【CEO Conversation】Dr. Shyi-Gen Chen

Dr. Shyi-Gen Chen

Dr. Shyi-Gen Chen

 

 

Generally, about 19-34% of diabetic patients develop foot ulcers, which often results in amputation. However, FESPIXON® brings new healing possibilities for DFUs. In the July 2022 QIC's “CEO Conversation” exclusive interview with, Vice President Dr. Shyi-Gen Chen, he shared how to utilize past experience with DFU treatments in the development and application of new drugs, as well as talked about the potential and development of FESPIXON®.  The full interview is enclosed below for reference. 

Dr. Chen, the Vice President of Oneness and its three oversee departments including Medical, Clinical and Sales and Marketing. Dr. Chen is also a decorated veteran in plastic reconstructive surgery (PRS), once served as the Deputy Superintendent and the Head of PRS department in the Tri-Service General Hospital and President of Taiwan Society of Plastic Surgery. Leveraging Dr. Chen’s extensive experiences treating diabetic foot ulcer (DFU), Oneness hopes to make the most of the newly approved DFU drug FESPIXON® to improve patient’s life quality.

 

What is diabetes foot ulcer (DFU)?

“Amputation due DFU is now the #1 cause of all amputations. In earlier years, car accidents and cancer were the major reasons.” Said Dr. Chen: “With economic development, DFU has surpassed other causes to become the top reason for amputation. Osteosarcoma patients now can be reconstructed even if a section of bone was sawed off. Microsurgery, on the other hand, changed the landscape of car accidents; damaged limbs can be saved nowadays. However, DFU still maintains a high amputation rate. The only progress is more amputation of toes or partial foot than higher position amputations (leg) to prevent the advance of illness.”

 

“There was a diabetes patient who attended a marathon for exercise, and got blistered. He didn’t take it too seriously until the wound got infected and developed into necrotizing fasciitis. As we opened the wound, immediately the rotten smell fills the operating room. The bacteria moved upward along the fascia, and we have to lance the leg open to let the pus out. For a period of time, he stayed in the hospital and we cleaned the wound (debridement) constantly, and finally did a graft surgery. ” I got goose bumps after Dr. Chen’s description. “Generally speaking, neuropathy and angiopathy are always entangled with DFU. But different bacterial infections will lead to different outcomes. If it was flesh-eating bacteria or Vibrio vulnificus infection, the illness will progress rapidly. Especially diabetes patients also have weaker liver and kidney functions, the condition could be pretty ferocious after the infection. Not only unknown to healthy persons, most patients and their families only knew of DFU only after it occurred.”

 

“Most of the DFU patients believe after treatment or amputation, the wound would heal and the issue is taken care of once and for all, but actually not. Diabetes is a systematic disease, treated wounds are just temporarily resolved. Like a rock rolling down a slope, if you carefully manage the disease, then the rock will roll down slowly. Otherwise it will lose control. Without proper health education, a patient can come in and out to a hospital several times and constantly amputate different part of the leg.” Dr. Chen sighed. “I always asked young staff and students to explain to the patients and families clearly about the mechanism behind DFU, and ask patients to pay extra attention on any problem they have, and inform doctors immediately.”

 

FESPIXON® is a new global Phase III trial, and a Phase IV study in Taiwan

After the astonishing first hand exposure, I also asked him about a DFU patient that I’d heard of: an old lady’s large area ulcer was completely healed after using FESPIXON®, and that wound was meant to be amputated. “Indeed it is a real case after FESPIXON® was approved. Before using our drug, the lady has already experienced a partial foot amputation. The relapse led to a 60cm2 large area wound. Due to her financial status, she joined Oneness’ medical subsidies program. The wound was completely healed after using 10 tubes of FESPIXON®, and no amputation needed. Her attending doctor was so surprised and recommended all other patients to try this new drug. If it was not our drug, very likely an amputation, or flap transplantation is needed.” Dr. Chen seems to be very satisfied about the results.

 

“Oneness have strong confidence in our product and would like to follow the best practice, we are planning on a Phase IV study in Taiwan. This move will ensure that Oneness brought the best treatment to the patient group and has a clear picture of the real world data.”

 

In fact, FESPIXON® is in the second Phase III trial in the US. The Company is expecting to bring this exciting new therapy to the global market and benefit patients around the globe. The collaboration with the US podiatry big wheel Dr. David G. Armstrong attracted everyone’s attention despite the fact that the general population is not familiar with Dr. Armstrong. Dr. Chen explained: “The hospital system in the US is different from Taiwan. There is no podiatrist in Taiwan, but in the US and Australia, podiatry is a common practice. This subspecialty takes care of only the foot, ankle and lower leg condition.

