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Treatment of Pervasive Developmental Disorders with Tocotrienols Or Tocotrienol Enriched Extracts

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Treatment of Pervasive Developmental Disorders with Tocotrienols Or Tocotrienol Enriched Extracts (19) TZZ Z __T (11) EP 2 609 921 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: (2006.01) (2006.01) 03.07.2013 Bulletin 2013/27 A61K 31/58 A61P 7/10 (21) Application number: 13161401.8 (22) Date of filing: 25.02.2010 (84) Designated Contracting States: (72) Inventor: Miller, Guy M. AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Mountain View, CA California 94043 (US) HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK SM TR (74) Representative: Sexton, Jane Helen J A Kemp (30) Priority: 25.06.2009 US 269627 P 14 South Square Gray’s Inn (62) Document number(s) of the earlier application(s) in London WC1R 5JJ (GB) accordance with Art. 76 EPC: 10792467.2 / 2 445 519 Remarks: This application was filed on 27-03-2013 as a (71) Applicant: Ampere Life Sciences, Inc. divisional application to the application mentioned Mountain View, CA 94043 (US) under INID code 62. (54) Treatment of pervasive developmental disorders with tocotrienols or tocotrienol enriched extracts (57) Methods of treating or suppressing Pervasive a subject in need thereof a therapeutically effective Developmental Disorders (PDDs) including; Autistic Dis- amount of a tocotrienol, a tocotrienol ester, a tocotrienol order, Asperger’s Disorder, Childhood Disintegrative ether, a tocotrienol enriched extract or mixtures thereof. Disorder (CDD), Rett’s Disorder, and PDD-Not Other- wise Specified (PDD-NOS) comprising administering to EP 2 609 921 A1 Printed by Jouve, 75001 PARIS (FR) 1 EP 2 609 921 A1 2 Description ron (2000) 28 (2): 355-63). [0006] Autism is a complex serious developmental dis- CROSS-REFERENCE TO RELATED APPLICATIONS ability that interferes with, among other things, the normal development of the brain in the areas of social interaction [0001] This application claims priority benefit of United 5 and communication skills and which causes severely re- States Provisional Patent Application No. 61/269,627 stricted interests and repetitive behavior. Typically, au- filed June 25, 2009. The content of that application is tistic children and adults have difficulties in verbal and hereby incorporated by reference herein in its entirety. non-verbal communication, social interactions, and lei- sure or play activities. Autism can include language dis- FIELD OF THE INVENTION 10 orders with impaired understanding, echolalia, pronom- inal reversal (such as using "you" instead of "I" or "me" [0002] The application discloses methods useful for when referring to one’s self), rituals and compulsive phe- treatment, prevention, or suppression of diseases, de- nomena, and uneven intellectual development with men- velopmental delays, and symptoms of Pervasive Devel- tal retardation. Autistic children are also at increased risk opmental Disorders including Autistic Spectrum Disor- 15 of developing seizure disorders, especially during their ders, with tocotrienols, tocotrienol esters, tocotrienol teen years. Autism typically appears during the first three ethers, tocotrienol enriched extracts, or mixtures thereof. years of life and is the result of a neurological disorder that affects the functioning of the brain. BACKGROUND OF THE INVENTION [0007] The overall incidence of autism is, for the most 20 part, globally consistent. Indeed, autism knows no racial, [0003] Pervasive Developmental Disorder (PDD) is a ethnic, or social boundaries, and family income, lifestyle, category of neurological disorders characterized by se- and educational levels do not affect the chance of au- vere and pervasive impairment in several areas of de- tism’s occurrence. However, it has been found to be four velopment, including social interaction and communica- times more prevalent in boys than girls. On the other tions skills. The five disorders under PDD are Autistic 25 hand, Rett’s Disorder is more prevalent in girls than boys. Disorder, Asperger’s Disorder, Childhood Disintegrative [0008] Since being first described by Dr. Leo Kanner Disorder (CDD), Rett’s Disorder, and PDD-Not Other- in 1943, the understanding of autism has grown tremen- wise Specified (PDD-NOS). Specific diagnostic criteria dously. Although autism is defined by a certain set of for each of these disorders can be found in the Diagnostic behaviors, it is a spectrum disorder in that its symptoms & Statistical Manual of Mental Disorders (DSM-IV-TR) 30 and characteristics can be present in a wide variety of as distributed by the American Psychiatric Association combinations, from mild to severe. Therefore, autistic (APA). Autistic Spectrum Disorder (ASD) is an umbrella children and adults can exhibit any combination of the term that is used to represent a broad heterogeneous behaviors in any degree of severity. Two individuals, both disorder by collectively grouping autistic disorder, As- with the same diagnosis, may have varying skills and perger’s Disorder and PDD-NOS. 35 display very different