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Cobalis Reports PreHistin Demonstrates Significant Potential for Treatment of Vitamin B12 Deficiency.


B12 Levels Increased an Average of More Than 250% Across Two PreHistin-Treated Patient Groups

IRVINE, Calif. -- Cobalis Corp. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:CLSC CLSC Centre Local de Services Communautaires
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), a pharmaceutical development company specializing in anti-allergy medications, today reported that further review of the results from two Phase III clinical trials for its drug PreHistin[TM] in patients with seasonal allergic rhinitis seasonal allergic rhinitis,
n See hay fever.

seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis.
, commonly known as hay fever hay fever, seasonal allergy causing inflammation of the mucous membranes of the nose and eyes. It is characterized by itching about the eyes and nose, sneezing, a profuse watery nasal discharge, and tearing of the eyes. , demonstrated a significant average increase of more than 250% in post-treatment blood serum Blood serum
A component of blood.

Mentioned in: Bites and Stings


blood serum

the residual fluid of blood after clotting has occurred. It is plasma after the fibrinogen has been removed.
 cobalamin cobalamin: see coenzyme; vitamin.  (Vitamin B vitamin B
n.
1. Vitamin B complex.

2. A member of the vitamin B complex, especially thiamine.



vitamin B, vitamin B complex

a group of water-soluble substances described separately.
12) levels across two PreHistin-treated patient groups compared with essentially no B12 level increase in placebo-treated patients.

The parallel, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind Phase III clinical trials for PreHistin involved 1,551 patients at 23 sites across the central, southern and eastern U.S. The patients received either a placebo or a 3.3mg dosage of PreHistin twice daily for 42 consecutive days. A blood sample was taken from subjects before treatment with PreHistin and after the 42 days. The samples were sent to a laboratory for analysis and results detailing the change in average B12 levels are in the following tables:
Clinical Study with Protocol RA3333
ACTIVE                                 pg/mL  n=301
Pre-treatment Mean B12 level          554.60
Post-treatment Mean B12 level        2050.50
Percent Change                        269.73


PLACEBO                                pg/mL  n=303
Pre-treatment Mean B12 level          521.90
Post-treatment Mean B12 level         526.50
Percent Change                          0.88
Clinical Study with Protocol RA5555
ACTIVE                                 pg/mL  n=262
Pre-treatment Mean B12 level          581.58
Post-treatment Mean B12 level        1938.31
Percent Change                        233.28


PLACEBO                                pg/mL  n=263
Pre-treatment Mean B12 level          508.54
Post-treatment Mean B12 level         514.70
Percent Change                          1.21


Cobalis' Chief Scientific Officer Ernest Armstrong commented: "To our knowledge, these are the largest Phase III studies that have demonstrated such a significant and dramatic increase in serum B12 levels as compared to any other delivery mechanism studies done."

The Company's Chief Executive Officer, Gerald Yakatan, Ph.D., said: "We continue to believe in PreHistin as a product. Cobalis remains committed to a corporate strategy based on bringing PreHistin to the consumer market and these positive results provide the potential for another commercial market for PreHistin."

Although the study protocols were different, the amount of increase in blood cobalamin levels provided by PreHistin compares favorably to other means of cobalamin delivery as reported in these studies:

PreHistin increased cobalamin levels on average across the two studies by 1426 pg/mL, or more than 250%.

In comparison, Oral cobalamin increased blood cobalamin by 93 pg/mL, tablet with cobalamin increased blood cobalamin by 51 pg/mL, sublingual sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue.

sub·lin·gual
adj. Abbr. SL
Below or beneath the tongue; hypoglossal.
 tablet with cobalamin increased blood cobalamin by 194 pg/mL, intranasal in·tra·na·sal
adj.
Within the nose.
 spray with cobalamin increased blood cobalamin by 179 pg/mL. (Wenig, et al. US Patent 4,724,231)

Lozenge lozenge /loz·enge/ (loz´enj) [Fr.]
1. troche; a discoid-shaped, solid, medicinal preparation for solution in the mouth, consisting of an active ingredient incorporated in a suitably flavored base.

2.
 with cobalamin increased blood cobalamin by 396 pg/mL. (Libby, et al. US Patent 4,432,975)

Lozenge with cobalamin increased blood cobalamin by 388pg/mL. (Delpre, G, et al. The Lancet. Vol 354 p740-741 August 28, 1999.)

15 mcg IM injection with cobalamin increased blood cobalamin by 206pg/mL. (Broncorp, Inc. IND #30,488)

Serum cobalamin concentration is generally considered normal if it is within a 200-900pg/mL or 200-1100pg/mL reference range.

About PreHistin

The active ingredient, cyanocobalamin cyanocobalamin: see coenzyme; vitamin. , has a well-known safety profile and has been shown in studies to relieve symptoms related to seasonal allergies, asthma and other atopic atopic /atop·ic/ (a-top´ik) (ah-top´ik)
1. ectopic.

2. pertaining to atopy; allergic.


atopic

1. displaced; ectopic.

2. pertaining to atopy.
 allergic diseases. PreHistin may represent a novel approach to treatment by rectifying imbalances in the immune system immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
 that trigger the over-production of allergy symptom-causing substances including histamines. By preventing or reducing the over-production of these substances before they are released from cells, the need to block the symptom-causing effects of histamine may be eliminated, or minimized. PreHistin is patented for the treatment of atopic allergic diseases such as seasonal and perennial allergies, dermatitis, migraine, food allergies Food Allergies Definition

Food allergies are the body's abnormal responses to harmless foods; the reactions are caused by the immune system's reaction to some food proteins.
 and asthma.

About Cobalis Corp.

Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache, atopic asthma and dermatitis. For further information, visit www.cobalis.com

Safe Harbor Statement: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995 (the "Act"). Cobalis disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to securing funding for ongoing operations including clinical trials, difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the development of competing products by our competitors; uncertainties related to the Company's dependence on third parties and partners; and those risks described in our SEC filings and annual report on Form 10-KSB filed with the SEC on July 16, 2007.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
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Date:Aug 2, 2007
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