Quintiles officially opened its expanded regional headquarters facility in Singapore’s Science Park I. The new facility doubles the size of the company’s previous space in Singapore and provides additional room for future expansion.

Quintiles is leasing a total of 79,000 sq.-ft. of space in the new Cintech IV building, which is capable of accommodating approximately 550 employees when fully occupied.

The new, 13,000-sq.-ft. central lab facility doubles the size of the previous Singapore lab, providing the additional space necessary to accommodate the demand for central lab services in the region. The lab facility provides globally harmonized lab services and plans are underway to expand these capabilities to include an assay development lab (ADL) and an anatomic pathology lab.

“Quintiles’ expansion today, to make Singapore its strategic home-base in Asia to drive regional expansion, represents a strong endorsement of Singapore’s capabilities in regional clinical trial coordination and research. Coupled with our capabilities in translational research, pharmaceutical and biotech companies can leverage Singapore as a one-stop location to carry out through-train drug discovery and development,” said Gan Kim Yong, Minister for Manpower, Singapore.

Gloucester Pharmaceuticals received approval from the FDA for Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

The approval was based on disease response defined as the number of patients with confirmed complete response or partial response. The NDA included efficacy data from two studies involving 167 patients. Istodax is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors and is expected to be commercially available in January 2010.

“The approval of Istodax is the result of an extraordinary commitment by our clinical investigators and the patients and their families who volunteered to participate in the Istodax clinical trials,” said Jean Nichols, Ph.D., president and chief operating officer of Gloucester Pharmaceuticals. “Gloucester would also like to recognize the National Cancer Institute which played an invaluable role in the development of Istodax.”

Ziopharm Oncology, Inc. achieved positive data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) in patients with unresectable or metastatic soft tissue sarcoma.

Having achieved the study’s efficacy milestone following safety and efficacy review, it was determined that the data is sufficient to proceed to a pivotal study in support of product registration and to conclude enrollment in the trial.

In the Phase II trial, patients are randomized either to doxorubicin (the only currently FDA-approved agent in sarcoma) or to palifosfamide in combination with doxorubicin. As of the October 5th cut-off date, there were 67 patients randomized to the trial, with 65 treated and 61 eligible for analysis. The 61 patients were evaluated for progression-free survival (PFS).

The median (PFS) for doxorubicin is 4.4 months, the median PFS for palifosfamide + doxorubicin has not yet been reached; the 1st PFS was 1.5 months for doxorubicin vs. 3.5 months for palifosfamide + doxorubicin. PFS is a biologically important end point in sarcoma, and has been well demonstrated to be a relevant measurement of the effect of treatment on outcome.

The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin. The company is in the process of finalizing a registration trial plan in soft tissue sarcoma for review by regulatory authorities.

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