Monday, June 22, was a down day for the stock market. But stock in Medarex, a biotech on State Road, rose nearly 17 percent on news that its drug had played a part in a dramatic turnaround for two cancer patients. By late afternoon it was the market’s leading gainer.
This development followed a Mayo Clinic statement announcing that two patients with advanced prostate cancer, treated with Medarex’s ipilimumab, are now cancer free.
Ipilimumab is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells that plays a critical role in regulating natural immune responses.
The associated press release entitled “Mayo Researchers: Dramatic Outcomes in Prostate Cancer Study” reported on the following data: Two Mayo Clinic patients whose prostate cancer had been considered inoperable have no evidence of disease thanks in part to an experimental drug therapy that was used in combination with standardized hormone treatment and radiation therapy. The men were participating in an investigator sponsored clinical trial of ipilimumab.
In these two cases, physicians say the approach initiated the death of a majority of cancer cells and caused extensive tumor shrinkage, allowing surgery. In both cases, the aggressive tumors had grown well beyond the prostate into the abdominal areas.
The patients first received a type of hormone therapy called androgen ablation, which removes testosterone and usually causes some initial reduction in tumor size. Researchers then introduced a single dose of ipilimumab, an antibody, which builds on the anti-tumor action of the hormone and causes a much larger immune response, resulting in massive death of the tumor cells. Both men experienced consistent drops in their prostate specific antigen (PSA) counts over the following weeks until both were deemed eligible for surgery. Then, during surgery, extensive tumor shrinkage was observed. One patient underwent radiation therapy after surgery; both have resumed their regular lives.
Medarex (MEDX), 707 State Road, Princeton 08540; 609-430-2880; fax, 609-430-2850. Howard H. Pien, president and CEO. Home page: www.medarex.com.
Amicus Therapeutics, 5 Cedar Brook Drive, Cranbury 08512; 609-662-2000; fax, 609-662-2001. John F. Crowley, CEO. www.amicustherapeutics.com.
Amicus Therapeutics has begun the U.S. registration Phase 3 trial with its investigational drug, Amigal for the treatment of Fabry disease. The FDA is in agreement that Amicus is eligible to seek accelerated approval for Amigal. The company has begun submitting the Phase 3 protocol to investigational sites worldwide and expects to begin the dosing of subjects in the second half of this year.
“The start of our Phase 3 trial with Amigal is a major milestone for Amicus and highlights our transition into a late-stage development company,” John Crowley, the company’s CEO, said in a prepared statement. “We are very pleased with the outcome of our interactions with FDA around the design of this pivotal study and are confident we have set the stage for a successful Phase 3 study. We continue to believe that Amigal may be an important treatment option for patients who suffer with Fabry disease and a significant step forward for them and their families.”
Fabry disease is a lysosomal storage disorder caused by inherited genetic mutations, which result in the various symptoms including pain, kidney failure, and increased risk of heart attack and stroke.
Cornerstone Pharmaceutical, 1 Duncan Drive, Cranbury 08512; 609-409-7050; fax, 609-409-6035. Bob Rodriguez, president & COO. www.cornerstonepharma.com.
Cornerstone Pharmaceuticals has begun a phase I/II clinical trial of a drug for the treatment of pancreatic cancer. CPI-613, the initial candidate to emerge from the company’s Altered Energy Metabolism Directed technology platform, will be used in combination with gemcitabine, a standard chemotherapeutic for the treatment of pancreatic and other cancers. Patients newly diagnosed and intended to be treated with gemcitabine may be eligible for this study.
CPI-613 is the first drug in a new chemical class that targets metabolic changes that may be common to many cancer types. CPI-613 has been granted orphan drug status by the FDA for pancreatic cancer, a cancer type that typically has a poor prognosis, spreads rapidly, and often goes undetected in its early stages.
It is projected that this year there will be more than 42,000 Americans diagnosed with pancreatic cancer and approximately 35,000 deaths associated with pancreatic cancer.
The open-label trial is currently underway at the Eastchester Center for Cancer Care in New York. Additional clinical sites will be added.
Robert Wood Johnson University Hospital Hamilton, 1 Hamilton Health Place, Hamilton 08619; 609-586-7900; fax, 609-584-6525. Anthony J. Cimino, CEO. www.rwjhamilton.org.
