[Source: BUSINESS WIRE] - Apthera, Inc., a Scottsdale, Arizona-based biotechnology company focused on cancer immunotherapy, today announced an alliance with TGen Drug Development Services (TD2) under a Master Services Agreement. TD2 will provide key drug development and regulatory services related to the clinical development of NeuVax(TM), Apthera's lead immunotherapy drug indicated for the adjuvant treatment of early-stage, lymph-node-positive breast cancer that contains the HER2 oncogene. Apthera is currently preparing NeuVax for pivotal international Phase III clinical trials.
"We feel that the extra capacity TD2 provides will help accelerate the development of our lead product, NeuVax, filling in vital, near-term responsibilities for our rapidly growing Company," said Dr. Alton C. Morgan, Apthera's President and Chief Executive Officer.
"The clinical team at TD2 is very excited to support Apthera as it prepares for its pivotal Phase III clinical trial, with the goal to improve outcomes in women who received adjuvant treatment for breast cancer, as advances in this arena are still clearly needed," said Dr. Stephen P. Anthony, Chief Medical Officer of TD2.
Showing posts with label TD2. Show all posts
Showing posts with label TD2. Show all posts
Tuesday, August 12, 2008
Monday, April 14, 2008
Data Confirming Anti-Cancer Effect of Naturally Occurring Heart Hormones Presented at Experimental Biology 2008 Symposium
[Source: Pr-Inside.com] - Kalos Therapeutics, a privately held biopharmaceutical company developing the Atrial Natriuretic Peptide (ANP) family for the treatment of human cancers, announced that David L. Vesely, M.D.,Ph.D., (University of South Florida) presented additional positive xenograft data today at the Experimental Biology 2008 Symposium on Heart Hormones. The data confirmed and expanded pre-clinical studies establishing the anti-cancer effect of this family of peptides naturally expressed in the human heart.
Dr. Vesely had shown that the ANP family of peptides has very broad activity in animal models, inhibiting the growth of all of the cancers examined to date: human pancreatic, lung, and breast cancers. The additional studies reported at the Symposium were performed by TD2, an oncology drug development contract research organization affiliated with the Translational Genomics Research Institute (TGen, Scottsdale, AZ), and focused on the most active member of the ANP peptide family that is designated KT-220. These studies were designed to extend Dr. Vesely's previous findings by using a more challenging pancreatic tumor model system and including an additional, more aggressive type of pancreatic cancer. The results showed that KT-220 also has significant activity in these models.
Kalos Therapeutics holds an exclusive, worldwide license to a 2005 patent resulting from the pioneering work of Dr. Vesely, at the University of South Florida's Cardiac Hormone Center. The patent covers the use of this family of cardiac hormones as cancer therapeutics. Dr. Vesely now serves on Kalos' Scientific Advisory Board.
Dr. Norrie Russell, president and CEO of Kalos, said, "We are very encouraged by these study results, particularly in light of the National Cancer Institute analysis showing that an anti-cancer compound's breadth of activity in xenograft animal models is the best predictor of activity in human clinical studies. Based on these findings, and on the previous safe administration of KT-220 and other ANP family members to humans for another indication, we can confidently move forward with clinical development. Kalos is currently raising capital from institutional investors and qualified private individuals to initiate clinical trials of KT-220 in cancer."
KT-220 and the other peptides of the ANP family exert their anti-cancer effects through a novel mechanism involving the inhibition of the Mitogen Activated Protein Kinase (MAPK) signaling pathway, a key mechanism in cancer cell proliferation. These peptide hormones selectively shut off the proliferative effects of this kinase pathway in cancer cells but not in normal cells.
About the ANP Family of Peptides
The ANP family of peptides consists of four peptides derived from the pro-ANP gene, and includes ANP itself. These peptides, which share certain structural features, act through cell surface receptors to produce their antiproliferative effects. These peptides occur at the highest concentration in the heart, and much lower levels throughout the body. High natural levels of ANP peptides in the heart may be responsible for the low incidence of metastatic as well as primary cardiac tumors.
More information can be found on Kalos' web site at www.kalostherapeutics.com. For further information contact Dr. Russell at nrussell@kalostpx.com or 858-552-6890 or Linda Press of FD at Linda.press@fd.com or 213-452-6453.
Dr. Vesely had shown that the ANP family of peptides has very broad activity in animal models, inhibiting the growth of all of the cancers examined to date: human pancreatic, lung, and breast cancers. The additional studies reported at the Symposium were performed by TD2, an oncology drug development contract research organization affiliated with the Translational Genomics Research Institute (TGen, Scottsdale, AZ), and focused on the most active member of the ANP peptide family that is designated KT-220. These studies were designed to extend Dr. Vesely's previous findings by using a more challenging pancreatic tumor model system and including an additional, more aggressive type of pancreatic cancer. The results showed that KT-220 also has significant activity in these models.
Kalos Therapeutics holds an exclusive, worldwide license to a 2005 patent resulting from the pioneering work of Dr. Vesely, at the University of South Florida's Cardiac Hormone Center. The patent covers the use of this family of cardiac hormones as cancer therapeutics. Dr. Vesely now serves on Kalos' Scientific Advisory Board.
Dr. Norrie Russell, president and CEO of Kalos, said, "We are very encouraged by these study results, particularly in light of the National Cancer Institute analysis showing that an anti-cancer compound's breadth of activity in xenograft animal models is the best predictor of activity in human clinical studies. Based on these findings, and on the previous safe administration of KT-220 and other ANP family members to humans for another indication, we can confidently move forward with clinical development. Kalos is currently raising capital from institutional investors and qualified private individuals to initiate clinical trials of KT-220 in cancer."
KT-220 and the other peptides of the ANP family exert their anti-cancer effects through a novel mechanism involving the inhibition of the Mitogen Activated Protein Kinase (MAPK) signaling pathway, a key mechanism in cancer cell proliferation. These peptide hormones selectively shut off the proliferative effects of this kinase pathway in cancer cells but not in normal cells.
About the ANP Family of Peptides
The ANP family of peptides consists of four peptides derived from the pro-ANP gene, and includes ANP itself. These peptides, which share certain structural features, act through cell surface receptors to produce their antiproliferative effects. These peptides occur at the highest concentration in the heart, and much lower levels throughout the body. High natural levels of ANP peptides in the heart may be responsible for the low incidence of metastatic as well as primary cardiac tumors.
More information can be found on Kalos' web site at www.kalostherapeutics.com. For further information contact Dr. Russell at nrussell@kalostpx.com or 858-552-6890 or Linda Press of FD at Linda.press@fd.com or 213-452-6453.
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