Clinical Trials to Start for a NEW AT/RT Treatment
Posted Nov 03 2008 9:03pm
It sounds to me from my incredibly minimal understanding that pediatric clinical trials have started for a brand new treatment for, among other things, AT/RT. As far as I can tell, this appears to be a virus that kills tumor cells, perhaps exclusively. While we will ask Vivi's oncologist about it, if anyone has any understanding, comment, information or otherwise can shed some light on this, we would be interested to hear about it.
MALVERN, PA -- (Marketwire) -- 10/22/08 -- Neotropix®, Inc., a clinical-stage development company focused on neuroendocrine cancer treatments, announced today exciting data from an extensive pediatric preclinical study performed by the National Cancer Institute (NCI) funded Pediatric Preclinical TestingProgram on the use of NTX-010 (Seneca Valley Virus-001), a tumor-selective naturally-occurring oncolytic virus. The results support the initiation of clinical development of Neotropix's lead candidate, NTX-010 for the treatment of pediatric cancers. NTX-010 has been developed as a cancer therapeutic to treat some of the most aggressive cancers known which occur in adults including small cell lung cancer, large cell non-small cell lung cancer, as well as other adult cancers such as carcinoid and various neuroendocrine cancers.
The detailed study results are being presented at the 20th Annual MolecularTargets and Cancer Therapeutics International Meeting in Geneva,Switzerland from October 21-24, 2008. The meeting is hosted jointly by the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI), and the American Association for CancerResearch (AACR). The Pediatric Preclinical Testing Program (PPTP) presentation described encouraging results from an extensive evaluation of NTX-010 in over 30 different tumor models representing the most common types of childhood solid tumors. Extensive analysis has previously determined that these carefully selected models, many derived directly from patients' tumors, are predictive of clinical activity and an important tool for screening promising new drug candidates for their relevance for specific childhood cancers. The PPTP results indicated that NTX-010 was active against a widerange of pediatric solid cancers, including neuroblastoma,rhabdomyosarcoma, Wilms tumors, rhabdoid, Ewing sarcoma and glioblastoma. Complete responses were observed following a single intravenous treatmentin the majority of neuroblastoma models and in all alveolarrhabdomyosarcoma tumor models, demonstrating both activity and potency.
Paul Hallenbeck, Ph.D., President and Chief Scientific Officer ofNeotropix®, Inc., commented, "We are very encouraged by the results ofthis extensive analysis of NTX-010 in pediatric oncology models, particularly because these in vivo cancer models that the NCI has developed can prospectively identify novel agents subsequently shown to have clinical activity against specific cancers of children and adolescents." Dr. Hallenbeck continued, "We are excited that the NCI-supported Children'sOncology Group Phase I Consortium has expressed the interest to lead aneffort to test NTX-010 in pediatric patients with cancer in the near future."
Neotropix® has been working closely with many collaborators around the world, including the NCI to create a treatment paradigm shift for hard to treat cancers. The Company has developed an innovative approach to harness the power of natural products screening using viruses to kill or slow down the spread of cancer. The result has been that many viruses have been identified that may provide simple, safe and effective ways to treat patients who would otherwise fail conventional treatments using traditional small molecule and antibody approaches.
About NTX-010 and the Current Clinical Trial
NTX-010 is a natural occurring oncolytic virus, which is highly selective for certain tumor cell types expressing a biomarker that indicates the cancer has neuroendocrine properties such as synaptophysin, chromogranin A,or CD56. At least one of them is required to be positive before treatment.Unlike many previous oncolytic virus product candidates developed by others, NTX-010 is a stable, naturally occurring virus, is systemically deliverable, and has not been observed to be pathogenic to humans, and therefore, has not had to be genetically modified. NTX-010 is systemically delivered in a single one-hour infusion on anoutpatient basis at each of the treatment centers, which simplifies the treatment process for patients. The product is anticipated to have enhanced efficacy and less toxicity than currently approved therapies for permissive cancers. The clinical trial is being conducted at multiple institutions around thecountry, including John Hopkins (MD), Mary Crowley (TX), Lahey Clinic (MA)and many U.S. Oncology Cooperative Group treatment sites (FL, IN, NY, OH,SC, TX, VA, and WA). In addition, other treatment centers are joining the trial in the New England area of the U.S.
The current Phase I / II clinical trial is enrolling adults (18 and over)that meet the criteria for the following cancers: carcinoid cancers (alltypes), large cell lung cancer-neuroendocrine, alveolar rhabdomyosarcoma,neuroblastoma, glioblastoma, Ewing's family of tumors, Wilms tumors,retinoblastoma, rhabdoid, and medulloblastoma.
Neotropix® Inc., is focused on the development of anti-cancer products that have a high degree of selectivity for cancer cells resulting in an excellent safety and therapeutic efficacy profile. Neotropix® develops and commercializes systemically deliverable oncolytic viruses for the treatment of solid tumors. Capitalizing on its unique sources of naturallyoccurring viruses that selectively target tumors discovered using thecompany's proprietary technology platform Viruscreen(TM), the Company hasthe knowledge and skills to translate these discoveries into commercial products. Neotropix® is committed to making a difference in the lives of cancer patients. Neotropix® commenced operations in 2005 in Malvern, Pennsylvania. Neotropix ® is funded by venture-capital investors including AuroraFunds, Quaker BioVentures and VIMAC Ventures. For more information, pleasevisit http://www.neotropix.com/.
About the Pediatric Preclinical Testing Program
The NCI-supported Pediatric Preclinical Testing Program (PPTP) is acomprehensive program to systematically evaluate new agents againstchildhood solid tumor and leukemia preclinical models. The PPTP issupported through an NCI research contract to St. Jude Children's Research Hospital (SJCRH) with Dr. Peter Houghton as the Principal Investigator. Testing occurs both at SJCRH and also at subcontract sites that haveexpertise in specific childhood cancers, including: Children's Hospital ofPhiladelphia (John Maris), Albert Einstein Medical Center (E. Anders Kolb &Richard Gorlick), Duke University (Stephen Keir), Texas Tech UniversityHealth Sciences Center (Patrick Reynolds), and Children's Cancer InstituteAustralia (Richard Lock). Detailed information about the PPTP and itstesting procedures is available at http://pptp.stjude.org/.