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Karunix Pharmaceuticals

A research and development company in the physical, engineering, and life sciences industry

Presenters: Nicholas Landekic, President and CEO, and Bozena Korczak, VP Drug Development

 

Monday, November 10, 2014

Embassy Suites, Chesterbrook, Pennsylvania (directions)

 

About

 

Karunix has developed a novel drug for treatment of sickle cell disease, fibrosis and cancer, by halting disease progression and symptoms: S-NACH, non-anticoagulant heparin.

 

LMWHs are widely used for the treatment of venous thromboembolic disorders, though full utilization of their polypharmacological properties is hampered by a narrow safety margin. The clinical experiences with heparin and LMWH in sickle cell anemia, liver fibrosis and cancer provide robust proofs of clinical efficacy. However, further optimization of dosing regimens was prevented by the most frequent adverse event – bleeding. S-NACH, by eliminating anti-coagulant properties and enhancing of all other activities, provides an excellent opportunity to explore the activity of this remarkable class of molecules in multiple therapeutic areas.

 

Karunix will initially focus on the fastest, least expensive, and lowest risk path to market – short-term treatment of sickle cell vaso-occlusive crisis, by ameliorating pain and shortening hospitalization. There are appx. 100,000 sickle cell sufferers in 

 

the U.S., and 15 million worldwide. Clinical data show that LMWH can significantly ameliorate pain and shorten the duration of hospitalization in sickle cell vaso-occlusive crisis. The pathophysiology of SCA is complex, and requires multi-modal therapy. SNACH should be able to achieve comparable or superior efficacy in treating pain but without risk of systemic bleeding caused by LMWH. SNACH will be positioned for alleviating pain in acute sickle cell crises, and shortening or avoiding hospital stays – a strong pharmacoeconomic benefit which should allow premium pricing. Accelerated approval (fast track) and orphan drug status should also be possible. Longer term, an expanded indication is possible for chronic use to prevent occlusive crisis in sickle cell anemia patients.

 

Cancer is a second potential indication with unique positioning: short term use as an adjunct to surgery to prevent tumor progression. Heparin and LMWHs have been shown to substantially improve overall survival in cancer patients. The anti-cancer benefits of LMWHs can be obtained with SNACH- without the systemic anticoagulant properties and risk of bleeding of those drugs. Elimination of bleeding complications is particularly important in cancer patients, whose coagulation systems may be disrupted. S-NACH’s anticancer activity is characterized by antiproliferative, pro-apoptotic and anti-angiogenic activities, as well as inhibition of metalloproteases and selectin-mediated adhesion. Through these multiple pathways S-NACH can control primary tumor growth as well as metastasis. S-NACH has shown positive efficacy in animal models of many cancers, including pancreatic, liver, breast, lung, bladder, and brain.

 

 

3 Major Issues

 

  1. What type of Phase 1 studies will be required to advance S-NACH in SCA?
    a. Phase 1 in healthy volunteers or in stable SCA patients?
    b. Single, ascending dose?
    c. Multiple doses?
    d. Pros and cons for adaptive phase 1/2 and phase 2/3?
  2. Does Sickle Cell Disease vaso-occlusive crisis have its own DRG code for reimbursement?
    a. In considering pricing and reimbursement for S-NACH for SCD vaso-occlusive crisis, what is included in the DRG or total reimbursement for the crisis?
    b. Are the associated costs of opiate analgesics (e.g., additional monitoring, respiratory depression, extended hospitalization) considered in the total cost of treating vaso-occlusive crisis? How important would it be to demonstrate an associated reduction in use of opiate analgesics?
  3. Regarding the potential indication for S-NACH in fibrotic disorders, which disease would you consider to be the most attractive in terms of attempting to both maximize the commercial opportunity but also minimize the time to market?
    a. Idiopathic Pulmonary Fibrosis?
    b. Pulmonary Arterial Hypertension?
    c. Hepatic Fibrosis?
    d. Renal Fibrosis?
    e. What clinical endpoint(s) do you think would be the most important in an anti-fibrotic clinical trial?

 

Program:

 

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

8:00 - Nicholas Landekic, President and CEO, and Bozena Korczak, VP Drug Development, will deliver the Company's "Elevator" Pitch to the Group

8:20 - Panel will address three major issues crucial to helping the Company reach the next level.

9:00 - Open discussion: members and guests

 

 

Available Media

Please note: All information obtained here is the property of those presenting and should not be copied or duplicated without written consent.

 

Slides

None available at this time

Audio

Karunix Presentation - 11/10/14

Video

None available at this time

Webcast

None available at this time

Contact Info:

 

 

 

Our Sponsors

EisnerAmperIdeas x Innovation Network i2nNew Jersey Institute of TechnologyScience Center

 

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Questions or Coments?

Contact: Peter van der Kam,

peter@rxpcci.com | (610) 296-8086

 

 

 

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

 

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