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Anyone know whats happening with this company? No, new knews nor any progress statement from their R&D team ...
PharmaGap 1,293,462 shares for debt
2010-09-16 19:56 ET - Shares for Debt
Further to the TSX Venture Exchange bulletin dated July 9, 2009, PharmaGap Inc. has confirmed that the proposed debt settlement of $215,201.44 was not settled as disclosed in the company's news release dated July 16, 2009. The company is now seeking to settle debt in the amount of $219,888.62 to the same creditor. As a result, the exchange has accepted for filing the company's proposal to issue 1,293,462 shares at a deemed price of 17 cents per share to settle outstanding debt for $219,888.62.
PharmaGap Announces Completion of Private Placement
Ottawa, Ontario/ September 14, 2010 – PharmaGap Inc. (TSX-V: GAP; OTC.BB: PHRGF) (“PharmaGap” or “the Company”) announced today that it has completed the second tranche of an offering of equity units (the “Units”). A total of up to 16,666,667 Units were made available to subscribers at the offering price of $0.18. Each Unit consists of one common share and one warrant to purchase a common share at an exercise price of $0.25 for the first two years and $0.35 for the third year of the three year warrant term. PharmaGap announced the first closing of the private placement (which occurred on August 27, 2010) in a news release dated August 30, 2010.
The second closing is in the amount of $304,278 being 1,690,433 Units, to accredited investors, and is subject to final TSX-V approval.
In connection with this second closing of the private placement, cash finder’s fees and broker warrants will be paid to Capital Street Group ($9,128 cash fees and 50,712 broker warrants), to Northern Securities ($630 cash fees and 3,500 broker warrants) to Canaccord Genuity Corp. ($7,649 cash fees and 42,498 broker warrants), and to Wellington West Financial Inc. ($13,020 cash fees and 72,333 broker warrants. Broker warrants are issued on the same terms and conditions as the warrants included in the Units.
For the first and second closings combined, a total of 4,429,750 Equity Units were issued for total gross proceeds of $797,355. For the combined closings, cash finder’s fees and broker warrants have been or will be paid to Capital Street Group ($30,612 cash fees and 170,068 broker warrants), to Northern Securities ($10,458 cash fees and 58,100 broker warrants), to Canaccord Genuity Corp. ($14,934 cash fees and 82,972 broker warrants), and to Wellington West Financial Inc. ($13,020 cash fees and 72,333 broker warrants).
The Units and broker warrants issued pursuant to the Private Placement are subject to a trading restriction for a period of four months and one day from the respective dates of closing.
With the second closing, the private placement initially announced on August 11, 2010 has now been completed and no further Units will be issued pursuant to this placement.
About PharmaGap Inc.
PharmaGap Inc. (TSX-V: GAP), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel peptide therapeutics for the treatment of cancer. PharmaGap’s GAP-107B8 is a novel peptide drug that has been shown to be highly cytotoxic to numerous cancer types, including chemo-resistant cancers, in vitro. For more information on PharmaGap please visit the Company's website at www.pharmagap.com.
For information relating to this Release, please contact:
Robert McInnis, President & CEO
(613) 990-9551 bmcinnis@pharmagap.com
Note: Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. No Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially.
Not going anywhere until the financing uncertainty is resolved.
I wonder which way it breaks?
OTTAWA, ONTARIO--(Marketwire - June 28, 2010) -PharmaGap Inc. (TSX VENTURE:GAP) (OTCBB:PHRGF) ("PharmaGap" or "theCompany") today announced the appointment of Mr. Ian Malone to its Board of Directors at the Company's Annual General Meeting in Ottawa. Mr.Malone has extensive finance and biotech industry experience and will bring key insights to the Board of PharmaGap as it proceeds toward clinical trials and out-licensing of its lead cancer drug GAP-107B8.
At the Annual General Meeting, in response to a question from a shareholder, Mr. Rod Bryden, Chairman of the Company, disclosed that the Company is looking to further expand its Board to add drug licensing experience. The Company also expects to appoint an experienced Executive to lead Clinical Development in the third quarter.
Mr. Bryden said "We are in the home stretch of bringing our lead drug to clinical trials. Recent test results have stimulated interest with potential licensees and highlighted the need for dedicated clinical development leadership to carry the final pre-clinical program to successful conclusion. We also recognize that a partnership with an established Pharma is the best path to bring this drug treatment to patients and to realize value for shareholders. Mr. Malone will add a new dimension to our Board and we will seek also to attract someone with drug licensing experience. This broadened Board and the addition of an experienced Vice President Clinical Development will position Pharmagap for the opportunities and challenges ahead".
The full presentation made at the Annual General Meeting maybe downloaded at www.pharmagap.com.
About PharmaGap Inc.
PharmaGap Inc. (TSX-V: GAP), based in Ottawa, ON, is abiotechnology company with a core focus on developing novel peptidetherapeutics for the treatment of cancer. PharmaGap's GAP-107B8 is anovel peptide drug that has been shown to be highly cytotoxic tonumerous cancer types, including chemo-resistant cancers, in vitro.For more information on PharmaGap please visit the Company's website atwww.pharmagap.com.
Note: Neither the TSX Venture Exchange nor its RegulationServices Provider (as that term is defined in the policies of the TSXVenture Exchange) accepts responsibility for the adequacy or accuracy ofthis release. No Securities Commission or other regulatory authorityhaving jurisdiction over PharmaGap has approved or disapproved of theinformation contained herein. This release contains forward lookingstatements that may not occur or may change materially.
OTTAWA,ONTARIO--(Marketwire - June 24, 2010) - PharmaGap Inc. (TSXVENTURE:GAP)(OTCBB:PHRGF) ("PharmaGap" or "the Company") todayannounced 80% average growth inhibition (at 20 micromolar dose) in invitro testing of its lead cancer drug GAP-107B8 in Ocular andCutaneous Melanoma at Memorial Sloan-Kettering Cancer Center (MSKCC).
"In addition to seeing these strong in vitro resultsin melanoma, we are very excited to learn that the test program atMSKCC will proceed to animal tests, and I anticipate results from thesetests during our 3rd quarter", said, President RobertMcInnis.
"We are seeing promising results in the melanoma cell linepanel, and I am excited to be continuing with further testing, both invitro and in animal models, to explore the potential for this newdrug compound," stated Dr. Gary Schwartz, chief of the Melanoma andSarcoma Service at Memorial Sloan-Kettering Cancer Center.
In these tests, GAP-107B8 was tested in cell proliferationassays in 6 Ocular Melanoma and 4 Cutaneous Melanoma human cancer celllines with established cell signaling profiles in order to generatefurther understanding of GAP-107B8's efficacy in slowing proliferation,its time course of effect in cells, dose level response patterns, andinhibition of known cell signaling targets.
In the dose levels of 10, 15, and 20 micromolars (um),GAP107B8 slowed cell growth by, 29%, 62%, and 80% (average across allcell lines), showing a clear effect in slowing cancer cell proliferationand a clear effect of different dose levels.
Image analysis of cells over time showed biological effectsin cells in as early as 15 minutes, and inhibitory effect on signalingpathways was observed to be time-dependent and observed as early as 2hours following treatment. Inhibition of known cancer-related signalingpathways was observed in mTOR, MAPK, and PKC pathways (alpha and delta).
This in vitro test program will continue over thenext few weeks with additional analysis of GAP-107B8's mechanism onautophagic cell death, cell cycle effects in order to elucidateadditional mechanism of action information, and testing of the drugagainst normal, non-cancer cells in order to continue to establish thesafety profile of the drug.
"A series of tests are underway to provide the basis for selection of the cancer target for clinical trial application. I expect results from the pharmacokinetics program at the National ResearchCouncil, carried out in conjunction with Tandem Labs, to be availablenext week. I will be outlining the company's program to licensing at the Annual General Meeting later today, and we will report further on thatprogram in the next few days", Mr. McInnis said.
About PharmaGap Inc.
PharmaGap Inc. (TSX-V: GAP), based in Ottawa, ON, is abiotechnology company with a core focus on developing novel peptidetherapeutics for the treatment of cancer. PharmaGap's GAP-107B8 is anovel peptide drug that has been shown to be highly cytotoxic tonumerous cancer types, including chemo-resistant cancers, in vitro.For more information on PharmaGap please visit the Company's website atwww.pharmagap.com.
Note: Neither the TSX Venture Exchange nor its RegulationServices Provider (as that term is defined in the policies of the TSXVenture Exchange) accepts responsibility for the adequacy or accuracy ofthis release. No Securities Commission or other regulatory authorityhaving jurisdiction over PharmaGap has approved or disapproved of theinformation contained herein. This release contains forward lookingstatements that may not occur or may change materially.
For more information, please contact
PharmaGap Inc.
Robert McInnis
President & CEO
613-990-955
bmcinnis@pharmagap.com
or
PharmaGap Inc.
Martin Tremblay
IR Consultant
514-351-3736
IR@pharmagap.com
Clickhere to see all recent news from this company
TGen partner, PBS-Bio, makes first breakthrough drug analysis
Enables PharmaGap to advance development of promising anti-cancer drug
PHOENIX, Ariz. — June 18, 2010 — Predictive Biomarker Sciences Inc. (PBS-Bio) has completed its first drug analysis, enabling Canadian biotech company PharmaGap Inc. to significantly advance a potentially significant anti-cancer medication.
PharmaGap is an early-stage biotech company based in Ottawa, Ontario developing novel peptide compounds for cancer. Its lead compound, GAP-107B8, exhibits potent cytotoxic characteristics against cancer cells and has recently completed screening at the National Cancer Institute in Bethesda, Md., and was the subject of a data poster by researchers at the Ottawa Hospital Research Institute at the recent American Association for Cancer Research meeting in Washington, D.C. Proprietary real-time computer imaging technology from PBS-Bio has been instrumental in assisting PharmaGap to determine the drug's potential mechanism of action and thereby identifying suitable cancers to target for eventual clinical use.
As part of its pre-clinical development program, PharmaGap hired Phoenix-based PBS-Bio to analyze more specifically how the drug worked. PBS-Bio is a privately held, for-profit corporation owned in part by the non-profit Translational Genomics Research Institute (TGen). Data from the PBS-Bio analysis indicated that GAP-107B8 rapidly compromises the outer membrane of colorectal cancer cells, leading to either oncolytic or apoptotic cell death, while having significantly less affect on non-cancerous cells. Unlike many protein kinase inhibitor drugs now in development, GAP-107B8 works within mere minutes through "an assault on the plasma membrane," said Dr. Isabella Steffensen, a PharmaGap pre-clinical development consultant. She said that GAP-107B8 appears to be reacting with surface receptors apparently more prevalent on cancer cells than normal cells.
