San Diego-based Pharmatek Laboratories Inc. said Aug. 16 it would add cytotoxic and high-potent drug development capabilities to its host of pharmaceutical chemistry development services.
The decision to add the services was driven by an increase in demand, according to the company.
Newly added services include analytical method development, preformulation testing, formulation development, manufacturing for early phase clinical trials, release testing and stability testing and storage.
“This investment positions Pharmatek to become a leading cytotoxic and high-potent drug development service provider,” said Timothy Scott, president of Pharmatek, in a company release.
Pharmatek’s cytotoxic and high-potent development services will be carried out in a separate dedicated facility, it said.
The company recently expanded its facility space when it moved into a 34,000-square-foot facility located at 7330 Carroll Road. Its lease included an option to expand to 64,000 square feet.
Pharmatek focuses on bringing client compounds from discovery to the clinic with services including compound selection, analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing.
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Fast-Track Status:
The Food and Drug Administration granted Adventrx Pharmaceuticals Inc. fast-track status Aug. 16 for its metastatic colorectal cancer drug candidate ANX-510.
San Diego-based Adventrx is testing the CoFactor injection in a pivotal Phase 3 study in conjunction with Avastin, Gen & #173;en & #173;tech’s tumor growth inhibitor, and chemotherapy.
CoFactor is designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU.
“The FDA’s fast-track designation represents a significant step towards bringing CoFactor to market as rapidly as possible,” said Evan Levine, chief executive officer of Adventrx, in a company release. “We look forward to working closely with the FDA to expedite the review and approval process for CoFactor.”
The FDA’s fast-track designation can boost the development and review of drugs that serve unmet medical needs.
Colorectal cancer is the third most common cancer and a leading cause of cancer-related mortality in the United States.
There were an estimated 112,340 new patients diagnosed with colon cancer and 41,420 patients diagnosed with rectal cancer in the United States last year.
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Study’s Results Are Positive:
Tysabri, the multiple sclerosis drug originally slated for manufacture in Oceanside, demonstrated significant health-related quality of life improvements in an article published in the Annuals of Neurology on Aug. 20.
The Phase 3 study’s objective was to assess the relationship between disease activity and quality of life improvements in relapsing forms of MS and Tysabri’s impact on the measures.
Study results showed improvements as early as 24 weeks compared with a placebo.
Tysabri was pulled from marketplace shelves in 2005 after it was linked to a rare brain disease called progressive multifocal leukoencephalopathy, or PML. Three clinical trial patients contracted the disease and two died.
It was reintroduced into the marketplace last year with additional safety labeling.
The drug, being co-developed by Biogen Idec Inc. and Elan Corp., is approved by the Food and Drug Administration for the treatment of relapsed forms of MS.
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Connect Calls For Entries:
Connect, the local nonprofit technology and life sciences trade organization, is calling for entries to its most innovative new product awards, a tradition 20 years strong.
Entries are due Aug. 31.
This year, the event will feature a newly added category, the William W. Otterson Award, in memory of Connect’s first executive director. The award will recognize San Diego-based companies that have demonstrated a significant positive impact on society or quality of life.
Last year, the award was given to Tandem PSA, developed by Hybritech. Previous award winners include Qualcomm Inc. for code division multiple access, or CDMA technology, Idec Pharmaceuticals for Rituxan, Agouron Pharmaceuticals for Viracept and HNC Software for Flacon.
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Filing:
Cardium Therapeutics Inc. filed a shelf registration statement with the Securities and Exchange Commission on Aug. 15 that would allow it to periodically sell up to $50 million of its common stock in one or more registered direct offerings.
The statement is contingent on SEC approvals.
Contact Heather Chambers for news about the biotechnology industry, 858-277-6359, or
hchambers@sdbj.com
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