 

WHO and FDA both recognized DFU as an unmet medical need. There are over 500mn diabetes patients around the globe and 19%~34% of them will experience at least one episode of DFU, the prevalence of DFU in the US and Australia is especially high at 13%, where podiatrists became more important than ever. Dr. Armstrong, a legendary podiatrist, has extensive experiences in clinical trials and basic medical science. He published his work: Diabetic Foot Ulcer and their Recurrence in the New England Journal of Medicine, and it became the bible for any physician who is treating DFU patients. We wrote a letter to Dr. Armstrong for our new Phase III trial in the US, and he was so nice to keep in touch. Then we proposed to hire him as our advisor and he agreed. ”

 

But can a heavy hitter in podiatry agreed to be the advisor just because he is nice? “Of course not! Actually he knew it very well that because almost no drug can be approved for DFU, FESPIXON® is one of the very rare cases. He wanted to evaluate this drug, so we sent him all the clinical data and research to him. After studying our safety and efficacy data, he decided to accept our invitation.” Dr. Chen seems to be very proud of it: “We tried to let China officials understand our product and the needs of it. So we gathered DFU specialist all around the globe and wrote a recommendation for FESPIXON®. After we invited him as our advisor, Dr. Armstrong wrote another recommendation regarding mechanism of action, future prospect and the results from the first Phase III trial, it is a promising treatment for DFU. And he believes patients in China can be greatly benefited after China approval is obtained. According to his colleagues, he never recommended a drug like this.”

 

A perfect combination between clinical medicine and biotechnology reflects Oneness’ ambition to become a big pharma

“I think Oneness’s founder, Mr. William Lu, is very visionary and wants to turn Oneness into a big pharma. It is not just focusing on R&D, but to find the real application in the clinic. In the past, people believe that the biotechnology industry is high R&D cost and crazy valuations. After the products were launched, the true colors revealed. Investors would rather to sit and wait until the revenue meets their expectation, causing the valuation to fall sharply. Chairman Lu invited me to extend the strong R&D momentum all the way to really improve patient’s life quality. I totally agree with this mindset. We will make Oneness bigger together and bring Oneness’s R&D closer to the medical field and clinical applications. These research, development, and scientific results are merely a thesis without commercial value if we aren’t able to find applications. Fulfilling the patients and doctors’ needs is the core value and the most critical target for every pharmaceutical company.”

 

Dr. Chen continued to talk about his vision entering the industry: “Before we successfully developed FESPIXON®, our target was meeting the unmet needs of DFU patients. Now FESPIXON® has been successfully launched, and the efficacy is proved with complete data, our next step is to create new demand. In the past, there were diseases without proper medicines, and the demand for treatment was not apparent. But now that FESPIXON® was approved, doctors can unleash FESPIXON®’s potential with its unique mechanism! Just like the iPhone was originally developed to combine the functions of making calls (traditional mobile phones) and listening to music (iPod) at the same time. Moreover, the launch of the iPhone has brought more applications other than these two functions. We see FESPIXON® the same. The most important thing is that Mr. Lu, also agrees with this R&D mindset which is closely related to the medical field and clinical applications.”

 

Oneness is currently actively developing several indications other than DFU, including skin ulcers after radiation therapy, venous leg ulcers, scars, biomembrane wounds, and bedsores. Each is a skin lesion that is refractory or doesn’t have a better treatment.

 

“I am very optimistic about radiation dermatitis. Now there are more and more cancer patients, which is the largest cause of death in the world. 50%~70% of all cancer patients require receiving radiation therapy, and the proportion varies from different cancers. For women, breast cancer is the top among all cancers. 50.6% of breast cancer patients have received radiation therapy regardless of the stage. Right after the exposure to radiation, the skin became rubeosis and itchy. Some may have wet desquamation, pigmentation and then turn into chronic ulcer. Basically, the DNA of the skin cells were damaged, cell dehydrated, death and fibrosis developed; it’s a mix of acute and chronic injuries. No drug treatment for this exists. Radiation can bring much more serious damage than ultraviolet, and the damage is cumulative. Therefore, it will cause skin ulceration to some patients. Women suffered both physically and mentally due to cancer. Additionally, their skin became wet and ulcerated after the radiation exposure, and they can hardly even put their clothes on. It’s terrifying. Although radiation therapy is improving, the medicine for the skin condition after radiotherapy is still primitive. There are only medical materials, moisturizer, and dressings to make patients a little less painful. Most wounds will heal after the treatment is completed, but it is a painful experience during the treatment. There are almost twenty thousand breast cancer patients per year in Taiwan, and half of them need radiation therapy. In addition, we found in the animal experiment that FESPIXON® can make such skin damage less severe and preventable.

 

Fig 1: The result showed that the skin damage caused by the radiation of the experimental group using FESPIXON® (green) was far less than that of the control group which are untreated (blue) or steroid-treated (red).