By providing PharmaGap with a more accurate analysis of how the drug functioned, PBS-Bio saved the company months of research and an estimated $400,000 in costs. Moreover, the PBS-Bio data has assisted PharmaGap to expand the scope of possible cancer targets for GAP-107B8, said Robert McInnis, the company's President and Chief Executive Officer. McInnis said PharmaGap is now also better positioned with GAP-107B8 to run clinical trials, anticipated in 2012, and expand the scope of its intellectual property and business development potential. "Based on the insights gleaned from working with the PBS-Bio team in Arizona, we have a much clearer idea of how this compound is acting," McInnis said. "Overall, it was a very successful collaboration. We certainly look forward to a continuing relationship with PBS-Bio"
Like plugging a computer diagnostic into a running car engine, PBS-Bio's technology uses live cancer cells to show pharmaceutical companies how their drugs work, or don't work, said Dr. Michael Bittner, Co-Director of TGen's Computational Biology Division. "For the first time, we can show — at the molecular level — exactly how drugs will affect cancer cells in real-time, identifying precisely along which cellular pathways drugs produce results, or fail,'' said Dr. Bittner, who also is a Principal Investigator at TGen for the PBS-Bio technology, and a Member of PBS-Bio's Scientific Advisory Board. "The success of targeted oncology drugs can vary from tumour to tumour, and the range of the specific types of tumour molecular pathologies that are susceptible or resistant to a given drug are frequently unknown. The purpose of the PBS-Bio technology is to make pre-clinical research more predictive of actual patient outcomes," Dr. Bittner said.
The technology is expected to save pharmaceutical companies millions of dollars in drug development costs, especially by showing what drugs might not work, thereby avoiding costly clinical trials, said Dr. Edward Smith, founder and CEO of PBS-Bio. The technology also is expected to show which drugs might work better in tandem with other drugs, thereby salvaging promising drug lines that otherwise might be shelved, said Dr. Smith, who also is an adjunct faculty member at TGen and at the University of Arizona College of Medicine. "Specifically, the TGen-PBS-Bio technology shows, in real time, how drugs affect the genes and their signalling pathways within cells that cause cancers to grow out of control," Dr. Smith said.
The hope is that by using this technology, drug companies will be able to develop cancer drugs more quickly, and at lower costs, while giving researchers a better idea of which patients will best respond to the therapies, Dr. Smith said.
PBS-Bio is working with three large pharmaceutical companies on projects to: determine which of several similar compounds to move into clinical trials, identify which drugs to add to their investigational drug to make it most effective, and identify biomarker tests that will identify patients most likely to respond to the new drug combination.
###
About PharmaGap Inc.
PharmaGap Inc. (TSX-V: GAP; OTC.BB: PHRGF), based in Ottawa, Ontario, is a biotechnology company with a core focus on developing novel peptide therapeutics for the treatment of cancer. For more information please visit www.pharmagap.com.
Press contact:
Robert McInnis
PharmaGap President & CEO
613-990-9551
bmcinnis@pharmagap.com
About PBS-Bio
Predictive Biomarker Sciences Inc. (PBS-Bio) is a privately held corporation based in Mesa, Arizona, and founded in 2006 with funding from private investors, mostly based in Arizona. In addition to Dr. Bittner, a biologist, and Dr. Smith, a medical doctor, the TGen/PBS-Bio collaborative team includes Dr. Edward Dougherty, an electrical engineer and the other Co-Director of TGen's Computational Biology Division. The three began their collaborations while working under TGen President and Research Director Dr. Jeffrey Trent when Dr. Trent was the Scientific Director of the National Human Genomics Research Institute in Bethesda, Md. Their professional relationships continued after TGen was founded in Phoenix in 2002. For more information, please visit: pbs-bio.com.
Press contact:
Dr. Ed Smith, M.D.
President and CEO
602-418-9300
edsmith@pbs-bio.com
About TGen
The Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. TGen is affiliated with the Van Andel Research Institute in Grand Rapids, Michigan. For more information, please visit: www.tgen.org.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
syozwiak@tgen.org
What is this all about?
Well, we have here a cancer development company with deep pocketed backing - Bryden - with a drug for MDR (Multi Drug Resistance) that is already developed and tested looking for a big pharma partner to go for the gold.
All for 25¢!
Great buy!!
No guarantee, of course, but what an interesting possibility.
And I know it is in Canada - the "V" indicating "V"ancouver once upon a time but now is for "V"enture I believe on the Toronto Stock Exchange.
A NASDAQ listing would be most helpful in dispensing any lingering doubts.
Yes, it sure does. ;)
Looking good Karin
US residents can trade it via OTC.BB:PHRGF
That was a huge volume spike back in May.
Interesting. Thanks for posting. ;)
Stormont and Bryden involved!
Last time I was with Bryden, I was in Systemhouse - many years ago.
He's moved on to generating electricity from garbage (Plasco) while I have mostly been investing IN garbage!
Time for something significant to occur - could the GAP be it?
Ref:
http://finance.yahoo.com/news/PharmaGap-Announces-iw-1193779959.html?x=0&.v=1
http://www.canada.com/ottawacitizen/news/city/story.html?id=0db2ae62-44a0-4ac0-adc0-375254caaab8
PharmaGap Seeks Licensing Deal
Press Release Source: PharmaGap Inc. On Thursday June 3, 2010, 8:30 am EDT
OTTAWA, ONTARIO--(Marketwire - 06/03/10) - PharmaGap Inc. (TSX-V:GAP - News)(OTC.BB:PHRGF - News) ("PharmaGap" or "the Company") announced today that it is seeking a Licensing Agreement with a major pharmaceutical company for its lead cancer drug.
The Company has maintained contact with and continues to provide data to the in-licensing groups in several major companies active in the cancer field. Recent tests at the National Cancer Institute and results from current and near term studies have been important in advancing these discussions.
A key element in the licensing interest is the toxicity profile of the drug. Very low to no toxicity within the effective dose range has been observed in earlier animal tests conducted by the Company and confirmed in the results of animal tests recently completed at the Ottawa Hospital Research Institute ("OHRI").
A number of testing activities are underway or are about to start that will provide the Company with additional data for the selection of the cancer target, route of administration and dose levels for GAP-107B8. Results of formal toxicology tests will be announced when available, and additional tests will be designed and pursued in order to complete the data dossier required for clinical trial application and for building value with potential licensing partners. Tests currently underway include:
-- a test designed to determine the duration of time the drug remains
active in blood plasma (using rat subjects at the National Research
Council), in collaboration with Tandem Laboratories. Results of this
study are expected to be available in the next few weeks;
-- an in vitro test of efficacy in melanoma and sarcoma cancer cells at
Memorial Sloan Kettering Cancer Centre, with results expected during
June;
-- a test of GAP-107B8's relative effect against non-cancerous "normal"
cells, an indicator of the drug's toxicity profile, with results
expected in July;
"Targeted testing will continue at an accelerated pace as we work to deliver the data required for a valuable licensing agreement and the introduction of our lead drug to clinical use", said President Robert McInnis. "I hope to announce soon the addition to the company of an experienced executive to lead in this opportunity to deliver an exciting new choice of treatment for cancer sufferers and reward to those who have carried the company to this position", he said.
About PharmaGap Inc.
PharmaGap Inc. (TSX-V:GAP - News), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel peptide therapeutics for the treatment of cancer. PharmaGap's GAP-107B8 is a novel peptide drug that has been shown to be highly cytotoxic to numerous cancer types, including chemo-resistant cancers, in vitro. For more information on PharmaGap please visit the Company's website at www.pharmagap.com.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. No Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially.
Contact:
Contacts:
PharmaGap Inc.
Robert McInnis
President & CEO
613-990-9551
bmcinnis@pharmagap.com
PharmaGap Inc.
Martin Tremblay
IR Consultant
514-351-3736
IR@pharmagap.com
The technicals are showing positive signs of moving up. Looks like a good entry point here.
http://canada.stoxline.com/q_ca.php?s=gap.v
Yes, on Stockhouse as well. The share price is insane right now.
Nope....Area Code 403....Kippers my Goalie LOL
Do you follow Gap on stockhouse at all?
Lot of p'd off investors there...great results though SP should have been 50cents plus...I'm sticking around.
Management supposed to meet with NCI in late November...so that can only be good IMO.
Just joined this board last week in the hopes of making a bit off of the Pinks..
You bet. Are you in the States?
Not too much known about GAP or PHRGF in the USA right now, obviously. Ed...I take it you're an Oiler's fan?
PharmaGap Reports That GAP-107B8 Showed Strong and Consistent Anti-Cancer Activity in a Wide Range of Cancers in NCI Test
Last Update: 10/27/2009 8:30:49 AM
OTTAWA, ONTARIO, Oct 27, 2009 (Marketwire via COMTEX) -- PharmaGap Inc. (GAP)(PHRG.F) ("PharmaGap" or "the Company") is pleased to announce highly positive results from the United States National Cancer Institute ("NCI") 5-dose in vitro anti-cancer screen of PharmaGap drug GAP-107B8. These results confirm and extend results announced in August from the single-dose study and provide definitive independent validation of GAP-107B8 as an active pharmaceutical ingredient against a wide range of cancers.
GAP-107B8 is a novel peptide protein kinase inhibitor that was designed to specifically target molecular signaling pathways in cancer cells. Targeted therapies are designed to target cancer cells while sparing surrounding normal, healthy, cells, thus causing less toxic effects than many standard chemotherapeutic agents currently in use.
Within a dose concentration range of 10 to 100 micromolar (u M), GAP-107B8 caused 100% growth inhibition (measured against cancer cell growth in untreated groups) in 51 of 56 cancer cell lines and caused at least 50% cancer cell death (measured against the number of cancer cells at the beginning of the test period) in 29 of 56 cancer cell lines.
The standard NCI test methodology generates three values that are used to measure the drug compound's activity against the cancer cell-line panel. These are: the GI50, the dose that causes an average 50% growth inhibition in the cell lines; the TGI, the dose that causes an average 100% growth inhibition in the cell lines; and the LC50, the dose that causes an average 50% cell death in the cell lines. For GAP-107B8, the GI50 was determined to be 23 u M, the TGI was 51 u M, and the LC50 was 89 u M. These data provide a very clear range of focus for all future studies.
These results provided a large amount of data, from the NCI testing which will be used by the Company to select specific cancer types and to determine an optimum dosing range for future animal studies and subsequent clinical trials. Based on these and prior results, the Company will be focusing its immediate development program on ovarian cancer and melanoma. The first of these animal studies is currently underway at the Ottawa Hospital Research Institute ("OHRI") in ovarian cancer. Further testing of GAP-107B8 on melanoma is about to commence under the guidance of Dr. Gary Schwartz at Memorial Sloan Kettering Cancer Center in New York. GAP-107B8 showed a strong effect in both melanoma and ovarian cancers in both single-dose and 5-dose testing at the NCI. In addition, the Company and NCI staff will meet in late November to discuss these results and ways in which the NCI may participate in various aspects of the development program for GAP-107B8.
The results across such a wide range of cancer cell lines, including a number which are known to be resistant to standard chemotherapy, indicate that GAP-107B8 has the potential to become a new cancer drug with less toxic side effects than common chemotherapeutic regimens.
