By a News Reporter-Staff News Editor at Drug Week According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventor Giesing, Dennis (Lee's Summit, MO), filed on February 23, 2015, was published online on May 2, 2017 (see also Pharmaceutical Companies).
The assignee for this patent, patent number 9636488, is TARIS Biomedical LLC (Lexington, MA).
Reporters obtained the following quote from the background information supplied by the inventors: "Delivery of diagnostic or therapeutic agents to the prostate is difficult. Current practice requires systemic administration, such as by intravenous, intramuscular, oral, transdermal, or intranasal routes, using doses which result in significant exposure to healthy tissues and relatively low exposure within the prostate gland. Frequently the systemic exposure leads to unwanted or harmful side effects which limit the usefulness of the therapeutic agent in treating prostate disease.
"Targeted and local delivery strategies have been explored to minimize peripheral exposure with limited success. Some targeting strategies rely on prostate cells to express specific receptors to which a drug-targeting ligand complex binds. These receptors may not always be present, limiting the utility of the approach. The receptor density on prostate cells also can vary widely and restrict the actual amount of drug delivered to the prostate. In addition, other cells in the body may also express the same receptor leading to unwanted drug exposure. Lastly, the drug targeting ligand complex can be degraded prior to reaching the prostate, defeating the targeting mechanism.
"Direct injection into or near the prostate also has been tried. Patient acceptance is low due to the pain and risk of infection. In addition, the mean residence time of the drug often is relatively short, which necessitates the use of multiple injections for treatment. Furthermore, the disruption of prostate tumors during injection can lead to metastasis. Depot formulations extend the drug presence in the prostate but reduce the amount of drug that can be injected into the prostate and may enhance local tissue toxicity.
"Radionucleotide-containing pellets placed near the prostate are used to treat prostate cancer but provide only one treatment modality. Radiation therapy is also non-selective, leading to significant damage to surrounding healthy tissue structures including nerves.
"The use of a suppository or drug eluting stent placed in the prostatic urethra is known, but these are difficult to place and poorly tolerated in men. Furthermore, these delivery means have a limited payload capacity.
"Accordingly, there remains a need for improved drug delivery methods and systems for treating the prostate, such as in the treatment of prostate cancer or prostatitis."
In addition to obtaining background information on this patent, NewsRx editors also obtained the inventor's summary information for this patent: "In one aspect, a medicament is provided that includes gemcitabine for use in the treatment of the prostate by locally administering the gemcitabine into the bladder of a patient to achieve a sustained concentration of the drug in the urine in the bladder sufficient to produce a therapeutic concentration of the drug in the prostate, wherein the locally administering into the patient's bladder is at a mean average amount of from 1 mg to about 300 mg per day. The locally administering of gemcitabine may be continuous or intermittent. In one embodiment, the patient is in need of treatment for prostate cancer. In an embodiment, the gemcitabine is delivered into the bladder from an intravesical drug delivery device which continuously releases the gemcitabine into the urine in the bladder over a sustained period. In an alternative embodiment, the gemcitabine is delivered into the bladder from a coating substance applied to the bladder, which coating substance continuously releases the gemcitabine into the urine in the bladder over a sustained period. The coating substance may include a mucoadhesive formulation. In a further alternative embodiment, a liquid form of the gemcitabine is pumped into the bladder through a urethral catheter inserted into the bladder. In various embodiments, the gemcitabine is released into the patient's bladder continuously over a period of at least 2 hours, such as from 1 day to 14 days. In an embodiment, the gemcitabine is released into the patient's bladder at a mean average amount of from 1 mg to about 100 mg gemcitabine per day for up to 7 days. In another embodiment, the gemcitabine is released into the patient's bladder at a mean average amount of from 20 mg to 300 mg per day for up to 7 days.
"In another aspect, a medical device is provided for intravesical administration of gemcitabine. In an embodiment, the medical device includes a housing configured for intravesical insertion and a dosage form including gemcitabine, wherein the housing holds the dosage form and is configured to release the gemcitabine into the bladder in an amount therapeutically effective for the treatment of the prostate, and wherein the device is configured to release gemcitabine into the bladder at a mean average amount of from 1 mg to about 300 mg per day of the gemcitabine. The gemcitabine contained in the housing may be in a non-liquid form. The housing may be elastically deformable between a retention shape configured to retain the device in a patient's bladder and a deployment shape for passage of the device through the patient's urethra. In an embodiment, the device is configured to release from 1 mg to 100 mg of gemcitabine per day for up to 7 days. In another embodiment, the device is configured to release from 20 mg to 300 mg of gemcitabine per day for up to 7 days.
"In still another aspect, a method is provided of administering a drug to a patient in need of treatment of the prostate. The method includes locally administering gemcitabine into the bladder of a patient to achieve a sustained concentration of the gemcitabine in urine in the bladder sufficient to produce a therapeutic concentration of the gemcitabine in the prostate. In one embodiment, the method includes administering at least a second therapeutic agent to the patient. The second therapeutic agent may be administered intravesically. The second therapeutic agent may include a cytotoxic agent, an analgesic agent, an anti-inflammatory agent, or a combination thereof. The second therapeutic agent may prevent, treat, or ameliorate cystitis of the bladder."
For more information, see this patent: Giesing, Dennis. Drug Delivery Systems and Methods for Treatment of Prostate. U.S. Patent Number 9636488, filed February 23, 2015, and published online on May 2, 2017. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9636488.PN.&OS=PN/9636488RS=PN/9636488
Keywords for this news article include: Antimetabolites, Antineoplastics, Antivirals, TARIS Biomedical LLC, Pharmaceutical Companies, Oncology, Prostate Cancer, Drugs and Therapies, Gemcitabine Therapy, Prostatic Neoplasms, Risk and Prevention, Drug Delivery Systems, Immunosuppressive Agents, Radiation-Sensitizing Agents.
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