actions. Those only mildly affected [0004] Autism, the most common of the Pervasive De- may exhibit slight delays in language or communication velopmental Disorders, affects an estimated 1 in approx- and may face greater challenges in social interactions. imately 150 births. Estimates of the prevalence of ASD For example, one may have difficulty initiating and/or are in the range of 6.5 to 6.6 per 1000 based on Autism maintaining a conversation. Communication by autistic and Developmental Disab ilities Monitoring Network Sur- 40 children or adults is often displayed as talking at others veillance (Year 2002). Indeed, as of 2003-2004, as many (for example, a monologue on a favorite subject that con- as 1.5 million Americans are believed to have some form tinues despite attempts by others to interject comments). of autism. Autism is a childhood encephalopathy char- [0009] Autism seems to cause those affected by it to acterized by deficiencies in social interaction and com- process and respond to information in unique ways. In munication and by repetitive and stereotyped behaviors. 45 some individuals with PDD including Autism, aggressive Based on statistics from the U.S. Department of Educa- and/or self-injurious behavior may exist. The following tion and other governmental agencies; autism is growing traits, as identified by the ASA, may also be present in at a rate of 10-17 percent per year. At these rates, the persons with autism: insistence on sameness or resist- Autism Society of America (ASA) estimates that the prev- ance to change; difficulty in expressing needs; (i.e. uses alence of autism could easily reach 4 million Americans 50 gestures or pointing instead of words); repeating words in the next decade. or phrases in place of normal, responsive language; [0005] Of the other four PDD forms, Asperger’s syn- laughing, crying, or showing distress for reasons not ap- drome is closest to autism in signs and likely causes; parent to others; preferring to be alone or an aloof man- Rett’s disorder and childhood disintegrative disorder ner; tantrums; difficulty in mixing with others; may not share several signs with autism, but may have unrelated 55 wanting to cuddle or be cuddled; little or no eye contact; causes; PDD not otherwise specified (PDD-NOS) is di- unresponsive to normal teaching methods; sustained agnosed when the criteria are not met for a more specific odd play; spinning objects; inappropriate attachments to disorder (Lord C, et al. "Autism spectrum disorders" Neu- objects; apparent over-sensitivity or under-sensitivity to 2 3 EP 2 609 921 A1 4 pain; no real fears of danger; marked physical over-ac- may cause a gagging reflex. Some children or adults with tivity or extreme under-activity; uneven gross/fine motor autism are particularly sensitive to sound, so that even skills;and/or non- responsiveness to verbal cues (i.e. acts the most ordinary daily noises are painful. as if deaf although hearing tests in normal range). [0014] Although there is no single known cause for au- [0010] People with autism have social impairments 5 tism, it is generally accepted that it is caused by abnor- that appear early in childhood and continue through malities in brain structure or function. The shape and adulthood. Autistic infants show less attention to social structure of the brain in autistic versus non-autistic chil- stimuli, smile and look at others less often, and respond dren showdifferences whenbrain scans areviewed. Cur- less to their own name. Autistic toddlers have more strik- rently the links between heredity, genetics and medical ing social deviance; for example, they have less eye con- 10 problems are being investigated by researchers, as well tact and anticipatory postures and are more likely to com- as a number of other theories. The theory of a genetic municate by manipulating another person’s hand (Volk- basis of the disorder is supported by the fact that, in many mar F, et al "Autism in infancy and early childhood" Annu families, there appears to be a pattern of autism or related Rev Psychol (2005) 56: 315-36.) Three- to five-year-old disabilities. While no one gene has been identified as autistic children are less likely to exhibit social under- 15 causing autism, researchers are searching for irregular standing, approach others spontaneously, imitate and re- segments of genetic code that autistic children may have spond to emotions, communicate nonverbally, and take inherited. While researchers have not yet identified a sin- turns with others. However, they do form attachments to gle trigger that causes autism to develop, it also appears their primary caregivers. (Sigman M, et al. "Early detec- that some childrenare bornwith a susceptibilityto autism. tion of core deficits in autism" Ment Retard Dev Disabil 20 [0015] Other researchers are investigating the possi- Res Rev. (2004) 10 (4): 221-33). They display moder- bility that under certain conditions, a cluster of unstable ately less attachment security than usual, although this genes may interfere with brain development resulting in feature disappears in children with higher mental devel- autism.
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