Robert McInnis, President of the Company, stated "We are very pleased with the extent of activity in the NCI panel, as this activity against all cell lines provides a wide range of development opportunities for us, and provides us with additional support for a focus on ovarian cancer and melanoma. Our objective of the testing at the NCI - independent and verifiable validation of activity - has been fully realized. Over the past 12 months we have made significant progress in moving our lead drug to clinical trials: generating quality- controlled gram-scale production of the compound; achieving verifiable independent validation of compound activity at both the NCI and here in Ottawa at the OHRI; and programs underway in the area of bioassay development, understanding of signalling pathways involved, and continued testing programs at Memorial Sloan Kettering. This progress is very encouraging to me and to our team. Most importantly, results so far indicate a potential for new hope for the future of patients suffering from several types of cancer".
About The National Cancer Institute
The National Cancer Institute (NCI), located in Bethesda, MD is an institute of the National Institutes of Health, the primary U.S. Federal Agency for conducting and supporting medical research. The NCI has a mandate to select and screen novel drug compounds that could potentially make a material difference in the "war against cancer". Selection to the NCI screening program is through a competitive application process. Details on the NCI's compound screening program can be found at http://dtp.nci.nih.gov/ . More general information on the NCI is found at www.cancer.gov .
About PharmaGap Inc.
PharmaGap Inc. (GAP)(PHRG.F), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel peptide therapeutics for the treatment of cancer. PharmaGap's GAP-107B8 is a novel peptide drug designed to inhibit the activity of protein kinase C (PKC), a cell signalling enzyme implicated in certain types and stages of cancer. Independent peer-reviewed research has demonstrated that over-expression of PKC plays a role in the development of many cancer types. For more information please visit www.pharmagap.com .
Note: Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. No Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially.
SOURCE: PharmaGap Inc.
PharmaGap Inc.
Robert McInnis
President & CEO
613-990-9551
bmcinnis@pharmagap.com
www.pharmagap.com
Copyright (C) 2009 Marketwire. All rights reserved.
PharmaGap Announces Completion of Securities Lending Arrangements with Stormont
Last Update: 10/21/2009 9:28:59 AM
OTTAWA, ONTARIO, Oct 21, 2009 (Marketwire via COMTEX) -- PharmaGap Inc. (GAP)(PHRG.F) ("PharmaGap" or "the Company") today advises that the Securities Lending Agreements ("SLA") between SC Stormont Holdings Inc. ("Stormont") and subscribers to the 5,387,000 PharmaGap Equity Units issued on June 17, 2009 (the "Private Placement") have been satisfied in full.
Pursuant to these arrangements, Stormont committed to lend up to 13,125,000 freely trading common shares of PharmaGap held by it to subscribers in the Private Placement, repayable by the subscriber to Stormont in the form of freely tradable shares on the conclusion of the 4 month hold period on October 19, 2009. The total amount made available by Stormont included common shares issued directly and for issuance if all warrants in the Private Placement were exercised.
The effect of the SLAs was to restrict sale of shares held by Stormont for four months and to allow subscribers for equity units from treasury of PharmaGap to trade an equal number of common shares received from Stormont. This agreement was put in place after consulting with the TSX Venture Exchange.
Since June 17, 2009, a total of 6,757,060 common shares were lent to subscribers by Stormont, and were reported by Stormont as dispositions in the market in regulatory filings. These 6,757,060 common shares have now been repaid to Stormont, and will accordingly be reflected in regulatory filings as an acquisition of shares, as prescribed.
Mr. Rod Bryden, Chairman of both PharmaGap and Stormont, stated that "I am very pleased that I was in a position to enable PharmaGap to complete the issuance of shares and warrants in very difficult market conditions by adding the incentive of freely trading shares, by restricting sale of shares held by my company Stormont . I have full confidence in PharmaGap, as shown over the past 4 years of my involvement, and the confirmatory testing so far at the U.S. National Cancer Institute and at the Ottawa Hospital Research Institute has supported that confidence. I am less happy that I have had to reduce my holdings in PharmaGap recently, however this has been necessitated in order to meet obligations of Stormont originally entered into to provide funding to PharmaGap."
An additional 1,139,095 shares were made available to subscribers of 717,000 PharmaGap Equity Units issued on July 16, 2009 by Stormont in a second closing of the Private Placement under further SLA. These shares are scheduled to be returned to Stormont on November 19, 2009
About SC Stormont Holdings Inc.
SC Stormont Holdings Inc. is a holding company principally owned by Roderick M. Bryden, which currently holds 20,692,493 Common Shares, (23.1%) of PharmaGap and is PharmaGap's largest shareholder.
About PharmaGap Inc.
PharmaGap Inc. (GAP)(PHRG.F), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel peptide therapeutics for the treatment of cancer. PharmaGap's GAP-107B8 is a novel peptide drug designed to inhibit the activity of protein kinase C (PKC), a cell signalling enzyme implicated in certain types and stages of cancer. Independent peer-reviewed research has demonstrated that over-expression of PKC plays a role in the development of many cancer types. For more information please visit www.pharmagap.com .
Note: Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. No Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially.
SOURCE: PharmaGap Inc.
PharmaGap Inc.
Robert McInnis
President & CEO
613-990-9551
bmcinnis@pharmagap.com
Copyright (C) 2009 Marketwire. All rights reserved.
PharmaGap Advises That NCI Test Results Are Completed and Expected to Be Provided to the Company Shortly
Last Update: 10/20/2009 11:05:59 AM
OTTAWA, ONTARIO, Oct 20, 2009 (MARKETWIRE via COMTEX) -- PharmaGap Inc. (GAP)(PHRG.F) ("PharmaGap" or "the Company") advises that the results of dose-range testing of the Company's cancer drug GAP-107B8 at the United States National Cancer Institute ("NCI") can be expected "shortly". NCI staff has indicated to the Company that testing has been completed and the results can be expected to be received by the Company after analysis and review of these results by the NCI has been completed.
The Company announced the results from single dose testing at the NCI on August 24, 2009, which showed significant inhibition of cancer cell growth at a low drug concentration across a wide range of human cancer cells. In this initial single dose test, GAP107B8 demonstrated greater than 50% inhibition in cancer cell growth in 26 of 57 cell lines tested, across all 9 cancer types included in the test panel. The full release can be found on the Company's website.
The NCI dose range test repeats the single dose test at 5 different dose concentrations across the same cell lines, in order to provide further insights into the drug's activity at low dose concentrations. With this data, the PharmaGap drug can be compared with the estimated 40,000 drug compounds in the NCI database, using the NCI's COMPARE software programs, enabling NCI and Company researchers to further understand the drug's mechanism of action against defined pathways associated with specific cancer types, in order to better define the target cancer or cancers for which application for clinical trials will be made.
Mr. Robert McInnis, President and C.E.O. of PharmaGap, stated that "while we had expected to have the results of this testing in hand earlier, the NCI has indicated that their analysis of the data is proceeding in normal course and will be released to us when that analysis is completed"
About The National Cancer Institute
The National Cancer Institute (NCI), located in Bethesda, MD is an institute of the National Institutes of Health, the primary U.S. Federal Agency for conducting and supporting medical research. The NCI has a mandate to select and screen novel drug compounds that could potentially make a material difference in the "war against cancer". Selection to the NCI screening program is through a competitive application process. Details on the NCI's compound screening program can be found at http://dtp.nci.nih.gov/ . More general information on the NCI is found at www.cancer.gov .
About PharmaGap Inc.
PharmaGap Inc. (GAP)(PHRG.F), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel peptide therapeutics for the treatment of cancer. PharmaGap's GAP-107B8 is a novel peptide drug designed to inhibit the activity of protein kinase C (PKC), a cell signalling enzyme implicated in certain types and stages of cancer. Independent peer-reviewed research has demonstrated that over-expression of PKC plays a role in the development of many cancer types. For more information please visit www.pharmagap.com .
Note: Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. No Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially.
Contacts:
PharmaGap Inc.
Robert McInnis
President & CEO
613-990-9551
bmcinnis@pharmagap.com
SOURCE: PharmaGap Inc.
mailto:bmcinnis@pharmagap.com
Copyright 2009 Marketwire, Inc., All rights reserved.
Developing story here
NCI Phase 1 results
OHRI Phase 2 results
OHRI animal tests
MD Biosciences update
NCI Phase 2 results
And whatever else... News could come out of nowhere.
Looking Good
60Min Chart (displays properly if you are a StockCharts 'Realtime' sub)
PharmaGap Raises Additional Equity Financing
OTTAWA, July 16 /CNW Telbec/ - PharmaGap Inc. (TSX-V: GAP) ("PharmaGap"
or "the Company") today announced completion of a non-brokered private
placement financing of 717,000 equity units, each unit consisting of one
common share and one warrant to purchase one common share (the "Private
Placement").
The price per unit was $0.16, for total gross proceeds of $114,720.
Warrants have a two year term and an exercise price of $0.20 per share. These
terms mirror the private placement announced on June 17, 2009 and the two
private placements combined resulted in approximately $976,000 of equity
financing. Proceeds from this Private Placement will be used to further
advance PharmaGap's portfolio of drug compounds and for general working
capital. The shares issued pursuant to the Private Placement and subsequent
warrant exercises are subject to a four month restriction from trading on the
TSX-Venture Exchange ("TSX-V") in accordance with TSX-V rules and regulations
for equity private placements. The Private Placement has been filed under the
TSX-V Expedited Private Placement Filing System.
Capital Street Group Investment Services Inc. was paid a cash fee for
advisory and structuring services for the Private Placement of $8,317 and
48,397 warrants on the same terms as the Private Placement. Northern
Securities Inc. was paid $8,030 plus 50,190 warrants on the same terms as the
Private Placement as a finders fees.
The Company also advises that the agreement with the National Research
Council of Canada ("NRC") to convert $215,201 owed by the Company to the NRC
into common shares at a price of $0.15 per common share, as previously
announced on June 23, 2009, has not been completed, pending receipt of final
approval to the transaction by the NRC's legal and financial services staff.
The transaction as announced on June 23, 2009 has been approved by the TSX-V.
PharmaGap to raise $861,920 to advance drug compounds
2009-06-17 08:17 ET - News Release
Mr. Robert McInnis reports
PHARMAGAP ANNOUNCES COMPLETION OF $861,920 PRIVATE PLACEMENT OF SHARES AND WARRANTS
PharmaGap Inc. has arranged a non-brokered private placement financing of 5,387,000 equity units consisting of common shares and warrants to purchase common shares. The price per unit was 16 cents, for total proceeds of $861,920. Warrants have a two-year term and an exercise price of 20 cents per share. The shares issued pursuant to the private placement and subsequent warrant exercise are subject to a four-month restriction from trading on the TSX Venture Exchange, in accordance with TSX-V rules and regulations for equity private placements.
Proceeds from this private placement will be used to further advance PharmaGap's portfolio of drug compounds, for investor relations activities and for general working capital.
PharmaGap has engaged Capital Street Group Investment Services Inc., a limited market dealer registered with the Ontario Securities Commission, to act as its lead broker for this offering.
