Simcere Pharmaceutical Group Announces SFDA Approval to Manufacture and Market Palonosetron in China

On August 12, 2010 Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE:SCR – News), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, reported that its subsidiary company Simcere Dongyuan Pharmaceutical Co., Ltd. has recently received SFDA new drug certification and registration approval to manufacture and market Palonosetron material and injections in China (Press release, Jiangsu Simcere Pharmaceutical Company, AUG 12, 2010, View Source [SID1234591865]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Palonosetron is a second generation 5-HT3 antagonist used for the prevention and control of acute chemotherapy-induced nausea and vomiting (CINV). According to industry analysis, 5-HT3 antagonists account for 90 percent of the CINV market in China.

CRT and ValiRx sign licensing deal to develop Prostate Cancer treatment

On August 12, 2010 Cancer Research Technology reported it has signed a deal to provide biotech company ValiRx plc with the global rights to develop a promising compound to treat hormone-resistant prostate cancer (Press release, Cancer Research Technology, AUG 12, 2010, View Source [SID1234523334]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The compound, now called VAL 201, has been shown in pre-clinical tests in mice to stop growth of tumours which have been unresponsive to hormone treatments. VAL 201 blocks genes which can cause prostate cancer to develop. The compound has been shown to be effective in treating mice with breast and prostate cancer and is now rapidly progressing towards the first clinical trials in patients.

Under the terms of the deal, ValiRx has exclusive rights to use the compound to treat, prevent and diagnose cancer and other diseases. Cancer Research Technology will receive milestone payments throughout the development and commercialisation of the compound and royalty payments for potential licensed treatments.

Currently, prostate cancer is the most common cancer amongst men with 36,000 men being diagnosed and around 10,150 deaths each year in the UK. Of all men with advanced stage prostate cancer, hormone therapy will work for between eight and nine out of every 10. But many men will become resistant to the treatment at some stage. This does not appear to be related to the length of time a man is receiving treatment.

Dr Phil L’Huillier, Cancer Research Technology’s director of business management, said:
"This partnership demonstrates CRT’s ability to maximise its broad network, having identified and licensed this project from Naples, and then in turn partnered it for further preclinical and clinical development with ValiRx.

"We will follow further trials to test its suitability as a new treatment to potentially increase survival from this disease with great interest."

Under the terms of the licence with Cancer Research Technology, ValiRx will be responsible for performing the pre-clinical regulatory development of VAL 201 to prepare the compound for early clinical trials in patients. ValiRx will manage the commercialisation of potential treatments after clinical trials.

Satu Vainikka, CEO of ValiRx, said: "This is a significant and exciting opportunity for ValiRx and we look forward to continue working with CRT and in taking VAL 201 forward in its next stage of development as a potentially exciting treatment against prostate cancer."

Antibody Licence Agreement with Scancell Holdings Plc

On August 9, 2010 Cancer Research Technology Ltd (‘CRT’) – Cancer Research UK’s commercialisation and development arm, and Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines – reported that they have signed an agreement under which Scancell has been granted a licence to use a human antibody known as 105AD7 (Press release, Cancer Research Technology, AUG 9, 2010, View Source [SID1234523335]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

105AD7 is a human monoclonal antibody that mimics the complement regulatory protein, CD55. The antibody was discovered and originally developed at the University of Nottingham with support from Cancer Research UK and has previously been evaluated in clinical trials for osteosarcoma. The agreement will give Scancell a worldwide licence to use 105AD7 for the development of new ImmunoBody vaccines for any immunotherapy indication.

The licence will be restricted to the use of the antibody as a framework for future ImmunoBody vaccines. Scancell’s current ImmunoBody vaccines, such as SCIB1, its vaccine currently in Phase I clinical trials for the treatment of melanoma, use a deimmunised* antibody as the framework. 105AD7 will allow Scancell to use a fully human framework for the development of future ImmunoBody vaccines.

Under the terms of the agreement, Scancell will make an upfront payment to CRT in addition to development milestone payments, and royalty payments on future sales. Scancell will exclusively fund the development work, and have sub-licensing rights on agreed terms.

Professor Lindy Durrant, Chief Executive Officer of Scancell, commented:
"I am pleased that we have secured this important agreement with Cancer Research Technology. By utilising antibody 105AD7, Scancell will be able to further enhance the clinical utility and safety of Scancell’s ImmunoBody platform both in cancer and other immunotherapy indications."

Dr Phil L’Huillier, Cancer Research Technology’s director of business management, said:
"Through this deal with Scancell we are able to take forward this antibody arising from research from our worldclass scientists into commercial development to potentially make new vaccines to treat a range of diseases."

(Filing 10-Q , Exelixis, AUG 5, 2010, View Source [SID:1234501029])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Tumor specific vaccination therapy for advanced/recurrent cervical cancer using HLA-A*2402 restricted Specific Epitope Peptides Cocktail derived from Tumor genom/Tumor related Angiogenetic factors genom

Cancer, cervical
It is in a Phase I/II tumor specific vaccination therapy for advanced/recurrent cervical cancer using HLA-A*2402 restricted specific epitope peptides cocktail derived from tumor genome/tumor related angiogenetic factors genome (Clinical trial, Trial ID:UMIN000003902, UMIN, JUL 11, 2010, View Source [SID1234520547]). Advanced/recurrent cervical cancer with the conditions of unremoval by surgery, or refractory, chemo-resistant disease. Objective I: To elcidate the feasibility and efficacy of HLA-A*2402 restricted Specific Epitope Peptides Cocktail of FOXM1,MELK,and HJURP. Objective 2: Safety,Efficacy

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!