 

As we can see in the Oneness’ animal trial, a part of mice’s skin was shaved and irradiated with radiation, and the unshaved parts were covered with lead plates. There was one control group while another group received steroid and the third group was treated by FESPIXON® before radiation. The results demonstrated that dermatitis immediately occurred in the untreated group. The second group treated by steroid group has less serious reaction. The inflammatory reaction of the mice that used FESPIXON® was the least serious and healed rapidly.

 

“If the patient is exposed to radiation, the skin condition of the first and second week is quite serious. Although the patient’s skin will heal in the end, the healing process is be very painful. With FESPIXON®, the symptoms that should appear in the first week will be delayed to the third week. When radiation treatment ends, the skin condition starts to improve. It is very helpful to patients. The market potential is very significant. “said Dr. Chen.

 

“Other applications like pressure ulcers and scar healing are all have great potential. We found that some patients' wounds healed smoothly without scars in the DFU Phase III clinical trial. That’s why we start to think that if there is a good application in this field as well.

 

In the beginning, FESPIXON® was a new drug developed for a single unmet medical need. With such a good tool, more and more new indications will be developed in the future. As I said earlier, if we create an excellent product, it is easy to find lots of applications.”

 

Research Topics Project Name Current Progress

Lower limb varicose ulcer

Assess the safety and efficacy in lower limb varicose ulcer patients

Trial in progress
Scar-1 Assess the short and med-term efficacy to improve scar aesthetics after neck thyroidectomy or caesarean section Trial in progress
Scar-2 Study of the mechanism of action inhibiting hypertrophic scar formation, scar microenvironment and regulation of chemotactic epithelial stem cells by translational research Trial in progress
Wound biofilm Research on the efficacy of wound biofilm infection in diabetic animal model Trial in progress
Decubitus ulcer Efficacy and Safety in Patient with sacral vertebrae pressure ulcer Trial in progress
DFU-1 Evaluate the safety and efficacy of chronic diabetic foot ulcers in dialysis patients (TEXAS 1A, 2A) Trial in progress
DFU-1 Evaluate the effecacy of treating diabetic foot ulcers (TEXAS 3A, 3B)  IRB amendment
mellitus under review

Table 1: For FESPIXON®, Oneness has started a series of clinical trials for different indication

 

No matter in which stage of life, one can only be successful by devoting yourself to what you love.

Dr. Chen also shared his background and experiences with us. “Before I entered the National Defense Medical College, I actually had multiple choices. At that time, I took the entrance exam for regular college, military school, and the police academy. I was admitted to all three categories. My father wanted me to go to the police academy, because the locals respect police officers a lot. But I thought that doctors can save lives and it is hard to have a chance to get into a medical school, so I chose it. I gradually developed more interest into surgery because it’s a very hands-on subject. Plastic surgery, in particular, is very creative. The same trauma can be treated in a variety of different ways. Cosmetic surgery is not as popular today as back in the 80s so most of our work focused on burn and trauma reconstruction. Some patients asked: ‘Dr. Chen, why you are such a visionary to choose this department years ago?’ In fact, it was never my intention to choose the subject for cosmetic surgery. On the contrary, it was a tough job that we were saving lives every day, and I didn’t expect it would become such a popular field 20 years later. So I encourage students to do what they really love. The subjects which are very popular now may become less popular ten years from now, while the less popular subjects may become very popular. As long as you love what you are studying, you can pull through this decade. Otherwise even if the subject is very popular, you may be washed out quickly."

 

“In addition, being admitted to the best department can be ascribed to the ones effort in high school. Likewise, a successful career achievement depends on your endeavor in college. For example, Professor Dr. Huey-Kang Sytwu, who was recently elected as an academician of the Academia Sinica, is a senior colleague of mine in the National Defense Medical College. He worked very hard to get a doctorate from Stanford, kept working on his research, and has now been elected as an academician of the Academia Sinica. Now in school, I am not only teaching textbook knowledge, but trying to give students some encouragement from life. My decision to join the biotechnology industry also gives them lots of encouragement, they now know that a physician's career could be very broad.

 

I've done a lot of clinical trials in my tenure in the hospital, so now I could connect seamlessly when I joined Oneness. I am now in charge of the Medicine Department at Oneness, which is originally my profession. We now have more than a dozen clinical trials, which are also the business scope of the clinical department I am in charge of. We have to pull this off; otherwise we are just wasting shareholder’s money. The other department I am in charge of is Sales & Marketing, which targets to promote FESPIXON® to medical institutions as fast as possible. These three departments are all interesting and full of challenges. I believe we can see more achievement soon, to improve patient’s life quality.”

 

Source: https://www.qtumic.com/insights/1551483981113851904

 

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