Capital Street Group was paid a cash fee for advisory and structuring services equal to 6.75 per cent of the gross proceeds, which amounts to $58,180, and 363,622 warrants on the same terms as the private placement. Capital Street Group was also paid a total of $48,154 (5.6 per cent of gross proceeds) plus 275,695 warrants for finders fees for its distribution group. Northern Securities was paid $16,800 (1.9 per cent of gross proceeds) plus 105,000 warrants as finders fees.
The private placement has been filed under the TSX-V expedited private placement filing system.
yup great opportunity since the science hasnt changed
ran this one right into the ground again
PharmaGap files prospectus for $4.5-million offering
2008-06-19 09:51 MT - News Release
Mr. Robert McInnis reports
PHARMAGAP TO RAISE APPROXIMATELY $4.5 MILLION IN PUBLIC OFFERING OF EQUITY SECURITIES
PharmaGap Inc. has filed a preliminary short form prospectus in connection with an agreement entered into with Dundee Securities Corp. and Wellington West Capital Inc. to raise gross proceeds of approximately $4.5-million. The agents, acting as co-leads, have invited Capital Street Group, of Vancouver, a limited market dealer, to join as special selling group member.
The company is selling equity units consisting of common shares plus common share purchase warrants. The company has agreed to pay the agents a selling concession consisting of 10 per cent of proceeds raised, along with broker warrants equal to 10 per cent of the units issued.
The company has granted the agents an option to purchase additional units, equal to 15 per cent of the offering, for purposes of covering overallotments and for market stabilization purposes. The option can be exercised in whole or in part at any time over a period of 30 days following the closing of the offering, which is expected to occur on or before July 18, 2008. Closing of the offering is also subject to receipt of all necessary regulatory and TSX Venture Exchange approvals.
Net proceeds from the offering will be used primarily to complete studies required to garner regulatory approval in the United States and Canada to begin human clinical trials of the company's lead drug for cancer treatment, PhG-alpha-1, a novel peptide inhibitor of protein kinase C alpha. In addition, proceeds will also finance continued development of the company's drug pipeline, for development of licensing and partnering relationships, and for general corporate and working capital purposes.
The preliminary prospectus is available on SEDAR. Copies of the preliminary prospectus are also available from Dundee Securities and Wellington West Capital.
News tomorrow? They might need money for this clinical development initiative.
PharmaGap forms group for PhG-alpha-1 development
2008-06-06 07:03 MT - News Release
Mr. Robert McInnis reports
PHARMAGAP ESTABLISHES CLINICAL DEVELOPMENT GROUP TO TAKE DRUG TO CLINICAL TRIALS
PharmaGap Inc. has formed a clinical development group to direct and deliver the company's clinical development of its PhG-alpha-1 compound for treatment of cancer. The clinical development group has the mandate to execute the program required to generate the data needed for an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for PhG-alpha-1, for approval for use in humans. These studies, often referred to as IND-enabling studies, build upon the compelling animal study data recently announced. The company is pleased that Dr. David Barnes, Dr. Douglas Cowart and Dr. Gary Schwartz have each agreed to join the PharmaGap clinical development group to take PhG-alpha-1 through the process required to gain approval to commence clinical trials in humans. Others will be named to the group as specific elements of the program require.
Dr. Barnes, a physician and molecular biologist, has worked with industry and government in the clinical development, regulation and safety of biologics since 2001, and has extensive experience with both clinical and preclinical drug development. He is a former clinical evaluator, Biologics and Genetic Therapies Directorate, and former head of the biotechnology products surveillance unit, Marketed Health Products Directorate, Health Canada. Dr. Barnes has served as the company's director of clinical development and regulatory affairs since 2005, and will have overall responsibility for the program, reporting to Robert C. McInnis, president of the company.
Dr. Cowart, PharmD (Medical University of South Carolina), a board certified pharmacologist, has over 25 years experience in clinical trials design and planning, with both FDA and international clinical trials experience in over 50 clinical studies. In his practice, Dr. Cowart has developed a consortium of medical, scientific and regulatory consultants to facilitate the developmental needs of emerging pharmaceutical, biotechnology and medical device companies. These same relationships will be brought to bear in pursuing PharmaGap's clinical development program as required.
Dr. Schwartz, chief, melanoma and sarcoma service for Sloan-Kettering's Department of Medicine's division of solid tumour oncology, has been working with the company since 2006. Dr. Schwartz is a medical oncologist specializing in the identification and development of new targeted drugs for cancer therapy, specifically aimed at understanding the mechanisms underlying the cell cycle and cell death, and the role that proteins, including protein kinases, play in these mechanisms. He is a member and attending physician at Memorial Sloan-Kettering Cancer Center and professor of medicine at Weill Medical College of Cornell University in New York. He is a current member of the American Society of Clinical Oncology's (ASCO) Cancer Foundation Grants Selection Committee (GSC), a former member of the ASCO Scientific Program and Cancer Education committees, and has served as the American Association of Cancer Researcher's (AACR) co-chairperson for the program committee on translational research in molecular biology. Dr. Schwartz is also an editorial board member of the Journal of Clinical Oncology and an associate editor of Clinical Cancer Research.
Each of Dr. Barnes, Dr. Cowart and Dr. Schwartz has developed an extensive network of drug development professionals and contacts within the medical and pharmaceutical industry with specific expertise in all areas of drug development required to take a drug compound into clinical trials. This extended network will be called on to deliver components of the PharmaGap program as required.
Mr. McInnis, president and chief executive officer of the company, said: "We are pleased to have attracted these highly respected physicians to form the core of our clinical development program to take PhG-alpha-1 toward and into clinical trials. I anticipate the naming of other members bringing both general and specific areas of expertise as the program moves forward in the near future. The creation of this development group is significant in that it provides us with a range of experienced professionals working to take PhG-alpha-1 into the clinic that would otherwise not be available to us on a full-time staffed basis, at a cost to the company that provides maximum value to our shareholders."
The initial work to be undertaken will be directed to standard ADME (absorption, distribution, metabolism and excretion) analyses in order to refine the understanding of PhG-alpha-1's interaction with the human physiology, required for establishment of a therapeutic dose range in humans. This work will be carried out by independent contract research organizations to specifications stipulated by the company's clinical development group working in conjunction with Dr. Jenny Phipps, the company's chief scientific officer.
The program will also include the optimization of the drug formulation aimed at maximizing the effectiveness, safety and ease of administration, development of large-scale manufacturing processes and process controls, and definitive toxicology studies required to gain approval for use in human clinical trials.
During the course of this clinical development program the company will continue to develop its pipeline of future drug compounds, and to generate business development opportunities aimed at securing a development partnership, licensing or similar arrangement for PhG-alpha-1 with an established pharmaceutical or biotech company aimed at bringing both additional financial and drug development depth to the program.
GENERAL DEVELOPMENT OF THE BUSINESS
Three Year History
Commencing in December 2004, to the present, executive management of the Company,
including the full-time services of the President and Chief Executive Officer has been provided
under the auspices of a Strategic Advisory Contract with SC Stormont Inc. (“Stormont”, a
company controlled by Roderick M. Bryden, Chairman of PharmaGap), providers of executive
and operational management as well as financial structuring and management expertise.
Research
In January 2005 the Company made the decision to focus 100% of its resources on its drug
development program to develop selective inhibitors and/or activators of the protein kinase C
(“PKC”) family of isoforms, of which there are 12. These PKC isoforms are known to be
associated with many human disease conditions, including cancer, diabetes, Alzheimer’s disease
and cardiac disease, among others. To date, the Company’s focus has been on the development
of a selective (meaning that it acts primarily on one PKC family member to the exclusion of
others) inhibitor of PKC alpha for application in cancer therapy, either alone or in combination
with known chemotherapeutic agents already in use. The Company had previously been focussed
on developing the drug compound for use as a therapeutic in neuroblastoma, a type of children’s
cancer, but in 2005 expanded that focus to include large-population cancers. Also at that time,
the business model was changed to position the Company as a provider of pipeline drugs,
through out-licensing, to larger pharmaceutical companies at the preclinical stage, rather than as
previously established which envisioned the Company taking each drug compound through all
stages of research, preclinical development and testing, clinical testing, full scale drug
production for human use, regulatory approvals, and eventual marketing and sales. This business
model is consistent with that adopted by other companies of PharmaGap’s size and stage of
development, and is also consistent with the change in business model by pharmaceutical
companies looking to early stage biotech entities such as PharmaGap as the source for their drug
development activities.
3
Also at that time, the Company discontinued research and development activities in its cell-based
assay programs and its non-invasive animal immuno-assay programs.
Since that time, the Company has focussed its efforts in development and testing of its lead drug
compound candidate, PhGα1 (“PhGα1”; pronounced as “P” “H” “G” “alpha” “one”) in animals,
to the legal protection of its intellectual property rights by filing provisional patent applications
for its lead drug and pipeline program, to expanding its outreach program to the pharmaceutical
industry in order to develop out-licensing opportunities, to continued development of software
based models and compound design tools, and to the design and initial testing of its pipeline of
potential future drug compounds, all of which are inhibitors and/or activators of one or more
members of the PKC family.
In the past three years, in light of the shift from the research phase to the drug development and
testing phase and combined with the decision to discontinue the peripheral product activities
mentioned above, the Company has reduced its number of full time scientific staff from 12 to 3,
which is augmented by external advisors and experts as required. The Company will continue to
maximize the use of third party service providers (e.g. contract research organizations (“CRO”),
academic collaborators), experts and advisors to deliver its drug program, a strategy that is well
established in the biotech industry. Direction of the Company’s drug development program will
be provided by advisors to the Company expert in the drug development process, in consultation
with the Company’s Chief Scientific Officer.
During this period, the Company has carried out its testing of PhGα1 in its own laboratories, at
the NRC’s Animal Research Facility in Ottawa, at Memorial Sloan-Kettering Cancer Center in
New York City, and at Queen’s University in Kingston, Ontario. Its computer-based drug
pipeline design program has been carried out at the University of Lyon, France.
Financing
On August 26, 2005, the Company issued a Series 2 Convertible Debenture (the “Series 2
Debenture”) to SC Stormont Holdings Inc. (“Stormont Holdings”, a company controlled by
Roderick M. Bryden, Chairman of PharmaGap) in the principal amount of $1,500,000. The
Series 2 Debenture is interest bearing at 10% per annum, compounding monthly, due and
payable on demand, with an original maturity date of August 26, 2007.
Between December 19, 2005 and September 12, 2006, PharmaGap issued six tranches of Series
3 Secured Convertible Debentures (the “Series 3 Debentures”) to accredited investors by way of
private placements in the aggregate principal amount of $1,287,120 (of which $970,000 was
issued to Stormont Holdings). The Series 3 Debentures matured on August 26, 2007 and
accrued interest at 10% per annum. The Series 3 Debentures were convertible any time by the
holder into equity units of the Company (the “Equity Units”) at a price of $0.30 or $0.325 for
each Equity Unit (each Equity Unit consisted of one common share and one warrant with a two
year term to acquire one common share at an exercise price of $0.45 or $0.4875 per common
share). The Series 3 Debentures were also callable by the Company under certain circumstances.
