CRO Merger Widens Pediatric Trials Portfolio

Syneteract, a global North Carolina-based CRO, has acquired niche CRO KinderPharm in a deal Synteract says will help it expand its pediatric trials footprint.

Martin Graham, Synteract’s senior vice president for pediatric development and scientific innovation, said the move was driven by “increased regulatory requirements for pediatric trials and the need to advance treatments for diseases that are unique to children.”

Synteract CEO Steve Powell says he hopes the combined company will offer “a single source model for preclinical and clinical development.”

KinderPharm is based in Pennsylvania and has focused on rare disease pediatric trials. KinderPharm alumnae Lynne Georgopoulos becomes vice president for pediatric development in the Americas and Synteract’s Martine Dehlinger-Kremer becomes VP for pediatric development in Europe.

Terms of the deal were not disclosed.

Therapy Helps Rare Cancers

Novartis has scored an early victory by combining a pair of its cancer drugs to treat two deadly gastrointestinal cancers.

The combination of Tafinlar (dabrafenib) and Mekinist (trametinib) helped shrink tumors in patients in a Phase II trial with biliary tract cancer or adenocarcinoma of the small intestine.

Tumors in 13 out of 32 biliary cancer and two out of three intestinal cancer patients shrunk after they took daily doses of 150 mg of Tafinlar and 2 mg of Mekinist, said lead researcher Zev Wainberg of the University of California, Los Angeles.

“These are patients with rare, aggressive cancers that have very poor prognoses and for which there are currently limited therapeutic options,” Wainberg said. “Their cancer has failed to respond to previous treatments — at least two prior chemotherapies had failed in 78 percent of them — so these are significant and promising results.”

The median overall survival time of each of the patients in the trial was 11.3 months.

FDA Cites Doc in Antibiotic Trial

Federal regulators cited a Philadelphia doctor for starting an antibiotic clinical trial without proper permission and failing to obtain informed consent from participants.

The FDA says David Schlossberg, an independent researcher, began dosing patients with Lamprene (clofazamine) in February 2016, without filing an investigational new drug application. At least one patient was given the antibiotic before signing an informed consent form, the agency says in a form 483 obtained under the Freedom of Information Act.

Schlossberg did not respond to requests for comment. He’s listed as the lead author of the 2017 edition of “Antibiotics Manual: A Guide to Commonly Used Antimicrobials,” which includes a chapter on Lamprene. Lamprene’s marketing license is owned by Novartis.

Trial Freezes Out Breast Cancer

Early results of an ongoing clinical trial appear to show that cancer can be put on ice.

Researchers in 18 sites have enrolled some 200 women with low-risk breast cancer in the Ice3 Trial. The trial is slated to run through 2023 but early results show that cryoablation — freezing the tumors — is working. “The preliminary results have been very promising,” said lead researcher Kenneth R. Tomkovich of the private company Princeton Radiolology in New Jersey.

Researchers so far have studied 20 patients for three years and another 75 for two years. There were no reports of serious adverse events and the cancer recurred in only one patient.

In cryoablation, doctors make a pea-sized incision into the patient’s skin and send a high-definition, ultrasound probe to the tumor. The tumor is then frozen with liquid nitrogen in two different, eight-minute cycles. The whole process takes about an hour.

The trial is being sponsored by New Jersey-based IceCure, which manufactures the cryoablation device. Tomkavich sits on IceCure’s scientific advisory board. Company officials hope their device can replace the more invasive lumpectomy.

Ice3 began in October 2014, and recruited women who were at least 50 and had biopsy-proven, low-risk breast cancer. The women had mammograms at six months and a year after the procedure — and then annually for five years.

FDA Warning Letter: Doctor Violated Clinical Hold

The FDA slapped a doctor at Cornona Doctors Medical Clinics with a warning letter for giving multiple clinical trial participants an experimental drug in violation of a clinical hold ordered by the agency.

The full clinical hold took effect during a teleconference between the Corona, California-based doctor, Faro Owiesy, and the agency on Aug. 10, 2017, due to a lack of information available to assess the potential risks to human study participants. During that meeting, Owiesy acknowledged that he could not begin the trial. But the FDA charged he administered the investigational drug anyway, giving it to six subjects between Aug. 10 and 21, 2017 — with one subject receiving it just hours after the teleconference.

The agency sent a full clinical hold letter — dated Sep. 7, 2017 — reiterating that no studies under the investigational new drug application (IND) could be conducted because of a lack of information.?