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Company News: MediGene Presents Overall Survival Data from a Phase II Trial of EndoTAG®-1 in Triple-Negative Breast Cancer (TNBC)

– Positive efficacy trend of EndoTAG®-1/Paclitaxel combination therapy confirmed
– Subgroup analysis reveals encouraging overall survival data with EndoTAG®-1 plus paclitaxel combination therapy

MediGene AG today announced median overall survival data from its phase II trial of EndoTAG®-1 for the treatment of triple-negative breast cancer (TNBC), which was presented at the San Antonio Breast Cancer Symposium in San Antonio, USA. The secondary endpoint data confirm the positive efficacy trend of EndoTAG®-1 in combination therapy with standard weekly paclitaxel, which was previously reported by the primary endpoint data (progression-free survival rate at 16 weeks). Furthermore, an additional analysis of a subgroup of patients not predefined in the study protocol (119 of 140 patients: ECOG 0/1, first-line therapy for advanced cancer) showed encouraging overall survival data with EndoTAG®-1/paclitaxel combination therapy. The data were presented by Prof. Dr. Ahmad Awada, principal investigator of this trial and Head of the Medical Oncology Clinic at Jules Bordet Institute in Brussels, Belgium.

140 patients diagnosed with TNBC participated in the phase II clinical trial. Patients were randomized to three groups and received either EndoTAG®-1 in combination with weekly paclitaxel (55 patients) or EndoTAG®-1 monotherapy (57 patients). The third group (28 patients) only received weekly paclitaxel. The patients treated with combination therapy received 22 mg/m2 EndoTAG®-1 plus 70 mg/m2 paclitaxel once per week. EndoTAG®-1 monotherapy was administered twice per week, in a dosage of 44 mg/m2 per treatment. The paclitaxel monotherapy consisted of a once weekly 90 mg/m2 dose. The clinical trial was conducted in more than 30 centers in several European countries and in India. The study was not powered for intergroup comparisons.

Median overall survival time (as at reference date “visit week 41” of the last patient treated) for those 133 patients with TNBC status confirmed by central lab was 13.0 months in the EndoTAG®-1/paclitaxel combination therapy arm (51 patients), 11.9 months in the EndoTAG®-1 monotherapy arm (57 patients), and 10.1 months in the paclitaxel monotherapy arm (25 patients). Further data analysis of this group was done for those 124 patients treated per protocol. Median overall survival in this group was 15.1 months in the EndoTAG®-1 combination therapy arm (48 patients), 12.5 months in the EndoTAG®-1 monotherapy arm (52 patients), and 8.9 months in the paclitaxel monotherapy arm (24 patients).
Additionally, MediGene analyzed a subgroup of patients that was not predefined in the study protocol. This included patients with centrally confirmed TNBC status, ECOG performance status of 0/1 at the start of the clinical trial and who received first-line treatment after tumor relapse (119 patients). Median overall survival in this group was 17.8 months in the EndoTAG®-1 combination therapy arm (45 patients), 11.7 months in the EndoTAG®-1 monotherapy arm (50 patients), and 10.1 months in the paclitaxel monotherapy arm (24 patients).

Data regarding the primary endpoint of the trial (progression-free survival rate at week 16), the secondary endpoints progression-free survival rate, clinical benefit rate, and best overall response, as well as safety and tolerability of EndoTAG®-1 have previously been published and are available at http://www.medigene.de/presse_en/endotagTNBC.

Innovation Radar: Brilliant Mistakes – Finding Success on the Far Side of Failure

Everybody knows of instances in their own life where initial “mistakes” or wrong decisions turned out to be exactly the right thing. Trivial examples include going to a party that you never really wanted to attend and ending up meeting the person of your life – or running ten minutes late and thereby avoiding a fatal car crash that had just occured down the road.

But what about the most carefully managed area in life – your own career and business? Thinking that wrong business decisions must mean the end of your career? The opposite may be the case, says Paul J.H. Schoemaker, research director of Wharton’s Mack Center for Technological Innovation and chairman and founder of consulting firm Decision Strategies International.

In his book Brilliant Mistakes: Finding Success on the Far Side of Failure, Schoemaker argues that mistakes often open the door to totally new perspectives and findings – and help you reinvent your business or personal career for good. Mistakes have been the basis for many innovations that revolutionized the way we live today – including the discovery of penicillin and the development of ATM machines.

Knowledge@Wharton features an interview with Paul J.H. Schoemaker, who talks about the concept of brilliant mistakes – i.e. ignoring conventional wisdom at the time – and the innovative potential of this approach. Being risk averse, he says, is not going to take businesses very far and will kill their productivity and their ability to adapt to new markets and opportunities. Instead, both executives and researchers should be able to learn from surprises and turn failures into successes by looking at them from a totally different angle.

