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L.A.M. IPM Wound GeI™

L.A.M. IPM Wound GeI™

In mid-April 2002, a 51O(k) Pre-Marketing Notification submission (K020325) to the FDA for L.AM. IPM Wound Gel™ was cleared. This clearance gives us the ability to market L.AM. IPM Wound Gel™ as a Class I OTC device, while also acting as a platform to enable us to market the product internationally. Diabetics often have poor circulation and are prone to the development of severe and hard to treat ulcers in the extremities, particularly in the area of the lower legs. These refractory ulcers pose a serious health risk to those affected and can cause life-threatening gangrenous states. Up to now, ulcers of this type have been very difficult to treat.

L.AM. IPM Wound Gel™ is designed to deliver high concentrations of sodium hyaluronate to an ulcer bed, providing an optimal environment for wound healing. L.AM. IPM Wound Gel™ takes full advantage of the proprietary L.AM. Ionic Polymer Matrix ™ technology to saturate an ulcer bed with the L.AM.IPM ™ active ingredient, hyaluronic acid, a highly purified derivative of sodium hyaluronate, derived from avian sources .

QST Consultations Ltd., an independent consulting firm based in Allendale, Michigan, reported very positive results of a study using L.AM. ' s IPM Wound Gel ™ in the treatment of hard to heal skin ulcers. Prior to the study the candidates had the ulcers ranging from 1 week to 156.5 weeks with the average duration of25.53 weeks. By the end of the study, 47 of the 53 ulcers (89%) reported in the study, had healed within 25 weeks of applying L.AM. IPM Wound Gel TM. The mean time to healing was 12 weeks and the median time was 8.2 weeks. Studies were not performed on the healing time of ulcers that were not treated with our L.AM. IPM Wound GeI™.

An Independent Review Board (lRB) of the State of California conducted a major 50 person clinical study to elucidate the benefits of the "IPM" Matrix. In initial results of this study, at Redding Medical Center, Redding, California, L.A.M's ucler matrix produced cures in 8 out of9 diabetic and refractory skin ulcers. These breakthrough results were published in an issue of The Dermatology Times, the leading industry publication in North America. The study focused on severe ulcers that had been non-responsive to conventional treatment for periods of over a year.

In addition, breakthrough results were also received from studies conducted at the University of Miami School of Medicine. In these animal studies, L.A.M's ucler matrix demonstrated healing efficacy of 87% vs. the leading drug on the market today, which showed efficacy of only 53%. The leading drug on the market commands several hundred million in sales.

The Company expects this to be a flagship product and capture a substantial share of the approximate $2 billion US market. 129


L.A.M. IPM™ Personal Female Lubricant (Sexual Dysfunction)

L.A.M. IPM™ Personal Female Lubricant (Sexual Dysfunction)

The Company has developed a highly effective personal lubricant for mature women in their post menopausal years, who are experiencing problems relating to dryness, pain with intercourse and other age related symptoms. L.A.M. personal lubricant is designed to provide fast relief of these symptoms and allow for more satisfying sexual encounters.

L.AM. IPM™ Personal Female Lubricant (Sexual Dysfunction) Matrix is a highly viscoelastic (lubricating) liquid incorporating proprietary L.AM. IPM™ technology. The matrix provides enhanced lubrication while Vitamin B3 (Niacin), encapsulated in the technology, stimulates the tissues of the female genitalia. Vitamin B3 has long been associated with a process known as "flushing", whereby the blood supply in the stimulated area is increased.

The L.AM. IPM™ - Personal Female Lubricant (Sexual Dysfunction) Matrix is designed primarily to address the problems of mature women who often experience post-menopausal problems that may inhibit their intimate relationships. Specifically, the matrix acts to either eliminate or at least substantially minimize post-menopausal symptoms including vaginal dryness, pain during intercourse and absence of feeling or sensation. It is a moisturizing solution designed to enhance a woman's intimate pleasure and comfort. It minimizes (or eliminates) vaginal dryness; pain during intercourse related to such dryness and stimulates feeling and sensation during the arousal stage of sexual intimacy.

L.AM.IPM™ Personal Female Lubricant (Sexual Dysfunction) Matrix is not classified as a drug. The product uses substances that have been approved by the regulatory authorities for many applications. Vitamin B3, for example, forms a part ofB Complex taken orally as a daily supplement by millions of people worldwide.

The total market for this product is estimated to be in excess of $2 billion US market .


