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Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients.
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Access Pharmaceuticals MuGard Selected As Cover Article In The Print Edition Of The Journal Cancer

NEW YORK, May 1, 2014

ACCESS PHARMACEUTICALS, INC. announced that the data from its multi-institutional post-approval trial of MuGard® that was recently published in Cancer, has been selected as a cover article in the premier publication. Cancer, the journal of the American Cancer Society is one of the oldest peer-reviewed journals in oncology. The publication, entitled “Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck,” discusses data on Access’ post-marketing clinical trial that evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis in 120 patients receiving chemoradiation therapy for the treatment of cancers of the head and neck. In the trial, MuGard was shown to be superior to the sham control saline-bicarbonate rinse in mitigating oral mucositis symptoms and delaying oral mucositis progression.

The article discusses the findings from the trial, including MuGard meeting the primary and secondary endpoints, achieving a statistically significant reduction in mouth and throat soreness associated with oral mucositis and in the measure of mucositis severity at the end of radiation treatment using a physician-based assessment of severity (WHO score), respectively.

The publication is available at http://onlinelibrary.wiley.com/enhanced/doi/10.1002/cncr.28553/

Commenting on the impact of the published data, Stephen T. Sonis, DMD, DMSc, an expert on cancer treatment complications, Clinical Professor of Oral Medicine at Harvard and the primary author of the protocol for this trial, stated, “Oral mucositis continues to be a significant unmet medical need with horrific symptomatic consequences. This multi-institutional study provides strong evidence of MuGard’s effectiveness in reducing pain associated with radiation-induced injury. Access’ commitment to demonstrate MuGard’s benefit through a rigorous clinical trial process separates MuGard from currently available rinses and sets a new standard for evidence-based use of agents in this class.”

“Oral mucositis is one of the most challenging adverse side-effects we face when treating our cancer patients,” stated Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC. Dr. Allison, a principal investigator in the MuGard trial, continued “From a patient quality-of-life perspective, the reduction in mouth-and-throat soreness and reduced dependence upon opioids are extremely important. Patients using MuGard showed better weight maintenance, indicative of a superior nutritional status during the intensive cancer treatment regimen. As a physician, I was particularly impressed by the fact that the reduction of oral mucositis severity and mouth-and-throat soreness in the MuGard group was statistically significant.”

No difference in adverse events was observed between patients receiving MuGard and those patients receiving the saline-bicarbonate control. No patients discontinued MuGard treatment because of an adverse event while two patients using the sham-control ended their medication use due to nausea or vomiting.

“Access is extremely pleased with the outcome and publication of this clinical study of MuGard, and thank the many participating clinicians, sites and authors for the participation in this important trial,” stated Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. “Raising the level of visibility for MuGard should expand its usage, and availability, both domestically and abroad. Access is actively seeking additional marketing agreements in Europe, the Far East and in other un-licensed territories and will keep all stakeholders apprised as to developments in this area.”

About Oral Mucositis: Oral mucositis (“OM”) is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. There are an estimated 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.

About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States.

About Access: Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

 



ACCESS PHARMACEUTICALS ANNOUNCESPOSITIVE TOP-LINE DATA FROM MUGARD™ PHASE IV CLINICAL TRIAL IN ORAL MUCOSITIS PATIENTS PRESENTED AT MASCC/ISOO 2013 SYMPOSIUM

Met Primary Endpoint of Statistically Significant Reduction in Mouth and Throat Soreness Associated With Oral Mucositis; MuGard Patients Also Had Decreased Severity of Oral Mucositis by WHO Score

Dallas, TX and New York, NY, June 27, 2013

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, announced that Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC, presented top-line results today from a phase IV clinical trial evaluating MuGard™ Mucoadhesive Oral Wound Rinse at the MASCC/ISOO International Symposium on Supportive Care in Cancer in Berlin, Germany. The prospective, randomized, multi-center, double-blind, placebo-controlled study evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis in 120 patients receiving chemoradiation therapy for the treatment of cancers of the head and neck.

