SEOUL-headquartered Crystal Genomics is a structure-based drug delivery and development company. The company was founded in 2000 and was listed on the KOSDAQ in early 2006. It has a wholly-owned subsidiary, CG Pharmaceuticals, in Emerville, US.

The company has a diverse pipeline of drugs for cancer, inflammation and anti-infectives, and two other pre-clinical candidates of a novel antibiotics for MRSA and VRSA and an oral/IV HDAC inhibitor for cancer. In December 2008, the company reported a positive phase II a results for the osteoarthritis study of its lead compound CG100649. In an e-mail interview with
BioSpectrum, Dr Joong Myung Cho, CEO of Crystal Genomics talks about the company and its ambitions to become a leading structural chemoproteomics-based drug discovery company.

Can you please give an overview of the products in the company’s pipeline?
Firstly in the clinical and pre-clinical space we have CG100649. It is a novel and next generation non-steroidal anti-inflammatory drugs (NSAID) with a dual inhibition mechanism of binding COX-2 as well as carbonic anhydrases for improved cardiovascular, gastrointestinal, and renal safety profile. It has completed phase IIa clinical trial with 248 osteoarthritis patients in Europe.

Secondly, we have novel HDAC inhibitor, CG200745 for cancer. This is under pre-clinical studies in Europe and will be ready for IND filing by August 2009. The third product in our pipeline is a novel antibiotic, CG400549 for Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Staphylococcus aureus (VRSA). This is under pre-clinical studies in Europe and will be ready for IND filing in the first half of 2009.

However, in our lead optimization and candidate selection projects we have: HIF Stabilizer for anemia in candidate selection process; GSK3 for cancer and CNS in candidate selection process; Aurora K for cancer in candidate selection process; SYK for inflammation in final optimization; PDE10 for CNS in final optimization;  and Fab K for infectious disease in lead
optimization.

How is the company’s NSAID CG100649, different from existing OA/RA drugs?
CG100649 has the dual inhibition mechanism of binding both COX-2 and carbonic anhydrases for improved cardiovascular, gastrointestinal, and renal safety profiles. Traditional NSAIDS like Naproxen, Piroxicam, Diclofenac and others, inhibit COX-1 enzymes and these drugs cause serious problems in terms of GI which includes stomach pain, ulceration, and bleeding.

Later, COX-2 inhibitors such as Celebrex and Vioxx did address the GI issues from the traditional NSAIDS, but their inhibition of COX-2 in cardiovascular and renal tissues led to serious cardiovascular side effects which ultimately lead to withdrawal of Vioxx.

Since CG100649 has been designed to address all of these known GI, CV, and renal problems, we don’t anticipate any major side effects and observed superior efficacy during phase IIa studies. We believe that CG100649 will be the answer for the unmet medical need of osteoarthritis and rheumatoid arthritis patients in near future.

There is a report that the company might not start the phase III trials for CG100649 as yet. Why is it? What plans does the company have for this compound?
Currently, we are actively seeking partners for collaboration or to out-license CG100649 program completely. We are in discussion with many pharma companies right now, but regardless of the outcome, CG100649 will move into further clinical development stages as we are presently designing study protocols for phase IIb and III trials and plan to file IND by March 2009 in Korea, China, and Japan.

Is the company entering any new area or is there any new drug in the offering?
As you may already know, we have well established structural chemoproteiomics-based drug discovery platform technologies for generating novel pre-clinical candidates productively. We will continue to focus on oncology, inflammation, and infectious disease as we have in the past.

In addition, we are currently exploring with other therapeutic areas such as hypoxia for treatment of anemia, stroke, and wound healing as we have formed a joint venture company, Palkion in San Diego with ProQuest Investments (US) last year. We are currently in the process of selecting a pre-clinical candidate for this project. Another new area of interest for us is the CNS-related therapeutics such as Alzheimer’s disease and schizophrenia as we are currently in the process of final optimization of novel scaffolds.

If we find other novel and exciting targets from partners or journals, we are willing to explore these areas, even if they do not fall under our focus areas. This is because we specialize in various families of proteins such as kinases and phosphodiesterases, and are able to apply our platform technologies in new therapeutic areas and targets without any
difficulties.

Does the company have specific plans for Asia Pacific?
We already have partnered with the second largest pharmaceutical company in Korea, Hanmi Pharmaceuticals to expedite the development process and marketing in Asia. However, our long term goal is to become a true global company and all of our projects are discovered and developed under the assumption that they will enter global markets at
some point.

How do you compare the Asian life sciences market with that of the US and EU?
The economies in Asia are rapidly growing, which stimulate and expand the Asian life sciences industry as well. Asia has much greater population than the US and Europe and this represents excellent growth opportunities for the life science industry as Asian market is relatively untapped coupled with rising demand for quality treatments.

What challenges and opportunities does the company face in operating out of Korea?
Because Korea is still relatively unknown in the biotech and pharmaceutical industries, it takes extra efforts to be noticed by potential global partners to consider CrystalGenomics as a collaborating partner or to in-license our assets for further development. Also, because Korea is fairly new entrant in the biotech industry, the assets produced by Korean companies is substantially undervalued compared to their counterparts from Europe or America.

Despite all the challenges, there are great opportunities in Korea. For example, overall infra-structures such as third generation synchrotron, high field 900 MHz NMR, super-computers, mega hospitals with more than 2,000 beds, and the Korean government’s support for biopharma R&D in Korea are well established. CrystalGenomics is fortunate to maximize these infrastructures and is rapidly becoming a novel drug R&D center as a global player. We are actively recruiting talented and experienced scientists from around the world in the areas of cell biology, pharmacology, medicinal chemistry, and clinical development.

Has the current economic slump affected the company’s plans?
We have enough cash for next four-to-five years and the current global financial crisis has not altered our plans. We still plan to continue what we do best which is novel drug discovery and development in high unmet medical need areas. Our three candidates mentioned previously will continue to be developed as we anticipate, and two of these will enter clinical phase I studies this year.

We have several projects in the pipeline that are currently in candidate selection process and plan to invest in all of these candidates into pre-clinical studies this year.