Neotropix Announces Enrollment of Patients in NCI-Sponsored Phase II Clinical Trial for Small Cell Lung Cancer

Neotropix Announces Enrollment of Patients in NCI-Sponsored Phase II Clinical Trial for Small Cell Lung Cancer
 
Chester Spring, PA and Rochester, MN - May 14, 2010 - A clinical trial for patients with extensive stage small cell lung cancer is currently enrolling patients in a Phase II clinical trial at the North Central Cancer Treatment Group (NCCTG). The focus of the study is to assess the clinical effectiveness of the novel oncolytic virus, NTX-010, developed by Neotropix, Inc. NTX-010 has been shown to be highly selective for certain neuroendocrine tumor types including Small Cell Lung Cancer (SCLC). 
The Phase II clinical trial overview will be presented during NCCTG's Radiation Oncology Committee, a symposium dedicated to current lung cancer research, taking place today, Friday, May 14, 2010, from 7:00 to 9:00 a.m. at the Mayo Civic Center in Rochester, Minnesota.
 
Julian Molina, M.D., Ph.D., a researcher at Mayo Clinic is the lead investigator in the Phase II study, "A Randomized Double-Blinded Phase II Study of NTX-010 in Patients with Extensive Stage Small Cell Lung Cancer (N0923)" which is funded, in part, by the National Cancer Institute, part of the National Institutes of Health (NIH), and is a multi-center study which includes numerous NCCTG sites across the United States.
 
Anthony Williams, M.D., Chief Medical Officer at Neotropix, commented on the Company's investigational cancer treatment, "Oncolytic viruses are an innovative approach to cancer treatment in which the very specific destruction of cells by a virus are directed against a patient's tumor cells, offering the ability to kill the cancer without affecting normal cells, resulting in significantly less side effects."  Dr. Williams continued, "Neotropix's NTX-010 is highly unique among this class of agents in that it is an unengineered 'natural product' with innate anti-cancer activities."
 
The current study is designed to determine activity of a single dose of NTX-010 when utilized immediately after the completion of standard first line therapy for SCLC as
NTX-010 replicates within the tumor generating more drug as it destroys the cancer cells.  Dr. Williams concluded, "If successful, NTX-010 would be a first-in-class agent that would transform how we think about treating cancer and could open up a completely new treatment paradigm."
 
Peter Lanciano, CEO of Neotropix, commented on the initiation of the clinical study, "The Phase II NCCTG study of NTX-010 in SCLC patients is a model of collaborative biomedical research between industry, academia and the government for patients with a serious need for an effective front line cancer treatment. NIH's decision to fund this study was data driven with the expectation that this new technology could become a transformative event in the treatment of cancer, as new treatment approaches using viruses and the body's own immune system will become critical for combating hard to treat cancers. We are excited to be working closely with the teams at NIH, NCCTG and Mayo Clinic."
 
Recruiting Patients Currently
The Phase II NCCTG Study N0923 is currently recruiting adult patients with extensivestage SCLC who are receiving or have just completed standard of care first line chemotherapy. In this study, NTX-010 is delivered as a single one-hour intravenous infusion within four to twelve weeks from completion of chemotherapy. More information regarding the study and its criteria, including sites can be found at http://clinicaltrials.gov/ct2/show/NCT01017601?term=N0923&rank=2NCCTG.
 
About NTX-010
NTX-010 is a novel naturally occurring oncolytic virus, which is highly selective for certain neuroendocrine tumor types. NTX-010 is a stable, non-pathogenic virus, and therefore, does not require genetic modification. Additionally, NTX-010 can be systemically delivered in a single infusion on an out-patient basis as the virus is self- replicating and the patients' cancer acts as a factory making more of the virus/drug to attack the cancer systemically and control the tumor locally and in a natural way. This unique approach simplifies the treatment process for patients by reducing the frequency that patients need to visit the cancer care center, thus reducing the time and costs associated with cancer treatment.
 
A Phase I dose-escalation safety study of NTX-010 in adults with advanced neuroendocrine tumors was completed without dose-limiting toxicity. The most common drug-related side effects were mild flu-like symptoms that resolved in 1-2 days without specific treatment. Clinical benefit was observed in a majority of patients, including decreases in tumor volume, pain and neuroendocrine-related symptoms and most importantly the durable stabilization of disease progression and apparent improvement in overall long-term survival.
 
About North Central Cancer Treatment Group
The North Central Cancer Treatment Group is a national clinical research group sponsored by the National Cancer Institute. NCCTG consists of a network of cancer specialists at community clinics, hospitals and medical centers in the United States and Canada. The research base for NCCTG is located at Mayo Clinic in Rochester, MN.

NCCTG is dedicated to bringing clinical trials with promising new cancer therapies to communities where patients live. NCCTG specializes in researching methods of treating and preventing cancer, and in researching methods to alleviate the side effects of cancer and cancer treatments.

About Neotropix
NeotropixTM Inc. is focused on the development of anti-cancer products that have a high degree of selectivity for tissues resulting in both therapeutic efficacy and an excellent safety and tolerability profile. Neotropix develops and commercializes systemically deliverable oncolytic viruses for the treatment of solid tumors. Capitalizing on its unique sources of naturally occurring viruses that selectively target tumors discovered using the Company's proprietary technology platform ViruscreenTM, the Company has the knowledge and skills to translate these discoveries into commercial products. Neotropix is committed to making a difference in the lives of cancer patients.

Neotropix is venture-capital-funded company by investors including Aurora Funds, Quaker BioVentures and VIMAC Ventures. For more information about Neotropix, please visit www.neotropix.com.
Contacts:
For patients, physicians and caregivers supporting patients with extensive stage small cell lung cancer:

Nora Boyer RN, MBA, Ph.D.
Director, Medical Science Liaison
Tel: 219-796-4829
E-mail: [email protected]
 
For media and business development professionals
Peter Lanciano
CEO
617-460-1200
E-mail: [email protected]
 
Lisa Rivero
Director of Media Relations
978-745-4200 X 106
E-mail: [email protected]

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