The presentation, entitled “The Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of MuGard in Mitigating Oral Mucositis (OM) in Chemoradiation-Treated Head and Neck Cancer Patients” summarized top-line data on 78 patients who were enrolled in the study for a minimum of two weeks. The patients were randomized 1:1 to receive either MuGard or placebo (a saline-bicarbonate rinse), with 37 evaluable MuGard patients and 41 evaluable placebo patients summarized in this analysis.

The primary endpoint of the study was the reduction of symptoms of oral mucositis, as determined by the area-under-the-curve (AUC) of Oral Mucositis Daily Questionaire (OMDQ) Mouth and Throat Soreness (MTS) question 2, a validated mucositis assessment tool. MuGard met the primary study endpoint, with patients receiving MuGard experiencing a statistically significant reduction versus placebo in mouth and throat soreness.  In addition, fewer patients receiving MuGard had ulcerative OM (WHO score ≥2) at the end of radiation therapy.

“For this head and neck cancer population, the debilitating side effect of oral mucositis remains one of our most significant clinical challenges. The benefits of MuGard shown in these results are critically important, both clinically and from a patient quality-of-life perspective,” stated Dr. Ron R. Allison, a principal investigator in the MuGard trial, Carolina Radiation Medicine, Greenville, NC.  “MuGard helps patients manage their mucositis during these tough treatment regimens.”

“Oral mucositis is a significant medical need for this population and these study results provide strong evidence of MuGard’s effectiveness in managing the mouth and throat soreness associated with it,” stated expert on cancer-treatment mucosal toxicities, Stephen T. Sonis, DMD, DMSc, Clinical Professor of Oral Medicine at Harvard and consultant to Clinical Assistance Programs for this trial.

About Oral Mucositis

Oral mucositis (“OM”) is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. The NIH estimates that there are 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher.

About MASCC

MASCC, or the Multinational Association of Supportive Care in Cancer, is the leading international organization dedicated to the research and education in all aspects of supportive care for patients with cancer.  It joined forces with the International Society of Oral Oncology (ISOO) in 1998, and its members represent over sixty countries. The MASCC/ISOO membership includes oncology medical, surgical, and radiology physicians, nurses, dentists, dental hygienists, pharmacists and representatives from industry and non-profit sectors. Symposia are convened annually to share the most recent research in supportive care from throughout the world.

About MuGard

MuGard™ Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States.

About Access

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard, a prescription oral rinse for the management of mucositis and is developing multiple products, and recently licensed US commercialization rights to AMAG Pharmaceuticals, Inc.  Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.  For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.



Access Pharmaceuticals Announces US MuGard License Agreement With AMAG Pharmaceuticals

 

New York, NY – June 10, 2013

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, announced that it had entered into an exclusive license agreement with AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) related to the commercialization of MuGard™ in the US and its territories. Under the terms of the license agreement, Access will receive an upfront licensing fee of $3.3 million and a tiered, double digit royalty on net sales of MuGard in the licensed territories.  AMAG will also purchase existing MuGard inventory from Access.  MuGard is an oral mucoadhesive that is designed to manage oral mucositis by forming a protective hydrogel coating over the oral mucosa to shield the membranes of the mouth and tongue. Oral mucositis is a common side effect of cancer treatments, with approximately 400,000 patients developing the condition each year.

“I am pleased to announce this license agreement with AMAG Pharmaceuticals, as we believe that expansion of reach is critical to the commercial success of MuGard,” said Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, Inc. “AMAG’s domestic presence, resources, and strategic emphasis on expansion of product offerings in complementary therapeutic areas, makes them ideally suited to enhance commercialization of MuGard here in the US.”

“Oral mucositis can be a frequent and problematic side effect of both chemotherapy and radiation therapy for cancer patients,” said Greg Madison, chief commercial officer of AMAG. “We believe that MuGard could become a category leader in the hands of our skilled sales force and that our experienced commercial team, our relationships with hematology/oncology practices and our partnerships with key group purchasing organizations can help drive significant growth of this brand.”

