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T Cell Sciences Announces Encouraging Results from Phase I Clinical Trial of TP10

Strategic Insights

— 2 min read

Researchers at T Cell Sciences, Inc. have reported positive outcomes from the company's first Phase I clinical trial of TP10, a soluble form of complement receptor 1 (sCR1), in patients at risk for Adult Respiratory Distress Syndrome (ARDS). The trial involved 24 patients with acute lung injury arising from various medical conditions and aimed to assess the safety, pharmacokinetics, and immunogenicity of TP10. The results demonstrated that TP10 was well tolerated, with no drug-related adverse events or laboratory test abnormalities observed. Furthermore, data from the trial indicate that TP10 significantly reduces activation of the complement cascade as dosage levels increase.

Key Takeaways:

  • The Phase I clinical trial of TP10 was conducted in 24 patients with acute lung injury, with objectives to determine the safety, pharmacokinetics, and immunogenicity of the compound.
  • The trial involved five dose levels of TP10, administered in escalating single doses of 0.1 to 10 mg/kg, and resulted in no drug-related adverse events or laboratory test abnormalities.
  • The amount of TP10 detected in the blood was directly proportional to the doses administered, indicating a favorable pharmacokinetic profile.
  • The half-life of TP10 was more than 30 hours, suggesting a prolonged duration of action.
  • TP10 significantly reduces activation of the complement cascade as dosage levels increase, indicating potential therapeutic benefits.
  • The company has reached its first milestone and is poised to enter Phase II clinical trials for TP10, marking an important step in the company's growth.
  • TP10 is being developed to treat diseases of inflammation and autoimmunity, with ongoing clinical trials in reperfusion injury and potential applications in organ transplantation rejection and cardiopulmonary bypass.

Statistics:

  • 24 patients participated in the Phase I clinical trial of TP10.
  • Five dose levels of TP10 were administered, with doses ranging from 0.1 to 10 mg/kg.
  • No drug-related adverse events or laboratory test abnormalities were observed in the trial.
  • The amount of TP10 detected in the blood was directly proportional to the doses administered, with a half-life of more than 30 hours.
  • TP10 has demonstrated potential therapeutic benefits in reducing activation of the complement cascade, with ongoing clinical trials in reperfusion injury, organ transplantation rejection, and cardiopulmonary bypass.

Sources:

  • Press Release: T Cell Sciences, Inc. "T Cell Sciences Announces Encouraging Results from Phase I Clinical Trial of TP10." October 30, 1995. /PRNewswire/
  • /CONTACT: Alan W. Tuck, President & Chief Executive Officer, 617-433-0771 or Lori Martin, Investor Relations, 617-433-3107, both T Cell Sciences/ (TCEL) CO: T Cell Sciences, Inc. ST: Massachusetts IN: MTC SU: JL -- NE019 -- 5938 10/30/95 09:49 EST

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