An OTCPicks.com Corporate Profile Access Pharmaceuticals
Inc.
Company Overview
Access Pharmaceuticals, Inc.
is an emerging biopharmaceutical company that
focuses on adding value to exciting product concepts
in research by advancing those products through
clinical development. Access has adopted a semi-virtual
model to control costs, and advances projects
by utilizing its experienced clinical and regulatory
team and a small team of experienced pharmaceutical
scientists. Access's scientists have unique expertise
in nanopolymer chemistry platform technologies,
which are utilized in several of the company's
R&D programs. Through careful strategic planning
designed to maximize shareholder returns, Access
will either seek to advance products towards regulatory
and marketing approval, co-develop products in
collaboration with R&D and marketing partners
or out-license products once development has advanced
to a predetermined point.
While the the company’s primary
focus is in oncology and supportive care of cancer
patients, Access has recently acquired product
candidates in the dermatology field as well as
additional oncology assets. Access has an approved
supportive care product, one product in Phase
3 clinical development, four Phase 2 clinical
candidates, and six preclinical programs in oncology,
including products arising from a promising oral
drug delivery technology.
In the area of supportive care,
Access has received marketing allowance for MuGard™
in the United States from the Food and Drug Administration
(FDA). MuGard is indicated for management of mucositis.
Mucositis is a debilitating side effect of various
cancer treatments resulting in ulceration of the
oral cavity. MuGard, a proprietary nanopolymer
rinse formulation, provides a protective coating
to the mucosal surfaces in the mouth. A clinical
study has shown MuGard to be effective in lowering
the incidence and severity of mucositis. The market
for mucositis treatment is estimated to be in
excess of US$1 billion world-wide. In addition
to receiving FDA marketing allowance in the U.S.,
Access has marketing partners for MuGard in three
major world territories; SpePharm, for the commercialization
of MuGard in the EU, Milestone Biosciences for
North America, and RHEI Pharmaceuticals for certain
Asian territories.
ProLindac™ links
Access' nanopolymer technolgy with the principals
of prodrugs to enhance the delivery of a platinum
drug to tumors. In preclinical models ProLindac
protects normal tissue from the cytotoxic drug
while in circulation and enhances uptake of drugs
to tumors, where drug is released by virtue of
a pH-sensitive linker. ProLindac completed a Phase
1 clinical study demonstrating promising signs
of efficacy. ProLindac has completed a Phase 2
clinical study in patients with recurrent ovarian
cancer. The drug used in ProLindac is DACH platinum,
which is also the active moiety of oxaliplatin
(Eloxatin; Sanofi – Aventis), a drug which currently
has sales of over $2.0 billion worldwide. Access
has a codevelopment agreement with Nanjing Aosaikang
Medicinal Group for development of ProLindac in
China.
Thiarabine is a novel nucleoside
product which demonstrated very promising anticancer
activity in preclinical models (read
the full press release regarding the preclinical
data). Following completion of two Phase 1 clinical
studies, Access plans to advance thiarabine in
a Phase 2 study at a leading US institute for
the treatment of leukemia.
Access also has Cobalamin technologies
in early-stage development. This technology is
based upon the use of cobalamin–coated particles
derived from the company's nanopolymer chemistry
technologies. The company has extensive intellectual
property surrounding the use of this technology
for oral drug delivery including oral delivery
of insulin and other proteins and peptides. Access
receives funding from a major pharmaceutical company
for the development of a Cobalamin oral drug delivery
formulation of human growth hormone. In preclinical
development are the Angiolix®, Prodrax®, Alchemix®,
and Cobalamin™ programs, which have the potential
to provide an exciting array of new clinical candidates.
Angiolix (HuMc3) is a humanized
monoclonal antibody which binds to Lactadherin,
a 46kDa extracellular matrix protein, expressed
by most breast tumor cells. This binding blocks
vascular endothelial cell proliferation, and induces
selective programmed cell death (apoptosis) in
blood vessels supporting tumors. This cuts off
or reduces the supply of nutrients and oxygen
to tumors and reduces tumor growth. Angiolix thus
acts as an anti-angiogenesis factor like drugs
such as Avastin. In preclinical studies, Angiolix
displays potent anti-tumor activity in the MX-1
breast cancer tumor model.
Prodrax is a non-toxic prodrug
which is targeted to be active in the low oxygen
(hypoxic) regions of solid tumors. The Prodrax
program comprises a series of compounds which
are N-oxide prodrugs of cytotoxic anthraquinone
derivatives. The N-oxide deactivates the toxic
cytotoxic alkylating function while the drug is
in circulation; it also serves to enhance the
ability of the compound to traverse biological
membranes, ensuring that the prodrug is widely
distributed in the body. Prodrax compounds are
non-toxic in normally oxygenated tissues as well
as the oxygenated areas of solid tumors but become
highly toxic in the low oxygen (hypoxic) region
of tumors.
Alchemix molecules are proprietary
molecules that attack tumors by two modes of action:
through intercalating and alkylating properties
that result in irreversible binding of the compounds
to tumor DNA, thus preventing tumor replication
and inducing tumor cell death. It has also been
shown that Alchemix molecules are a potent inhibitors
of topoisomerase II. Alchemix molecules possess
potent activity across a variety of different
human tumor cell lines and significantly show
potent activity in cisplatin and anthracyline
resistant xenograft human tumor models.
The Cobalamin oral drug delivery
technology has been extended to provide nanoparticulate
formulations for the enhanced targeting of drugs
to sites of disease. Targeting results from the
increased demand for vitamins such as cobalamin
that often occurs at disease sites, such as cancer.
Access is developing Phenylbutyrate
(PB) which is also in Phase 2 clinical trials.
PB is a pleotropic agent which current evidence
suggests acts as both an HDAC inhibitor and a
differentiating agent. HDAC inhibitors have potent
anticancer activity by suppressing specific enzymes
found in cancer cells.