 

About MuGard

MuGard™ Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.

About Access

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access markets MuGard™ (www.MuGard.com), a prescription oral rinse for the management of mucositis and is developing multiple products, including ProLindac™, an investigational DACH platinum drug. The Company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.  For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.



Rush University Medical Center Presents Positive MuGard Clinical Data at the Oncology Nursing Society 38th Annual Congress

128 Patient MuGard Study Underscores the Powerful Clinical Impact MuGard Provides Cancer Patients Suffering with Oral Mucositis

MuGard Continues to Demonstrate Significant Reduction in Pain, Weight Loss and the Use of Opioid Pain Medication Associated With Oral Mucositis

Dallas, TX and New York, NY, April 29, 2013

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, announced that Carrie Daly, MS, RN, APN, AOCN of Rush University Medical Center presented data from a MuGard study, performed by the Institution, at last week’s Oncology Nursing Society Annual Congress in Washington, DC. Daly’s presentation titled, “Outsmarting Oral Mucositis” summarized results from 128 cancer patients undergoing radiation therapy for head and neck cancer. Patients that were compliant in using MuGard experienced significant clinical benefits including reduced pain, reduced use of pain medication, and reduced weight loss. Importantly, use of MuGard resulted in a significant reduction in the number of patients that progressed to Grade 3 oral mucositis as measured by the NCI OM scale. The presentation highlighted the clinical benefit experienced when implementing the use of MuGard in patients who have undergone radiation therapy for head and neck cancer.

Commenting on the excitement surrounding the ONS presentation of the MuGard study, Jeffrey Davis, CEO of Access Pharmaceuticals, Inc. stated, “Access was pleased to see the great interest in Carrie Daly’s presentation at the ONS Congress this week, and the significant interest and positive feedback on MuGard that we received at our exhibition booth. The benefits of MuGard shown in the results from this study conducted by Rush are both important clinically and from a pharmacoeconomic perspective, but most importantly from a patient quality-of-life view. There is a critical need to keep patients comfortable and well nourished during their cancer treatment, to ensure patient compliance and to positively impact clinical outcomes. These results are consistent with results presented from other clinical studies supporting MuGard’s ability to provide significant clinical benefit in the management of oral mucositis.”

Cary Daly, MS, RN, APN, AOCN concluded her presentation commenting, “MuGard has been adopted as the standard of care for Radiation Therapy patients at Rush University Medical Center that are at risk of developing mucositis as a result of cancer therapy. MuGard proves to be a critical tool in treating and preventing oral mucositis in our cancer patient population. Patients that used MuGard and were compliant with patient instructions had a significant clinical benefit, with lower grades of oral mucositis, reduced pain, and reduced analgesic use and were able to stay better nourished and maintain their weight.”

The “Outsmarting Oral Mucositis” presentation poster can be viewed by visiting the MuGard website homepage at www.MuGard.com.

About Carrie Daly, MS, RN, APN, AOCN:

Carrie is the Chief Nurse at Rush University Medical Center’s Radiation Oncology department. Daly has been a member of the Oncology Nursing Society (ONS) for more than 20 years and a member of the Radiation Oncology Special Interest Group through ONS. Having received excellence accolades like the American Society for Radiation Oncology (ASTRO) Nurse Excellence Award (2009) and ONS Excellence in Radiation Oncology Nursing (2005), Carrie goes above and beyond the normal standards of nursing practice. Carrie is also a member of the Cancer Committee and Cancer Survivorship Committee at Rush University Medical Center.

