out of this space maybe one or two years from now because our momentum and our size will continue to increase rapidly.


CEOCFO: Do you have the funding necessary?

Dr. Parhami: We have been very fortunate to receive two SBIR Phase 1 grants during the past year which have focused us more on our osteoporosis program. Because of the partnership that we have formed we have generated some revenue for the company that is going to allow us to focus our energy and attention on our other programs that have not yet been licensed. Funding remains a challenge and we are constantly looking for investors that would partner with us and move our technologies forward. We are offering an opportunity for a rather novel and disruptive technology that is going to change a lot of medicines that are provided by pharmaceutical companies to patients in terms of making them safer and providing a new class of drug candidates that could be developed in the future for a number of indications. We have chosen to focus on bone and cancer namely because of our resources and our expertise but because of the mechanism of action of these molecules there are plenty of other indications that could be targeted by our compounds. A lot of indications in regenerative medicine could benefit from our compounds and our molecular targets including nerve repair, cartilage repair, and hair growth as well as a number of others. We are just starting to scratch the surface of this novel technology and this is why we think that this is such a great opportunity for investors to come and partner with us.


CEOCFO: What is the relationship with CNSI; does it need to be kept under wraps?

Dr. Parhami: It does not need to be kept under wraps. We have a relationship with CNSI in terms of the incubator space that we have leased from them. There are a number of companies in CNSI incubator including MAX BioPharma and we just happen to be one of them that has been successful in its endeavors.


CEOCFO: Why does MAX BioPharma standout?

Dr. Parhami: It is a huge opportunity and it has a novel technology that is ground breaking and will provide significant opportunities for developing drugs for unmet medical needs. There are very large markets and huge demands out there. We are pioneers in the field of research that we are performing and pioneers in the field of oxysterol technology and drug therapeutics so I think our expertise and our eagerness to get this program moving forward towards clinical trials and eventually the markets really creates a unique opportunity for investors and others to partner with us.


“It has been a year of tremendous activity and a lot of momentum in the company.” - Farhad Parhami


MAX BioPharma Inc.

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Farhad Parhami








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