Access recently acquired two
dermatological products as well as the proprietary
nanopolymer drug delivery technology used in one
of these products. Pexiganan is topical product
for the treatment of diabetic foot ulcers. It
is based on the proprietary synthetic analog of
a naturally-occuring broad-spectrum antimicrobial
peptide. Clinical studies have shown Pexiganan
to be at least as effective as one of the standard
oral antibiotics used in the treatment of diabetic
foot ulcers, without the potential issues of systemic
use of antibiotic. EcoNail is a nail lacquer for
the treatment of onychomycosis, a common nail
fungal infection.
Investment Highlights
Access’ nearest-term property
is its proprietary treatment for oral mucositis,
MuGard, which was launched in
a number of European countries this quarter by
partner SpePharm. Next up are launches in the
US, China and
Korea (all three already have partnerships) by
the end of this year, with more territory partnerships
potentially signed this year or next for Canada/Japan/Australia-New
Zealand, and possibly product launches there as
well. The current quarter (Q2/09) will also be
the first to see revenues from this product, and
set the stage for further growth in this fragmented,
$300 million market.
ProLindac is the Company’s product
addressing the largest potential market; the multi-billion
DACH platinum cancer therapeutic area now served
by Sanofi-Aventis’ Eloxatin. Access’ second generation
nanopolymer
based Platinum therapeutic enables more delivery
of active ingredient DACH platinum with fewer
side effects, and has already completed a Phase
II trial in Europe for relapsed ovarian cancer.
Next up for Access are two combination trials
for ProLindac, for recurrent ovarian with Taxol
and for pancreatic cancer with gemcitabine, again
in Europe. The signing of a partnership for these
indications either worldwide or country-by-country
would illuminate the value of this asset and simultaneously
allow new trials to begin.
Access’ Thiarabine is a new
nucleoside analogue – in the same class as Bayer’s
Fludara and J&J’s Leustatin
– and is ready for Phase II trials. Thiarabine
has already been in two Phase II trials in advanced
solid tumors
and the Company is currently working with researchers
at the MD Anderson Center in Houston to develop
Phase II protocols for acute myeloid leukemia
(AML), acute lymphocytic leukemia (ALL) and other
indications. What’s more, Access recently announced
preclinical data for the use of Thiarabine with
Clofarabine (Genzyme’s Clolal) and the Company
continues to actively seek co-development partners.
With Cobalamin, a unique oral
delivery nano-polymer platform using vitamin B-12,
Access has focused on
insulin as its first target, along with human
growth hormone, EPO, Interferon and other hard-to-stomach
compounds. Access has already signed five non-exclusive
partnerships, including two just last month, which
typically provide for reimbursement of Company
research expenditures and could lead to much larger
joint
ventures if early proof-of-concept studies prove
positive.
Monoclonal Antibody therapies
such as Avastin, Erbitux and Herceptin have seen
commercial success, and
with Angiolix Access is vying to go head-to-head
with Avastin in two solid cancer tumor types in
pre clinical
studies conducted at Imperial College in London.
Angiolix has a proprietary target, lactadherin,
key in tumor
angiogenesis, and early results show that Angiolix
has anti-tumor activity alone and in combination
with
chemotherapy. Unlike Avastin, however, Angiolix
has anti-proliferative activity by itself. Access
is actively
seeking development partners for their monoclonal
antibody, which could include big pharma or major
biotech firms in the US or worldwide.
Access had a little over $2.2
million in cash on its balance sheet at the end
of the most recent March 2009
quarter. The Company has reduced its annual cash
burn rate thanks to recent revenue-producing agreements,
product launch royalty streams and cost-saving
initiatives, down from $4 million to $3 million
currently. We expect Access’ cash burn to continue
to be reduced as this year goes on, due to increases
in royalties from MuGard product sales, more MuGard
country launches, and potentially additional partnerships
signed. The Company also has $5.5 million in outstanding
debt, which is due at the end of 2011. Company
management has stated that they expect cash on
hand to last into next year.
Access also has a number of
other projects and properties of lower development
priority than the five listed
above. These include two dermatology products,
Pexiganan, a topical antibiotic for the treatment
of diabetic
foot ulcers which has two completed Phase III
trials, and EcoNail, a proprietary lacquer formulation
of antifungal econozale and SEPA indicated for
the treatment of nail fungus or onychomycosis
which has completed Phase II trials; the Company
is seeking to partner or perhaps out-license these
two products. Other programs at Access include
Prodrax, a non-toxic prodrug targeted at the low
oxygen regions of solid tumors in preclinical
development; Alchemix proprietary molecules which
possess potent activity across a variety of different
human tumor cell lines and significantly show
potent activity in cisplatin and anthracyline
resistant xenograft human tumor models, also in
preclinical development, and Phenylbutyrate, a
small molecule drug found to have a potent anticancer
effect in Phase I and Phase II trials conducted
by the NIH.
Business Development
The Business Development team
at Access Pharmaceuticals is interested in identifying
out-licensing candidates, as well as alliance
and merger opportunities for their oncology and
dermatology products, as well as for the company's
nanopolymer technologies, including Cobalamin™
for oral drug delivery, Cobalamin™ for disease
targeting, and SEPA, Access’ nail and transdermal
drug delivery technology.
MuGard™ is
its product for oral mucositis which has received
US FDA marketing allowance. Access has licensing
agreements with Milestone Biosciences (North America),
SpePharm (Europe) and RHEI Pharmaceuticals (certain
Asian territories), and is seeking commercial
partners in other territories.
Access has exclusive
worldwide rights to the oncology applications
of phenylbutyrate (PB), a histone deacetylase
(HDAC) inhibitor. Access is seeking licensing
and commercialization partners for use of PB in
cancer therapy and for the topical treatment of
radiation proctitis.