About ONS:

The Oncology Nursing Society (ONS) is a professional organization of over 35,000 registered nurses and other healthcare providers dedicated to excellence in patient care, education, research, and administration in oncology nursing. Each year, renowned nursing leaders and dedicated nursing professionals gather at Congress to take advantage of the dialogue it offers—the one-on-one, face-to-face networking and conversation that will give you insights on improving your practice at home or advancing your career. After four days in the company of thousands of other oncology nurses, you’ll leave with exciting new ideas about cancer care.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (www.MuGard.com), which has received FDA-marketing clearance for the management of patients with mucositis, and ProLindac™, a second generation DACH platinum drug. The Company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

 

 

 



ACCESS PHARMACEUTICALS TO HOST FOURTH QUARTER AND FISCAL YEAR INVESTOR CALL ON WEDNESDAY, APRIL 3RD AT 11:00AM ET

MuGard Gross Revenues up 586% year-on-year, and 256% quarter-on-quarter

Dallas, TX and New York, NY, March 20, 2013

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, will host an investor call to update investors on financial results for the quarter and the fiscal year ended December 31, 2012. The company will also review ongoing commercial activities and progress made within its MuGard program. MuGard, Access’ lead product, is a novel; ready-to-use mucoadhesive oral wound rinse and coating indicated for the management of oral mucositis and stomatitis, debilitating side effects of many anticancer treatments, and all types of oral wounds.

Some the Company’s fourth quarter highlights to be discussed on the call include:

  • MuGard gross revenues for the quarter ended December 31, 2012 were $1.05 million, an increase of 256% compared to the fourth quarter of 2011;
  • Continued growth in the MuGard distribution network through additions of pharmacy wholesalers and specialty pharmacies;
  • Signing of a Federal Supply Schedule Agreement with the U.S. Department of Veterans Affairs (VA), a large contract through which federal customers can acquire MuGard directly from commercial suppliers;
  • Acceptance by Oncology Nursing Society (ONS) for a presentation of MuGard data at the ONS Congress in April 2013;
  • Successfully added Walgreens to its MuGard Pharmacy Benefit Management (PBM) list.

Investor Call Details:

The investor conference call is scheduled to be held on Wednesday, April 3, 2013 at 11:00 am ET. Interested parties may participate by dialing 877-407-4019 (US) or 201-689-8337 (International) approximately five to ten minutes before the call start time.

A replay of the call will be available starting on April 3, 2013 at 1:00 pm ET, through April 17, 2013 until 11:59 pm ET. Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and conference ID number 377785.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (www.MuGard.com), which has received FDA-marketing clearance for the management of patients with mucositis, and ProLindac™, a second generation DACH platinum drug. The Company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

 

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

 



Access pharmaceuticals To Host Third Quarter Investor Call on Wednesday, November 28th

Company Schedules Conference Call Wednesday, November 28th at 11:00AM ET to Update Investors on MuGard Commercial Activities

Dallas, TX and New York, NY, November 14, 2012 – ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, will host an investor call to update investors on MuGard commercialization activities, including progress with pharmacy benefit managers, payers and pharmacy formularies, and other new developments within the program.

 

The investor conference call is scheduled to be held on Wednesday, November 28, 2012 at 11:00 am ET.  Interested parties may participate by dialing 877-407-4019 (US) or 201-689-8337 (International) approximately five to ten minutes before the call start time.

 

A replay of the call will be available starting on November 28, 2012 at 1:00 pm ET, through December 11, 2012 until 11:59 pm ET.  Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and conference ID number 377785.

 

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, and ProLindac™, a second generation DACH platinum drug. The Company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.  For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

 



ACCESS PHARMACEUTICALS ANNOUNCES PRIVATE PLACEMENT FINANCING

Company financing includes $4.7 million of new investment and the exchange of approximately $5.3 million of outstanding dividends payable

Use of Proceeds Include Repayment of Outstanding Debt and Working Capital

Dallas, TX and New York, NY, October 25, 2012

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP),an emerging biopharmaceutical company, announced that it has entered into definitive agreements for the purchase of $10.0 million of units, consisting of newly issued Access Series B Convertible Preferred Stock and warrants in a private placement with existing investors. The Series B Convertible Preferred Stock is convertible into common stock at $0.50 per share, and the unit provided for 100% warrant coverage with an exercise price of $0.50 per share and a term of six years.  The financing consists of approximately $4.7 million of new investment and the exchange of approximately $5.3 million of outstanding dividends payable. The transaction is expected to close today, subject to the satisfaction of customary closing conditions.

