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Texaphyrins


Large, Texas-sized Porphyrin-like Macrocycles
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This condition afflicts ca. 90,000 new cases/year US and is one for which there is no FDA-approved treatment.
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The primary endpoint was time to neurological progression (TNP). An across-the-board increase was seen for the full intent-to-treat population.  Median TNP of 15.4 months for patients receiving WBRT plus Xcytrin® (Gd-Tex; MGd) vs. 10.0 months for patients treated with WBRT alone (P = 0.122, hazard ratio = 0.78).  This was not up to the pre-negotiated level of statistical significance.
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Treatment Delay Affects Outcome
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Even Without Adjusting for the Imbalance in Time-to-Treatment, A Significant Benefit in Time-to-Neurological Progression is Seen with Xcytrin (Gd-Tex; MGd) Across-the-Board for all NSCL Brain Met Patients (i.e., Data from Both Phase 3 Trials Combined, N = 805)
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This decision was made in spite of the fact that:
1) Outstanding efficacy is seen in North American patients
2) Positive results were actually seen in 62 of the 64 centers involved
3) Combining the results from the > 800 NSCL patients in the two phase     III trials gives a P = 0.016, which is highly significant
4) Xcytrin® (texaphyrin; MGd) is exceedingly safe
5) Brain mets are a wide-spread, debilitating cancer condition, and
6) There is no alternative treatment option
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"The GMP synthesis of Xcytrin..."
  • The GMP synthesis of Xcytrin has been worked out and validated.  Precursors are obtained from a number of suppliers world-wide and the final assembly is conducted at Lonza, AG (Visp, Switzerland).  Sterile filling is carried by Baxter under contract.
  • The yield for 20 steps is > 20% (Hugo Madden, Greg Hemmi, et al.).
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 Mechanism of Action -- A Bit of Evidence
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A First Anecdotal Result from Study of Single Agent Xcytrin in Lung Cancer
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Okay, That is Where We Stand!
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