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樓主 / manerfeifei
- 時間: 2011-8-16 10:19
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- 時間: 2011-8-16 12:41
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- 時間: 2011-8-16 13:01
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- 時間: 2011-9-12 06:32今天gap的好消息。
PharmaGap Announces Successful Completion of Liposomal Development With Significantly Improved Potency of Cancer Drug
12 Sep 2011 07:27 ET
Marketwire Canada
PharmaGap Inc. (TSX VENTURE:GAP)(OTCBB
HRGF) ("PharmaGap" or "the Company") today announced that it has successfully completed the design, development, manufacture and testing of a liposome formulation of both basic and enhanced versions of its lead cancer drug GAP-107B8, and will proceed to in vivo testing of both formulations in bladder and ovarian cancer models in order to select one formulation and cancer target for first human clinical trials. This in vivo testing will be undertaken between now and the end of 2011, with a final selection based on the results seen in these tests.
This development program has involved the production of a number of prototype designs, each at a range of drug concentrations within the liposome carrier. These prototypes were tested for potency across a 3 human bladder cancer and 3 human ovarian cancer cell lines, and compared head to head with the GAP-107B8 peptides alone (basic and enhanced versions), and with the empty liposome carriers. This testing was carried out at PharmaGap labs over the past 6 months. The liposome formulations and the enhanced version of GAP-107B8 represent novel and material new intellectual property for PharmaGap, and is the subject of a patent filing for the Company.
Dr. Ken Sokoll, Vice President of Clinical Development and Chief Operating Office for PharmaGap, stated "I am very pleased that we have achieved our objective of successfully identifying a liposomal formulation of both versions of our lead cancer drug, in the time frame established when we embarked on this program in the first quarter of the year. We now are presented with the prospect of a widened therapeutic window, and are seeing in vitro effectiveness at dose ranges suitable to proceed to human clinical trials. This has been a very labour intensive effort both internally by our staff as well as at our contractor sites, and I want to thank each of them for a high degree of effort and diligence in arriving at this key point in our program."
The successful development of the liposomal formulations of basic and enhanced GAP-107B8 has significantly widened the GAP-107B8 Therapeutic Window (the range of doses between the lowest effective dose and the highest dose where unacceptable toxicity become evident), which is a key consideration for effective clinical trial design and ultimate success of the drug in the marketplace.
Liposomal delivery systems are an accepted, proven, and commercially viable strategy for the formulation of pharmaceuticals for clinical use. These delivery systems are employed to improve tumour targeting, modulate the pharmacokinetics of the active agent and enhance its stability following administration. Therapeutic activity may be improved by modulating drug exposure and accumulation (controlled release) in the region where the target cells are located.
The two formulated GAP-107B8 compounds will now both proceed through in vivo pharmacokinetic and pharmacodynamic testing (to assess physical characteristic of the drug in a live system), as well as the determination of Maximum Tolerated Dose, in order to determine the optimum dose ranges for use in the in vivo efficacy testing of both formulations in bladder cancer (using intravesical administration) and ovarian cancer (using intraperitoneal administration) in the 4th quarter of this year. -
- 時間: 2011-9-12 06:37
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- 時間: 2011-9-12 08:28
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- 時間: 2011-9-12 09:19
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- 時間: 2011-11-21 19:18Gilead said Monday it will pay $137 per share in cash for Pharmasset, a Princeton, N.J., company with no products on the market and a stock that has traded as low as $20.49 in the past year. The announcement sent Gilead's stock tumbling and Pharmasset's soaring.
Shares of Pharmasset soared 85 percent, or $61.47, to close Monday at $134.14, while Gilead's stock dropped more than 9 percent, or $3.62, to close at $36.26.
(from: market watch)
什麼時候輪到gap呢? -
- 時間: 2011-11-28 09:12今天gap的消息給力~
OTTAWA, ONTARIO--(Marketwire -11/25/11)- PharmaGap Inc. (TSX-V: GAP.V - News)(OTC.BB: PHRGF.PK - News) ("PharmaGap" or "the Company") today announced that liposomal formulations of its cancer drug have proven to meet and surpass expectations for three key elements important for clinical trials - potency, pharmacokinetic profile, and therapeutic index. Peptide half-life has been increased from a range of 0.4 to 0.7 for unformulated peptides to approximately 8 hours using intravenous administration and to approximately 40 hours using intraperitoneal administration. Liposomal associated peptide was detectable up to 72 hours post administration indicating that peptide remains in circulation for extended periods of time.
Rats administered liposomes via the intraperitoneal route in the current PK study were observed for clinical signs over 72 hours and results indicate that liposomal formulations would be well tolerated over a wide dosing range (10-40 mg/Kg). These results would be expected to provide a wide therapeutic index (the dosing range between effective dose and the dose at which toxic effects are seen) for drug administered by this route.
In the order of 250,000 new cancer cases annually in the US are known to arise from cancers with origins in the peritoneal cavity. Intraperitoneal injection is an attractive route to deliver liposomal peptides to tumour sites for certain cancers, including ovarian, pancreatic, colorectal, gastric and liver. While focusing on ovarian cancer for definitive efficacy testing to provide proof of concept for first clinical trial application, the Company continues investigation and development of these liposomal peptides in order to expand initial application to other cancer indications for future marketing.
Dr. Ken Sokoll, Vice President of Clinical Development and Chief Operating Officer for PharmaGap, commented "rapid metabolism and elimination of peptide drugs is known to be a major factor contributing to the failure of peptide drugs. Our ability to overcome this problem using these new liposomal formulations and demonstrating that we have viable formulations when administered by both the intravenous and intraperitoneal routes will be key factors in achieving success for our drug compounds." -
- 時間: 2011-11-28 09:21
manerfeifei 寫道:今天gap的消息給力~
OTTAWA, ONTARIO--(Marketwire -11/25/11)- PharmaGap Inc. (TSX-V: GAP.V - News)(OTC.BB: PHRGF.PK - News) ("PharmaGap" or "the Company") today announced that liposomal formulations of its cancer drug have proven to meet and surpass expectations for three key elements important for clinical trials - potency, pharmacokinetic profile, and therapeutic index. Peptide half-life has been increased from a range of 0.4 to 0.7 for unformulated peptides to approximately 8 hours using intravenous administration and to approximately 40 hours using intraperitoneal administration. Liposomal associated peptide was detectable up to 72 hours post administration indicating that peptide remains in circulation for extended periods of time.
Rats administered liposomes via the intraperitoneal route in the current PK study were observed for clinical signs over 72 hours and results indicate that liposomal formulations would be well tolerated over a wide dosing range (10-40 mg/Kg). These results would be expected to provide a wide therapeutic index (the dosing range between effective dose and the dose at which toxic effects are seen) for drug administered by this route.
In the order of 250,000 new cancer cases annually in the US are known to arise from cancers with origins in the peritoneal cavity. Intraperitoneal injection is an attractive route to deliver liposomal peptides to tumour sites for certain cancers, including ovarian, pancreatic, colorectal, gastric and liver. While focusing on ovarian cancer for definitive efficacy testing to provide proof of concept for first clinical trial application, the Company continues investigation and development of these liposomal peptides in order to expand initial application to other cancer indications for future marketing.
Dr. Ken Sokoll, Vice President of Clinical Development and Chief Operating Officer for PharmaGap, commented "rapid metabolism and elimination of peptide drugs is known to be a major factor contributing to the failure of peptide drugs. Our ability to overcome this problem using these new liposomal formulations and demonstrating that we have viable formulations when administered by both the intravenous and intraperitoneal routes will be key factors in achieving success for our drug compounds."
HUG!
GAP