ProLindac™
is its major chemotherapeutic compound, currently
in Phase 2 clinical development. Access has licensed
ProLindac to Nanjing Aosaikang Medicinal Group
Co., Ltd for development and commercialization
in China, and is seeking codevelopment partners
for other territories.
Angiolix®, Alchemix®,
and Prodrax® are anticancer products
in preclinical development, while thiarabine is
a novel nucleoside in phase 2 clinical development.
Pexiganan is a phase 3 cream product for the treatment
of diabetic foot ulcers and EcoNail is a phase
2 nail lacquer for treatment of onychomycosis.
New Strategy for Commercialization
of MuGard in North America
ACCESS is evaluating strategic
options for the commercialization of MuGard in
North America. The previously announced licensing
agreement between Access and Milestone Biosciences,
LLC for North American rights to MuGard has been
terminated.
MuGard is an FDA approved treatment
for oral mucositis, a debilitating side effect
of radiation treatment and chemotherapy, and previously
announced data suggest that the market for MuGard
is significantly greater than previously expected.
Frank Jacobucci, formerly President & CEO
of Milestone Biosciences, has joined Access as
a consultant, and will assist with ongoing reimbursement,
manufacturing and commercial launch activities
at Access, while discussions with potential licensee
and co-promotion partners is ongoing.
"Access is focused on
maximizing the potential of MuGard, both for patients
and for its shareholders," states Jeffrey
B. Davis, Access' President & CEO. "Bringing
MuGard back in-house will enable Access to capture
more of MuGard's value for shareholders, and be
more intimately involved in the ongoing commercialization
activities. I welcome the expert insight and experience
of Frank Jacobucci, who brings great knowledge
and expertise in launching pharma products, with
a particular expertise in oral mucositis and related
indications, and of course MuGard."
Mr. Jacobucci has over 20 years
experience in sales management, including senior
sales executive positions at oncology focused
companies including MGI Pharma, Genetics Institute,
Wyeth Oncology, Aventis, Precision Therapeutics
and CRC Oncology Services.
"I have always known the
substantial potential for MuGard in the prevention
and treatment of oral mucositis as well as it
being very important for the medical community,
and an exciting commercial opportunity in the
pharma sector," stated Frank Jacobucci. "I
look forward to working with the Access team while
preparing for a MuGard launch in North America
and bringing additional pharma resources to bear
as needed. These efforts will not only maximize
the potential for MuGard but, more importantly,
provide access and availability for patients;
thus improving outcomes I continue to believe
that MuGard is a very important product for the
cancer community, as the negative impact of oral
mucositis on patient health and treatment is very
significant."
MuGard is a novel, ready-to-use
mucoadhesive oral wound rinse for the management
of oral mucositis, a debilitating side effect
of many anticancer treatments. Up to 80% of all
patients receiving radiotherapy and approximately
40% of all chemotherapy patients develop oral
mucositis, and almost all patients receiving radiotherapy
for head and neck cancer and those undergoing
stem cell transplantation develop mucositis. Updated
clinical practice guidelines for the prevention
and treatment of mucositis recommend the use of
a preventive oral care regimen as part of routine
supportive care along with a therapeutic oral
care regimen if mucositis develops. The market
for the treatment of oral mucositis, expanding
to include all patients undergoing chemotherapy
and radiotherapy, is estimated to be in excess
of $5 billion world-wide.
MuGard forms a protective coating
over the oral mucosa when swirled gently around
the mouth. In a comparison of cancer patients
receiving standard mucositis care with those patients
receiving MuGard, the incidence and severity of
mucositis was significantly lower in the MuGard
treated group using a validated scale for the
assessment of oral mucositis.
Recent ACCP News:
September
1 -
Access Pharmaceuticals to Present at the Rodman &
Renshaw Annual Healthcare Conference
Access to Provide Update on MuGard Global Commercial
Launch and ProLindac Clinical Development Plans
ACCESS PHARMACEUTICALS, INC. (OTC
Bulletin Board : ACCP) announced today that Access will
present at the Rodman & Renshaw 11th Annual Healthcare
Conference to be held September 9-11, 2009 at the New
York Palace Hotel in New York City. Jeffrey B. Davis,
President and CEO of Access is scheduled to speak on
Friday, September 11, 2009 at 10:50 am EDT in the Fahnestock
Salon (5th Floor) and will give a corporate overview
and discuss the Company's product opportunities.
The presentation will be available
via a webcast and can be accessed at: http://www.wsw.com/webcast/rrshq15/accp.ob
.The replay can be obtained at the same link for up
to 90 days after the live presentation.
About MuGard: MuGard is a novel,
ready-to-use mucoadhesive oral wound rinse for the management
of oral mucositis, a debilitating side effect of many
anticancer treatments. Up to 40% of all patients receiving
chemotherapy and/or radiotherapy develop moderate to
severe mucositis, and almost all patients receiving
radiotherapy for head and neck cancer and those undergoing
stem cell transplantation develop mucositis. Updated
clinical practice guidelines for the prevention and
treatment of mucositis recommend the use of a preventive
oral care regimen as part of routine supportive care
along with a therapeutic oral care regimen if mucositis
develops. The market for the treatment of oral mucositis,
used prophylactically for patients undergoing chemotherapy
and radiation therapy, is estimated to be in excess
of $5 billion world-wide.
About ProLindac(TM):
ProLindac is a novel DACH platinum
prodrug which has been shown to be active in a wide
variety of solid tumors in both preclinical models and
in human trials. Access believes that ProLindac's unique
molecular design potentially could eliminate some of
the toxic side effects seen in the currently marketed
DACH platinum, Eloxatin, which has sales in excess of
$2 billion. Access has previously announced that it
has licensed ProLindac to Aosaikang Medicinal Group
("ASK") for the Greater China Region and to
JCOM, Ltd for South Korea. Under these agreements both
of these partners will be conducting Phase 2 combination
studies with ProLindac in specific tumor types at their
expense based on these results.