4
On May 3, 2007 the Company completed the issuance of 2,000,000 common equity units
(“Units”) to Dundee Securities Corporation (“Dundee”) for aggregate gross proceeds of
$250,000. The Units were issued at $0.125 per Unit and consist of one common share and one
warrant to purchase one common share at $0.165 for a two-year period.
Also on May 3, 2007 the Company completed the issuance of 2,400,000 Series I First Preferred
Shares (“Series I Shares”) to Dundee, as part of the same offering, for aggregate gross proceeds
of $300,000. The Series I Shares were priced at $0.125 per Series I Share and were convertible
at the request of the holder into Units on a one for one basis at no further cost. Each Unit
consists of one common share and one warrant to acquire one common share for a two-year
period at an exercise price of $0.165 per common share. The Series I Shares carry no fixed
dividend and have no priority on liquidation. Series I Shares are eligible to vote in all votes of
common shareholders to the extent of one vote for every one hundred Series I Shares held, and
are subject to a voting agreement that directs Series I Share votes to be cast in favour of the
majority of the common shares voted. On April 28, 2008, all outstanding Series I Shares were
converted into Units and subsequently all warrants were exercised.
On June 14, 2007, the Company completed the issuance of 3,603,600 Units to accredited
investors in Canada for aggregate gross proceeds of $450,450. The Units were issued at $0.125
per Unit and consist of one common share and one warrant to purchase one common share at
$0.165 for a two-year period.
In connection with the May 3 and June 14 issuances of Units and Series I Shares, commissions
and finders fees of $102,587 were paid in cash and 414,800 broker warrants were issued. Each
broker warrant consists of one common share at an exercise price of $0.165 per common share
and has a two-year term. In April 2008 all broker warrants were exercised.
On August 31, 2007, the Company signed an agreement with holders of its Tranche 1 and 2
Series 3 Debentures in the principal amount of $317,120 to extend the maturity date of the
Tranche 1 and 2 Series 3 Debentures by 18 months to February 26, 2009. The extended Tranche
1 and 2 Series 3 Debentures are convertible into equity units of PharmaGap consisting of one
common share and one common share purchase warrant. In return for the granting of the
extension of the maturity date, the conversion price of the Tranche 1 and 2 Series 3 Debentures
was reduced from $0.30 to $0.175, and the warrant exercise price of the Tranche 1 and 2 Series 3
Debentures was reduced from $0.45 to $0.2625.
On October 15, 2007, PharmaGap signed an agreement with Stormont Holdings, holders of the
Series 2 convertible secured debentures in the principal amount of $1,500,000 and Tranche 3, 4,
5 and 6 Series 3 Debentures in the aggregate principal amount of $970,000 to extend the
maturity date of the debentures by 18 months to February 26, 2009. In return for the granting of
the extension of the maturity date, the terms of conversion were changed, reducing the
conversion price to $0.13 and eliminating the common share purchase warrant previously
provided on conversion. Original terms provided for conversion into equity units consisting of
one common share and one warrant, with a conversion price of $0.30 or $0.325 and warrant
exercise price of $0.45 or $0.4875.
5
On October 19, 2007, the Company announced the approval of up to $500,000 of secured
convertible debentures (“Series 4 Notes”), and the issuance of $265,200 of these Series 4 Notes
to Stormont Holdings by way of a private placement. The Series 4 Notes are due on the earliest
to occur of: (i) demand; or (ii) February 26, 2009 and accrue interest at 10% per annum. The
Series 4 Notes are convertible at any time by the holder into equity units of the Company (the
“Series 4 Equity Units”) at a price of $0.13 for each Series 4 Equity Unit (each Series 4 Equity
Unit consists of one common share and one warrant with a two year term to acquire one common
share at an exercise price of $0.195 per common share). The Series 4 Notes are also callable by
the Company under certain circumstances. On April 4, 2008, the Company issued additional
Series 4 Notes to Stormont Holdings in the amount of $234,800, bringing the total principal
amount of outstanding Series 4 Notes to $500,000.
On April 4, 2008, PharmaGap issued a seventh tranche of the Series 3 secured convertible
debentures (“Tranche 7 Series 3 Notes”) to Stormont Holdings by way of a private placement in
the amount of $112,880. The Tranche 7 Series 3 Notes mature February 26, 2009 and accrue
interest at 10% per annum.
The Tranche 7 Series 3 Notes are convertible at any time by the holder into equity units of the
Company (the “Tranche 7 Series 3 Equity Units”) at a price of $0.175 for each Tranche 7
Series 3 Equity Unit (each Tranche 7 Series 3 Equity Unit consists of one common share and one
warrant with a two year term to acquire one common share at an exercise price of $0.2625 per
common share). The Tranche 7 Series 3 Notes are also callable by the Company under certain
circumstances.
Following the issuance of the Tranche 7 Series 3 Notes, the aggregate principal amount of
outstanding Series 3 Debentures issued was $1,400,000. Up to May 28, 2008 , Series 3
Debentures held by parties other than Stormont Holdings in the principal amount of $251,778
and accrued interest in the amount of $66,635 for a total of $318,413 were converted into
1,819,502 common shares and 1,819,502 warrants to purchase common shares. Following this
conversion, the aggregate principal amount of Series 3 Debentures outstanding is $1,148,222.
DESCRIPTION OF THE BUSINESS
Business Overview
PharmaGap is developing novel drug compounds for therapeutic use in potentially a wide range
of human diseases. The Company’s farthest advanced (or lead) drug compound, PhGα1, is
designed to treat certain cancers, including breast and colon cancer. These are two of the leading
causes of cancer-related deaths in North America and despite significant advances in treatment
options for these types of cancer over the past few decades there remains a large unmet need for
the development of novel and more efficacious therapies. PhGα1 is currently at the preclinical
stage of development and has been successfully tested in animal models of human cancer disease
at this point. The Company anticipates filing a regulatory approval application to conduct
human trials of the lead drug compound in 2010.
6
Drug Development Platform
PharmaGap’s drug development platform focuses on a specific family of protein kinase targets
called PKC. Protein kinases are a large group of enzymatic proteins that are rapidly emerging in
importance within the pharmaceutical industry as therapeutic targets in drug development due to
their involvement in cell signalling pathways affecting gene transcription and protein translation.
Over 500 protein kinase families have been identified to date, including the PKC family. The
PKC family comprises 12 closely related members or “isoforms.” PKC are ubiquitous
intracellular isoenzymes found in almost all tissue and body organs and when expressed within
cells at normal levels, are essential for modulating important cell signalling pathways and the
resulting cellular physiological processes controlled by these signalling pathways. In many
disease conditions however, such as cancer, cellular levels of certain PKC isoforms are
abnormally over or under-expressed and as a result, the signalling processes in these afflicted
cells goes awry.
PKC & Cancer
The Company’s lead drug compound targets one isoform of PKC known as alpha. PKC alpha is
well characterized as a novel target for potential cancer therapy as its been clearly demonstrated
in research over the past 30 years that aberrant levels of PKC alpha are associated with cancer
tumorigenesis, including tumour growth, invasiveness and cancer’s ability in many cases to
become resistant to continued treatment with cytotoxic chemotherapy.
By inhibiting or modulating the enzymatic activity of PKC alpha in cancer cells, PharmaGap’s
lead drug aims to decrease tumour cell growth and proliferation and enhance cancer cell death.
PhGα1 is anticipated to be used as adjunct combination therapy with standard chemotherapy.
Administration of PhGα1 may potentiate the cytotoxic effect of chemotherapy against cancer
cells, thereby reducing the amount and/or duration of chemotherapy and therefore potentially
lowering unpleasant patient side effects resulting from chemotherapeutic treatment.
Peptide Drug Design & Synthesis
PharmaGap’s drug platform is focused on the development of modified peptide drug compounds,
including the lead drug PhGα1. Peptides are short sequences of amino acids; natural molecules
that are the “building blocks” of all proteins found in the human body. Peptide drugs composed
of amino acids potentially offer the benefit of drug compounds that exhibit very low toxicity
outside of their intended therapeutic use. Peptide drug development is a relatively new
phenomenon in the pharmaceutical industry. Hitherto most drugs approved for use were
synthetic or naturally sourced small organic molecules. The emergence of the biotechnology
industry has now resulted in protein-based therapeutics (often referred to as biologics) becoming
more common, including antibodies, recombinant proteins and now increasingly, peptides.
Recent advances in peptide stabilization and delivery technologies have also accelerated peptide
drug development.
7
PharmaGap’s peptide compounds are developed by way of sophisticated computer modeling
techniques and a drug development approach known as rational drug design. PharmaGap has
developed proprietary computer models of selected PKC isoforms, including PKC alpha, that
allow development of peptide drug designs in silico, or on the computer. Rational drug design is
a methodology that builds from first principles. In other words, with a selected target strongly
implicated in tumour processes identified (PKC alpha), computer modeling is then used to
develop an iterative series of possible peptide drug designs that preferentially target and inhibit
the activity of PKC alpha. The series of pro-drug candidates are then screened by software for
utility and potential efficacy. Synthesis of identified drug candidates then occurs and these are
tested in the laboratory and the data used to optimize the next generation of computer designs.
This iterative process occurs until molecular candidates are designed with maximum potency.
PharmaGap’s peptide drug compounds are synthesized in-house and undergo a proprietary
modification procedure post-synthesis.
Rational drug design contrasts with a drug candidate identification process known as highthroughput
screening (“HTS”) which is more commonly used in the pharmaceutical industry,
especially for small molecule drug development. HTS involves screening thousands, and in
some cases millions, of chemical compounds found in “compound libraries”, looking for some
activity against a chosen molecular or physiological target. By deploying computer aided design
techniques instead, PharmaGap believes it can develop drugs quicker and with less cost than
HTS methods.
Corporate Objectives & Strategy
PharmaGap’s core competence is the development of peptide drug compounds able to
preferentially target PKC. The Company is developing a portfolio of novel drug compounds
using proprietary expertise and has filed patent protection to protect this value. The first drug
compound PhGα1 is being developed to treat cancer, but it is anticipated that other compounds
in the development pipeline may have therapeutic use in other diseases, such as for example, in
diabetes. The business strategy to maximize value for shareholders is to eventually partner and
license these compounds to larger pharmaceutical and biotechnology companies at the
preclinical or early to mid-human clinical trial stage of development.
Partnering early stage compounds is a business development strategy pursued by many early
stage biotechnology companies in North America. Generally a smaller biotechnology company
will form a development alliance, or enter into an outright licensing transaction, with a larger
pharmaceutical or biotechnology company partner. The larger partner provides drug
development expertise and access to capital and other resources often unavailable to the smaller
biotechnology company. In addition, sharing the development reduces risks to both parties.
PharmaGap’s specific aim for its lead cancer drug is to partner PhGα1 at the preclinical stage;
the drug development stage immediately prior to testing the compound in humans. Management
believes that partnering the lead compound at the preclinical stage of development with a larger,
experienced drug development organization reduces financial and product risk to the Company
and will provide access to capital and resources currently unavailable to the Company, while
better ensuring the drug’s success in later stage human clinical trials.
