About Us

 

Led by a team with vast experience in biopharmaceuticals, toxicology, botany, and emergency medicine, ToxEM LLC is a pharmaceutical company committed to the development of drugs derived from botanical sources that target life-threatening illnesses with high impact to the public health. 

 

ToxEM seeks to capitalize on the opportunity created by the FDA upon issuance of its Guidance for Industry-Botanical Drug Products which seeks to encourage and clarify the development of new therapies from botanical sources.  

 

ToxEM’s first drug product (TXM-24631) targets a complex bleeding disorder, disseminated intravascular coagulopathy (DIC), a life-threatening by-product of sepsis and a complication associated with a number of other acute diseases.  The main feature of DIC is abnormal release of thrombin which leads to rampant clotting until clotting factors are consumed. The result is unchecked bleeding.  DIC complicates up to 60 % of cases of severe sepsis, which is a significant cause of mortality in the United States, and globally.  Once contracted, DIC increases mortality by up to 40%. Hence, an effective treatment for DIC in sepsis should significantly decrease death rate from sepsis, especially if given early in treatment. ToxEM’s product acts as an anti-coagulant (antithrombotic) to prevent the abnormal clotting that characterizes DIC. DIC complicates other diseases with high impact to public health such as trauma, especially traumatic brain injury, and neoplasms. Moreover, its anti-coagulant activity suggests potential follow-on indications for thromboembolic diseases such as stroke, acute coronary syndromes, pulmonary embolism, and deep vein thrombosis.

      The Team

Mary E. Palmer, MD – Founder and Board Member

Dr Palmer is broadly experienced in botany, emergency medicine, toxicology and environmental conservation with particular focus on research and education. While Assistant Endangered Species Botanist for NC Department of Agriculture, she initiated the first comprehensive review of stewardship methods to monitor endangered plant populations on selected conservation lands in the US. As Director/Research Botanist for the Model Virginia Heritage Program for The Nature Conservancy (TNC), she successfully ushered the program into permanency into VA state government. In medicine she transferred her research interests into promotion of evidence-based clinical standards through co-Chairing the Practice Guidelines Committee of American Academy of Emergency Medicine (AAEM) as well as by organizing international (Iceland 2002) and national educational conferences at The George Washington University in 2004 and 2005. Blending botany, medicine and toxicology, Dr. Palmer has authored publications on plant toxicity including a multi-center study of adverse events associated with dietary supplements which was published in The Lancet. Dr. Palmer earned a BA from Kenyon College, an MS from The University of Virginia, her MD from The George Washington University before completing her residency in EM at the Medical College of Pennsylvania in Philadelphia and fellowship training in Medical Toxicology at the NYC Poison Control Center associated with NYU/Belleview Medical Centers.  Dr. Palmer currently practices EM part-time in the Washington metropolitan area.

 

Stephen N. Kirnon, Ed.D. – Business Advisor and Board Member

Dr. Stephen N. Kirnon joined ToxEM in 2008 as a business advisor and board member.  Dr. Kirnon has over 20 years of operational experience in biomedical organizations.  Dr Kirnon was previously the President and Chief Executive Officer of Pepgen Corporation, a biopharmaceutical company based in Alameda, CA specializing in autoimmune diseases. He was formerly the President and CEO of Target Protein Technologies, Inc., a pharmaceutical company based in San Diego and specializing in the development of pharmaceutical compounds targeted to specific tissues and organs of the human body.  Prior to TPT, he was the President and COO and a member of the Board of Yamanouchi Pharma Technologies, Inc., which is responsible for developing and commercializing Yamanouchi’s proprietary drug delivery technologies as well as the US development and manufacture of Yamanouchi’s pharmaceuticals.  Previously, he was the President of the Drug Delivery Division of Cygnus, Inc., successfully leading the Division into profitability and subsequently through sale of its business.  Dr. Kirnon has also held various business development, sales, and marketing positions at Cygnus, Biogenex, and SmithKline Beecham.  In addition to a B.A. degree in Biochemistry from Harvard University and an MBA from Pepperdine University, Dr. Kirnon received his doctorate in organization change and transformational leadership from Pepperdine University.

      Selected Publications

Palmer ME. Effect of Dietary Supplements on Hemostasis: A Case of Bleeding in Context of Research and Surveillance. Thromb Res. 2005;117(1-2):33-8; discussion 39-42. Epub 2005 Sep 22.

Palmer ME, Haller C, McKinney PE et al. Adverse events associated with dietary supplements: an observational study.  The Lancet 2003; 361: 101-106.

Palmer ME, Nardi M. Traditional Snakebite Remedy from Belize Is a Thrombin-specific Anticoagulant. Acad Emerg Med 2001;8:495-496.

Smith RA, Calviello CM, Der Marderosian A, Palmer ME. Evaluation of antibacterial activity of Belizean Plants: An Improved Method. Pharmaceutical Biology 2000;38 (1):25-29.

Palmer M, Rao RB. Problems evaluating contamination of dietary supplements (letter). N Engl J Med. 1999;340(7):568.

Palmer ME. Kava’s (Piper methysticum) methysticin: protection from strychnine and veratridine.(abstract). J Toxicol Clin Toxicol August 1999:37(5):609.

 

Palmer ME. A Gap in the Safety Net: Results from A Multi-Center Prospective Study of Herbals and Other Dietary Supplements (abstract) . J Toxicol Clin Toxicol August 1999:37(5):610.

 

Rao RB, Hoffman RS, Desiderio R, Raysor D, Palmer ME, Hung OL. Nicotinic toxicity from tincture of blue cohosh (Caulophyllum thalictroides) used as an abortifacient (abstract 68). J Tox Clin Tox August 1998:36(5):455.

 

Palmer M, Nardi M, Gruber J et al. Traditional Snake Bite Remedies from Belize Limit DIC in a Murine Model (abstract 184). J Toxicol Clin Toxicol. 1997;35(5):358.

 

Rao RB, Palmer M, Touger M Thrombocytopenia after rattlesnake envenomation. Ann Emerg Med. 1998 Jan;31(1):139-41.

 

Palmer M, Travis J, Antonovics J. Temporal mechanisms influencing gender expression and pollen flow within a self-incompatible perennial, Amianthium muscaetoxicum (Liliaceae). Oecologia 1989;78:231-236.

 

Palmer M, Travis J, Antonovics J. Seasonal pollen flow and progeny diversity in  Amianthium  muscaetoxicum (Liliaceae): ecological potential for multiple-mating in a self-incompatible, hermaphrodite perennial. Oecologia 1988;77:19-24.

 

Palmer M. A critical look at rare plant monitoring in the United States. Biological Conservation 1987;39(2):113-127.

 

Palmer M. A survey of rare plant monitoring in the United States: programs, regions and species priority. Natural Areas Journal 1986;6(1):27-42.

 

Book Chapters and Invited Review Articles:

 

Palmer ME, Betz JM. Plant Toxicity. Goldfrank’s Toxicologic Emergencies, 7^th 8^th and 9^th editions,  NY. 2001, 2006, 2010 in press.

 

Palmer M. Poisonous Plants. Eds. Kazzi ZN, Roberge RJ. AAEM Toxicology Handbook.  2005; pp 123-134.

 

Palmer ME, Howland MA.  Herbals and Dietary Supplements. In Clinical Toxicology, Ed. Ford M et al. W.B. Saunders, Philadelphia, 2000.

 

Palmer ME. Toxicity of Herbals and Other Dietary Supplements. Emergency Medicine. September 1998.