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CrystalGenomics Initiates Phase I Study of CG200745, its Novel Molecular Targete

On May 31, 2019 CrystalGenomics, Inc. (www.cgxinc.com), a leading biopharmaceutical company developing novel small molecule therapeutics reported that it has received an approval from the Korea Food & Drug Administration (KFDA) to begin Phase I clinical study of CG200745, its novel molecular targeted cancer therapeutic (Press release, CrystalGenomics, MAY 31, 2010, View Source;id=836&page=8&num=51&nowpos=1017&type=&sermun=&qu=&tb_name=eng_news&rt_page=/en/news/news.php [SID1234539171]). This KFDA approval makes it CrystalGenomics’ second recent announcement of initiating clinical trials as it has only been 20 days since its previous announcement on plans to initiate the Phase I Multiple Ascending Dose Study for CG400549, its novel antibiotic candidate for MRSA.

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CG200745 is being developed to potentially overcome negative side effect profiles of traditional cancer therapies. One of the major flaws of traditional oncology agents is the severe toxicity issue as current agents tend to target and kill even the normal healthy cells that are around the cancerous cells. Because CG200745 has been designed to specifically target the cancerous cells, it is also referred to as a "Molecular Targeted Cancer Therapeutic" that will not harm the non-cancerous cells.

While being designed to test human safety as its primary objective, this Phase I study will also attempt to collect efficacy profiles of CG200745 on various types of cancers and also, its effects of combination therapy to see if CG200745’s co-administration will result in synergic effect of increasing effectiveness of existing cancer therapies. It is anticipated that CG200745 will be developed to treat cancer types of high incidences such as colon cancer, breast cancer, gastric cancer, and hematological cancers including lymphoma, leukemia and multiple myeloma.

Preclinical study results have confirmed CG200745’s safety profile done in Europe, and its efficacy was also demonstrated against various cancer cell lines. It was also observed that CG200745 had better efficacy profile than Merck’s recently approved Zolinza.

"We are excited to conduct our study at the Seoul Asan Medical Center, a premier hospital with one of the highest standards in Korea. We are highly optimistic moving forward and look forward to the opportunity to provide new hope and improved quality of life for many suffering cancer patients," commented Dr. Joong Myung Cho, President & CEO of CrystalGenomics.

CrystalGenomics Announces a Merger with BexPharm and Emerges as an Integrated Biopharmaceutical Company

On May 28, 2010 CrystalGenomics, Inc. (www.cgxinc.com), a leading biopharmaceutical company developing novel small molecule therapeutics reported that it will merge with BexPharm, a specialty pharmaceutical company that imports and distributes foreign market approved drugs in Korea (Press release, CrystalGenomics, MAY 28, 2010, View Source [SID1234539170]).

The main motive for this merger is to provide necessary tools and infrastructures for CrystalGenomics to transform into an integrated biopharmaceutical company with discovery, development and commercialization capabilities. CrystalGenomics recently announced successful completion of Phase I SAD study for CG400549, its novel antibiotic candidate in Europe and plans to begin the MAD study to complete Phase I studies. Additionally, its novel NSAID candidate CG100649 is in Phase II and with CG200745, its molecular targeted cancer therapeutic candidate entering Phase I shortly, CrystalGenomics will have three solid drug candidates in clinical stage within this quarter.

This merger would instantaneously add sales and marketing infrastructures to CrystalGenomics’ long list of abilities whose core competencies used to just comprise of drug discovery and development capabilities prior to merger. BexPharm merger will enable CrystalGenomics to independently develop and commercialize drugs without the need for partnering in Korea and gives a clear competitive advantage over other biotechs with ‘traditional’ business models.

BexPharm is a hospital specialty pharmaceutical company that primarily deals with inpatient prescription products. Its sales revenue for 2009 was USD 13 million and it is anticipated that two additional launches of a liver cancer drug and an atopic dermatitis drug will boost sales. After the merger has been finalized, CrystalGenomics plans to utilize its global network of pharmas, biotechs, and venture capital companies to aggressively License-In either marketed products or clinical stage novel candidates.

President & CEO of CrystalGenomics, Dr. Joong Myung Cho said, "Although this is a small scale merger, we are glad that the entire transaction was completed without having to use any of our cash. We expect to see great synergy between CrystalGenomics’ discovery & development capabilities and BexPharm’s pharmaceutical business empowered by its sales force and strong network with Korean hospitals. The steady revenue from our pharmaceutical business will support our R&D and we will do our best to emerge as a successful biopharmaceutical company with a goal to be in the same league as our counterparts in US and EU."

Novocell Becomes ViaCyte, Inc, as it Accelerates Pre-clinical Development of a Stem Cell Derived Treatment for Diabetes

On May 5, 2010 Novocell, Inc., a preclinical stage stem cell engineering company focused on diabetes, reported the Company’s shareholders and Board of Directors approved a name change to ViaCyte, Inc (Press release, ViaCyte, MAY 5, 2010, View Source [SID1234517100]).

The name ViaCyte retains the Company’s identity as a leading cell therapy company, as"-cyte" is derived from the Greek "kytos" which means cell. As the Company is moving towards the market, clear and unambiguous brand recognition is increasingly important. With its new name, the Company has also adopted a new corporate logo. An abstract flower emphasizes the rejuvenation possible through a stem cell-derived therapy.