About Access:
Access Pharmaceuticals, Inc. is an
emerging biopharmaceutical company that develops and
commercializes propriety products for the treatment
and supportive care of cancer patients. Access' products
include ProLindac(TM), currently in Phase 2 clinical
testing of patients with ovarian cancer, and MuGard(TM)
for the management of patients with mucositis. The company
also has other advanced drug delivery technologies including
Cobalamin(TM)-mediated targeted delivery and oral drug
delivery, its proprietary nanopolymer delivery technology
based on the natural vitamin B12 uptake mechanism; Angiolix(R),
a humanized monoclonal antibody which acts as an anti-angiogenesis
factor and is targeted to breast cancer; and Thiarabine,
a new generation nucleoside analog which has demonstrated
both pre-clinical and clinical activity in certain cancers.
For additional information on Access Pharmaceuticals,
please visit our website at www.accesspharma.com.
Sept
1 -
Access Pharmaceuticals Provides Update on ProLindac
Clinical Development Program
Enrolling
Ovarian Cancer Patients in France; Finalizing Clinical
Trial Programs with Partners in China and Korea
ACCESS PHARMACEUTICALS, INC. (OTC
Bulletin Board: ACCP), provided an update today on its
clinical development strategy for ProLindac, a novel
DACH platinum drug that has shown to be active in many
solid tumors in human clinical studies. Access has commenced
a new clinical study of ProLindac in France. The study
will examine dose levels and regimens of ProLindac monotherapy
in cancer patients, provide additional data to support
design of combinations studies, and extend the safety
database. Two ovarian cancer patients have been enrolled
in the study to date, and it is anticipated 6 to 12
patients will be enrolled this year in advance of enrolling
patients in trial evaluating ProLindac in combination
with other chemotherapies. Access recently announced
data from a recurrent ovarian cancer trial that showed
that ProLindac was more active than currently available
platinum drugs in that patient population, and that
the drug was very well tolerated.
ProLindac is a novel DACH platinum
drug that has shown to be active in many solid tumors
in human clinical studies. Platinum drugs are one of
the most clinically and commercially successful class
of chemotherapies and generated more than $3 billion
in revenue globally in 2008. Access believes that ProLindac,
as a well-tolerated and active DACH platinum, represents
a important improvement in the design and tolerability
of platinum chemotherapies.
Later this month, an Access management
and clinical development team is meeting with Access'
partner, Aosaikang Medicinal Group (ASK) and several
key oncology opinion leaders to finalize plans for ProLindac
development in China. In addition, Access is meeting
with its Korean partner, JCOM of Seoul, South Korea
to finalize development plans in that territory. Access
believes that three ProLindac combination trials will
start shortly upon regulatory approvals of protocols
in both China and Korea. Further, Access has reported
receipt of additional milestone payments from its Far
East partners in the ordinary course under their collaborative
agreements.
"Our Chinese partner, ASK, has
made great progress on manufacturing scale-up of ProLindac
and advancing the Regulatory process with the SFDA.
We are excited about finalizing protocols with ASK and
the leading oncologists in China, and look forward to
their continued progress," stated Jeffrey B. Davis,
Access' President and CEO. "Additionally, we are
meeting this month with JCOM and key opinion leaders
in Korea, and hope to get the combination trials started
in Korea as soon as reasonably possible."
Access intends to design all clinical
studies of ProLindac in accordance with FDA standards
and intends to use the clinical data from all three
planned clinical trials in the Far East to further development
in North America and Europe. Access has the right to
all clinical data generated in the Far East under the
agreements entered into with their Far East partners,
and as previously announced, believes that these trials
run by its ProLindac partners will save Access between
$20 and $30 million in clinical development expenses.
Access is currently in discussion
with potential partners for development and commercialization
of ProLindac in additional territories.
About ProLindac(TM):
ProLindac is a novel DACH platinum
prodrug which has been shown to be active in a wide
variety of solid tumors in both preclinical models and
in human trials. Access believes that ProLindac's unique
molecular design potentially could eliminate some of
the toxic side effects seen in the currently marketed
DACH platinum, Eloxatin, which has sales in excess of
$2 billion. Access has previously announced that it
has licensed ProLindac to Aosaikang Medicinal Group
("ASK") for the Greater China Region and to
JCOM, Ltd for South Korea. Under these agreements both
of these partners will be conducting Phase 2 combination
studies with ProLindac in specific tumor types at their
expense based on these results.
About Access:
Access Pharmaceuticals, Inc. is an
emerging biopharmaceutical company that develops and
commercializes propriety products for the treatment
and supportive care of cancer patients. Access' products
include ProLindac(TM), currently in Phase 2 clinical
testing of patients with ovarian cancer, and MuGard(TM)
for the management of patients with mucositis. The company
also has other advanced drug delivery technologies including
Cobalamin(TM)-mediated targeted delivery and oral drug
delivery, its proprietary nanopolymer delivery technology
based on the natural vitamin B12 uptake mechanism; Angiolix(R),
a humanized monoclonal antibody which acts as an anti-angiogenesis
factor and is targeted to breast cancer; and Thiarabine,
a new generation nucleoside analog which has demonstrated
both pre-clinical and clinical activity in certain cancers.
For additional information on Access Pharmaceuticals,
please visit our website at www.accesspharma.com.
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Oral mucositis is a frequent complication
of cancer chemotherapy or of radiation therapy to the
head and neck region. Currently available products are
usually inadequate, and more effective treatment to minimize
the extent and duration of mucositis is clearly needed.