Robert Wood Johnson University Hospital Hamilton has named Anthony J. Cimino president and CEO. Cimino, who has been on the hospital’s board of directors since 1988, replaces Ellen Guarnieri, who will resume work in her healthcare consulting company in mid-July after working on Cimino’s transition team.
Cimino has worked in both the public and the private sectors. He was Commissioner of Personnel for the state from 1992 to 1994, and before that was an Assemblyman for four years. He has served as a member of the state’s Pension and Healthcare Benefits Commission.
A Hamilton resident, Cimino was president of CMX Engineering, a Manalapan-based company with 21 offices throughout the country.
American List Counsel, 4300 Route 1, Building 2, CN 5219, Princeton 08543-5219; 609-580-2800; fax, 609-580-2818. Susan Rappaport, CEO. www.alc.com.
Susan Rappaport has been named president and CEO of data marketing services provider American List Council. She succeeds Donn Rappaport, her husband, who founded ALC in 1978 and retains the title of chairman.
For the past five years Susan Rappaport has served as COO of ALC and president of the company’s list brokerage operation. She also founded Direct Media, a list brokerage company, which merged with ALC in 1997.
Donn Rappaport had been named CEO of Zumbox, which has developed technology to deliver paperless mail to digital corporate or personal inboxes.
Swine Flu Vaccine
VaxInnate, 3 Cedar Brook Drive, Cedar Brook Corporate Center, Suite 1, Cranbury 08512; 609-860-2260; fax, 609-860-2290. Alan Shaw, CEO. Home page: www.vaxinnate.com.
VaxInnate Corporation has reported positive preclinical results for a recombinant swine flu vaccine it developed in less than three weeks, making it one of the first companies in the world to begin testing a vaccine that could help halt the spread of the swine flu pandemic.
Preclinical studies in mice suggest that VaxInnate’s recombinant swine flu vaccine could provide protection against the pandemic H1N1 influenza A swine flu strain. Further preclinical testing of the vaccine is already underway.
The company is hoping to work with the U.S. government on further development of its swine flu vaccine, and is also seeking international partners for the development of this and other pandemic vaccines.
The vaccine must undergo review and licensure by the U.S. Food and Drug Administration (FDA) before it could become available in the United States. Similarly, regulatory agencies in other countries or regions must license the vaccine before it can be used in those areas.
Conventional means of making flu vaccines using eggs takes 6-9 months. VaxInnate points out that the federal government is funding alternative cell-based production and that vaccine production using cell culture takes about six months, while its technology takes only weeks.
New in Town
United Stationers Supply Co. (USTR), 100 Liberty Way, Cranbury 08512; 609-619-4000; fax, 609-409-9066. Wayne Scott, general manager. www.ussco.com.
North America’s largest distributor of business products has moved its New York regional office and distribution center from Edison to Cranbury, bringing 350 jobs to the town.
Distributor of more than 100,000 business items, United Stationers reported $5 billion in net sales for 2008 and has 67 distribution centers across the continent. Its headquarters is in Deerfield, Illinois.
United Stationers was founded in 1922 and was the first company, beginning in the 1930s, to print and distribute an office products catalog. Today the company supplies resellers with a broad range of such supplies, from paper cups to file storage equipment.
Alfred L. Kettell Jr. Esq., 215 North Main Street, Pennington 08534; 609-737-9898; fax, 609-737-7405.
Alfred Kettell has moved his law office from Route 31 to North Main Street in Pennington. He specializes in real estate and municipal law.
Danka Office Imaging, 1095 Cranbury-South River Road, Suite 22, Jamesburg. Home page: www.danka.com.
One year after a $240 million sale to Konica Minolta, Danka Office Imaging is closing its Jamesburg facilities and relocating its operations to Iselin.
Danka sold office imaging units and systems, a line the Japan-based Konica Minolta sought to expand. The company was in business for more than 30 years before entering into an agreement with Konica Minolta last April.
The closure of the Jamesburg site takes 25 employees from there, but a spokeswoman for Konica Minolta said that all employees have been relocated, none downsized. Most are going to the Iselin headquarters. The move is expected to conclude by the end of July.
Bruce L. Stackhouse, 70, on June 19. A stock car racer and master mechanic, he worked at Al’s Sunoco in Pennington.
Judith Febo, 56, on June 18. She was an executive secretary at Bristol-Myers Squibb.
John T. Daugherty, 65, on June 2. He was director of group benefits administration at Bristol-Myers Squibb.