The name ViaCyte was previously used by ViaCell, Inc., but their use was discontinued following acquisition of ViaCell by Perkin Elmer, Inc. The Company has acquired all rights to the ViaCyte service marks and internet domain name addresses previously owned by ViaCell. The Company’s product developments are not related to those of ViaCell or Perkin Elmer.

The Company’s new name also provides consolidation. The Company is the result of a three-way merger in 2004 of Novocell, Inc. (Irvine, CA), Cythera, Inc. (San Diego, CA) and BresaGen, Inc. (Athens, GA). Going forward, the Company is focused on stem cell innovations initiated in its San Diego and Athens locations, and has discontinued work on PEG-encapsulated islets that were the focus of its former Irvine location. All of the Company’s operations will use the ViaCyte name. The Company’s wholly owned subsidiary in Athens, Georgia will take the name ViaCyte Georgia.

CRT DISCOVERY LABORATORIES TEAM UP WITH INDUSTRY

On April 24, 2010 CRT reported that in recent months real proof of success of our cutting edge technology transfer and Drug Discovery capabilities has come from major industry partnerships (Press release, Cancer Research Technology, APR 29, 2010, View Source [SID1234523527]). In February 2010, they teamed up with biopharmaceutical, AstraZeneca, in a multi project alliance to create ‘cancer metabolism drugs’. A month later, they announced an exclusive agreement with international biotechnology company Cephalon, to collaborate on the development of small molecule inhibitors.

Set up as a major strategic initiative by CRT, our laboratories form a fully integrated part of Cancer Research UK’s long-term Drug Discovery strategy. The CRT Discovery Laboratories (CRT-DL) typically focus on both small molecule and biological therapeutics, with the view to generating compelling data packages for novel targets. The CRT-DL works closely with the originating academics, bringing drug discovery disciplines to bear to discover novel prototype therapeutics that are used to confirm target validation and provide a platform for development candidate identification with a pharmaceutical industry partner.

These relationships represent a significant milestone in the development and success of the CRT-DL and are a positive affirmation from industry that CRT is at the forefront of advancing cancer discoveries.

Harpal Kumar, Cancer Research UK’s Chief Executive said: "Investing in partnership with pharmaceutical companies in the discovery and development of new cancer drugs will help us to accelerate progress towards our goal of finding new treatments for cancer patients. We hope these alliances will result in a number of new weapons in our fight to beat cancer."

CRT was the first technology transfer organisation to establish a substantial in-house drug discovery capability. Our unique model brings together the strengths of academic exploration of novel biology with the rigor of our industrially-sourced drug discovery team. In the case of the Cephalon partnership, Cancer Research UK funded researchers Professors Peter Parker and Neil McDonald, working within the London Research Institute has been an integral part of the target validation and development of the small molecule inhibitors.

Being able to ‘matchmake’ promising hot areas of cancer research from our leading translational researchers across the UK with the interests of biotechnology companies puts CRT and our Discovery Laboratories at the centre of novel strategic alliances with industry. Over the coming year, CRT will explore similar possible alliances in other promising areas of cancer biology.

UK-NZ collaboration to home in on new anti-cancer drug for leukaemia

On April 22, 2010 Cancer Research Technology (CRT) – Cancer Research UK’s development and commercialisation arm reported it has teamed up with The University of Auckland to advance the discovery of new molecular targeted compounds for the treatment of leukaemia (Press release, Cancer Research Technology, APR 22, 2010, View Source [SID1234523337]).

Scientists based at the Auckland Cancer Society Research Centre and CRT’s Discovery Laboratories in London and Cambridge will focus on developing a treatment that will target an enzyme that has been linked to the growth and development of leukaemia cells.

The target enzyme’s role in leukaemia was discovered by scientists at the University of Birmingham, funded by the charity Leukaemia & Lymphoma Research. Collaborative effort between CRT’s Discovery Laboratories and Dr Christopher Bunce, whose group made the discovery, has led to the identification of a series of compounds that will form the basis of this UK/NZ collaboration.

Work at The University of Auckland is supported by a pre-seed investment from Auckland UniServices Ltd, the commercial research and knowledge transfer company of the University. CRT retains exclusive rights to commercialise the intellectual property arising from this deal.

Dr Phil L’Huillier, CRT’s director of business management said: "This exciting partnership exemplifies CRT’s expertise in ‘matchmaking’ promising areas of cancer research with expert drug discovery teams across the globe. By establishing partnerships with groups with complementary expertise, CRT aims to advance discovery of novel treatments for cancer."

Leukaemia is a cancer of the blood or bone marrow which is characterised by uncontrolled growth of blood cells, usually white blood cells. The term leukaemia covers a spectrum of diseases that affects around 7,000 people in the UK and 600 people in New Zealand each year.

Professor Bill Denny, co-director of the Auckland Cancer Society Research Centre, School of Medical Sciences said: "Growing evidence is showing that targeting this important enzyme has the potential to lead us to new treatments for leukaemia and potentially other cancers, so we are extremely excited to be taking the programme forward. The first step will be to generate improved compounds which could ultimately move into preclinical development."

Dr Hamish Ryder, CRT’s director of drug discovery, said: "We’ve identified several promising series of compounds which, in combination with the strong therapeutic rationale established at the University of Birmingham, make for a very exciting project. We look forward to working with the drug discovery team at The University of Auckland to progress these compounds into a potential therapy for cancer."