Historically, treatment of mucositis has been palliative
and aimed at minimizing mucosal trauma. Treatments include
frequent mouth cleansing and rinsing with buffered saline
and fluoride solutions and administration of topical and
systemic antimicrobial agents. Mucositis and infection
of the mouth have remained major complications despite
the usual oral care provided for patients with cancer.
What is MuGard?
MuGard is a viscous, mucoadhesive rinse
which provides a protective coating to the oral mucosa.
In a comparison of patients undergoing standard care with
patients using MuGard, the incidence and severity of mucositis
was significantly lower for the MuGard group. MuGard has
received marketing allowance in the United States under
a 510(k) from the Food and Drug Administration.
Clinical Trials of MuGard
Access has conducted a clinical trial
of MuGard, the results of which were compared to historical
data from two different sources for patients at risk of
developing mucositis and who had received prior standard
of care treatment. (Cancer; 1999, 85 (10): 2103-2113,
and Cancer; 2000, 89 (11): 2258-2265). In both cases,
it was shown mucositis scores, as measured by the oral
mucositis assessment scale (OMAS), were lower for patients
using MuGard than for similar patients on standard care.
EcoNail Fact Sheet
Onychomycosis
Onychomycosis is a fungal infection
of the nail. It can occur in nails of either hands or
feet, but is most common in toe nails, and afflicts 6-8%
of the US population. Because the fungal infection is
embedded in the nail, treatment of onychomycosis is difficult,
and so it can require a year or more of treatment to eradicate
all symptoms.
Standard Treatments for
Onychomycosis
Onychomycosis can be treated with either
systemic antifungal agents such as itraconazole or terbinafine.
Topically delivered lacquer formulations or antifungal
agents, like EcoNail, have specific advantages over systemic
treatments because they are applied like nail polish,
treat fungal nail infections locally, and facilitate close
and extended contact between an antifungal drug and the
outer, or dorsal, nail surface. Developers of topical
nail lacquers for onychomycosis face two major challenges.
First, lacquers with acceptable hardness, durability and
drying time tend not to release antifungal drugs from
the lacquer matrix readily. Second, most antifungal drugs
do not penetrate into the deep, or ventral, nail plate
adequately when applied to the outer, or dorsal, nail
surface, which results in insufficient antifungal concentrations
at the site of infection.
EcoNail
EcoNail is a topically applied lacquer
formulation containing econazole and SEPA for the topical
treatment of onychomycosis
SEPA® drug delivery technology
Access’ SEPA drug delivery technology
is a family of patented compounds that can enhance the
transport, penetration and controlled delivery of a wide
range of drugs into nails and through the skin. We have
chosen SEPA 0009, a member of the SEPA family, for clinical
development.
ProLindac™ Fact Sheet
What is ProLindac?
ProLindac is Access Pharmaceutical’s
lead oncology drug, which has completed a phase 2 monotherapy
study in ovarian cancer patients. It is a therapeutic,
previously known as AP5346. It utilizes a safe, water-soluble
nanoparticulate system to deliver DACH platinum (the active
moiety of oxaliplatin) to tumors. Platinum-based drugs
are among the largest classes of chemotherapeutics and
oxaliplatin (Eloxatin; Sanofi-Aventis) is a DACH platinum
drug that is projected to have had worldwide sales of
over $2 billion in 2006.
The role of the Access’ nanoparticulate
formulation of DACH platinum is to deliver more drug to
the tumor while reducing delivery to normal tissue, thus
increasing the drug’s effectiveness and decreasing the
toxic side-effects. A major drawback of existing therapies
is acute neurotoxicity. ProLindac has been shown to be
much more effective than oxaliplatin in a large number
of murine tumor models. In a phase 1 clinical study, at
least five times more DACH platinum could be administered
to patients with ProLindac than oxaliplatin. Moreover
there was no indication in ProLindac of the acute neurotoxicity
associated with oxaliplatin.
While new cancer drugs often display
minimal activity in phase 1 studies, ProLindac produced
two partial responses based on MRI analysis, one partial
response based on biomarker analysis (CA-125) and four
cases of stable disease in an evaluable patient population
of 16. A European phase 2 study to determine the efficacy
and safety of ProLindac in patients with recurrent ovarian
cancer has recently been completed.
OTCPicks.com
is located at 3533 Twin Lakes Drive, Prosper, TX 75078,
Telephone: (972) 546-3740, Email:
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DO
NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND
ON THIS REPORT. We are not registered as a securities
broker-dealer or an investment adviser either with the
U.S. Securities and Exchange Commission (the “SEC”) or
with any state securities regulatory authority. We are
neither licensed nor qualified to provide investment advice.
OTCPicks.com makes no recommendation that the purchase
of securities of companies profiled in this web site is
suitable or advisable for any person or that an investment
such securities will be profitable. In general, given
the nature of the companies profiled and the lack of an
active trading market for their securities, investing
in such securities is highly speculative and carries a
high degree of risk. You are receiving this email because
you have registered on OTCPicks.com or one of our affiliate
companies.
The
information contained in our report should be viewed as
commercial advertisement and is not intended to be investment
advice. The report is not provided to any particular individual
with a view toward their individual circumstances. The
information contained in our report is not an offer to
buy or sell securities. We distribute opinions, comments
and information free of charge exclusively to individuals
who wish to receive them.
Our
newsletter and website have been prepared for informational
purposes only and are not intended to be used as a complete
source of information on any particular company. An individual
should never invest in the securities of any company profiled
based solely on information contained in our reports.
Individuals should assume that all information contained
in the report about profiled companies is not trustworthy
unless verified by their own independent research.
Any
individual who chooses to invest in any securities should
do so with caution. Investing in securities is speculative
and carries a high degree of risk; you may lose some or
all of the money that is invested. Always research your
own investments and consult with a registered investment
advisor or licensed stock broker before investing.
