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Monday, March 8, 2010

Embassy Suites, Chesterbrook, Pennsylvania (directions)


TheraVasc Inc.

Biotechnology Company

Presenter: Tony Giordano Ph.D., President and CEO of TheraVasc



TheraVasc Inc. is a privately-held biotechnology C-Corp located in Ohio dedicated to reducing the risk, cost and time associated with drug development by focusing on developing repurposed drugs for unserved vascular disease markets. By focusing its efforts on drugs with established safety profiles, targeting diseases that result in a terrible quality of life or rapidly progress to death, and for which no current therapies exist, TheraVasc’s management believes that both patients and clinicians will readily embrace its products, facilitating development. The Company’s first program is ready to enter clinical trials for the treatment of peripheral artery disease (PAD) and other problems associated with poor blood flow to the limbs, including diabetic vascular disease (DVD).


TheraVasc’s lead product is being advanced into clinical trials for the treatment of PAD. Approved as a treatment of cyanide poisoning in an injectable form, the product is being developed into an oral formulation for Phase I and Phase IIa clinical trials. The Phase IIa trial is being designed to not only assess safety but also to give an indication of efficacy using the SPY Imaging System to analyze new blood vessel growth in the ischemic tissue. While the clinical development will be the key function during this initial round of financing, the Company will also develop new formulations, including sustained release formulations and novel combinations of the licensed compound with other repositioned compounds, which should provide for further and more rapid increased initial blood flow to the region providing for both an immediate improvement and a sustained effect. It is likely that this combination drug will have utility in the treatment of congestive heart failure (CHF), as well as PAD and DVD. TheraVasc will also investigate the potential of the drug to facilitate tissue regeneration for use with stem cell therapies and wound healing. This initial product development strategy is expected to add value quickly while developing additional opportunities around TV1001.



3 Major Issues


  1. TheraVasc will be developing a sustained release formulation of sodium nitrite for treating peripheral artery disease and/or diabetics with ischemic limbs.  Since the compound currently being moved into clinic is a rapid release and not the final drug, does TheraVasc need an IND to carry out a Phase IIa study with this enteric coated rapid release formulation?

  2. Patent applications are pending on the chronic use of sodium nitrite for treating ischemic problems and on formulations of sodium nitrite.  Sodium nitrite is thought to be carcinogenic and thus there are no generics on the market.  Ultimately, we will carry out a Phase II trial with the sustained release formulation for FDA approval.  Once we demonstrate safety and efficacy, how do we best keep generics from competing with us?

  3. Clinical trials to demonstrate efficacy in PAD are difficult (you need to show improvement on pain free treadmill walking, which is subjective).  The molecule promotes new blood vessel growth (at least in animals). A number of biomarkers (circulating proteins) are also altered following nitrite administration to animals prior to new blood vessel generation. Concerning endpoints in the Phase II trial: What hurdles does Theravasc face in trying to get the FDA to use biomarkers? Or to use much more objective criteria, such as the growth of new vessels, as determined by imaging using the SPY system or through biopsy?





6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)

8:00 - Tony Giordano Ph.D., President and CEO of TheraVasc will deliver the Company's "Elevator" Pitch to the Group

8:20 - A Panel will address 3 Major Issues for the Company

9:00 - Open discussion: members and guests



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TheraVasc Webcast 03/08/10

Contact Info:

Tony Giordano, Ph.D.

President and CEO


TheraVasc, LLC

11000 Cedar Avenue

BioEnterprise, Suite 100

Cleveland, OH 44106


TEL: (318) 349-3851





List of Attendees




Questions or Coments?

Contact: Peter van der Kam, | (610) 296-8086




Good Company! Good Drink! Good Food! Good Program! Good Fun!


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