“We believe this financing strengthens the Company’s financial position by enabling the repayment of overdue debt and significantly reducing the level of outstanding dividends payable,” said Jeffrey Davis, CEO of Access Pharmaceuticals, Inc.  He continued, “This financing gives us the resources to continue MuGard commercialization efforts, and we appreciate the continued support of our current investor group.”

The securities issued in this private placement have not been registered under the Securities Act of 1933, as amended, or any state securities laws, and were issued and sold in a private placement pursuant to Regulation D of the Securities Act.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, and ProLindac™, a second generation DACH platinum drug. The Company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.  For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard and Cobalamin, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

 



Access Pharmaceuticals To Host Second Quarter Investor Call on Thursday, August 23, 2012

Company Schedules Conference Call Thursday, August 23rd at 11:00AM ET to Update Investors on MuGard Commercial Activities

Dallas, TX and New York, NY, August 17, 2012

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology and oncology supportive care, will host an investor call to update investors on MuGard commercialization activities, including progress with pharmacy benefit managers, payers and pharmacy formularies, and other new developments within the program.

The investor conference call is scheduled to be held on Thursday, August 23, 2012 at 11:00 am ET.  Interested parties may participate by dialing 877-407-4019 (US) or 201-689-8337 (International) approximately five to ten minutes before the call start time.

A replay of the call will be available starting on August 23, 2012 at 1:00 pm ET, through September 6, 2012 until 11:59 pm ET.  Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and entering account number 383 and conference ID number 377785.

About MuGard:

MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. 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 is estimated to be in excess of $1 billion world-wide.  For more information, please visit www.MuGard.com.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation DACH Platinum, and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers.

The company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.  For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

 

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.



Access Pharmaceuticals Announces Positive Data From MuGard Phase 4 Clinical Trial In Oral Mucositis At MASCC/ISOO 2012 Symposium

MuGard Demonstrates Statistically Significant Reduction in Pain Associated With Oral Mucositis, Delay to Onset of Oral Mucositis, and Reductions In Weight Loss and the Use of Opioid Pain Medication

First-in-Kind Trial Design For Medical Device Sets New Standard For Evaluation Of Mucositis Treatment Regimens; Strength of Clinical, Quality of Life And Pharmacoeconomic Data Suggests Use in All Patients at Risk For Mucositis

First Oral Mucositis Treatment Option to Provide Significant Clinical Benefit to Head and Neck Cancer Patients Suffering with Oral Mucositis Side Effect

Dallas, TX and New York, NY, June 28, 2012 

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company developing treatments in areas of oncology and oncology supportive care, announced that Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC, presented results from its ongoing MuGard Phase 4 clinical trial in oral mucositis (OM) at the Multinational Association of Supportive Care in Cancer (MASCC) Conference in New York City. The presentation summarized data from 70 cancer patients undergoing chemoradiation therapy for head and neck cancer. Patients using MuGard experienced a statistically significant reduction in mouth and throat soreness, a statistically significant delay to onset of oral mucositis as measured in days or cumulative radiation, and statistically significant reductions in weight loss during therapy and in the use of opioid pain medication.

“Given the significant oral mucositis typically seen in this head and neck cancer population, the benefits of MuGard shown in the results from this trial are important both clinically and from a patient quality-of-life perspective. It’s critically important that we keep patients as comfortable and nourished as possible during this tough treatment regimen, to optimize clinical outcomes,” stated Dr. Ron R. Allison, a principal investigator in the MuGard trial, Carolina Radiation Medicine, Greenville, NC.  He continued, “MuGard is prescribed to patients at my institute who are not eligible to participate in the clinical trial, and we see less mucositis in those patients compared to other rinses. The MuGard benefits shown, to date, suggest broad application in patients at risk of this debilitating toxicity.”