Information
contained in our report will contain “forward looking
statements” as defined under Section 27A of the Securities
Act of 1933 and Section 21B of the Securities Exchange
Act of 1934. Subscribers are cautioned not to place undue
reliance upon these forward looking statements. These
forward looking statements are subject to a number of
known and unknown risks and uncertainties outside of our
control that could cause actual operations or results
to differ materially from those anticipated. Factors that
could affect performance include, but are not limited
to, those factors that are discussed in each profiled
company's most recent reports or registration statements
filed with the SEC. You should consider these factors
in evaluating the forward looking statements included
in the report and not place undue reliance upon such statements.
We are committed to providing factual information on the
companies that are profiled. However, we do not provide
any assurance as to the accuracy or completeness of the
information provided, including information regarding
a profiled company's plans or ability to effect any planned
or proposed actions. We have no first-hand knowledge of
any profiled company’s operations and therefore cannot
comment on their capabilities, intent, resources, nor
experience and we make no attempt to do so. Statistical
information, dollar amounts, and market size data was
provided by the subject company and related public information
sources which we believe to be reliable but we cannot
guarantee the accuracy of the information. To the fullest
extent of the law, we will not be liable to any person
or entity for the quality, accuracy, completeness, reliability,
or timeliness of the information provided in the report,
or for any direct, indirect, consequential, incidental,
special or punitive damages that may arise out of the
use of information we provide to any person or entity
(including, but not limited to, lost profits, loss of
opportunities, trading losses, and damages that may result
from any inaccuracy or incompleteness of this information).
We encourage you to invest carefully and read investment
information available at the websites of the SEC at http://www.sec.gov
and FINRA at http://www.finra.org.
Disclosure:
OTCPicks.com has been compensated eight thousand five hundred dollars from a third party (Longview Communications Corp.) for ACCP advertising and promotional services.
Had a fundamental role in the registration
strategy and post-registration development of cisplatin
and oxaliplatin
Positions at Memorial Sloan Kettering
Cancer Center (NY), Columbia Presbyterian (NY), Hospital
St. Louis (Paris), Instituto Mario Negri (Milan) and
Institut Gustave Roussy (Villejuif)
David P. Nowotnik, Ph.D., Senior
Vice President Research and Development
Senior Director, Product Development,
Guilford Pharmaceuticals, Inc.
Group Leader, Bristol-Myers Squibb.
Section Leader, Amersham International.
Research Chemist, Tate and Lyle and
Aspro-Nicholas.
PhD, Organic Chemistry, University
of London.
Stephen B. Thompson, Vice President
and CFO
Controller and Administration Manager,
API.
Controller, Robert E. Woolley, Inc.,
a hotel real estate company.
Controller, OKC Limited Partnership,
an oil and gas company.
Accounting and finance, Santa Fe
International Corporation.
Phillip Wise, Vice President
Business Development and Strategy
VP, Commercial and Business Development
and Chief Financial Officer, Enhance Pharmaceuticals.
VP, Commercial and Business Development,
Ardent Pharmaceuticals.
Director of Managed Care Marketing
& Director of New Product Planning, Glaxo Wellcome.
MBA, University of Virginia.
BS, Industrial and Systems Engineering,
Georgia Institute of Technology.
OTCPicks.com
is located at 3533 Twin Lakes Drive, Prosper, TX 75078,
Telephone: (972) 546-3740, Email:
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email address is being protected from spam bots, you need
Javascript enabled to view it
DO
NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND
ON THIS REPORT. We are not registered as a securities
broker-dealer or an investment adviser either with the
U.S. Securities and Exchange Commission (the “SEC”) or
with any state securities regulatory authority. We are
neither licensed nor qualified to provide investment advice.
OTCPicks.com makes no recommendation that the purchase
of securities of companies profiled in this web site is
suitable or advisable for any person or that an investment
such securities will be profitable. In general, given
the nature of the companies profiled and the lack of an
active trading market for their securities, investing
in such securities is highly speculative and carries a
high degree of risk. You are receiving this email because
you have registered on OTCPicks.com or one of our affiliate
companies.
The
information contained in our report should be viewed as
commercial advertisement and is not intended to be investment
advice. The report is not provided to any particular individual
with a view toward their individual circumstances. The
information contained in our report is not an offer to
buy or sell securities. We distribute opinions, comments
and information free of charge exclusively to individuals
who wish to receive them.
Our
newsletter and website have been prepared for informational
purposes only and are not intended to be used as a complete
source of information on any particular company. An individual
should never invest in the securities of any company profiled
based solely on information contained in our reports.
Individuals should assume that all information contained
in the report about profiled companies is not trustworthy
unless verified by their own independent research.
Any
individual who chooses to invest in any securities should
do so with caution. Investing in securities is speculative
and carries a high degree of risk; you may lose some or
all of the money that is invested. Always research your
own investments and consult with a registered investment
advisor or licensed stock broker before investing.
Information
contained in our report will contain “forward looking
statements” as defined under Section 27A of the Securities
Act of 1933 and Section 21B of the Securities Exchange
Act of 1934. Subscribers are cautioned not to place undue
reliance upon these forward looking statements. These
forward looking statements are subject to a number of
known and unknown risks and uncertainties outside of our
control that could cause actual operations or results
to differ materially from those anticipated. Factors that
could affect performance include, but are not limited
to, those factors that are discussed in each profiled
company's most recent reports or registration statements
filed with the SEC. You should consider these factors
in evaluating the forward looking statements included
in the report and not place undue reliance upon such statements.
