Archive for 'Uncategorized'

Mar 31

Apogee has successfully licensed exclusive rights to ABC294640 to RedHill Biopharma.  Apogee is thrilled to pass this promising drug into the capable, experienced hands of RedHill for late stage clinical development.

http://globenewswire.com/news-release/2015/03/31/720531/10126995/en/RedHill-Biopharma-Acquires-Phase-II-First-in-Class-Oral-Small-Molecule-SK2-Inhibitor-From-Apogee-Biotech.html

Dec 10

Apogee received a $1.5 million STTR grant in conjunction with the Louisiana State University Health Science Center to conduct a Phase 1b/II clinical trial in patients with diffuse large B-cell lymphoma.  The trial will be led by Dr. Christopher Parsons.  Information regarding the trial can be found at https://clinicaltrials.gov/ct2/show/NCT02229981?term=abc294640&rank=2 .

Aug 05

Apogee completed enrollment on the initial safety trial for ABC294640 in advanced solid tumor cancer patients.  Results showed that the ABC294640 safety profile correlated well to that observed in preclinical toxicology studies and that ABC294640 had an excellent pharmacokinetic profile that modulated the pharmacodynamic marker of circulating spingosine-1-phosphate as expected.  The results from this trial support additional clinical trials in cancer focused more on efficacy of this promising drug.  Information regarding this trial can be found at https://clinicaltrials.gov/ct2/show/NCT01488513?term=abc294640&rank=1 .

Aug 14

A Non-Formula Commonwealth Universal Research Enhancement (CURE) Program grant in the amount of $832,608 was awarded to Apogee to support preclinical research on Apogee’s phase I clinical drug, ABC294640.  The funds will support research to determine the optimum treatment protocols for the combination of ABC294640 with current standard of care drugs for pancreatic cancer.   ABC294640 is currently being evaluated in a phase I clinical trial for cancer as a single agent, and the PA CURE funds will provide an important bridge to clinical testing of new drug combinations in this cancer with a high unmet need for effective therapies.   The award was presented to Dr. Charles D. Smith, President and CEO of Apogee, and Dr. Lynn W. Maines, Vice President for Research and Business Affairs, at the Hershey Center for Applied Research in Hershey, PA, where Apogee is headquartered.

The CURE program funds health research with the purpose of discovering new scientific knowledge to help improve the health of all Pennsylvanians.  These competitive grants focus on specific research priorities established and reviewed by the Department of Health in conjunction with the Health Research Advisory Committee, a panel made up of universities and research institutes.  The funds, allocated in the 2011-12 fiscal year, focus on projects that translate the information found within the human genome.  The grants support research that commercializes and brings to market new, proven cancer diagnostics or therapeutics.

 

PA Department of Health press release on award can be viewed at:

 

http://news.gnom.es/pr/department-of-health-presents-nearly-3-1-million-in-health-research-grants

Aug 10

Apogee is pleased to announce receipt of a grant award in the amount of $400,000 from the Office of Orphan Products Development of the FDA.  This funding will partially support the ongoing phase I clinical trial of its lead compound, ABC294640, in patients with advanced solid tumors, with emphasis on pancreatic cancer patients.  ABC294640 is a first-in-class inhibitor of the enzyme sphingosine kinase-2, and has anti-proliferative and anti-inflammatory activity in several preclinical animal models.  Dr. Charles Smith, President and CEO of Apogee, stated “We are pleased to receive the support of the Orphan Drug Office at the FDA as we go after pancreatic cancer in the clinic.”  Apogee was eligible for this competitive grant because ABC294640 has received Orphan Drug designation from the FDA for the potential treatment of advanced pancreatic cancer.

Aug 03

The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) recently released information about the award.

http://www.hhs.gov/news/press/2011pres/08/20110801d.html

Sep 14

Apogee is pleased to announce approval from the Food and Drug Administration  for the Investigational New Drug Application for ABC294640 for advanced solid tumors and advanced pancreatic cancer .  Apogee anticipates the start of the clinical trial at the beginning of 2011.

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