FerroKin Enrolling Patients for Chelator Trial

Monday, November 30th, 2009 at 4:30 pm

November 30, 2009 – FerroKin BioSciences, Inc. has announced a Phase 1B trial to study the safety and pharmacology of its new oral iron chelator, FBS0701. A total of 16 patients will be enrolled in the study at centers in the U.S., Australia and Italy.

 

Eligibility

In general, patients can qualify for this study if they:

1. Are 18 years or older
2. Are male or female
3. Have iron overload from chronic transfusions
4. Are able and willing to stop their current chelation tharapy for up to 19 days total
5. Are able and willing to return for the clinic for up to 10 visits, the majority of which take place during the time the patient is taking the study medication
6. Are relatively healthy – no major medical problems or recent hospital admissions, no significant liver, kidney or heart problems
7. Have had an MRI to assess liver iron concentrations within the last year and if not, willing to have this procedure prior to joining the study

The goal of the study is to assess safety, tolerability and levels of drug in the blood after 7 daily doses of FBS0701. Four different dose levels of the drug will be studied in an “escalating” fashion. The first 4 patients will receive the lowest dose once a day for 7 days. If that dose is shown to be safe,4 new patients will receive the next, higher dose. This process will continue with a higher dose for the next set of 4 patients (provided no safety concerns have arisen from the previous dosing levels) and will escalate again for the final set of 4 patients.

 

Interested patients will be screened piror to enrollment (see sidebar for eligibility requirements). If they qualify, patients will be asked to discontinue their current iron chelator before starting the new drug. Patients will then be treated once daily for 7 days, during which they will need to visit the clinic almost every day. Patients will also be followed weekly for four weeks.

Compensation for travel costs and time is available in centers/countries which allow this, including, in some cases, overnight accommodations for patients traveling from out of town.

U.S. centers are in Boston, MA and Oakland,CA. There is potential for an additional center opening in January on the east coast.

Those seeking more information should contact Hugh Rienhoff or Maggie Neptune at (650) 218-5710 and ask for information concerning Study FBS0701-CTP-03.

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