L.A.M. IPM™ -ARTHRITIC PAIN MATRIX (Diclofenac)

L.A.M. IPM™ -ARTHRITIC PAIN MATRIX (Diclofenac)

The Company has developed a transdermal IPM drug designed to be used in topical form, for the relief of arthritic pain and pain caused by related conditions. It represents a significant advancement in the treatment of arthritis sufferers who experience acute pain and inflammation (flares).

To date no prescription pain or anti-inflammatory drug has been approved by the FDA for sale in the United States. This is due to lack of efficacy and failure to demonstrate measurable amounts of the drug agent in the blood and urine of patients treated with the competing preparations. L.A.M.'s Diclofenac patch. Clinical studies have confirmed that therapeutic levels of the drug delivered directly to the affected site and finally delivered into the blood and excreted in the urine of subjects treated, were significant.

A small dose, equivalent to a single oral dose, has been found to produce three or more days of significant pain relief when the novel and patented Diclofenac patch is applied to the site of pain. For example, a patch that has been impregnated with Diclofenac IPM matrix can be applied to the lower back, knee, elbow, wrist, neck, or other painful site when the origin of the pain is arthritis, trauma or other cause. The remarkable aspect of this invention is that a full three days of significant pain and inflammation relief is provided by the placement of the patch on the target site to be treated. No side effects from this transdermal product have been reported to date .

GlycoBioSciences Inc. will continue its studies and discussions with major multinationals for the full licensing, development and marketing of this remarkable product. The total market for this product is estimated at $5 billion.


L.A.M. IPM™ -ECZEMA AND DERMATITIS MATRIX

L.A.M. IPM™ -ECZEMA AND DERMATITIS MATRIX

The Company's transdermal eczema and dermatitis formulation is able to deliver therapeutic substances through the skin barrier, achieving complete saturation of the outer layers of the skin, including the stratum corneum, the epidermis as well as the deeper layer of the skin, the dermis.

The ability of the IPM-ED matrix to deliver therapeutic agents through the outer skin layers is essential because eczema, dermatitis and related conditions cause hardening of these layers, rendering other topical applications relatively ineffective. The IPM-ED matrix is visco-elastic and spreads easily over large areas of the skin. Absorption takes place rapidly and the onset of therapeutic activity is rapid. Benefits include relief from:_ severe itching and irritation, scaling, inflammation and bleeding, unsightly sores.

The total market for this product is estimated to be in excess of $1.0 billion .


L.A.M. IPM™ -MOTION SICKNESS MATRIX

L.A.M. IPM™ -MOTION SICKNESS MATRIX

L.A.M. has been working with a multi-national collaborator to develop a motion sickness patch that will incorporate the Company's patented, "IPM" drug delivery technology, with the corporate collaborator's internationally marketed motion sickness drug.

Delivering this widely accepted and well-known drug using the IPM technology is expected to achieve controlled release of the drug over a 24-hour period, thereby providing long-term relief in only one dose, with no gastrointestinal upset or other side effects. In addition, the IPM method requires a substantially smaller amount of the active drug per dose than if the same drug were taken orally. As a result, patch wearers experience little or no drowsiness.

The Company expects this product will be introduced to market within the next 12 months and will
represent revenues of approximately $100 million, in a market worth more than $1 billion .


L.A.M. IPM™ -IMMUNE MODULATOR MATRIX (Anverzil)

L.A.M. IPM™ -IMMUNE MODULATOR MATRIX (Anverzil)

The Company is currently conducting clinical studies for this product in several South American countries, in conjunction with its corporate collaborator. The IPM-IM Patch is being used in this respect, rather than a more painful, large-gauge hypodermic needle.

Immune modulators are used to boost the immune system and thus enhance the quality oflife for patients with fragile immune systems. Current testing is being conducted with post-chemotherapy cancer patients, AIDS patients and those suffering from Multiple Sclerosis. The Company expects that this vertical could mature into a very large market over the next few years, as the benefits are more fully elucidated and the FDA becomes more receptive to a greater number of compassionate therapies. The market value for these products is very difficult to estimate, but it is anticipated this vertical could mature into a multi-billion dollar market over time .


