Biotech drugmaker Threshold Pharmaceuticals Inc. said Thursday the Food and Drug Administration granted orphan drug status to its treatment for pancreatic cancer.
In August, the company said it was focusing on a late-stage clinical trial of glufosfamide for the second-line treatment of pancreatic cancer and a mid-stage clinical trial, in combination with another drug, for an initial treatment.
Orphan drug status is given to drugs meant to treat conditions affecting fewer than 200,000 patients in the United States.
The announcement caused shares to jump. Shares of Threshold rose 35 cents, or 14 percent, to $2.85 in early morning trading on the Nasdaq.
The company's shares hit a 52-week high of $16.98 in April but plummeted in May when the FDA found a safety risk with the company's treatment for enlarged prostate. They dropped again in July when the company discontinued development of the drug.
The orphan status allows a company seven years of market exclusivity for the particular use if approved, along with tax breaks, development funding, and other incentives.
WHAT IS GLUFOSFAMIDE? Glufosfamide Is a next-generation glucose conjugate of ifosfamide. It is an alkylating agent [Binds to DNA stops replication] in which isophosphoramide mustard, the alkylating metabolite of ifosfamide, is glycosidically linked to beta-D-glucose. Cellular uptake of glufosfamide is mediated by a sodium-dependent transmembrane transporter protein of glucose and possibly also by other transporter proteins. They are exploiting unique aspects of tumour metabolism, particularly the elevated glucose utilization of tumour cells [Remember pancreas]to selectively target glufosfamide to the tumour site. Pretty cool science there. !
Currently Threshold (THLD) is trading on the NASDAQ up 14% to 2.87.
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