“The study results are consistent with a conclusion supporting MuGard’s effectiveness in the palliation of oral mucositis. MuGard’s ability to mitigate symptom onset and lessen patient dependence on narcotic analgesics will have important consequences on individuals’ ability to more easily tolerate anti-cancer therapy” stated expert on cancer treatment-related mucosal toxicities, Dr. Stephen Sonis, Clinical Professor in Oral Medicine at Harvard and consultant to Clinical Assistance Programs for this trial.

Key points from the MASCC presentation include:

  • Trial design and populations:  Head and neck cancer patients whose treatment plan calls for receiving up to a maximum cumulative radiation dose of 72 Gray (Gy) are randomized into the MuGard arm or a control rinse (sham) arm. Data are collected and reported for two populations: the efficacy analysis population (EFF) are patients that stayed on study treatment throughout chemoradiation treatment (approximately seven weeks), and the full analysis set (FAS) are all subjects enrolled and randomized and have at least 1 post-radiotherapy assessment. Data presented today was from the first 70 of a planned 120 patients. The patient populations in each arm were well balanced as to age, gender, ethnicity, and mean Karnofsky score (a measure of functional impairment of patients). The Company believes that the rigorous design of the trial for a medical device is unprecedented and sets a high bar for competing products in the market.
  • Pain:  Patients taking MuGard throughout their treatment regimen had a statistically significant reduction in pain. The pain endpoint is a measure of reduction in mouth and throat soreness (MTS) over the course of cancer therapy as measured with the oral mucositis daily questionnaire (OMDQ), a validated mucositis assessment tool. MuGard patients in the EFF population experienced a statistically significant reduction in MTS pain relative to the control rinse (p=0.041). MuGard patients in the FAS population showed a strong trend in pain reduction relative to the control rinse (p=0.110).
  • Delay to Onset:  This endpoint is the delay in onset of oral mucositis as measured in cumulative dose of radiation (measured in grays). MuGard patients in the EFF and FAS populations both experienced a statistically significant delay to onset of oral mucositis (p=0.020 and p=0.007, respectively). The ability to extend the onset of oral mucositis out in time during treatment is important clinically and from a quality-of-life (QOL) perspective.
  • Time to First Occurrence:  This endpoint is a measurement, in days, to the time of first occurrence of oral mucositis. MuGard patients in the EFF and FAS populations both experienced a statistically significant delay in time to first occurrence (p=0.022 and p=0.009, respectively). This statistically significant delay in first occurrence of OM occurred in both the EFF and FAS populations, which the company believes is both clinically important and beneficial from a QOL perspective.
  • Maintenance of Weight:  The study also measured changes in patient weight, in kilograms, at various periods during the study. MuGard patients in the EFF population experienced a statistically significant reduction in weight loss (p=0.036) between their start and completion of radiation treatment. Mean weight loss was 9.1 kg (~20.0 lbs) and 5.2 kg (~11.4lbs) for the control and the MuGard arms, respectively. A reduction in weight loss suggests that patients on MuGard were able to keep themselves better nourished during chemoradiation, which presumably enables them to better tolerate this rather challenging treatment regimen.

Jeffrey B. Davis, President and CEO of Access Pharmaceuticals, commented, “Access believes this MuGard data is ground breaking and unique from at least two perspectives. First, this is the first product that has ever shown a statistically significant positive clinical benefit in managing the pain symptoms and delaying the onset of oral mucositis in the very difficult to treat head and neck cancer population. Second, the rigorous design of the MuGard trial is the first of its kind in a medical device treatment option for oral mucositis, setting a new standard in this area. The clinical and quality-of-life benefits shown in this data echoes what we hear in the marketplace and that is evidenced in the increasing commercial adoption of MuGard.”