8
Currently the pharmaceutical industry is actively pursuing and announcing alliances and
licensing partnerships with biotechnology companies developing preclinical and early stage
clinical trial compounds. With their strong balance sheets they have ample resources to fund
their partnership activities. While pharmaceutical companies historically preferred to partner or
license compounds developed by biotechnology companies at the human clinical trials stage,
over the past approximately three to five years the industry has seen a dramatic shift in
compound partnering dynamics in the industry and there is a growing trend towards earlier stage
partnering, especially at the discovery and preclinical stage. Many pharmaceutical companies
are pursuing a portfolio approach to managing their drug development pipelines and believe that
having third party-developed compounds at the discovery and preclinical stages in their pipeline
reduces their own risk and gives them access to novel technologies otherwise unavailable to
them internally. They in effect view the many smaller companies in the biotechnology industry
as a “virtual laboratory” that they can access to augment and leverage their own internal research
and development initiatives.
Also driving pharmaceutical company interest to partner and license at the early stage is their
need to augment their drug development pipelines earlier in order to offset the commercial
pressures many are facing from looming patent expiration, generic drug competition and the rise
of a low cost and efficient pharmaceutical industry, especially in India and China. As well, the
rise of fully integrated large biotechnology companies has raised the level of competition in the
pharmaceutical industry since the former have developed large sales forces that compete
aggressively with the traditional pharmaceutical companies.
A partnering transaction at the preclinical stage may take many forms. Companies may enter
into research alliances to further optimize one or more potential drug compounds or they may codevelop
an already identified compound in order to share development of the data required for
future regulatory approval to test the compound in humans. The partners may also enter into a
licensing arrangement with the company that owns the compound (the licensor) entering into an
economic and legal marketing agreement with a partner (the licensee), which typically takes full
control of future development. Research alliances and co-development arrangements typically
involve an upfront payment, shared development expenditures and often milestone payments.
Often a research alliance or co-development arrangement is a prelude stage to an eventual
licensing transaction. A licensing transaction also involves an initial up-front cash payment,
additional development funding payments and/or payments upon achievement of development
milestones, followed by royalty payments to the licensor based on sales of the eventual product
by the licensee.
PharmaGap will not necessarily pursue an early stage partnering strategy for other drugs now in
its development pipeline. Management will assess a partnering transaction for these drug
compounds on a case-by-case basis, depending upon their potential therapeutic indication, patent
position, strategic value to a partner, as well as the internal resources available to the Company at
that time. PharmaGap’s business model is to progress each drug as far as possible toward
commencement of clinical trials, given the level of resources available to it, prior to
relinquishing share of future value to development partners or completing an out-licensing
arrangement. However, this is balanced by the reduction of risk and time to reach clinical trials
that may result from earlier development collaborations, partnerships or licensing.
9
Medical Rationale for the Lead Drug Program
Almost 1.5 million new cases of cancer will be diagnosed in the United States alone during 2008
(American Cancer Society). Despite significant advances in cancer treatment over the past few
decades, cancer still remains the second leading cause of death in adults and almost 600,000 will
die from cancer this year in the United States. Clearly a large need exists for new treatment
paradigms.
Cancer is a catchall term used by the medical community to describe a variety of diseases
generally characterized by uncontrolled growth of abnormally aggressive cells and impaired cell
death. In normal tissue cell division and cell death are tightly regulated by a variety of genecontrolled
cell signalling molecules (including PKC). However, for a variety of reasons (genetic,
environmental, hormonal or immune system driven), cellular defects can lead to uncontrolled
cell proliferation or to a decrease in normal, programmed cell death (apoptosis). The result of
the imbalance between cell growth and death leads to formation of benign or malignant tumours.
During tumour development somatic mutations may accumulate leading to increased
malignancy. Malignant tumours can invade adjacent tissues and spread (or metastasize)
throughout the body, resulting in severe illness and without treatment, death.
Current cancer treatments generally involve one or a combination of surgery, radiation therapy,
chemotherapy, hormone suppression and immunotherapy drugs. Most chemotherapeutic agents
are cytotoxic chemicals that interfere with the synthesis of deoxyribonucleic acid (known as
DNA) or cell cycle division. They target cellular processes essential for both cancerous and
normal cells, and as a result they produce patient side effects that are often extremely unpleasant
and limit the dose of the therapeutic agent. In addition, many cancers may develop resistance to
chemotherapeutics. Oncologists generally employ a combination of these therapies since no one
type of treatment is typically sufficient to eradicate the cancer. No one “magic bullet” compound
is anticipated to be developed in that cancer is not one disease, but rather results a series of
approximately one hundred different aberrant processes.
The past five years approximately have seen the emergence of what is commonly referred to as
“targeted” cancer treatment; the use of drugs that directly act on a identified genetic or protein
defect within a cancer cell. Targeted therapy against selected protein kinase defects in cancer
cells have shown efficacy. Targeted treatments hold the promise of a focused and
“personalized” therapy that targets only the cancerous tissue defect within the patient’s specific
type of cancer and when used in combination with chemotherapy or radiation therapy may result
in lower doses of these conventional treatments, hence less patient side effects. PharmaGap’s
PhGα1 is a targeted protein kinase therapeutic. Targeted therapeutic drugs now marketed
include Novartis’ Gleevec, Genentech’s Herceptin and ImClone’s Erbitux. Each has been
approved as treatment for specific cancers and has shown remarkable success treating specific
cancers in certain instances.
PharmaGap’s Drug Platform Target - PKC
PKC was first associated with cancer induction in the 1980s when this enzyme was identified by
researchers in Japan and the United States as a receptor for natural cancer causing substances
known as phorbol esters. PKC has since attracted extensive research interest from around the
10
world and is widely confirmed as an important molecule involved in cancer and many other
types of disease.
PKC is characterized as an intracellular serine/threonine protein kinase that when activated by
way of certain signalling molecules (e.g. hormones, growth factors and neurotransmitters), is
involved in numerous intracellular signal transduction events. PKC regulates the behaviour of
numerous “downstream” proteins and molecular pathways within a cell and as a result, PKC is
associated with numerous essential cellular processes. PKC is found in almost all tissues and
organ systems. In healthy cells normal constitutive levels of PKC are important for regulating
cell cycle division and differentiation and the essential stage of pre-programmed cell death (or
apoptosis). Conversely, in diseased tissue such as cancer, abnormally activated and/or depressed
levels of PKC are, in part, implicated in malignant transformation of these processes, resulting in
tumour development.
PKC proteins exist as a family of 12 closely related isoforms (called alpha, beta, and so on,
ending at zeta) that are products of distinct genes. A high degree of polypeptide amino acid
sequence structure is shared between isoforms. As such, PKC isoforms are highly conserved.
Despite their similar structural homology PKC isoforms do differ from one another in their
biochemical properties, tissue-specific expression and intracellular localization. Moreover,
individual isoforms have been implicated in distinct disease conditions (and even in different
disorders within one type of disease). For example, the alpha isoform of PKC is strongly
implicated in certain cancers and cardiac disease. PKC beta is identified as important for certain
types of diabetes and related complications while PKC theta has been closely associated with
numerous inflammatory and neurological disorders. PKC epsilon and delta are also closely
associated with certain cancers, but also with other metabolic diseases. Moreover, within cancer
the alpha and epsilon isoforms are oncogenic and linked to different types of cancer and stages of
progression, while in general, the delta isoform triggers apoptosis of the tumour cells.
As a result, modulation of PKC as a therapeutic strategy to treat a certain disease, or stage of
disease, ideally requires the ability to target a specific isoform(s) of PKC. However, the
conserved sequence structure across the 12 PKC isoforms has made targeting a specific isoform
a significant challenge in PKC drug development. Many small molecule drugs in development
to date targeting PKC isoforms are unable to differentiate between isoforms with precision.
Compounding this problem, researchers have not yet been able to fully elucidate the complete
three dimensional structure of individual PKC isoforms, making drug design all the more
difficult.
Abnormally elevated levels of PKC alpha are found in tumours and cells of certain types of
cancer, such as certain types of breast, colon and lung cancer. Numerous independent studies
using cancer cell lines have demonstrated that over-expression and subsequent activation of PKC
alpha is linked to malignant transformation of healthy tissue due to cell cycle defects, with
resulting tumour proliferation, invasiveness and faulty apoptosis (i.e. cancer cells do not die).
PKC alpha also has been strongly associated with increasing the ability of cancer cell lines to
resist treatment by chemotherapy, a phenomenon known as multi-drug resistance. Every year in
the United States hundreds of thousands of cancer patients die as a result of tumours that have
become resistant to additional chemotherapeutic treatment.
11
As a result of these observations it was postulated by researchers that interference with
abnormally expressed and activated PKC alpha in certain types of cancer may be an attractive
strategy for potentially arresting tumour cell growth by enhancing apoptosis, locking invasion
and metastasis and overcoming cancer cell resistance to chemotherapy.
PhGα1 Preclinical Development Pathway
PhGα1 is currently at the mid-preclinical stage of development. The compound has progressed
through successive preclinical development stages, generating data needed for making critical
decisions and for implementing value-creating activities in subsequent steps of the process.
The Company has developed a preclinical development plan for PhGα1. Some of the steps along
this development pathway have been performed in-house while others have been undertaken by
our collaborators, including the Animal Testing Facility at the NRC in Ottawa. In future, we
anticipate that further studies will be contracted out to CROs and/or with a corporate
development partner, especially for human clinical trial enabling studies needed in preparation to
apply for regulatory approval to test PhGα1 in humans.
A summary of preclinical development steps completed and planned for PhGα1 includes, but is
not limited to:
1. Biological and empirical characterization of PKC alpha in selected cancer cell lines;
2. Demonstration that selectively inhibiting enzymatic activity of PKC alpha in cancer cells
retards the growth, or in some instances, kills cancer cells;
3. Use of sophisticated computer modeling to generate novel selective peptide inhibitors of
PKC alpha activity and eventual selection of lead peptide compound PhGα1;
4. Testing of PhGα1 in numerous cancer cell lines;
5. Toxicity studies in animal and efficacy testing in animal models of cancer;
6. Characterization of the compound’s bioavailability;
7. Characterization of the compound’s pharmacological effects on organ systems;
8. Drug and PKC alpha detection assays;
9. Formulation and delivery methods;
10. Human clinical trial enabling studies; and
11. Application to conduct human clinical trials: a Clinical Trial Application (“CTA”) in
Canada and an Investigational New Drug application (“IND”) in the United States.
Similar applications exist in the European Union.
12
In order to accelerate development and reach go/no go decisions rapidly, several of these steps
can be ongoing simultaneously.
Similar drug product development plans will be required for the Company’s pipeline compounds
targeting additional PKC isoforms for cancer and other therapeutic indications.
Lead Drug Compound – PhGα1
In vitro (cell line) testing has demonstrated the compound’s potent effect to control the growth
and kill cancer cells, including breast, colon, sarcomas and non-small cell lung cancers and
neuroblastoma (children’s neurological cancer).