Certainly an interesting concept for anyone working in an industry that is characterized by decreasing productivity, lack of true innovation and stagnation – e.g. the pharmaceutical sector. After all, cost-cutting and consolidation have not emerged as effective means to spur innovation.

Interview with Paul J.H. Schoemaker on Brilliant Mistakes

Company News: Keeping an Eye on Micromet

The human immune system is one of the body’s most powerful weapons to combat cancer, and therefore a lot of companies are working to activate it against tumors, writes Siegfried Hofmann in Handelsblatt this week. As an example, he features the BiTE antibodies developed by Micromet, Inc. These BiTE antibodies bind to T cells and subsequently to specific tumor antigens on cancer cells. Thereby, the T cells are activated and start destroying the tumor cells. The first drug candidate is in late-stage clinical development to treat Leukemia, Hofmann writes. The article is also being featured in the internet version of Wirtschaftswoche.

Micromet recently started a Phase 2 trial of its lead product blinatumomab (MT103) in relapsed/refractory acute lymphoblastic leukemia (ALL), a very difficult to treat disease. If initial results generated from this trial are compelling, Micromet plans to discuss with the FDA potential avenues to accelerate blinatumomab’s path to market. Blinatumomab is also being tested for the treatment of non-Hodkin’s Lymphoma (NHL). In addition, the company announced it hired Joseph Lobacki as Senior Vice President and Chief Commercial Officer. Previously, Lobacki was Senior Vice President and General Manager, Transplant and Oncology at Genzyme. Christian Itin, CEO of Micromet said “his extensive sales, marketing and medical affairs experience will be critical as we look to prepare the marketplace for blinatumomab’s potential launch.”

 

Food for Thought: Weekly Wrap-Up

Die Welt this week reports on plans by BayerCropScience, a division of Bayer AG, to develop new, heat- and drought-resistant wheat varieties. To accomplish this goal, BayerCropScience will refrain from introducing novel genes into the wheat genome for fear of protests in Europe. However, the company is cooperating, among others, with Israel-based Evogene to also develop genetically engineered crops for other markets.

Michael Simm in Focus features the latest accomplishments of synthetic biology in which researchers control artificially introduced networks of genes in cells and tissue. As an example, scientists from the Department of Biosystems Science and Engineering (D-BSSE) in Basle, Switzerland, have inserted genes for hormone production into cells. By adding genetic control elements that can be switched on by irradiation with blue light these genes can be controlled from outside. As an example, the researchers in vitro introduced a genetic network for the production of insulin into human tissue which subsequently was micro encapsulated and transplanted to the skin of diabetic mice. After a meal, blue light is applied to switch on insulin production in order to normalize blood sugar levels. The model works well so that the researchers are thinking about clinical trials. Already, the use of light to switch on genes has led to the new scientific discipline of optogenetics which is exploring light-controlled genes and cells to treat diseases such as Parkinson’s or epilepsy. D-BSSE researchers also developed cells carrying a network of genes that is able to normalize uric acid levels in gout patients.

Siegfried Hofmann in Handelsblatt is introducing various therapeutic approaches of biopharmaceutical companies in a series entitled “future lab 2020.” Topics range from personalized medicine to stem cell therapies to novel immune therapies.

David Shaywitz in Forbes provides a thoughtful article explaining why Silicon Valley failed to make a dent in the healthcare space: “most tech-savvy entrepreneurs lack an in-depth appreciation for the complexity of medicine in general, and the nuances of the doctor-patient dynamic they are confidently trying to influence or replace.” He goes on to say that management of high-tech companies needs to understand the science: “When a science-driven business is led by leaders who don’t even know what they don’t know, and who actually believe that the crisp powerpoint slides that bubble up for their review actually and adequately represent the science involved – then you risk making some very ignorant decisions.”

The New Scientist this week features a story on how cancer cells can be poisoned with  2-deoxyglucose. The sugar dislodges a protein protecting a suicide switch which subsequently can be triggered by ABT-263 navitoclax, a molecule under development at Genentech. The magazine also reports on a call for proposals by DARPA, the US military’s research arm, to develop small interfering RNA (siRNA) to fight bacteria. DARPA is seeking ideas for adaptable nanoparticles that can be reprogrammed “on the fly” by loading up specific siRNA to deal with outbreaks among troops.

And finally, the Economist features people pioneering the backyard generation of fuel to power their diesel cars. The recipe starts with collecting used kitchen oil, which after some filtering is broken down into esters and glycerol by adding sodium hydroxide and methanol and heating. Glycerol is drained away and the remainder is washed with water to get rid of impurities. Removing residual water and moisture is done with an aquarium bubbler. The resulting biodiesel, the article states, can be used in diesel cars without any modification. Already, British company Oilybits is selling devices to produce 120 liter batches of biodiesel in a more professional way.

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