We are committed to providing factual information on the
companies that are profiled. However, we do not provide
any assurance as to the accuracy or completeness of the
information provided, including information regarding
a profiled company's plans or ability to effect any planned
or proposed actions. We have no first-hand knowledge of
any profiled company’s operations and therefore cannot
comment on their capabilities, intent, resources, nor
experience and we make no attempt to do so. Statistical
information, dollar amounts, and market size data was
provided by the subject company and related public information
sources which we believe to be reliable but we cannot
guarantee the accuracy of the information. To the fullest
extent of the law, we will not be liable to any person
or entity for the quality, accuracy, completeness, reliability,
or timeliness of the information provided in the report,
or for any direct, indirect, consequential, incidental,
special or punitive damages that may arise out of the
use of information we provide to any person or entity
(including, but not limited to, lost profits, loss of
opportunities, trading losses, and damages that may result
from any inaccuracy or incompleteness of this information).
We encourage you to invest carefully and read investment
information available at the websites of the SEC at http://www.sec.gov
and FINRA at http://www.finra.org.
Disclosure:
OTCPicks.com has been compensated eight thousand five hundred dollars from a third party (Longview Communications Corp.) for ACCP advertising and promotional services.
OTCPicks.com
is located at 3533 Twin Lakes Drive, Prosper, TX 75078,
Telephone: (972) 546-3740, Email:
This email address is being protected from spam bots, you need Javascript enabled to view it
email address is being protected from spam bots, you need
Javascript enabled to view it
DO
NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND
ON THIS REPORT. We are not registered as a securities
broker-dealer or an investment adviser either with the
U.S. Securities and Exchange Commission (the “SEC”) or
with any state securities regulatory authority. We are
neither licensed nor qualified to provide investment advice.
OTCPicks.com makes no recommendation that the purchase
of securities of companies profiled in this web site is
suitable or advisable for any person or that an investment
such securities will be profitable. In general, given
the nature of the companies profiled and the lack of an
active trading market for their securities, investing
in such securities is highly speculative and carries a
high degree of risk. You are receiving this email because
you have registered on OTCPicks.com or one of our affiliate
companies.
The
information contained in our report should be viewed as
commercial advertisement and is not intended to be investment
advice. The report is not provided to any particular individual
with a view toward their individual circumstances. The
information contained in our report is not an offer to
buy or sell securities. We distribute opinions, comments
and information free of charge exclusively to individuals
who wish to receive them.
Our
newsletter and website have been prepared for informational
purposes only and are not intended to be used as a complete
source of information on any particular company. An individual
should never invest in the securities of any company profiled
based solely on information contained in our reports.
Individuals should assume that all information contained
in the report about profiled companies is not trustworthy
unless verified by their own independent research.
Any
individual who chooses to invest in any securities should
do so with caution. Investing in securities is speculative
and carries a high degree of risk; you may lose some or
all of the money that is invested. Always research your
own investments and consult with a registered investment
advisor or licensed stock broker before investing.
Information
contained in our report will contain “forward looking
statements” as defined under Section 27A of the Securities
Act of 1933 and Section 21B of the Securities Exchange
Act of 1934. Subscribers are cautioned not to place undue
reliance upon these forward looking statements. These
forward looking statements are subject to a number of
known and unknown risks and uncertainties outside of our
control that could cause actual operations or results
to differ materially from those anticipated. Factors that
could affect performance include, but are not limited
to, those factors that are discussed in each profiled
company's most recent reports or registration statements
filed with the SEC. You should consider these factors
in evaluating the forward looking statements included
in the report and not place undue reliance upon such statements.
We are committed to providing factual information on the
companies that are profiled. However, we do not provide
any assurance as to the accuracy or completeness of the
information provided, including information regarding
a profiled company's plans or ability to effect any planned
or proposed actions. We have no first-hand knowledge of
any profiled company’s operations and therefore cannot
comment on their capabilities, intent, resources, nor
experience and we make no attempt to do so. Statistical
information, dollar amounts, and market size data was
provided by the subject company and related public information
sources which we believe to be reliable but we cannot
guarantee the accuracy of the information. To the fullest
extent of the law, we will not be liable to any person
or entity for the quality, accuracy, completeness, reliability,
or timeliness of the information provided in the report,
or for any direct, indirect, consequential, incidental,
special or punitive damages that may arise out of the
use of information we provide to any person or entity
(including, but not limited to, lost profits, loss of
opportunities, trading losses, and damages that may result
from any inaccuracy or incompleteness of this information).
We encourage you to invest carefully and read investment
information available at the websites of the SEC at http://www.sec.gov
and FINRA at http://www.finra.org.
Disclosure:
OTCPicks.com has been compensated eight thousand five hundred dollars from a third party (Longview Communications Corp.) for ACCP advertising and promotional services.
OTCPicks.com
is located at 3533 Twin Lakes Drive, Prosper, TX 75078,
Telephone: (972) 546-3740, Email:
This email address is being protected from spam bots, you need Javascript enabled to view it
email address is being protected from spam bots, you need
Javascript enabled to view it
DO
NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND
ON THIS REPORT. We are not registered as a securities
broker-dealer or an investment adviser either with the
U.S. Securities and Exchange Commission (the “SEC”) or
with any state securities regulatory authority. We are
neither licensed nor qualified to provide investment advice.
OTCPicks.com makes no recommendation that the purchase
of securities of companies profiled in this web site is
suitable or advisable for any person or that an investment
such securities will be profitable. In general, given
the nature of the companies profiled and the lack of an
active trading market for their securities, investing
in such securities is highly speculative and carries a
high degree of risk. You are receiving this email because
you have registered on OTCPicks.com or one of our affiliate
companies.
The
information contained in our report should be viewed as
commercial advertisement and is not intended to be investment
advice. The report is not provided to any particular individual
with a view toward their individual circumstances. The
information contained in our report is not an offer to
buy or sell securities. We distribute opinions, comments
and information free of charge exclusively to individuals
who wish to receive them.
Our
newsletter and website have been prepared for informational
purposes only and are not intended to be used as a complete
source of information on any particular company. An individual
should never invest in the securities of any company profiled
based solely on information contained in our reports.