 

About the Study:  Access initiated the Phase 4 clinical trial of MuGard in 2010 with first sites opened and subjects enrolled in the first quarter of 2011. The rigorously designed trial is a prospective, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy of MuGard in controlling symptoms caused by oral mucositis in subjects receiving chemoradiation therapy for the treatment of cancers of the head and neck. The protocol, whose primary contributor was Stephen T. Sonis, DMD, DMSc, a thought leader in oral mucositis, is designed to evaluate MuGard with a rigor that is typically associated with drugs or biological. Access believes this trial design is the first to be used to evaluate a device for an oral mucositis indication and distinguishes Access and MuGard from competing companies and products. In addition to the primary study endpoints which assess MuGard’s efficacy, the protocol provides for the collection of a range of other endpoints including quality of life and pharmacoeconomic outcomes. Details on the MuGard Phase 4 clinical trial are available at the ClinicalTrials.gov website (http://clinicaltrials.gov/ct2/show/NCT01283906).

About Oral Mucositis: Oral mucositis (“OM”) is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing and continued cancer therapy difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. The NIH estimates that there are 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher. Oral mucositis can lead to pain and the need for strong pain medication, difficulty or the inability to talk, swallow, eat and drink, weight loss, infection, and in the most severe instances the interruption or stoppage of cancer treatment.

 

About MASCC: MASCC, or the Multinational Association of Supportive Care in Cancer, is the leading international organization dedicated to the research and education in all aspects of supportive care for patients with cancer.  It joined forces with the International Society of Oral Oncology (ISOO) in 1998, and its members represent over sixty countries. The MASCC/ISOO membership includes oncology medical, surgical, and radiology physicians, nurses, dentists, dental hygienists, pharmacists and representatives from industry and non-profit sectors. Symposia are convened annually to share the most recent research in supportive care from throughout the world.

About MuGard: MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. 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 is estimated to be in excess of $1 billion world-wide.  For more information, please visit www.MuGard.com.

About Access: Access Pharmaceuticals, Inc. is a biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and other product candidates, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

 



ACCESS PHARMA TO REPORT NEW MUGARD CLINICAL TRIAL DATA THIS WEEK AT THE MASCC/ISOO SYMPOSIUM IN NEW YORK CITY

Podium and Poster Presentations To Be Given On Interim Data From MuGard Phase IV Trial

Dallas, TX and New York, NY, June 26, 2012 – ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, today announced that the results of a recent interim analysis of data from an ongoing MuGard clinical trial will be presented at a joint international symposium of the Multinational Association of Supportive Care in Cancer (MASCC) and the International Society of Oral Oncology (ISOO) on Supportive Care in Cancer.  A podium presentation will be made by one of the lead investigators in the study on Thursday June 28th, and results will be presented in a poster displayed on Friday June 29th. In addition to these presentations, Access will have its MuGard booth in the commercial exhibit hall to educate the attendees on the clinical benefit MuGard offers patients undergoing cancer treatment.  The annual MASCC/ISOO Symposium is the preeminent international conference to focus on supportive care in oncology and will be held this week at the Hilton New York Hotel on Thursday, June 28th – Saturday, June 30th.

About MuGard:

MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments, characterized by inflammation and erythema or ulcerations throughout the oral mucosa.  For more information, please visit www.MuGard.com.

About MASCC:

The Multinational Association of Supportive Care in Cancer (MASCC) is the leading international organization dedicated to the research and education in all aspects of supportive care for patients with cancer.  It joined forces with the International Society of Oral Oncology (ISOO) in 1998, and its members represent over sixty countries. The MASCC/ISOO membership includes oncology medical, surgical, and radiology physicians, nurses, dentists, dental hygienists, pharmacists and representatives from industry and non-profit sectors. Symposia are convened annually to share the most recent research in supportive care from throughout the world.

About Access:

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access’ products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation DACH Platinum in Phase 2 clinical testing of patients with ovarian cancer, and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas.

The company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.  For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for ProLindac, MuGard, Thiarabine and Cobalamin and other product candidates, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to Access’ need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in Access’ Annual Reports on Form 10-K and other reports filed by Access with the Securities and Exchange Commission.

 

 




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