Heidelberg, Germany, November 6, 2012 - Apogenix, a clinical stage biopharmaceutical company developing novel protein therapeutics for the treatment of cancer and inflammatory diseases, today announced that its lead product, Apocept(TM) (APG101), has been selected by Elsevier Business Intelligence and Windhover Conferences as one of oncology`s "Top 10 Projects To Watch". This announcement is in conjunction with the "Therapeutic Area Partnerships" conference event taking place in Boston from Nov. 28 to 30. Apogenix`s CEO, Thomas Höger, Ph.D., will be presenting an overview on Apogenix`s controlled Phase 2 study of Apocept in patients with recurrent glioblastoma multiforme (GBM) on Nov. 29.
"We are honored that our lead candidate, Apocept, has been selected as one of Windhover`s Top 10 Projects to Watch," said Dr. Höger. "Apocept is the first drug in more than a decade that has shown clear benefits in a randomized, controlled clinical trial regarding quality of life, progression free survival as well as overall survival in patients with recurrent GBM, a disease that represents a tremendous unmet medical need. Best responses were seen in patients expressing a newly identified biomarker. Apocept`s unique mechanism of action has potential in many other cancers beyond GBM."
"Selected companies have been screened using a strict set of judging criteria for the Top 10 award and represent what our committees considered the most attractive oncology opportunities the industry has to offer," said David Cassak, Vice President, Content, Windhover Conferences, a division of Elsevier Business Intelligence. "Winners have met rigorous criteria, including: unmet medical need, market potential, diversity of indications, strong science, multi-level partnering opportunities (biotech and pharma), potential for new opportunities beyond initial indications and corporate stability."
Apogenix, a spin-out from the German Cancer Research Center (DKFZ), is developing novel protein therapeutics for the treatment of cancer and inflammatory diseases based either on the targeted modulation of apoptosis (programmed cell death) or on blocking the growth of tumour cells. The company`s lead product candidate Apocept (APG101) is being developed for the treatment of glioblastoma, the most common and aggressive type of primary brain tumour. In 2013, an additional clinical study with Apocept will be initiated in patients suffering from myelodysplastic syndromes. Since its inception in 2005, the company has raised more than €50 million with dievini Hopp BioTech Holding GmbH & Co. KG as main investor, and has been awarded public grants totaling over € 8 million. Apogenix is based in Heidelberg, Germany.
About Apocept (APG101)
The company`s lead product candidate, Apocept, a first-in-class, fully human fusion protein combining the extracellular domain of the CD95 receptor and the Fc portion of IgG, successfully completed a phase 1 study in 2009. In December 2009, Apogenix started a controlled phase 2 trial with the compound for the treatment of recurrent glioblastoma. The patient recruitment for this study was completed in September 2011. The primary endpoint as well as a number of secondary endpoints of the trial were successfully reached in 2012. Apogenix was granted orphan drug designation for Apocept in 2009 for the treatment of glioblastoma in Europe and in the US.
Glioblastoma is the most frequent and aggressive brain tumour belonging to the group of gliomas. The tumour cells show a high resistance to radiation and chemotherapy. They spread and infiltrate the neighboring tissue so quickly that eradicative surgery is often impossible. Due to the diffuse infiltration into brain tissue, recurrence is often experienced within months after initial treatment. Approximately 28,000 new cases of malignant glioma are diagnosed in the US and EU each year (Source: US National Cancer Registry). The current standard therapy focuses on surgery, followed by radiotherapy and chemotherapy. The relative survival rate for adults diagnosed with glioblastoma is less than 30% within one year of diagnosis. Only 3% of patients live longer than five years after primary diagnosis (Source: Central Brain Tumor Registry of the United States) showing the high unmet medical need in this indication. Currently, there are no approved treatment options available for recurrent glioblastoma patients with proven efficacy data from an actively controlled clinical trial.
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