Testing of the drug in animal models of human breast and colon cancer has demonstrated a
statistically significant reduction in tumour growth and proliferation versus untreated controls,
especially when administered in combination with standard chemotherapy. Significant
reductions in two clinical biomarkers of tumour malignancy were also observed.
Studies in animals also have demonstrated the relatively low toxicity of the compound when
delivered at dosages much higher than required for therapeutic treatment, a very important factor
for future regulatory approval to test the compound in humans.
Details of these test results can be found in press releases on the Company’s website at
www.pharmagap.com or on SEDAR (www.sedar.com).
The Company is now undertaking additional studies required to fully characterize the lead drug’s
efficacy and safety (regulatory approval enabling studies) and anticipates filing for regulatory
approval to test PhGα1 in cancer patients in 2010.
Competitive Advantage
PharmaGap researchers believe the use of peptides to target and inhibit the activity of PKC alpha
in cancer cells offers significant advantages over small molecules now in clinical development.
Using the Company’s proprietary computer modeling methodologies, novel peptide drugs are
being developed that preferentially target individual PKC isoforms. Despite the highly
conserved amino acid sequence structure found between PKC isoforms, the use of PharmaGap’s
peptide drug strategy allows for differentiation between isoforms, an approach not feasible with
the small molecule drugs now in clinical development.
Rather than affecting an array of PKC isoforms, and even other protein kinase targets, as do
small molecule pan-inhibitors, peptide drugs can be targeted with much greater precision and as
a result, the potential for lower toxicity and patient side effects is enhanced. The Company’s
peptidic lead drug compound for use in cancer preferentially targets PKC alpha.
13
The Company’s Drug Pipeline
PharmaGap’s drug designs are based on proprietary computer models it has developed for
protein kinase C (PKC) isoforms. There are 12 known PKC isoforms – PharmaGap has models
for 9. Designing compounds in silico, rather than pursuing traditional drug compound screening
strategies, translates typically into a less capital-intensive drug discovery process.
PharmaGap’s lead drug compound PhGα1 is designed to treat cancer and preferentially targets
PKC alpha. The Company’s ability to design additional inhibitors and activators of PKC give it
the ability to develop a series of novel peptide drugs targeting other high incidence disease
conditions, where aberrant levels of PKC are known to be implicated. The “architecture” of the
lead drug for cancer can be effectively repeated in the design of these new compounds, making
for efficient and rapid rational drug design.
PKC Isoform Implicated in:
PKC alpha cancer, cardiac, renal diseases
PKC beta I diabetes
PKC beta II diabetes
PKC delta cancer, cardiac disease
PKC gamma neurological diseases
PKC epsilon cancer, diabetes, neurological
diseases, Alzheimer’s
PKC iota Alzheimer’s, ovarian cancer
PKC theta inflammatory disorders, cancer
PKC zeta cancer
The focus of our lead generation program has been the development of peptide inhibitors PKC
alpha, theta and epsilon. Recently the Company announced promising early developments
concerning the PKC theta inhibitor peptide drug for cancer sarcomas and certain types of
leukemia.
Designs for peptidic activators of selected PKC isoforms are also ongoing. In some disease
indications, including certain cancers, activation of isoforms may provide therapeutic benefit.
14
Development Collaborations
In addition to the ongoing relationship with the NRC’s Animal Testing Facility in Ottawa,
PharmaGap has established collaborations with:
University of Lyon, France
Dr. Raphael Terreux, Assistant Professor, Institute of the Biology & Chemistry of
Proteins, for computer modeling and design expertise for the lead and pipeline drug
programs.
Memorial Sloan-Kettering Cancer Center, USA
Dr. Gary Schwartz, Chief, Melanoma and Sarcoma Service, for studies with the objective
of demonstrating the mechanism of action of PhGα1 in cancer cells.
Queen’s University, Canada
Dr. Michael Adams, Professor, Department of Toxicology and Pharmacology to assess
the pharmacodynamic properties of PhGα1 and showing its potency in modulating
physiological processes strongly associated with PKC alpha.
Competitive Conditions
Modulation of PKC alpha as a potential novel therapeutic strategy for cancer treatment has
received intense interest from the pharmaceutical and biotechnology industry. Human clinical
trial assessment of small molecule inhibitors of PKC alpha in combination with conventional
chemotherapy has occurred, as has testing of an experimental drug technology called anti-sense,
also in combination with chemotherapy. The small molecules were developed as general PKC
isoform inhibitors (or pan-inhibitors), with some showing modest affinity for PKC alpha.
However, none are preferentially specifically targeted towards PKC alpha. None of the small
molecules have shown compelling synergistic efficacy against solid tumours versus standard
treatment and in general exhibited unwanted toxicity and patient side effects in trials. The antisense
compound, designed to reduce the cellular levels or expression, but not the enzymatic
activity, of PKC alpha in cancer cells, did not show additive clinical efficacy in a pivotal human
trial and this program has been terminated by its developers.
The small molecules now undergoing testing are a class of anti-PKC molecule known as “ATP
competitive inhibitors”. As such, they are not designed to be specific inhibitors of PKC alpha;
rather they attempt to disrupt the enzymatic activity of PKC by interfering with PKC’s catalytic
activity. However, since many protein kinases have very similar molecular conformation around
their catalytic sites, the small molecules tested also show reactivity with numerous other protein
kinases and not just PKC alpha.
PharmaGap believes its competitive advantage is that its peptide cancer drug PhGα1 is designed
to be a preferential inhibitor of PKC alpha and as a result, may result in better targeted treatment
against cancers expressing aberrant levels of PKC alpha. Peptide drugs offer certain advantages
in drug development over small molecules; they are relatively inexpensive to manufacture and
15
typically exhibit lower toxicity in humans. Conversely, peptide drugs can be unstable and can
require significant modification to make them suitable for effective human use.
Other sources of competition to PharmaGap’s drug program for cancer stems from other types of
therapies now in development by other pharmaceutical and biotech companies, as well as
academia. These include anti-cancer antibodies, immunotherapy (anti-cancer vaccines),
hormone treatment drugs, gene therapy, novel drugs targeting additional protein kinases besides
PKC alpha (including small molecules, peptides or anti-sense oligonucleotides and silencing or
interference ribonucleic acids, also known as RNAi) and new types of chemotherapy. This
summary is not necessarily an exhaustive list of all such competing therapeutic treatments. As
well, many competitor companies developing these potential therapies are much larger and better
funded than PharmaGap.
Intangible Properties
Patent applications have been filed to protect proprietary inventions and technologies that
management has determined are important for the Company’s lead drug development program
(PhGα1). Additional patent applications are planned for both the lead drug and pipeline drug
programs. The Company also depends upon trade secrets to enhance its drug development
abilities, primarily with regards to the use of computer modeling to design its novel drug
compounds.
The Company has filed three International (PCT) patent applications relating to the Company’s
lead drug program. National phase applications based on the PCT applications have been filed
into the United States, the European Union, Japan and Canada. In each of these jurisdictions, an
issued patent provides twenty years of protection to its owner, calculated from the date of filing.
The currently pending National Phase patent applications represent an integrated and strategic
approach taken by the Company to provide broad coverage for compositions, methods and uses
relating to the Company’s lead cancer drug program. Copies of each of the three PCT patent
applications are available at the World Intellectual Property Organization website
(www.wipo.int) under the Patent Cooperation Treaty filings heading.
• WO 2006/108270: Inhibitors of Protein Kinases and Uses Thereof
The claims in this patent application encompass claims directed to a key aspect of the PhGα1
molecule and its use to inhibit protein kinase C - PhGα1’s intended target in cancer cells.
• WO 2007/016763: Peptides Targeted to Protein Kinase C Isoforms and Uses Thereof
The claims in this patent application encompass claims directed to the aspect of PhGα1 that
provides the compound’s novel ability to select its target molecule.
• WO 2007/016777: Targeted Protein Kinase C Inhibitors and Uses Thereof
The claims in this application encompass claims directed to the entire drug compound and
methods and uses to employ PhGα1 against cancer and other human diseases.
16
In June 2000 the Company executed a licensing agreement with the NRC for intellectual
property pertaining to novel 3-dimensional cell models, tests related to a children’s cancer called
neuroblastoma and other technologies related to a physiological phenomenon known as
intercellular gap junction communication.
In addition, the Company exclusively owns and has sole commercial rights to all intellectual
property developed by any of its third-party consultants.
Regulatory Requirements for Commercialization of PhGα1
Development and commercialization of PharmaGap’s drug product candidates is subject to
government regulation for safety and efficacy. In Canada the regulatory activities fall under the
Food and Drug Act, which is enforced, by the Health Products and Food (“HPFB”) division of
Health Canada. In the United States drugs and biological products are subject to various
regulations and rules enforced by the Food and Drug Administration (“FDA”). In general, these
regulations require carefully controlled research, testing, proper manufacturing and government
review and approval of data and results prior to receiving approval to conduct human clinical
trials and commercialization.
The principal activities to be completed before obtaining approval for commercialization of any
new drug product in Canada and the United States are in general as follows:
1. Preclinical Studies: studies conducted both in vitro (cell lines) and in vivo (animals) to
test for drug safety, efficacy and pharmacology and to carry out drug formulation work
based upon these results;
2. Product Development: manufacturing research and small scale synthesis to develop a
drug supply suitable for administration in humans, as well as to assess commercially
viable processes and formulations;
3. Application to test in humans: submission of a CTA and IND (which is updated
continually as the testing progresses through human clinical trials);
4. Phase I Clinical Trials: testing of the drug product in a relatively small number of
humans to characterize potential toxicity, dose tolerance, pharmacokinetic and
pharmacodynamic properties;
5. Phase II Clinical Trials: usually involves a larger patient population than Phase I testing
and is conducted to assess the efficacy of the drug in patients having the disease or
condition for which the drug is indicated. Also serves to identify possible common shortterm
side effects and risks in a larger group of patients. In cancer development Phase I
and II studies may be combined in some instances;
6. Phase III Clinical Trials: involves conducting tests in an expanded patient population
and geographically dispersed sites to establish clinical safety and effectiveness, especially
versus treatment regimens already in use. These trials generate information from which
17
the overall risk-benefit relationship can be determined and provides the basis for
commercial drug labelling (i.e. regulatory approved usage for specified indications).
In the course of conducting human clinical trials more than one trial of a particular phase may be
undertaken so as to evaluate the drug against a variety of disease indications, patient populations
and treatment regimens. In addition, protocols are implemented so that outcomes and data
cannot be influenced by any party. Moreover, information of drug manufacturing methods and
stability must be presented so as to ensure that the product eventually commercialized has the
same composition as that determined to be safe and effective in the clinical trials.
Upon completion of clinical trials, study results and a plan for proper manufacturing are
submitted to the HPFB as part of a new drug submission or to the FDA as part of biologics
license application or new drug application, as the case may be, to obtain approval to commence
marketing of the drug. Approval may take anywhere from 12 to 36 months typically. However,
in order to approve drugs quicker for serious indications such as cancer, the FDA has adopted a
statutory program to accelerate or “fast track” the approval of these sorts of products.