L.A.M. IPM™ -POST SURGICAL MATRIX

L.A.M. IPM™ -POST SURGICAL MATRIX

As a derivative ofL.A.M. IPM Wound GeI™, we are also developing a wound healing matrix designed to be used on incisions following surgical procedures. One of the most common post-surgical complications is the development of scar tissue in tissue sutured or stapled following surgery. Adhesions often form and result in a painful condition, which sometimes requires surgical treatment. Studies have shown that L.A.M. 's wound-healing matrix shows extreme potential as an efftctive postoperative treatment for the prevention of adhesions and scar tissue following surgery. This should prove to be a major area of opportunity for the Company going forward, as studies and tests have produced advanced discussions with a number of multi-national pharmaceutical companies. Studies have been performed which concluded that the IPM Wound Gel™ can be produced as a sterile product. The product is a variation of our L.A.M. IPM Wound GeI™, however no studies have been performed regarding the product's safety and efficacy. The cost of bringing this product to its current state has been minimal; however we expect to incur costs associated with obtaining regulatory clearance prior to the introduction of these products to market. Such costs would include limited clinical trials/studies and consulting fees for a 51 O(k) application as a Class I medical device. Any application to the FDA will be submitted only when we have completed the clinical trials/studies for the product Glyco will prioritize its post-operative patch designed to prevent scarring, adhesions and pain in patients who have undergone major bypass and other extensive surgical procedures. The total market for this product is estimated to be in excess of $4 billion .


L.A.M. IPM™ -MALE ERECTILE DYSFUNCTION MATRIX (Alprostadil)

L.A.M. IPM™ -MALE ERECTILE DYSFUNCTION MATRIX (Alprostadil)

The Company's gel offers several major advantages over current treatments (ie. Viagara, Muse, etc). Firstly, the gel is applied directly to the outside skin of the male genitals, thereby eliminating the pain associated with traditional invasive therapies. Furthermore, the side effects associated with tablets (drug interactions) are either non-existent or, very mild. Sexual activity can commence almost immediately after application of the gel (within 2-3 minutes). The total market for this product is estimated to be in excess of $3 billion .


L.A.M. IPM™ -Burn Matrix

L.A.M. IPM™ -Burn Matrix

The Bum Matrix is a sterile fonn of our IPM Wound GeI™. Testing was perfonned which concluded that the IPM Wound Ge1™ can be produced sterile. The product is a variation of our L.A.M. IPM Wound GeI™; however no studies have been perfonned regarding the product's safety and efficacy.

We anticipate that we will be applying for a Class I medical device through a 51 O(k) application at such time as we have sufficient funds to undertake such application and the other costs needed to bring this product to market. The cost of bringing this product to its current state has been minimal; however, we expect to incur costs for limited clinical trials/studies and costs associated with obtaining regulatory clearance prior to the introduction of these products to market. Any application to the FDA will be submitted only when we have completed the clinical trials/studies for the product.

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L.A.M. IPM ™ -Veterinary

L.A.M. IPM ™ -Veterinary

In 2004, L.A.M. announced an application for the veterinary industry. This application, incorporating L.A.M. Ionic Polymer Matrix ™ technology, which has demonstrated high efficacy in the treatment of pyotraumatic dermatitis and other skin ailments commonly suffered by dogs based on limited internal testing, which was not performed at levels to be statistically significant, and based on unsolicited consumer comments.

Pyotraumatic dermatitis, more commonly known as "hot spots", and other skin ailments are among the most common ailments that require dogs to be examined and treated by a veterinarian. Published data by the University of Pennsylvania in The Newsmagazine of the School of Veterinary Medicine, Spring/Summer 1999 suggests that nearly 32% of households in the United States own at least one dog, resulting in an estimated dog population of 53 million. New statistics published by the American Pet Product Manufacturer's Association also indicate that Americans spent approximately $32 billion on their pets in 2003. Although we do not have statistics as to what Americans spend specifically on "hot spots", we believe that a market opportunity for our veterinary application exists. Weare seeking an appropriate partner to conduct more extensive testing and to commence commercial marketing of this product.



Glyco Patents

US Patent #:

  1. 6,723,345        covers dermatological conditions
  2. 6,335,034        covers pain specifically, arthritis
  3. 6,063,405        generic, covers ratios, method of making, delivery, manufacturing
  4. 5,897,880        covers composition broadly, for topical administration including

Diclofenac Pain Gel &Anti Arthritic use 

  1. 6,335,035        generic, includes ratios
  2. 6,120,804        covers specifically pain, arthritis, making of product
  3. 6,036,977        covers all sexual dysfunction technology both male and female
  4. 6,251,436        sexual dysfunction, claim 1 varies a little from other two patents

covering sexual dysfunction

  1. 6,514,536        covers female sexual dysfunction, covers Niacin and Alprostadil as

active ingredient

  1. 5,709,883        covers long acting narcotic analgesics and antagonists,
 

 

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