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PolyMedix, Inc.(fka PYMXQ) RSS Feed

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New Class of Antibiotic: Defensin-Mimetic
Infections are a leading cause of death. 70% of infections in the U.S. are resistant to at least one antibiotic drug-creating a serious global medical problem. MRSA infections alone have increased 700% over 4 years. Annually in the U.S., 14.2 million people are treated for skin and skin structure infections and 7 million for MRSA infections, costing the U.S. healthcare system approxi-mately $17 billion in direct costs.

PolyMedix has developed a novel class of antibiotic drugs: small-molecules that imitate natural human immunity. With a completely different mechanism of action from other antibiotics, these unique compounds function in a way which makes bacterial resistance unlikely to develop. The first compound in this series which has recently completed a Phase 2 clinical trial for the treatment of Staphylococcus infections, including MRSA, is PMX-30063. In the study, PMX-30063 demonstrated consistently high clinical response rates comparable to those of daptomycin (the active control), and was shown to be safe and generally well-tolerated.

Defensin-Mimetic Attributes
- A unique mechanism of action fundamentally different from all current systemic antibiotics - direct disruption of bacterial cell membranes, the same as our own natural defensins - which makes bacterial resistance unlikely to develop
- Selectively targets bacteria and not mammalian cells
- Potent, broad spectrum activity against multiple Gram-positive and Gram-negative bacteria
- Bactericidal, not simply bacteristatic like other antibiotics
- Short course of therapy - Phase 2 trial demonstrated effectiveness with 5 days (vs. 7 for daptomycin), and PK/PD modeling and animal studies predict single dose efficacy, which will be studied in the next clinical trial.
- Many additional indications and applications are possible, such as bacteremia and pneumonia with the i.v. formulation, and oral mucositis in cancer patients with a topical oral rinse.

Phase 2 Results - Clinical Response per Study Analysis Plan and per Protocol Patient Population
Efficacy and Sustained Response
  Low Dose Middle Dose High Dose daptomycin control
Day 3 97.5% 91.4% 92.3% 91.5%
Day 7 92.5% 94.3% 97.4% 95.7%
Day 10 (for Day 3 responders) 92.3% 93.8% 100.0% 97.7%
Day 28 (for Day 10 responders) 97.2% 87.5% 100.0% 97.8%
Additional Phase 2 Discussion

Next Steps (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=76385858)
Initiate next Phase 2 trial in 2012; with goal to optimize dosing and study single dose regimen(s)
Continue animal toxicity studies and initiate Phase 2 in oral mucositis when funding is available
Company goal is to initiate pivotal Phase 3 trials in 2013

30063 Potential Indications
ABSSSI (IV)
Bacteremia (IV)
Endocarditis (IV)
Lung Infections (IV)
Oral Mucositis (Oral rinse) (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=76242340)
Clostridium difficile (Oral tablet)

Other Opportunities
Gram negative antibiotic (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=76028878)
XDR Tuberculosis (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=76399479)
Fungal Infections
Malaria
Polycides
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