Individuals should assume that all information contained
in the report about profiled companies is not trustworthy
unless verified by their own independent research.
Any
individual who chooses to invest in any securities should
do so with caution. Investing in securities is speculative
and carries a high degree of risk; you may lose some or
all of the money that is invested. Always research your
own investments and consult with a registered investment
advisor or licensed stock broker before investing.
Information
contained in our report will contain “forward looking
statements” as defined under Section 27A of the Securities
Act of 1933 and Section 21B of the Securities Exchange
Act of 1934. Subscribers are cautioned not to place undue
reliance upon these forward looking statements. These
forward looking statements are subject to a number of
known and unknown risks and uncertainties outside of our
control that could cause actual operations or results
to differ materially from those anticipated. Factors that
could affect performance include, but are not limited
to, those factors that are discussed in each profiled
company's most recent reports or registration statements
filed with the SEC. You should consider these factors
in evaluating the forward looking statements included
in the report and not place undue reliance upon such statements.
We are committed to providing factual information on the
companies that are profiled. However, we do not provide
any assurance as to the accuracy or completeness of the
information provided, including information regarding
a profiled company's plans or ability to effect any planned
or proposed actions. We have no first-hand knowledge of
any profiled company’s operations and therefore cannot
comment on their capabilities, intent, resources, nor
experience and we make no attempt to do so. Statistical
information, dollar amounts, and market size data was
provided by the subject company and related public information
sources which we believe to be reliable but we cannot
guarantee the accuracy of the information. To the fullest
extent of the law, we will not be liable to any person
or entity for the quality, accuracy, completeness, reliability,
or timeliness of the information provided in the report,
or for any direct, indirect, consequential, incidental,
special or punitive damages that may arise out of the
use of information we provide to any person or entity
(including, but not limited to, lost profits, loss of
opportunities, trading losses, and damages that may result
from any inaccuracy or incompleteness of this information).
We encourage you to invest carefully and read investment
information available at the websites of the SEC at http://www.sec.gov
and FINRA at http://www.finra.org.
Disclosure:
OTCPicks.com has been compensated eight thousand five hundred dollars from a third party (Longview Communications Corp.) for ACCP advertising and promotional services.
OTCPicks.com
is located at 3533 Twin Lakes Drive, Prosper, TX 75078,
Telephone: (972) 546-3740, Email:
This email address is being protected from spam bots, you need Javascript enabled to view it
email address is being protected from spam bots, you need
Javascript enabled to view it
DO
NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND
ON THIS REPORT. We are not registered as a securities
broker-dealer or an investment adviser either with the
U.S. Securities and Exchange Commission (the “SEC”) or
with any state securities regulatory authority. We are
neither licensed nor qualified to provide investment advice.
OTCPicks.com makes no recommendation that the purchase
of securities of companies profiled in this web site is
suitable or advisable for any person or that an investment
such securities will be profitable. In general, given
the nature of the companies profiled and the lack of an
active trading market for their securities, investing
in such securities is highly speculative and carries a
high degree of risk. You are receiving this email because
you have registered on OTCPicks.com or one of our affiliate
companies.
The
information contained in our report should be viewed as
commercial advertisement and is not intended to be investment
advice. The report is not provided to any particular individual
with a view toward their individual circumstances. The
information contained in our report is not an offer to
buy or sell securities. We distribute opinions, comments
and information free of charge exclusively to individuals
who wish to receive them.
Our
newsletter and website have been prepared for informational
purposes only and are not intended to be used as a complete
source of information on any particular company. An individual
should never invest in the securities of any company profiled
based solely on information contained in our reports.
Individuals should assume that all information contained
in the report about profiled companies is not trustworthy
unless verified by their own independent research.
Any
individual who chooses to invest in any securities should
do so with caution. Investing in securities is speculative
and carries a high degree of risk; you may lose some or
all of the money that is invested. Always research your
own investments and consult with a registered investment
advisor or licensed stock broker before investing.
Information
contained in our report will contain “forward looking
statements” as defined under Section 27A of the Securities
Act of 1933 and Section 21B of the Securities Exchange
Act of 1934. Subscribers are cautioned not to place undue
reliance upon these forward looking statements. These
forward looking statements are subject to a number of
known and unknown risks and uncertainties outside of our
control that could cause actual operations or results
to differ materially from those anticipated. Factors that
could affect performance include, but are not limited
to, those factors that are discussed in each profiled
company's most recent reports or registration statements
filed with the SEC. You should consider these factors
in evaluating the forward looking statements included
in the report and not place undue reliance upon such statements.
We are committed to providing factual information on the
companies that are profiled. However, we do not provide
any assurance as to the accuracy or completeness of the
information provided, including information regarding
a profiled company's plans or ability to effect any planned
or proposed actions. We have no first-hand knowledge of
any profiled company’s operations and therefore cannot
comment on their capabilities, intent, resources, nor
experience and we make no attempt to do so. Statistical
information, dollar amounts, and market size data was
provided by the subject company and related public information
sources which we believe to be reliable but we cannot
guarantee the accuracy of the information. To the fullest
extent of the law, we will not be liable to any person
or entity for the quality, accuracy, completeness, reliability,
or timeliness of the information provided in the report,
or for any direct, indirect, consequential, incidental,
special or punitive damages that may arise out of the
use of information we provide to any person or entity
(including, but not limited to, lost profits, loss of
opportunities, trading losses, and damages that may result
from any inaccuracy or incompleteness of this information).
We encourage you to invest carefully and read investment
information available at the websites of the SEC at http://www.sec.gov
and FINRA at http://www.finra.org.
Disclosure:
OTCPicks.com has been compensated eight thousand five hundred dollars from a third party (Longview Communications Corp.) for ACCP advertising and promotional services.