The Company’s, or any future co-development partner or licensor’s, success in obtaining
marketing approval for PhGα1 or other products in development will depend on the ability of the
parties to comply with these regulations on a multi-jurisdictional basis.
Business Cycles
Development of novel drug compounds is a non-cyclical business. Patient and clinician demand
for novel, efficacious drug compounds to control and treat cancer is not affected by economic
conditions, seasons or political events. New cancer drugs, especially the targeted cancer
therapies discussed above, typically command superior pricing. In the world’s largest cancer
drug market, the United States, insurance company pricing reimbursement policies have been
consistently attractive for these types of therapies.
Future Developments
PharmaGap will continue to undertake early stage design, synthesis, and testing of pipeline drug
products, all of which are selective inhibitors and/or activators of one or more PKC family
members, for therapeutic use against a range of disease conditions. It is anticipated that these
compounds will be made available for out-licensing to larger biotech or pharmaceutical firms in
order to complete human clinical trials, regulatory approval and commercialization.
The Company also intends to make increasing use of CROs to carry out future testing for its drug
compounds and compile the data needed for regulatory approval to move the compounds into
human testing. CROs offer out-sourced drug development services as their primary business
focus and as a result, can run preclinical and clinical trials usually more efficiently than
independent biotechnology companies. The use of CROs has increased significantly over the
past five years in the biotechnology industry and in general allows firms to direct their
development spending more efficiently, lower internal overheads and generate data in a
standardized and often more timely manner. CRO activities will be closely overseen by
PharmaGap’s internal scientific team and selected third party advisors.
PharmaGap animal tests show 34% reduction in tumour size and increased survival in solid tumour tests of two colon cancer cell lines
OTTAWA, June 2 /CNW Telbec/ - PharmaGap Inc. (TSX-V: GAP) ("PharmaGap" or
"the Company") released today additional results of animal studies indicating
effectiveness of its lead cancer drug, PhG-alpha-1, in treating two types of
highly aggressive human colon cancer. These results are consistent with and
augment earlier results using breast and colon cancers announced by the
Company on April 17, 2008.
The two human cancer cell lines used are both colorectal cancers which
are known to be aggressive and difficult to successfully treat.
In these final two of five human cancer models studied, a total of
100 mice in which human colon cancer cells of two different types had
previously been implanted subcutaneously and allowed to grow into solid body
tumours of a palpable size were then treated with PhG-alpha-1 at three doses
(1, 5, and 10 mg/kg body weight), both singly and in combination with
chemotherapeutic agents, or received saline solution or the chemotherapeutic
agent alone as test controls.
The results indicate an extension of survival and reduction of tumour
volume in groups treated with PhG-alpha-1, alone and in combination with
chemotherapy.
Robert McInnis, President & CEO commented "We are delighted with this
additional compelling evidence of efficacy seen with our lead compound in
these most recent results. These cancers are both aggressive and
representative of cancers found in real patients. These additional test
results add to the body of evidence that PhG-alpha-1 has the potential to be
developed into an effective agent against cancer in humans."
Colon Cancer (early stage type) subcutaneous model
--------------------------------------------------
Human colon cancer cells type LS180, known to be highly invasive, were
implanted beneath the skin and provided time to develop palpable tumours,
following which treatment began.
The group receiving PhG-alpha-1 both singly and in combination treatment
exhibited an extension of survival when compared to the group receiving
chemotherapy alone. Average days survival following commencement of treatment
was 31 for the group receiving chemotherapy alone (with a maximum of 37 days),
extended by almost 30% to 40 days in the groups receiving PhG-alpha-1 alone
(with a maximum of 56 days), and 32 days in the groups receiving combined
treatment (with a maximum of 47 days).
In the group receiving the chemotherapy treatment alone, average tumour
volume of 1,000 cubic mm was reached in 26 days, compared to 33 days (26%
slower) for the combined treatments at PhG-alpha-1 doses of 5 and 10 mg/kg,
and 44 days (69% slower) for groups treated with PhG-alpha-1 alone at each of
the 3 doses. Moreover, the average tumour size at time of euthanasia was
3,681 cubic mm for the group receiving the chemotherapy alone, 2,929 cubic mm
for all combined treatment groups, and 2,417 cubic mm for the groups receiving
PhG-alpha-1 alone. The overall reduction in tumour volume compared to the
control group receiving chemotherapy alone was approximately 20% for combined
treatments and approximately 34% for groups treated with PhG-alpha-1 alone.
Colon Cancer (later stage type) subcutaneous model
--------------------------------------------------
A later stage human colon cancer cell line, known to be highly drug
resistant, was implanted beneath the skin and provided time to develop
palpable tumours, following which treatment began. In earlier in vitro testing
at Memorial Sloan Kettering Cancer Center in New York, PhG-alpha-1 was shown
to have a strong effect against this cell line, increasing the efficacy of the
chemotherapy agent used by 50%.
This cancer cell line is known to exhibit very slow growth, resulting in
a lower number of tumour occurrences in this test cohort. In this current
test, observations of mice in which tumours did develop show a positive effect
of the combined treatment using PhG-alpha-1 when compared to the mice
receiving chemotherapy alone, on both extension of survival and limitation of
tumour volume. In ex vivo examination of cells obtained from the tumours,
those obtained from the tumours from the combined treatment groups exhibited a
very low yield of viable cells compared to the chemotherapy alone group, an
additional indicator of effectiveness of the combined PhG-alpha-1 treatment.
Overall, these results are consistent with and support those obtained earlier
at Memorial Sloan Kettering Cancer Center.
About PharmaGap Inc.
PharmaGap Inc. (TSX-V: GAP), based in Ottawa, ON, is a biotechnology
company with a core focus on developing novel therapeutic compounds for the
treatment of cancer. PharmaGap's research platform targets cellular signalling
pathways controlled by Protein Kinase C (PKC) isoforms. PharmaGap's lead drug
compound, PhG-alpha-1, is in preclinical development and targets PKC alpha.
The Company's strategy is to out-license drug compounds to larger life
sciences companies at the preclinical stage. For more information on PharmaGap
please visit the Company's website at www.pharmagap.com.
Note: The TSX-Venture Exchange does not accept responsibility for the
adequacy or accuracy of this release. No Securities Commission or other
regulatory authority having jurisdiction over PharmaGap has approved or
disapproved of the information contained herein. This release contains forward
looking statements that may not occur or may change materially.
For further information: relating to this Release: Robert McInnis,
President & CEO, (613) 990-9551, bmcinnis@pharmagap.com
NATIONAL INSTRUMENT 44-101
SHORT FORM PROSPECTUS DISTRIBUTIONS
NOTICE DECLARING INTENTION
TO BE QUALIFIED UNDER
NATIONAL INSTRUMENT 44-101
SHORT FORM PROSPECTUS DISTRIBUTIONS
(“NI 44-101”)
May 12, 2008
To: Ontario Securities Commission
And to: British Columbia Securities Commission
Alberta Securities Commission
Autorité des Marchés Financiers
PharmaGap Inc. (the “Issuer”) intends to be qualified to file a short form prospectus under NI
44-101. The Issuer acknowledges that it must satisfy all applicable qualification criteria prior to filing a
preliminary short form prospectus. This notice does not evidence the Issuer’s intent to file a short
form prospectus, to enter into any particular financing or transaction or to become a reporting issuer
in any jurisdiction. This notice will remain in effect until withdrawn by the Issuer.
PHARMAGAP INC.
By:
Simon Goulet
Chief Operating
Officer
Ya June 19 is Annual and special meeting
Maybe golfing in Ottawa next month...
$25M would be a start!
The sugar daddies of the healthcare sector
Get ready for a biotech buyout boom:
http://www.moneyweek.com/file/46767/get-ready-for-a-biotech-buyout-boom.html
Annual General and "Special Meeting"
We advise of the following with respect to the upcoming Meeting of Security Holders for the
subject Issuer:
Meeting Type : Annual General and Special Meeting
Record Date for Notice of Meeting : 20/05/2008
Record Date for Voting (if applicable) : 20/05/2008
Meeting Date : 19/06/2008
Meeting Location (if available) : Ottawa, ON
Voting Security Details:
Description CUSIP Number ISIN
COMMON SHARES 71715A104 CA71715A1049
Sincerely,
Computershare Trust Company of Canada /
Computershare Investor Services Inc.
Agent for
Stormont has a majority of shares and is controlled by Roderick M. Bryden, chairman of PharmaGap. They have over 60% of the float.
2008-04-07 13:14 GAP PharmaGap Inc 0.065 SEDAR Early Warning Report
SC Stormont Holdings Inc
In total, the Offeror owns PharmaGap Series 1, Series 2, Series 3 and Series 4 Debentures (including those Debentures described in part 3 of this report) in the aggregate principal amount of $2,945,000, which, if fully converted (including accrued interest to April 4, 2008 and the exercise of all attached warrants), are convertible into 34,588,286 common shares of PharmaGap. In addition, the Offeror will own 1,533,462 PharmaGap common shares, which represents approximately 6.1% of the issued and outstanding PharmaGap common shares. The Offeror also holds a further 3,193,811 options to purchase of PharmaGap common shares through over the counter options with certain principals of PharmaGap.
So they previously owned 1.5M shares = 6.1% of the existing float of approx 25M
34.6M from debentures are in the money now
3.2M options probably in the money now too
25 + 34.6 + 3.2 = 62.8 total float
1.5 + 34.6 + 3.2 = 39.3 total for Stormont
39.3/62.8 = 62.6%
No sign of any selling by Stormont.
This could be Mr. Bryden's goose that lays golden eggs.
sooner than later
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PharmaGap, Inc (TSX:GAP)
OTC.BB.PHRGF
Address:
100 Sussex Drive
Ottawa, Ontario
K1A 0R6 CANADA
613.998.3400
613.998.3399 (fax)
General inquiries: info@pharmagap.com
Employment inquiries: hr@pharmagap.com
PharmaGap is pursuing pre-clinical development of its lead drug candidate, GAP-107B8, for use in treating cancer. GAP-107B8 selectively targets Protein Kinase C (PKC), a validated target for potentially treating certain types and stages of cancer. GAP-107B8’s compelling bioactivity, efficacy and excellent safety profile has been demonstrated in vitro and in animal models. GAP-107B8 has been developed by way of computer assisted rational drug design.
PharmaGap’s researchers have deep knowledge of cell signaling pathways involved in the onset of cancer, particularly those controlled by the PKC family. Work is also being pursued developing a pipeline of drug modulators targeting PKC isoforms important in other disease conditions, such as heart disease and diabetes.
PharmaGap’s business model strategy is to out-license its drug compounds targeting PKC prior to commencement of later-stage clinical trials in humans. Management and the board are pursuing this strategy to maximize sustainable value for shareholders. PharmaGap shares trade on Toronto’s TSX-Venture Exchange.
Founded in 1999, PharmaGap is a spin-out from the National Research Council of Canada, Canada’s premier biological research organization. The Company’s development activities take place in labs and offices located in Ottawa, Ontario, Canada.
Management: http://www.pharmagap.com/company_overview/management.html
Drug Development: http://www.pharmagap.com/drug_development/index.html
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