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BioSante Pharmaceuticals Sells Oncolytic Virus Technology to Cold Genesys, Inc.

On November 17, 2010 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), reported it sold to Cold Genesys, Inc. exclusive, worldwide rights to develop and commercialize its oncolytic virus technology (Press release, BioSante, NOV 17, 2010, View Source [SID1234531732]). The technology includes CG0070, a replication-competent adenovirus that has completed a Phase I clinical trial for treatment of superficial bladder cancer. In exchange for the technology, BioSante received a 19.9 percent ownership position in Cold Genesys and a $95,000 upfront cash payment and is eligible to receive future milestone and royalty payments.

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Oncolytic (cancer cell killing) virus therapy is novel therapy that utilizes adenoviruses, a cause of the common cold, which are engineered to selectively replicate in targeted cancer cells, thereby killing these cells while leaving healthy cells largely unharmed. The virus is designed to replicate in cancer cells producing large amounts of oncolytic virus until the cancer cell can no longer contain the virus and bursts. The tumor cell is destroyed and the newly created oncolytic virus spreads to neighboring cancer cells to continue the cycle of viral replication and tumor cell destruction.

Stephen M. Simes, president and CEO of BioSante, said, "This is an important step in maximizing the value of technologies acquired late last year. This transaction allows us to transfer our oncolytic virus technology to a company with the expertise and ability to move it along the development path. By maintaining an ownership position in Cold Genesys, Inc. as well as the potential for future milestone and royalty payments, we have maintained important ‘upside’ in this exciting technology."

Paul A. DeRidder, MD, urologist and COO of Cold Genesys states, "CG0070 has demonstrated that tumor cell destruction may be achieved through direct adenovirus-mediated oncolysis and GM-CSF induced anti-tumor cell immune activation. Given the significant toxicity and limited efficacy of current treatment options, additional therapies for superficial and invasive bladder cancer are needed in order to increase bladder preservation and improve long term outcomes. Therefore, we are very excited to move this technology including CG0070 forward as an effective cancer treatment."

BioSante acquired rights to the oncolytic virus technology through its 2009 merger with Cell Genesys, Inc. BioSante also acquired other technologies and a full portfolio of cancer vaccines which may represent the widest portfolio of cancer vaccines in clinical development for a wide variety of cancers.

10-Q – Quarterly report [Sections 13 or 15(d)]

Advanced Life Sciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

(Filing, 10-Q, Zalicus, NOV 10, 2010, View Source [SID:1234504422])

4SC Announces Initial Phase II Data from the SAPHIRE Study with Resminostat at the 8th International Symposium on Hodgkin Lymphoma

On October 26, 2010 4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, reported the presentation of Phase II data from Hodgkin Lymphoma patients treated in the 1st Simon Stage cohort of the ongoing SAPHIRE study with resminostat (4SC-201), an oral pan-histone deacetylase (HDAC) inhibitor, at the 8th International Symposium on Hodgkin Lymphoma in Cologne, Germany (Press release, 4SC, OCT 26, 2010, View Source [SID1234533469]).

The oral presentation will be given by the lead investigator of the SAPHIRE study, Prof Dr Jan Walewski of the Marie-Skłodowska-Curie Memorial Institute in Warsaw, Poland. It highlights initial safety and tolerability as well as efficacy data from the first 18 patients with relapsed or refractory Hodgkin Lymphoma in this study.

Daily oral application of 600 mg resminostat for 5 consecutive days per 2-week treatment cycle was well tolerated with the majority being mild to moderate gastrointestinal and haematological side effects. In addition, a number of anaemia cases were observed, however these were judged as being primarily related to the underlying disease. Pharmacokinetic data indicate good bioavailability of this HDAC inhibitor and plasma exposure levels yielded significant pharmacodynamic activity as exemplified by time dependent HDAC enzyme inhibition after dosing.

In this first patient cohort, the average treatment duration with resminostat reached approximately nine weeks. Anti-tumour activity of the drug was assessed every six weeks by combination of computer tomography (CT) and positron-emission tomography (PET), a technique which allows the simultaneous evaluation of changes in the metabolic activity and the size of a tumour lesion. Based on established PET/CT evaluation criteria, 10 patients out of 18 benefited from treatment with resminostat with two patients being assessed as partial responders (PR) (i.e. more than 50% reduction in size of tumour lesions) and a further eight patients with stabilization of disease (SD). Based on PET analysis almost all of these patients showed a diminished metabolic activity of their lesions with the majority being evaluated as partial metabolic responders (more than 25% decrease in PET activity). These results are based on intermediate analysis of the data and are therefore subject to final review.

According to the statistical design of the SAPHIRE study (Simon two-stage design), a minimum number of five responders were required in this reported 1st Simon stage in order to extend the study to a second enrolment phase of an additional 15 patients (the 2nd Simon stage). After reaching this threshold the study has recently proceeded into the 2nd Simon stage recruitment phase. Due to the good tolerability and side effect profile observed in this relatively young HL patient population an optional increase of the daily dose of resminostat from 600 mg to 800 mg has been implemented.

Prof Walewski of the Marie-Skłodowska-Curie Memorial Institute in Warsaw, Poland, the lead investigator of the SAPHIRE study, commented: ‘Despite the fact that patients with Hodgkin Lymphoma often respond well to first-line treatment with chemotherapy, there is an urgent medical need for new therapeutic approaches for patients relapsing or becoming refractory to standard therapy. For patients not responding to second line high-dose chemotherapy the 5-year progression-free survival rate is as low as 17%. Hodgkin Lymphoma patients are often very young and the repeated use of chemotherapy can lead to secondary tumour developments in addition to the primary lymphatic cancer. Based on the initial data presented on the 1st Simon stage of the trial, we are hopeful that resminostat may provide a new therapy option to relapsed or refractory HL patients.’

Dr Bernd Hentsch, Chief Development Officer at 4SC, commented: ‘We were very pleased with these initial results and are hopeful of the potential of our oral, pan-HDAC Inhibitor resminostat as a monotherapy treatment for advanced Hodgkin Lymphoma patients. We feel that this indication could provide a clinical proof-of-concept for resminostat, which is currently also being evaluated as a combination treatment in solid tumour indications.’

Servier and Vernalis Achieve Research Milestone in 2nd Oncology Collaboration

On October 25, 2010 The Servier Research Group and Vernalis reported they have achieved a research milestone in their three year oncology drug discovery collaboration initiated in May 2009 (Press release, Servier, OCT 25, 2010, View Source [SID:1234508828]). This is the second collaboration between Servier and Vernalis, the first collaboration is focused on developing two promising oncology targets involved in protein-protein interactions.

Emmanuel Canet, MD, PhD, President Servier Research and Development, added: "We are very satisfied with this collaboration reaching an important milestone on a truly innovative oncology target. This is a step further in our aim to finalise the discovery of innovative compounds with potential use in therapeutic indications with high unmet medical need. Cancer represents a major cause of mortality worldwide and Servier is committed to providing patients with novel therapeutic approaches for treating this devastating disease.
Vernalis is an English biotech company which has a high-level technical background and recognised expertise in research and development.